RJR v. FDA: DEFENDANTS’ MOTION FOR SUMMARY JUDGMENT (Oct. 21, 2011)

February 1, 2012 2:33 am by Gene Borio

The PDF is Here

EXCERPT:

Only by ignoring the findings of Congress, the courts, and countless public health officials, can plaintiffs discount the compelling governmental interest in communicating health risks to consumers and potential consumers of their product—including the underage and often undereducated persons who constitute the bulk of their new clientele. And only by ignoring the record before Congress, and the overwhelming international consensus of public health officials, can plaintiffs attempt to claim that a text-only disclosure of the same size as the current Surgeon General warnings could communicate the health risks of smoking as effectively as the revised warnings prescribed by Congress.

Perhaps most notably, it is only by ignoring the addictive and lethal nature of their products that plaintiffs can with a straight face describe the disclosures mandated by Congress as “an ideological message” akin to the “compelled speech” involved in cases such as Wooley v. Maynard, 430 U.S. 705 (1977). Pl. S.J. Br. 24. Decisions such as Wooley reflect the core First Amendment principle that government shall not “prescribe what shall be orthodox in politics, nationalism, religion, or other matters of opinion or force citizens to confess by word or act their faith therein.” Zauderer, 471 U.S. at 651 (internal quotation marks omitted). Those decisions have no application here. That “smoking can kill you” is not an ideological message: it is a fact. There is no competing “ideology” maintaining that smoking does not account for more than 400,000 deaths each year.

4. Plaintiffs move seamlessly from decrying the burden of the disclosure requirements to insisting that the revised warnings would have no impact on smoking rates and thus serve no legitimate purpose. This relentlessly repeated refrain ignores two critical points. First, the purpose of the new disclosure format is to convey the health risks of smoking. Plaintiffs offer no basis whatsoever for disregarding Congress’s judgment that the revised health warnings communicate those risks more effectively than warnings without accompanying graphics, even as compared to text-only warnings that are far larger than the current Surgeon General warnings. The precise extent to which the enhanced communication of risks will ultimately reduce smoking rates is not a relevant metric in assessing plaintiffs’ constitutional claim. Second, plaintiffs’ contention fails on its own terms. Contrary to plaintiffs’ assertion, researchers have not concluded that the introduction of new warnings in Canada had no bearing on the subsequent decrease in Canadian smoking rates. Instead, researchers have recognized that the decline in Canadian smoking rates was influenced by a variety of regulatory measures and that it is difficult to make statistically significant determinations about the extent to which any single factor contributed to the decline. . . .

For the foregoing reasons, plaintiffs’ motion for summary judgment should be denied, and the government’s motion for summary judgment should be granted.

END EXCERPT

FULL TEXT:

Case 1:11-cv-01482-RJL Document 35 Filed 10/21/11 Page 1 of 66

UNITED STATES DISTRICT COURT FOR THE DISTRICT OF COLUMBIA

R.J. REYNOLDS TOBACCO

COMPANY, et al.,

Plaintiffs,

v.

UNITED STATES FOOD AND

DRUG ADMINISTRATION, et al.,

Defendants.

No. 1:11-cv-1482 (RJL)

DEFENDANTS’ MOTION FOR SUMMARY JUDGMENT

Pursuant to Federal Rule of Civil Procedure 56, the defendants move for summary judgment in this action. The grounds for this motion are set forth in the memorandum filed herewith.

Respectfully submitted,

Dated: October 21, 2011

Of Counsel: TONY WEST

Assistant Attorney General

WILLIAM B. SCHULTZ

Acting General Counsel

BETH S. BRINKMANN

Deputy Assistant Attorney General

ELIZABETH H. DICKINSON

Acting Associate General Counsel

MAAME EWUSI-MENSAH FRIMPONG

Food and Drug Division Acting Deputy Assistant Attorney General

Case 1:11-cv-01482-RJL Document 35 Filed 10/21/11 Page 2 of 66

ERIC M. BLUMBERG

Deputy Chief Counsel, Litigation

KAREN E. SCHIFTER

Senior Counsel

U.S. Department of Health & Human Services

Office of the General Counsel

10903 New Hampshire Ave.

Silver Spring, MD 20993-0002

________/s/________________

DRAKE CUTINI

DANIEL K. CRANE-HIRSCH

Attorneys, Consumer Protection Branch

PO Box 386

Washington, DC 20044

202-307-0044 (Cutini)

drake.cutini@usdoj.gov

________/s/_________________

MARK B STERN

ALISA B. KLEIN

SARANG V. DAMLE

DANIEL TENNY

LINDSEY POWELL

Attorneys, Appellate Staff

Civil Division, Room 7217

U.S. Department of Justice

950 Pennsylvania Ave., NW

Washington, DC 20530

202-514–5735 (Damle)

Fax: 202-514-9405

sarang.damle@usdoj.gov

Case 1:11-cv-01482-RJL Document 35 Filed 10/21/11 Page 3 of 66

UNITED STATES DISTRICT COURT FOR THE DISTRICT OF COLUMBIA

R.J. REYNOLDS TOBACCO

COMPANY, et al.,

Plaintiffs,

v. ) No. 1:11-cv-1482 (RJL)

UNITED STATES FOOD AND

DRUG ADMINISTRATION, et al.,

Defendants.

MEMORANDUM IN SUPPORT OF DEFENDANTS’ MOTION FOR SUMMARY JUDGMENT AND IN OPPOSITION TO PLAINTIFFS’ MOTION FOR SUMMARY JUDGMENT

TONY WEST

Of Counsel: Assistant Attorney General

WILLIAM B. SCHULTZBETH S. BRINKMANN

Acting General Counsel Deputy Assistant Attorney General

ELIZABETH H. DICKINSON MAAME EWUSI-MENSAH FRIMPONG

Acting Associate General Counsel Acting Deputy Assistant Attorney General

Food and Drug Division

DRAKE CUTINI

ERIC M. BLUMBERGDANIEL K. CRANE-HIRSCH

Deputy Chief Counsel, Litigation Attorneys, Consumer Protection Branch

KAREN E. SCHIFTERMARK B STERN

Senior CounselALISA B. KLEIN

U.S. Department of Health & Human ServicesSARANG V. DAMLE

Office of the General CounselDANIEL TENNY

10903 New Hampshire Ave.LINDSEY POWELL

Silver Spring, MD 20993-0002 Attorneys, Appellate Staff

Civil Division, Room 7217

U.S. Department of Justice

950 Pennsylvania Ave., NW

Washington, DC 20530 Case 1:11-cv-01482-RJL Document 35 Filed 10/21/11 Page 4 of 66

TABLE OF CONTENTS

Page

INTRODUCTION AND SUMMARY. ……………………………………………………………………………… 1

STATEMENT……………………………………………………………………………………………………………….. 5

A.

Background. ……………………………………………………………………………………………… 5

B.

The Supreme Court’s Brown & Williamson Decision…………………………………….. 8

C.

The Tobacco Control Act……………………………………………………………………………. 9

D. FDA’s Implementing Rule………………………………………………………………………… 10

ARGUMENT………………………………………………………………………………………………………………. 13

I.

Warnings and Other Disclosure Requirements Are Subject To “Less Exacting Scrutiny” Than Restrictions On Commercial Speech……………… 13

II.

Congress Mandated Health Warnings in a Format that Accurately Conveys the Extraordinary Risks of Smoking and Violates No First Amendment Principle……………………………………………………………………….. 14

A.

The Revised Warnings Substantially Advance the Government’s Overwhelming Interest in Informing Consumers About the Grave Dangers if Cigarette Smoking. ………………. 14

1.

The Current Surgeon General Warnings Are Essentially “Invisible”…………………………………………………………. 14

2.

Evidence Before Congress and the FDA Establishes that the Warnings Mandated by Congress Convey the Health Risks of Smoking More Effectively than Text-Only Warnings of Any Size…………………………………… 16

3.

The Required Health Warnings Do Not Impermissibly Burden Protected Commercial Speech. …………………………………. 20

B.

Plaintiffs’ First Amendment Contentions Are Without Merit. …………….. 23

1.

The Warnings Do Not Constitute an “Ideological Message”…………………………………………………………………………… 23 Case 1:11-cv-01482-RJL Document 35 Filed 10/21/11 Page 5 of 66

2.

The Health Warnings Convey Risks of Addiction and Smoking that Are Not Adequately Appreciated by Consumers Generally and Adolescents in Particular. ………….. 29

3.

The Constitutionality of the Required Warnings Does Not Require a Statistical Determination Regarding the Extent to Which the Decline in Smoking Rates in Canada Should Be Attributed to the Introduction of New Health Warnings………………………….. 31

III.

FDA Adopted Images to Accompany the Text of the Health Warnings that Accurately Convey the Extraordinary Risks of Smoking Consistent with the First Amendment and the APA. ………………………. 34

A.

The Images Selected By FDA Raise No First Amendment Concerns. …………………………………………………………………………………….. 34

1.

FDA Properly Considered the “Salience” of the Proposed Warnings, i.e., the Extent to Which Consumers Will Notice and Process the Warnings Over Time. ………………………………………………………………………… 34

2.

Plaintiffs Have Waived Any Challenge to the Specific Warnings Selected by FDA, Which Accurately Convey Consequences of Smoking. ……………………… 37

3.

The Inclusion of a Phone Number for a Smoking Cessation Resource Raises No First Amendment Concerns. ………………………………………………………………………….. 44

B.

Plaintiffs’ APA Challenge Reduces to the Contention that the Agency Should Have Declined to Implement the Statutory Mandate…………………………………………………………………………. 45

1.

The Regulatory Impact Statement…………………………………………. 46

2.

The Consumer Research Study. ……………………………………………. 49

3.

Other APA Challenges………………………………………………………… 51

IV.

There Is No Authority To Issue an Injunction that Would Delay Enforcement of the Warning Requirements Established by Statute. ……………….. 53

CONCLUSION……………………………………………………………………………………………………………. 55

ii

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TABLE OF AUTHORITIES

Cases: Page

Board of Trustees v. Fox,

492 U.S. 469 (1989)………………………………………………………………………………………………… 13

Brown v. Entertainment Merchants Ass’n,

131 S. Ct. 2729 (2011)……………………………………………………………………………………….. 28, 29

Canada v. JTI-Macdonald Corp.,

[2007] 2 S.C.R. 610, 2007 SCC 30…………………………………………………………………………….. 21

Central Hudson,

477 U.S. at 566………………………………………………………………………………………………….. 13, 14

Central Hudson Gas & Electric Corp. v. Public Service Commission,

447 U.S. 557 (1980)…………………………………………………………………………………………….. 2, 13

* Commonwealth Brands, Inc. v. United States, 678 F. Supp. 2d 512 (W.D. Ky. 2010), appeals pending sub nom.

Discount Tobacco City & Lottery, Inc. v. United States, Nos. 10-5234 & 10-5235 (6th Cir.). ……………………………………………. 1, 16, 17, 20, 21, 22, 31

Entertainment Software Ass’n v. Blagojevich,

469 F.3d 641 (7th Cir. 2006). …………………………………………………………………………………… 28

*FDA v. Brown & Williamson Tobacco Corp.,

529 U.S. 120 (2000)………………………………………………………………………………….. 3, 5, 8, 9, 25

Larus & Brother Co. v. FCC,

447 F.2d 876 (4th Cir. 1971). …………………………………………………………………………………… 26

Miami Herald Publishing Co. v. Tornillo,

418 U.S. 241 (1974)………………………………………………………………………………………………… 14

* Milavetz, Gallop & Milavetz, P.A. v. United States,

130 S. Ct. 1324 (2010)…………………………………………………………………………………………….. 13

Nat’l Citizens Comm. for Broad. v. FCC,

567 F.2d 1095 (D.C. Cir. 1977)………………………………………………………………………………… 26

* Authorities chiefly relied upon are marked with an asterisk.

iii

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Nat’l Petrochemical & Refiners Ass’n v. EPA,

630 F.3d 145 (D.C. Cir. 2010)………………………………………………………………………………….. 55

*National Electrical Manufacturers Ass’n v. Sorrell,

272 F.3d 104 (2d Cir. 2001)…………………………………………………………………………… 28, 29, 32

Pacific Gas & Electric Co. v. Public Utilities Commission,

475 U.S. 1 (1986)……………………………………………………………………………………………………. 29

Pub. Citizen v. Fed. Motor Carrier Safety Admin.,

374 F.3d 1209 (D.C. Cir. 2004)………………………………………………………………………………… 46

SEC v. Chenery Corp.,

318 U.S. 80, 63 S.Ct. 454, 87 L.Ed. 626 (1943)…………………………………………………………… 55

United States v. Philip Morris USA, Inc., et al.,

449 F. Supp. 2d 1 (D.D.C. 2006)………………………………………………. 3, 7, 8, 19, 25, 30, 31, 41

United States v. Philip Morris USA, Inc., et al.,

566 F.3d 1095 (D.C. Cir. 2009), cert. denied, 130 S. Ct. 3501 (2010). …… 3, 8, 15, 16, 27, 29

WJG Tel. Co., Inc. v. FCC,

675 F.2d 386 (D.C. Cir. 1982)………………………………………………………………………………….. 53

West Virginia State Bd. of Ed. v. Barnette,

319 U.S. 624 (1943)………………………………………………………………………………………………… 14

Wooley v. Maynard,

430 U.S. 705 (1977)…………………………………………………………………………….. 4, 14, 24, 27, 28

* Zauderer v. Office of Disciplinary Counsel of Supreme Court of Ohio,

471 U.S. 626 (1985)………………………………………………………………. 2, 4, 13, 14, 21, 27, 28, 29

Statutes:

5 U.S.C. § 706 …………………………………………………………………………………………………………….. 55

15 U.S.C. § 1333, Note………………………………………………………………………….. 1, 9, 10, 24, 45, 53

15 U.S.C. § 1333(b)(4). ………………………………………………………………………………………………… 54

21 U.S.C. § 387, Note………………………………………………………………………………………….. 3, 6, 7, 8

* Authorities chiefly relied upon are marked with an asterisk.

iv

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21 U.S.C. § 387f(d)(1). …………………………………………………………………………………………………. 54

49 U.S.C. § 31506(d). …………………………………………………………………………………………………… 47

Pub. L. 89-92, 79 Stat. 282 (1965)………………………………………………………………………………….. 14

Pub. L. 98-474, 98 Stat. 2200 (1984)…………………………………………………………………………. 14, 15

Pub. L. No. 111-31, 123 Stat. 1776 (2009)……………………………………………………………………. 1, 54

Regulations:

58 Fed. Reg. 51,735 (1993)…………………………………………………………………………………………….. 47

61 Fed. Reg. 44,396 (Aug. 28, 1996)………………………………………………………………………….. 5, 8, 9

75 Fed. Reg. 7,604 (Feb. 22, 2010)…………………………………………………………………………………. 52

75 Fed. Reg. 52,352 (Aug. 25, 2010)…………………………………………………………………………. 51, 52

75 Fed. Reg. 69,524 (Nov. 12, 2010)…………………………… 1, 5, 6, 7, 10, 16, 17, 27, 32, 33, 50, 52

75 Fed. Reg. 75,936 (Dec. 7, 2010). ……………………………………………………………………………….. 53

76 Fed. Reg. 3821 (2011)……………………………………………………………………………………………….. 47

*76 Fed. Reg. 36,628 (June 22, 2011). …………….. 1, 2, 5, 7, 11, 12, 20, 31, 33, 35, 36, 37, 38, 39,

40, 41, 42, 43, 44, 47, 48, 49, 50, 51, 52, 54

Orders:

Executive Order 12,866. ………………………………………………………………………………………….. 46, 47

Executive Order 13,563. ………………………………………………………………………………………….. 46, 47

Rules:

Local Rule 7(n). …………………………………………………………………………………………………………….. 2

* Authorities chiefly relied upon are marked with an asterisk.

v

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Legislative Materials:

146 Cong. Rec. H1849 (April 5, 2000)………………………………………………………………………………. 6

Family Smoking Prevention & Tobacco Control Act: Hearing Before the House Subcommittee on Health, Committee on Energy and Commerce, 110th Cong. 42 (2007). …………………………………………………………………………………………….. 15

Testimony of Richard Bonnie, Chair of IOM’s Committee on Reducing Tobacco Use

H.R. 1108………………………………………………………………………………………………………………. 15

Other Authorities:

Australia Department of Health and Ageing, Fact Sheet: Graphic Health Warnings, at www.quitnow.gov.au/intern… Content/fact-sheet-health-warnings. …………………………………………………………………………… 11

Campaign for Tobacco-Free Kids, Press Release (May 8, 2003). ………………………………………… 22

David Hammond, Health Warnings Messages on Tobacco Products: A Review, 20 Tobacco Control 327 (2011)………………………………………………………………………. 17, 33, 34

David Hammond, et al., Effectiveness of Cigarette Warning Labels in Informing Smokers about the Risks of Smoking, 15 Tobacco Control iii19 (2005)…………………………… 17

Ellen Peters, et al., the Impact and Acceptability of Canadian-style Cigarette Warning Labels Among U.S. Smokers and Nonsmokers, 9 Nicotine & Tobacco Research 473 (Apr. 2007)…………………………………………………………. 23

European Commission Directorate General For Health and Consumers, Pictorial Health Warnings, at ec.europa.eu/health/tobac…. ………………………………….. 11

FDA, Experimental Study of Graphic Cigarette Warning Labels, Final Results Report (Dec. 2010)………………………………………………………….. 11, 34, 35, 50, 51

Health Canada, Graphic Health Warnings, www.hc-sc.gc.ca/hc-ps/tob… legislation/label-etiquette/graph/index-eng.php. ………………………………………………….. 11

*Institute of Medicine, Ending the Tobacco Problem: A Blueprint for the Nation (2007)…………………………………………………………………. 6, 7, 15, 30

* Authorities chiefly relied upon are marked with an asterisk.

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Karine Gallopel-Morvan et al., The Use of Visual Warnings in Social Marketing: The Case of Tobacco, 64 J. Business Research 7 (2011)……………………………………………….. 17

Paul Slovic, Cigarette Smokers: Rational Actors or Rational Fools?, in SMOKING: RISK, PERCEPTION, & POLICY 97 (Paul Slovic ed., 2001)…………………………………………. 7, 18

Physicians for a Smoke-Free Canada, Canada’s Graphic Health Warnings, www.smoke-free.ca/warning………………………………………………. 16

President’s Cancer Panel, Promoting Healthy Lifestyles (2007). ……………………………………. 30, 42

R.J. Reynolds, Guiding Principles and Beliefs, available at www.rjrt.com/prinbeliefs…. 26

Robert A. Schnoll & Caryn Lerman, Smoking Behavior and Smoking Cessation among Head and Neck Cancer Patients, in HEAD AND NECK CANCER: EMERGING PERSPECTIVES 185 (John F. Ensley ed. 2003)…………………………………………….. 38

S. David Leonard, et al., Comprehension and Memory, in WARNINGS AND RISK COMMUNICATION 149 (Michael S. Wogalter et al., eds. 1999)…………………………………. 18

Steven Young & Michael Wogalter, Comprehension and Memory of Instruction Manual Warnings: Conspicuous Print and Pictorial Icons, 32(6) Human Factors 637 (1990)……………………………………………………………………………….. 18

Surgeon General, Preventing Tobacco Use Among Young People (1994)……………………….. 14, 15

Tobacco Products Information Regulations, SOR/2000-272 (Can.). ……………………………………. 55

W. Howard Levie & Richard Lentz, Effects of Text Illustrations: A Review of Research, 30 Educ. Comm. & Tech. J. 195 (1982). ……………………………………………………………………. 19

Wendy A. Rogers, et al., Warning Research: An Integrative Perspective, 42 Human Factors 102 (Spring 2000)………………………………………………………………………… 18

* Authorities chiefly relied upon are marked with an asterisk.

vii Case 1:11-cv-01482-RJL Document 35 Filed 10/21/11 Page 11 of 66

INTRODUCTION AND SUMMARY

1. The Family Smoking Prevention and Tobacco Control Act, Pub. L. No. 111-31, 123 Stat.

1776 (2009), empowers the Food and Drug Administration (“FDA”) to regulate the manufacture and sale of tobacco products, including cigarettes and smokeless tobacco. As relevant here, the Act revises the content and format of the health warnings that, for decades, have been required on cigarette packaging and advertising.

The Act specifies the text of nine health warnings, which include messages such as “Cigarettes are addictive,” “Cigarettes cause cancer,” “Tobacco smoke can harm your children,” and “Quitting smoking now greatly reduces serious risks to your health.” 15 U.S.C. § 1333 Note. The Act also specifies the format of the warnings, which will comprise the top 50% of the front and rear panels of cigarette packs and 20% of cigarette advertising. Ibid. In addition, Congress directed the Secretary of Health and Human Services to “issue regulations that require color graphics depicting the negative health consequences of smoking” to accompany the new warning statements. Ibid.

Congress “informed its warning requirement by looking at the use of a nearly identical warning requirement in Canada,” which had proven significantly more effective in conveying the risks of smoking than the warnings used in the United States. Commonwealth Brands, Inc. v. United States, 678 F. Supp. 2d 512, 531 (W.D. Ky. 2010), appeals pending sub nom. Discount Tobacco City & Lottery, Inc. v. United States, Nos. 10-5234 & 10-5235 (6th Cir.).

Pursuant to Congress’s directive, FDA published for public comment 36 proposed images. See 75 Fed. Reg. 69,524, 69,534 (Nov. 12, 2010). In selecting the final set of nine images, FDA reviewed over a thousand public comments as well as the results of an 18,000-person consumer research study, and a wealth of other relevant scientific and academic material. See 76 Fed. Reg. Case 1:11-cv-01482-RJL Document 35 Filed 10/21/11 Page 12 of 66

36,628, 36,629, 36,637 (June 22, 2011); see also Certified Index to the Administrative Record.1

FDA explained that the final set of images is “generally consistent with the graphic health warnings used in other countries,” id. at 36,647, and “effectively communicates risk information to a diverse range of audiences,” including the adolescent population that has been “targeted by tobacco industry marketing efforts.” Id. at 36,636.

2. Plaintiffs acknowledge, as they must, that the warnings prescribed by Congress are accurate. Cigarettes are addictive, and they do kill smokers when used as intended, by causing cancer, fatal lung disease, strokes and heart disease. Secondhand smoke does kill family and friends.

And it is not controversial that “[q]uitting smoking now greatly reduces serious risks to your health.” Congress does not infringe on protected First Amendment interests when it requires accurate disclosures in marketing. As the Supreme Court explained in Zauderer v. Office of Disciplinary Counsel of Supreme Court of Ohio, 471 U.S. 626, 650 (1985), there are “material differences between disclosure requirements and outright prohibitions on speech.” Unlike restrictions on speech, warnings and other disclosure requirements do not prevent advertisers “from conveying information to the public”; they only require sellers to provide “more information than they might otherwise be inclined to present.” Ibid. Claims that disclosure requirements are so burdensome that they“chill[] protected commercial speech,” id. at 651, are reviewed under the framework established by Central Hudson Gas & Electric Corp. v. Public Service Commission, 447 U.S. 557 (1980), for restrictions on commercial speech. See Zauderer, 471 U.S. at 651 & n.14. The health warnings mandated by Congress easily survive scrutiny under any applicable standard.

1 On October 19, we served on plaintiffs’ counsel the certified index to the administrative record, which is attached to this memorandum. As per Local Rule 7(n) of this Court, within 14 days of the final brief, we will file an appendix with the administrative materials which the parties have cited or on which they have relied. If the Court requires access to parts of the record not cited by the parties, we will submit them to the Court.

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3. The plaintiff cigarette manufacturers can no longer directly dispute the adverse health consequences of smoking or the nature of nicotine addiction, as they did for decades in a massive scheme of fraud and deception. See United States v. Philip Morris USA, Inc., et al., 566 F.3d 1095 (D.C. Cir. 2009), cert. denied, 130 S. Ct. 3501 (2010). They are, however, quite capable of ignoring those consequences, and ask this Court to do the same in considering the interests advanced by the health warnings, and the relationship between the warning format and the public health threats posed by plaintiffs’ products. Plaintiffs’ pleadings give no inkling “that tobacco use, particularly among children and adolescents, poses perhaps the single most significant threat to public health in the United States.” FDA v. Brown & Williamson Tobacco Corp., 529 U.S. 120, 161 (2000). They nowhere acknowledge the tenacity of nicotine addiction, even though the manufacturers have “engineered their products around creating and sustaining this addiction.” Philip Morris, 566 F.3d at 1107. Their pleadings give no hint that the “overwhelming majority” of new victims of nicotine addiction begin using tobacco products “while they are minors and become addicted to the nicotine in those products before reaching the age of 18.” Legislative Finding 31. 2 And no reader would discern from plaintiffs’ submissions that the “[a]dvertising, marketing, and promotion of tobacco products have been especially directed to attract young persons to use tobacco products,” Legislative Finding 15, and that “[t]he central purpose of the tobacco companies’ image advertising is motivating adolescents to smoke.” United States v. Philip Morris USA, Inc., et al., 449 F. Supp. 2d 1, 572 (D.D.C. 2006).

Only by ignoring the findings of Congress, the courts, and countless public health officials, can plaintiffs discount the compelling governmental interest in communicating health risks to consumers and potential consumers of their product—including the underage and often

2 The Legislative Findings are codified at 21 U.S.C. § 387, Note.

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undereducated persons who constitute the bulk of their new clientele. And only by ignoring the record before Congress, and the overwhelming international consensus of public health officials, can plaintiffs attempt to claim that a text-only disclosure of the same size as the current Surgeon General warnings could communicate the health risks of smoking as effectively as the revised warnings prescribed by Congress.

Perhaps most notably, it is only by ignoring the addictive and lethal nature of their products that plaintiffs can with a straight face describe the disclosures mandated by Congress as “an ideological message” akin to the “compelled speech” involved in cases such as Wooley v. Maynard, 430 U.S. 705 (1977). Pl. S.J. Br. 24. Decisions such as Wooley reflect the core First Amendment principle that government shall not “prescribe what shall be orthodox in politics, nationalism, religion, or other matters of opinion or force citizens to confess by word or act their faith therein.” Zauderer, 471 U.S. at 651 (internal quotation marks omitted). Those decisions have no application here. That “smoking can kill you” is not an ideological message: it is a fact. There is no competing “ideology” maintaining that smoking does not account for more than 400,000 deaths each year.

4. Plaintiffs move seamlessly from decrying the burden of the disclosure requirements to insisting that the revised warnings would have no impact on smoking rates and thus serve no legitimate purpose. This relentlessly repeated refrain ignores two critical points. First, the purpose of the new disclosure format is to convey the health risks of smoking. Plaintiffs offer no basis whatsoever for disregarding Congress’s judgment that the revised health warnings communicate those risks more effectively than warnings without accompanying graphics, even as compared to text-only warnings that are far larger than the current Surgeon General warnings. The precise extent to which the enhanced communication of risks will ultimately reduce smoking rates is not a relevant metric in assessing plaintiffs’ constitutional claim. Second, plaintiffs’ contention fails on its own

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terms. Contrary to plaintiffs’ assertion, researchers have not concluded that the introduction of new warnings in Canada had no bearing on the subsequent decrease in Canadian smoking rates. Instead, researchers have recognized that the decline in Canadian smoking rates was influenced by a variety of regulatory measures and that it is difficult to make statistically significant determinations about the extent to which any single factor contributed to the decline.

STATEMENT

A. Background

Congress crafted the provisions of the Tobacco Control Act on the basis of evidence gathered over decades by all three branches of government regarding the health risks posed by cigarettes and the tobacco industry’s marketing of those products. This background is crucial to understanding the nature and scope of the problems addressed by the new health warnings, the reasons that Congress required the new format, and why the revised warnings do not run afoul of the First Amendment.

First, when used as intended by the manufacturers, cigarettes are deadly. “[T]obacco use, particularly among children and adolescents, poses perhaps the single most significant threat to public health in the United States.” Brown & Williamson, 529 U.S. at 161. Smoking “is responsible for at least 443,000 premature deaths per year in the United States.” 76 Fed. Reg. at 36,630. It “‘kills more people each year in the United States than acquired immunodeficiency syndrome (AIDS), car accidents, alcohol, homicides, illegal drugs, suicides, and fires, combined.’” Brown & Williamson, 529 U.S. at 134–35 (quoting 61 Fed. Reg. 44,396, 44,398 (Aug. 28, 1996)); see also 75 Fed. Reg. at 69,526 (same). Because cigarettes are inherently dangerous when used as intended by their manufacturers, they would be banned outright if they were subject to regulation as drugs under the Federal Food, Drug, and Cosmetic Act (“FDCA”), see Brown & Williamson, 529 U.S. at 136, and, in light of current knowledge, if cigarettes “were being introduced for the first time,” they

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“would not be allowed to enter the marketplace.” Institute of Medicine, Ending the Tobacco Problem: A Blueprint for the Nation, at 152 (2007) (“IOM Report”) (discussed in H.R. Rep.

No. 111-58(I) (2009)).

Second, “the magnitude of public health harm caused by cigarettes is inextricably linked” to nicotine addiction. 75 Fed. Reg. at 69,528. “The pharmacologic and behavioral processes that determine tobacco addiction are similar to those that determine addiction to drugs such as heroin and cocaine,” ibid., and the force of nicotine addiction is illustrated by the failure rate of individual smoking cessation efforts. Data for 2004, for example, showed “that although approximately 40.5 percent of adult smokers reported attempting to quit in that year, only between 3 and 5 percent were successful.” Id. at 69,529.

The tobacco industry has long understood the importance of nicotine addiction to their sales.

An internal R.J. Reynolds memo from 1972, quoted by Congressman Ganske in 2000, acknowledged: “In a sense, the tobacco industry may be thought of as being a specialized, highly ritualized and stylized segment of the pharmaceutical industry. Tobacco products uniquely contain and deliver nicotine, a potent drug with a variety of physiologic effects.” 146 Cong. Rec. H1849 (April 5, 2000). 3 Plaintiffs’ own expert in Commonwealth Brands emphasized the tenacity of the addiction to nicotine, which, he explained, is the “substance in tobacco that inveterate smokers crave.” Rodu Decl. ¶ 40 (R. 72-2, No. 1:09-cv-117 (W.D. Ky.)). Tobacco companies “have designed their cigarettes to precisely control nicotine delivery levels and provide doses of nicotine sufficient to create and sustain addiction.” Legislative Finding 49.

Third, the tobacco industry has long depended on recruiting underage users who become

3 All citations to the Congressional Record are to the daily editions, and can be found at www.gpoaccess.gov/crecord….

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addicted by age 18. A 2008 study found that each day, nearly 4,000 Americans under the age of 18 experiment with cigarettes for the first time, and approximately 1,000 children become new daily smokers. 75 Fed. Reg. at 69,526–27. Congress found that—despite laws prohibiting the sale of tobacco products to minors—the “overwhelming majority of Americans who use tobacco products begin using such products while they are minors and become addicted to the nicotine in those products before reaching the age of 18.” Legislative Finding 31; see also 75 Fed. Reg. at 69,526 (“more than 80 percent of established adult smokers began smoking before age 18”); Philip Morris, 449 F. Supp. 2d at 562 (“over 80% of smokers start smoking before they turn eighteen”). According to a national survey of U.S. high-school students conducted in 2009, “almost half (46.3 percent) . . . had tried cigarette smoking, and an estimated 19.5 percent . . . were current cigarette smokers.” 75 Fed. Reg. at 69,526.

The adolescents who become the industry’s new customers systematically “misperceive the magnitude of smoking harms and the addictive properties of tobacco and fail to appreciate the long-term dangers of smoking, especially when they apply the dangers to their own behavior.” IOM Report at 93; see also Philip Morris, 449 F. Supp. 2d at 576–80. One survey showed that “fewer than 5 percent of daily smokers in high school think that they still will be smoking at all in 5 years, yet more than 60 percent of high school smokers are regular daily smokers 7 to 9 years later.” 76 Fed. Reg. at 36,633. Indeed, scientific research has shown that “adolescents begin to show evidence of nicotine dependence within days to weeks of the onset of occasional use of tobacco.” Paul Slovic, Cigarette Smokers: Rational Actors or Rational Fools?, in SMOKING: RISK, PERCEPTION, & POLICY 97, 109 (Paul Slovic ed., 2001) (emphasis added).

Tobacco companies have long known that they must reach potential customers while they are underage, and have targeted their marketing accordingly. Congress found that “[a]dvertising,

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marketing, and promotion of tobacco products have been especiallydirected to attract young persons to use tobacco products, and these efforts have resulted in increased use of such products by youth.” Legislative Finding 15; see also, e.g., Philip Morris, 449 F. Supp. 2d at 572 (finding that “[t]he central purpose of the tobacco companies’ image advertising is motivating adolescents to smoke”).

Fourth, the tobacco industry has for decades misled customers and potential customers about the health risks and addictiveness of cigarettes. The tobacco companies’ “efforts to deny and distort the scientific evidence of smoking’s harms are demonstrated by not only decades of press releases, reports, booklets, newsletters, television and radio appearances, and scientific symposia and publications, but also by evidence of their concerted[] efforts to attack and undermine the studies in mainstream scientific publications such as the Reports of the Surgeon General.” Philip Morris, 449 F. Supp. 2d at 855. The D.C. Circuit expressly concluded, when it rejected the companies’ First Amendment defenses to racketeering liability, that the tobacco companies’ public statements were “clearly and deliberately false,” and that they “knew of their falsity at the time and made the statements with the intent to deceive.” Philip Morris, 566 F.3d at 1124. Indeed, the industry’s joint public relations representative admitted internally that the industry’s “‘basic position in the cigarette controversy is subject to the charge, and may be subject to a finding, that we are making false or misleading statements to promote the sale of cigarettes.’” Id. at 1120 (citation omitted).

B. The Supreme Court’s Brown & Williamson Decision

FDA issued regulations in 1996 to regulate cigarettes and smokeless tobacco. 61 Fed. Reg. 44,396 (Aug. 28, 1996). The Supreme Court ultimately concluded that FDA generally lacked authority under the FDCA to promulgate those regulations, but the Court left no doubt as to the seriousness of the public health crisis that FDA had addressed. Brown & Williamson, 529 U.S. at

126. The Court emphasized that, “[i]n its rulemaking proceeding, the FDA quite exhaustively 8

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documented that ‘tobacco products are unsafe,’ ‘dangerous,’ and ‘cause great pain and suffering from illness.’” Id. at 134 (quoting 61 Fed. Reg. at 44,412). The Court recognized that “tobacco use, particularly among children and adolescents, poses perhaps the single most significant threat to public health in the United States.” 529 U.S. at 161.

Indeed, the dangers of smoking were central to the Supreme Court’s reasoning. The Court concluded that because cigarettes are inherently dangerous when used as intended by their manufacturers, cigarettes would have to be banned outright if they were subject to regulation as drugs under the FDCA—a result that Congress had not authorized. Id. at 136; see also id. at 142 (“As the FDA has documented in great detail, cigarettes and smokeless tobacco are an unsafe means to obtaining any pharmacological effect.” (emphasis in original)).

The Court also noted FDA’s determination that a cigarette ban was not a practicable means to address the public health crisis caused by cigarettes, given “the high level of addiction” among smokers. Id. at 139. The Court did not question FDA’s conclusion that, if cigarettes were banned, “current tobacco users could suffer from extreme withdrawal, the health care system and available pharmaceuticals might not be able to meet the treatment demands of those suffering from withdrawal, and a black market offering cigarettes even more dangerous than those currently sold legally would likely develop.” Ibid. (citing 61 Fed. Reg. at 44,413). The Court concluded, however, that the FDCA did not permit FDA to take such considerations into account. See id. at 139-142.

C. The Tobacco Control Act

Congress enacted the Tobacco Control Act in 2009 to fill the regulatory void left by Brown & Williamson. As relevant here, the Act updated, for the first time since 1984, the health warnings that must appear by federal law on cigarette packaging and advertising, to ensure that cigarette manufacturers effectively inform smokers and potential smokers of the health risks and

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addictiveness of cigarettes. 15 U.S.C. § 1333 Note. The Act provides that product labels and advertisements for cigarettes must bear one of several prominent warning statements describing the adverse health effects of smoking, including statements regarding addictiveness and the impact on smokers and nonsmokers. Ibid. The required statements are:

WARNING: Cigarettes are addictive.

WARNING: Tobacco smoke can harm your children.

WARNING: Cigarettes cause fatal lung disease.

WARNING: Cigarettes cause cancer.

WARNING: Cigarettes cause strokes and heart disease.

WARNING: Smoking during pregnancy can harm your baby.

WARNING: Smoking can kill you.

WARNING: Tobacco smoke causes fatal lung disease in nonsmokers.

WARNING: Quitting smoking now greatly reduces serious risks to your health.

Ibid.

The Act also revised the format of the warnings, by providing that they must comprise the top 50% of the front and rear panels of cigarette packs and 20% of cigarette advertising. Ibid. In addition, Congress directed the Secretary to promulgate regulations “that require color graphics depicting the negative health consequences of smoking to accompany” the text of these nine warnings. Ibid.

D. FDA’s Implementing Rule

Pursuant to that statutory directive, FDA published for comment a total of 36 proposed images to accompany the textual warnings. See 75 Fed. Reg. at 69,534. In developing the proposed images, FDA drew upon the advice of “various experts in the fields of health communications, marketing research, graphic design and advertising,” a substantial body of scientific literature analyzing the effectiveness of such warnings, and the experience of the more than thirty countries and jurisdictions that have, since 2001, implemented pictorial health warnings on cigarette packages.

Id. at 69,525, 69,534.

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In selecting the final nine images, FDA reviewed well over a thousand public comments, including joint comments submitted by plaintiffs R.J. Reynolds (“Reynolds”), Lorillard, and Commonwealth Brands. See 76 Fed. Reg. at 36,629. FDA also reviewed the results of an 18,000person consumer study that tested the relative effectiveness of the 36 proposed images in communicating the information in the text. See FDA, Experimental Study of Graphic Cigarette Warning Labels, Final Results Report (Dec. 2010) (hereinafter “FDA Study Report”). FDA emphasized “the importance of selecting a set of required warnings that includes a diversity of styles (e.g., photographic versus illustrative), themes, and human images (e.g., race, gender, age).” 76 Fed. Reg. at 36,636. That diversity is necessary to ensure that “the final set of required warnings effectively communicates risk information to a diverse range of audiences,” including audiences, like youth, that “have been targeted by tobacco industry marketing efforts.” Ibid.

The pictorial health warnings included in the final rule are, FDA explained, “generally consistent with the graphic health warnings used in other countries.” 76 Fed. Reg. at 36,647. For instance, in Canada, images similar to the ones selected by FDA have appeared on cigarette packs for more than a decade. See Health Canada, Graphic Health Warnings.4 Similar warnings have appeared on cigarette packs in Australia since 2006 and in the United Kingdom since 2008. 5 See also, e.g., European Commission Directorate General For Health and Consumers, Pictorial Health Warnings, at ec.europa.eu/health/tobac….

When FDA evaluated the comments to the rulemaking, it specifically addressed contentions

4 www.hc-sc.gc.ca/hc-ps/tob….

The websites cited in this brief were last visited on October 10, 2011.

5 Australia Department of Health and Ageing, Fact Sheet: Graphic Health Warnings, at www.quitnow.gov.au/intern…;

U.K. Health Department, Picture Warnings on Tobacco Products, at www.dh.gov.uk/en/ Publichealth/Healthimprovement/Tobacco/Picturewarningsontobaccoproductspressimages/.

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that images provoke emotions rather than convey information. The agency noted, for example, that some comments had criticized various proposed images as “‘disturbing’” or “eliciting emotions,” including the image “depicting a man smoking through a tracheostomy opening,” the image “depicting healthy lungs juxtaposed with lungs damaged by smoking,” the image “depicting a lesion consistent with that caused by oral cancer,” and the image “depicting a man with an autopsy scar.” 76 Fed. Reg. at 36,696. FDA explained that “[t]he comment did not assert, however, that the effects shown in the images are false, i.e., that they are not manifestations of negative health consequences of smoking, such as throat, lung, and oral cancer, and death.” Ibid. The agency emphasized: “The fact that the images are disturbing or evoke emotion does not mean that they are not factual representations of the effects of smoking. . . . As such, it is not surprising that the warnings regarding the negative health consequences of smoking would evoke emotions such as fear of being stricken with life-threatening cancer or disgust at what it might be like to have that happen.” Ibid.

FDA explained that the emotional responses are germane because they predict the likelihood that viewers will notice and process the accompanying textual information. The agencystressed that “[t]he overall body of scientific evidence indicates that health warnings that evoke strong emotional responses enhance an individual’s ability to process the warning information, leading to increased knowledge and thoughts about the harms of cigarettes and the extent to which the individual could personally experience a smoking-related disease.” Id. at 36,641. The images selected “were designed to correlate with [the] warning statements,” and the “available evidence base highlights the value of the text and images in graphic health warnings relating to one another in a meaningful way.” Id. at 36,637 (citations omitted).

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ARGUMENT

I.

Warnings and Other Disclosure Requirements Are Subject To “Less Exacting Scrutiny” Than Restrictions On Commercial Speech.

The Supreme Court has long recognized that there are “material differences between disclosure requirements and outright prohibitions on speech.” Zauderer, 471 U.S. at 650. Warnings and other disclosure requirements do not prevent advertisers “from conveying information to the public”; instead, they require sellers to provide “more information than they might otherwise be inclined to present.” Ibid. Thus, the Supreme Court has explained, disclosure requirements are subject to “less exacting scrutiny” than restrictions on commercial speech. Milavetz, Gallop & Milavetz, P.A. v. United States, 130 S. Ct. 1324, 1339–40 (2010).

In general, mandated disclosures raise First Amendment concerns only when it is claimed that “unjustified or unduly burdensome disclosure requirements . . . [are] chilling protected commercial speech.” Zauderer, 471 U.S. at 651 & n.14. Such claims are evaluated under the framework established by Central Hudson, 447 U.S. 557, for review of restrictions on commercial speech. See Zauderer, 471 U.S. at 651. In applying those standards, a court upholds restrictions that directly advance a substantial government interest and are no more extensive than is necessary to serve that interest. Central Hudson, 477 U.S. at 566. That standard does not require the legislature to employ “the least restrictive means” of regulation or to achieve a perfect fit between means and ends. Board of Trustees v. Fox, 492 U.S. 469, 480 (1989). It is sufficient to achieve a “reasonable” fit by adopting regulations “‘in proportion to the interest served.’” Ibid. (citation omitted).

When the Supreme Court described in Zauderer the standard of scrutiny that applies to disclosure requirements in the commercial speech context, it expressly distinguished its cases involving “compelled speech” in areas of core protected speech. The Court noted that, “to be sure,”

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it has “held that in some instances compulsion to speak may be as violative of the First Amendment as prohibitions on speech.” Zauderer, 471 U.S. at 650 (citing Wooley, 430 U.S. 705; Miami Herald Publishing Co. v. Tornillo, 418 U.S. 241 (1974); and West Virginia State Bd. of Ed. v. Barnette, 319 U.S. 624 (1943)). The Court stressed, however, that “the interests at stake” in the commercial speech context “are not of the same order as those discussed in Wooley, Tornillo, and Barnette,” which involved attempts by the government to “prescribe what shall be orthodox in politics, nationalism, religion, or other matters of opinion or force citizens to confess by word or act their faith therein.” Id. at 651 (quotation marks and citation omitted). “Because the extension of First Amendment protection to commercial speech is justified principally by the value to consumers of the information such speech provides,” an advertiser’s “constitutionally protected interest in not providing any particular factual information in his advertising is minimal.” Ibid.

As we explain next, the health warnings mandated by Congress and implemented by the FDA readily satisfy the standards established by Zauderer and Central Hudson, and would even survive the strict scrutiny that plaintiffs (wrongly) insist is required.

II.

Congress Mandated Health Warnings for Cigarettes in a Format that Accurately Conveys the Extraordinary Risks of Smoking and Violates No First Amendment Principle.

A.

The Revised Warnings Substantially Advance the Government’s Overwhelming Interest in Informing Consumers About the Grave Dangers of Cigarette Smoking.

1.

The Current Surgeon General Warnings Are Essentially “Invisible.” Congress has required that cigarette packaging and advertising bear health warnings since

1965. Federal Cigarette Labeling and Advertising Act of 1965, Pub. L. No. 89-92, 79 Stat. 282 (1965). Prior to the 2009 legislation now at issue, the content and the format of the warnings had not been revised since 1984. Comprehensive Smoking Education Act of 1984, Pub. L. No. 98-474,

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98 Stat. 2200 (1984). As early as 1994, however, the Surgeon General reported that empirical studies dealing “with the visibility of cigarette warnings in advertising . . . consistently indicate that the Surgeon General’s warnings are given little attention or consideration by viewers.” Surgeon General, Preventing Tobacco Use Among Young People 168 (1994). 6 Evidence presented to Congress showed that the current warnings “fail to conveyrelevant information in an effective way,” IOM Report at 291, and are essentially “invisible.” Testimony of Richard Bonnie, Chair of IOM’s Committee on Reducing Tobacco Use, H.R. 1108, Family Smoking Prevention & Tobacco Control Act: Hearing Before the House Subcommittee on Health, Committee on Energy and Commerce, 110th Cong. 42 (2007).

In the intervening quarter century, regulators’ understanding of nicotine addiction and the health risks of smoking has increased dramatically. This enhanced understanding has resulted, in significant part, from the exposure of the tobacco industry’s concerted campaign to discredit public health officials and minimize consumer concerns about health risks and addiction. For decades, the industry sought to convince consumers that they might reasonably choose to smoke because sufficient doubt existed as to the risks of smoking and the nature of nicotine addiction. The D.C.

Circuit explained in Philip Morris that “[e]vidence at trial revealed that at the same time Defendants were disseminating advertisements, publications, and public statements denying any adverse health effects of smoking and promoting their ‘open question’ strategy of sowing doubt, they internally

6 Although plaintiffs cite the Surgeon General’s 1994 report in support of their claim that the revised warnings are unnecessary, Pl. S.J. Br. 15, that report, in fact, concluded that studies dealing “with the visibility of cigarette warnings in advertising . . . consistently indicate that the Surgeon General’s warnings are given little attention or consideration by viewers.” Surgeon General, Preventing Tobacco Use, supra, at 168. The report also noted that a “comprehensive review of studies on health risk awareness” conducted by the Federal Trade Commission found that “significant numbers of consumers and still higher numbers of smokers were unaware of even the most rudimentary risk information about smoking,” which led the FTC to “call for a larger and more attention-demanding format.” Id. at 169.

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acknowledged as fact that smoking causes disease and other health hazards.” 566 F.3d at 1106.

Based on this fuller understanding of health risks, nicotine addiction, and consumption patterns, an international consensus has developed regarding the minimum requirements for warnings that will effectively convey the health risks of smoking. These standards are reflected in the World Health Organization’s Framework Convention on Tobacco Control and include “warnings that are rotating, ‘large, clear, visible and legible,’” that “ occupy 50 percent or more of the principal display areas,” and “may be in the form of or include pictures or pictograms.” 75 Fed. Reg. at 69,525 (citation omitted). “Worldwide, over 30 countries/jurisdictions have implemented pictorial warnings on tobacco packages and requirements for pictorial warnings are pending in several other countries/jurisdictions.” Ibid.

2.

Evidence Before Congress and the FDA Establishes that the Warnings Mandated by Congress Convey the Health Risks of Smoking More Effectively than Text-Only Warnings of Any Size.

In formulating the new health warnings, Congress and the FDA looked, in particular, to the Canadian disclosure requirements that went into effect in 2000. See Commonwealth Brands, 678 F. Supp. 2d at 531 (Congress “informed its warning requirement by looking at the use of a nearly identical warning requirement in Canada”). Like the warnings mandated by Congress, those warnings comprised the top 50% of the front and rear panels of cigarette packs and included color graphics depicting the negative health consequences of smoking. See Physicians for a Smoke-Free Canada, Canada’s Graphic Health Warnings.7

The evidence before Congress and the FDA amply demonstrated that this size and placement attract and retain consumer attention far more effectively than the current Surgeon General warnings, particularly when the textual message is combined with accompanying pictures. One

7 www.smoke-free.ca/warning….

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study showed that whereas “‘83 percent of Canadian students mentioned health warnings in a recall test of cigarette packages,’ only ‘7 percent of U.S. students’ did the same.” Commonwealth Brands, 678 F. Supp. 2d at 531 (citation omitted). In another study, when “U.S. college students were shown images of the Canadian cigarette warnings and the current warnings appearing on cigarette packs sold in the United States . . . the Canadian graphic warnings significantly increased aided recall of the warnings, increased depth of message processing, and increased the perceived strength of the message.” 75 Fed. Reg. at 69,531. These findings are consistent with focus group research in which young adults in the United States “reported that the Canadian warnings were more visible and more informative than the warnings appearing on cigarette packages in the United States.” Ibid.

Recent research confirms that cigarette warnings that combine images and text are more effective than text alone in conveying the risks identified in the text. For instance, from 1995 to 2005, Australia required cigarette manufacturers to display large, text-only warnings that covered the top 25% of the front of the pack. David Hammond, et al., Effectiveness of Cigarette Warning Labels in Informing Smokers about the Risks of Smoking, 15 Tobacco Control iii19, iii20 (2005).

After Australia introduced larger pictorial warnings in 2006, a longitudinal study of youth “found that students were more likely to read, attend to, think about, and talk about health warnings after the pictorial warnings were implemented.” David Hammond, Health Warnings Messages on Tobacco Products: A Review, 20 Tobacco Control 327, 330 (2011) (discussing 2008 study); see also Karine Gallopel-Morvan, et al., The Use of Visual Warnings in Social Marketing: The Case of Tobacco, 64 J. Business Research 7, 7 (2011) (study comparing the EU’s large text-only warnings to its new pictorial warnings concluded that the results “clearly demonstrate[] that visual messages, as opposed to text warnings, are more effective”). Research also “suggests that larger pictorial warnings sustain their effects longer” than text-only counterparts. See 20 Tobacco Control at 333.

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These results should not be surprising. It is axiomatic in cognitive psychology that “pictures are easier to remember than words.” S. David Leonard, et al., Comprehension and Memory, in WARNINGSAND RISK COMMUNICATION 149, 158 (Michael S. Wogalter et al., eds. 1999). The brain has distinct coding systems for words and for images, and information in the “image” memory system is more likely to be retained and is more easily retrieved. Ibid. This is particularly the case for words “representing abstract concepts.” Ibid. Information that is coded in both systems is particularly easy to remember “because theoretically more ‘paths’ are created in memory, making the information more accessible (more likely to be cued) at later times.” Ibid. Thus, even apart from tobacco-specific research, studies have “found that pictorials in combination with conspicuous print facilitated recollection of warning contents,” and that “the enhanced memory was directly related to the fact that the warning was noticed in the first place.” Wendy A. Rogers, et al., Warning Research: An Integrative Perspective, 42 Human Factors 102, 114 (Spring 2000); see also, e.g., Steven Young & Michael Wogalter, Comprehension and Memory of Instruction Manual Warnings: Conspicuous Print and Pictorial Icons, 32(6) Human Factors 637, 646 (1990) (comparing the relative effectiveness of instruction-manual warnings with and without pictorials, and finding that “warnings that have both conspicuous print and illustrative pictorial icons enhance comprehension and memory of the warnings’ message content”).

Conveying information in cigarette warnings poses special difficulties that make using images particularly appropriate. First, although the health consequences of smoking are severe, they generally do not become manifest for many years. Because of that time lag, smokers—and adolescents in particular—tend to disregard or discount discomforting factual information about the long-term consequences of using plaintiffs’ product. Dr. Paul Slovic has explained that “[a]lthough most smokers acknowledge a high degree of risk associated with many years of smoking, many

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believe they can get away with some lesser amount of smoking before the risk takes hold.” Paul Slovic, Cigarette Smokers: Rational Actors or Rational Fools?, supra, at 109.

Dr. Slovic notes that “[m]any young smokers, in particular, believe that smoking for only a few years poses negligible risk,” and “are more prone to belief in this safety of short-term smoking than are young non-smokers.” Ibid. This failure to fully appreciate the risks of tobacco smoking is compounded by the powerful nature of nicotine addiction, which starts to take hold “within days to weeks of the onset of occasional use of tobacco.” Ibid.; see also Philip Morris, 449 F. Supp. 2d at 577 (citing Dr. Slovic’s testimony in finding that “[b]ecause the most serious harmful consequences of smoking are cumulative, and occur in the distant future, and because teenagers are focused on the present rather than the future and lack an understanding of the addictive properties of cigarettes, it is unlikely that the decisions by teenagers to initiate smoking are influenced by concerns about future harmful consequences”).

Second, new consumers, who are not alreadyaddicted, are primarilychildren and adolescents who “are particularly vulnerable to cigarette marketing because they are not capable of making a fully informed decision whether to start or continue smoking for a variety of reasons, including the fact that they underestimate personal risks and lack the judgment which can only be developed through experience.” Philip Morris, 449 F. Supp. 2d at 578. Including pictorial content is particularly important in conveying information to underage consumers and potential consumers.

Summarizing the results of more than 50 youth studies, one review explained that “[i]llustrations can help learners understand what they read, can help learners remember what they read, and can perform a variety of other instructional functions.” See W. Howard Levie & Richard Lentz, Effects of Text Illustrations: A Review of Research, 30 Educ. Comm. & Tech. J. 195, 226 (1982).

Smoking rates are also closely correlated with education levels. FDA noted that “49.1

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percent of adults with a General Education Development certificate (GED) and 28.5 percent of adults with less than a high school diploma were current smokers in 2009, compared with 5.6 percent of adults with a graduate degree,” and “that graphic health warnings may be particularly important communication tools for these smokers, as there is evidence suggesting that countries with graphic health warnings demonstrate fewer disparities in health knowledge across educational levels.” 76 Fed. Reg. at 36,630 (citations omitted); see also Commonwealth Brands, 678 F. Supp. 2d at 531 (“[G]raphical warnings ‘may be particularly important for communicating’ with consumers with low levels of education, given evidence that such smokers ‘are less likely to recall health information in text-based messages than people with more education.’”) (citation omitted).

Plaintiffs’ only response is to contend that images, by their nature, do not help to convey the content of the warnings. Accordingly, at the preliminary injunction hearing, plaintiffs’ counsel made clear that, in plaintiffs’ view, the only type of image that could constitutionally be included with the warning “Smoking is addictive” would be “some kind of graphic chart that shows how many people smoke [and] how many people are able to quit.” P.I. Hr’g Tr. 16 (9/21/2011). (Given that plaintiffs also maintain that the warnings cannot exceed the size of the current Surgeon General warnings, see id. 21, the proposed graph would convey as much information as a hieroglyph.)

This, of course, is not the type of warning required by Congress, and plaintiffs offer no basis for accepting their overarching position that all images considered by the FDA and, indeed, any remotely similar image, somehow violate the First Amendment.

3.

The Required Health Warnings Do Not Impermissibly Burden Protected Commercial Speech.

Plaintiffs fail to demonstrate that the format required by Congress transforms the health warnings into “unjustified or unduly burdensome disclosure requirements [that] might offend the

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First Amendment by chilling protected commercial speech.” Zauderer, 471 U.S. at 651. The warnings do not in any sense burden such speech because “[h]alf of cigarette packs” and “80% of advertisements remain available for their speech.” Commonwealth Brands, 678 F. Supp. 2d at 531.

Plaintiffs’ affiliated companies have operated under comparable warning requirements in Canada for more than a decade. Nevertheless, neither in this case, nor in Commonwealth Brands, where they presented the same claim, have plaintiffs offered any evidence that the format chilled their protected commercial speech. Indeed, the Canadian Supreme Court unanimously rejected a challenge analogous to the one asserted here, finding that “[t]he benefits flowing from the larger warnings are clear” while “[t]he detriments to the manufacturers’ expressive interest in creative packaging are small.” Canada v. JTI-Macdonald Corp., [2007] 2 S.C.R. 610, 2007 SCC 30, ¶ 139 (rejecting freedom-of-expression claim under the Canadian Charter of Rights and Freedoms).

Plaintiffs’ contention that the government failed to consider less-speech-restrictive alternatives was considered and rejected by the district court in Commonwealth Brands. Notably, the primary support plaintiffs offer for their argument is a declaration that was filed in that case and then resubmitted to FDA during its current rulemaking. See Pl. S.J. Br. 29 (citing Reynolds Decl., filed as Exhibit D to Comment Letter). There, as here, plaintiffs argued that Congress should have considered alternatives to the health warnings, such as “requiring states to use CDC-recommended levels of tobacco revenues for tobacco control programs,” “increasing support for interventions that address the personal and social factors that influence tobacco use,” “preventing the unlawful retail sale of tobacco products to youth by, e.g., increasing the compliance rate required by the Synar Amendment, Pub. L. No. 102-321, § 1926,” and “increasing the price of tobacco products.” Commonwealth Brands, 678 F. Supp. 2d at 537 (internal quotation marks and brackets omitted); compare Pl. S.J. Br. 29.

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But the district court in Commonwealth Brands correctly observed that “this is not a case where Congress went ‘straight to [plaintiffs’] speech,’” and emphasized that, rather, it is “a case where Congress, after decades of implementing various measures that did not affect Plaintiffs’ speech, decided to add label and advertising restrictions to its comprehensive regulation of the tobacco industry.” 678 F. Supp. 2d at 538. Indeed, the alternatives that plaintiffs offer are not new measures that the government has not not yet considered, but instead are all “‘variations on strategies already adopted’”: Congress has already barred tobacco sales to persons under 18, provided civil penalties for retailer violations, directed the Secretary to implement a program to ensure compliance, and enacted a 62-cent increase in the federal excise tax on cigarettes. Id. at 537–38 (citations omitted).

Plaintiffs’ proposals would also “impose substantial new costs on state and local governments and private persons.” Id. at 537. Plaintiffs themselves have argued that cigarette tax increases can unfairly burden low-income users, encourage illicit purchases, and produce other adverse effects. See, e.g., www.nocigtax.com/why-cig-… (Reynoldssponsored website); Campaign for Tobacco-Free Kids, Press Release (May 8, 2003) (noting that “Lorillard’s ads, which are running in Delaware, New Jersey and Pennsylvania, argue that cigarette tax increases lead to increased crime and cigarette smuggling”). 8 Plaintiffs’ other proposals would primarily punish states and retailers for taking inadequate measures to combat the evils of plaintiffs’ products, and minors for becoming addicted to plaintiffs’ product. See id. exh. D, Declaration of Cecil Reynolds ¶ 51 (recommending, among other things, measures to “[e]nhance the penalties for underage tobacco use and identify penalties that will be motivational and meaningful to the adolescents involved (e.g., loss of driver’s license)”).

8 www.tobaccofreekids.org/p… 22

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In short, the congressionally mandated health warnings directly advance a substantial— indeed, compelling—interest in conveying to consumers generally, and adolescents in particular, the devastating consequences of smoking and nicotine addiction. The means chosen by Congress do not chill speech and are narrowly tailored to achieve effective communication. Indeed, “there is no more efficient method of reaching smokers than through the use of graphic and highly visible warning labels.” Ellen Peters, et al., the Impact and Acceptability of Canadian-style Cigarette Warning Labels Among U.S. Smokers and Nonsmokers, 9 Nicotine & Tobacco Research 473, 479 (Apr. 2007). Thus, plaintiffs’ claim fails under any standard of review given the government interest at stake and the means adopted.

B. Plaintiffs’ First Amendment Contentions Are Without Merit.

Plaintiffs advance three principal contentions, all of which lack merit.9 First, they claim that the health warnings constitute impermissible “compelled speech” on the theory that they constitute an “ideological” message. Second, they argue that the warnings serve no purpose because all consumers are already fully aware of the consequences of smoking. Third, they argue that the warnings are impermissible in the absence of empirical proof demonstrating the extent to which larger pictorial warnings have caused the declines in smoking rates in Canada and other countries.

1. The Warnings Do Not Constitute an “Ideological Message.”

Plaintiffs seek to persuade the Court that the required health warnings are an impermissible attempt to require plaintiffs to espouse governmental “ideology.” In plaintiffs’ view, any expansion of the existing format converts the concededly accurate health warning into an ideological

9 Because the Commonwealth Brands litigation is still pending in the Sixth Circuit, we do not address the extent to which issue or claim preclusion would bar claims brought by Commonwealth Brands, Lorillard, and Reynolds, who are plaintiffs in that litigation, and Reynolds’ corporate affiliate Santa Fe. After the Sixth Circuit rules, we will address the issue as appropriate.

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“Government[] anti-smoking message.” Pl. S.J. Br. 2. Thus, in their joint comments to FDA, plaintiffs Reynolds, Lorillard, and Commonwealth Brands argued that the agency should “order that the Tobacco Control Act’s new textual warnings be displayed in the same manner in which the Surgeon General’s warnings have been displayed for years”—that is, without Congress’s changes to the size and placement of the warnings, and without the congressionally required images that depict the negative health consequences of smoking. See Comment Letter 3–4.

In their comments, as in their pleadings, plaintiffs laid particular stress on the requirement that the warnings contain “color graphics depicting the negative health consequences of smoking.” 15 U.S.C. § 1333 Note. They urged that images do not “simply convey information intended to enable smokers to make informed decisions about whether to smoke cigarettes” but instead convey “the Government’s viewpoint that the risks associated with smoking cigarettes outweigh the pleasure that smokers derive from them and, therefore, that no one should use these lawful products.” Comment Letter 2. Plaintiffs thus declared that “the proposed warnings convey to smokers the Government’s view that they should change in a significant way how they lead their lives,” and argued that “[t]he viewpoint the Government proposes to be conveyed on the manufacturers’ packaging and advertising is thus every bit as ideological as the message at issue in Wooley v. Maynard, 430 U.S. 705 (1977): ‘Live Free or Die.’” Ibid. They asserted that, “[i]n effect, the message and viewpoint of FDA’s proposed graphic warnings is: ‘Live Smoke-Free or Die.’” Ibid.

Plaintiffs’ attempts to portray the warnings as an ideological message are particularly remarkable because this tactic parallels so closely the tobacco industry’s traditional strategy of characterizing the Surgeon General’s reports on health risks as government propaganda that

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appealed to fear rather than to reason. 10 Plaintiffs can no longer overtly question the accuracy of the crippling health consequences of smoking. Instead, they refer to the health warnings as an “ideology” as if they constituted statements of political viewpoint to be weighed against the competing claims of other “ideologies.”

There are no clashing ideologies at work here. The disclosures seek to effectively convey to individual consumers the undisputed facts that “tobacco use, particularly among children and adolescents, poses perhaps the single most significant threat to public health in the United States,” and that smoking “kills more people each year in the United States than acquired immunodeficiency syndrome (AIDS), car accidents, alcohol, homicides, illegal drugs, suicides, and fires, combined.” Brown & Williamson, 529 U.S. at 134–35, 161 (internal quotation marks omitted). As discussed in detail below, each of the images chosen by FDA accurately enhances the communication of an entirely noncontroversial disclosure about the risks of smoking.

Plaintiffs’ mistaken attempt to transform accurate warnings into an ideological message is epitomized bytheir repeated assertion that the FDA Commissioner acknowledged that “the warnings are intended to ensure that ‘every single pack of cigarettes in our country will in effect become a mini-billboard’ for the Government’s anti-smoking message.” Pl. S.J. Br. 2. What the Commissioner actually said is that the warnings are intended to ensure that “every single pack of cigarettes in our country will in effect become a mini-billboard that will tell the truth about

10 Thus the tobacco industry once proclaimed that “opponents of cigarettes are endeavoring to scare pregnant women with such statements as that of the Surgeon General that ‘we are losing babies because of mothers’ smoking.’” Philip Morris, 449 F. Supp. 2d at 194. And it responded to the 1988 Surgeon General report by declaring that “CLAIMS THAT CIGARETTES ARE ADDICTIVE IRRESPONSIBLE AND SCARE TACTICS.” Id. at 283.

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smoking.”11 (Emphasis added.) Plaintiffs have identified no respect in which the warnings do not “tell the truth about smoking.”

Indeed, plaintiffs have recognized in a variety of other forums that an “anti-smoking message” has long ceased to be controversial, and it cannot plausibly be characterized as an “ideology.” Plaintiffs not only publicly recognize the risks associated with their own product but further declare that, in light of those undisputed risks, consumers should not begin to smoke or should cease smoking. Santa Fe Natural Tobacco Company offers this message to nonsmokers: “[W]e cannot stress this enough: If you don’t smoke, don’t start.” www.sfntc.com. Elsewhere on their web site the company asserts: “[W]e never encourage non-smokers to start, or existing smokers to smoke more.” www.sfntc.com/Quit-Smokin…. The website provides links to twenty cessation resources and wishes smokers “the best of luck” in trying to quit.

Ibid. Lorillard’s website states that “[t]he only way to avoid the health effects of cigarette smoking is to not smoke. The best way to reduce the health effects of cigarette smoking is to quit, and quitting smoking greatly reduces serious risks to health.” www.lorillard.com/?s=quit… smoking. And, in a recent submission to FDA, Reynolds acknowledged that “it is indisputable that quitting is the only safe alternative to using any tobacco product.” R.J. Reynolds, Citizen Petition 4, Docket No. FDA-2011-P-0573 (Jul. 8, 2011); see also R.J. Reynolds, Guiding Principles and Beliefs, available at www.rjrt.com/prinbeliefs…. (“The best course of action for tobacco consumers concerned about their health is to quit.”). Plaintiffs’ expert in Commonwealth Brands explained that it is uncontested that persons seeking to avoid the deadly consequences of smoking should not consume cigarettes. Rodu Decl. ¶ 30 (R. 72-2, No. 1:09-cv-117 (W.D. Ky.)); see also

11 www.fda.gov/TobaccoProduc… (audio, minute21:24) (quoted at Pl. S.J. Br. 2, 16).

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Nat’l Citizens Comm. for Broad. v. FCC, 567 F.2d 1095, 1100 n.13 (D.C. Cir. 1977) (citing with approval Larus & Brother Co. v. FCC, 447 F.2d 876, 880 (4th Cir. 1971), for upholding the FCC’s determination that the broadcast of “anti-smoking messages” did not trigger an obligation under the fairness doctrine to broadcast views advocating smoking “because the issue is no longer a matter of public controversy”).

Plaintiffs also assert that the health warnings convey “the Government’s viewpoint that the risks associated with smoking cigarettes outweigh the pleasure that smokers derive from them.” Comment Letter 2. In doing so, they resurrect the thoroughly discredited claim that consumers continue to smoke for pleasure after rationally weighing their immediate enjoyment against the prospect of lung and heart disease. But plaintiffs have understood for decades that they retain their customers not because of their pleasure in smoking, but because smokers must satisfy their need for nicotine, which, plaintiffs’ expert explained in Commonwealth Brands, is the “substance in tobacco that inveterate smokers crave.” Rodu Decl. ¶ 40 (R. 72-2, No. 1:09-cv-117 (W.D. Ky.)). Thus, in the single year of 2004, “approximately 40.5 percent of adult smokers attempted to quit, [but] only between 3 and 5 percent were successful.” 75 Fed. Reg. at 69,529. Indeed, as long ago as 1985, Philip Morris’s top management was informed that research showed that “the majority of smokers wished they did not smoke.” Philip Morris, 566 F.3d at 1128 (quotation marks omitted).

Even if an “anti-smoking message” were not so clearly noncontroversial, cases such as Wooley would have no bearing on the analysis here. As the Supreme Court in Zauderer explained, Wooley stands for the proposition that the government may not “prescribe what shall be orthodox in politics, nationalism, religion, or other matters of opinion or force citizens to confess by word or act their faith therein.” Zauderer, 471 U.S. at 651 (citation and internal quotation marks omitted).

In contrast, “[b]ecause the extension of First Amendment protection to commercial speech is

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justified principally bythe value to consumers of the information such speech provides, [the seller’s] constitutionally protected interest in not providing any particular factual information in his advertising is minimal.” Ibid.

Appellate decisions cited by plaintiffs distinguish between factual disclosures (which are reviewed under the relaxed standard of Zauderer) and “subjective” or “opinion-based” disclosures.

In Entertainment Software Ass’n v. Blagojevich, 469 F.3d 641 (7th Cir. 2006), for example, the Seventh Circuit invalidated a law that required video game manufacturers to place a warning label on games deemed to be “sexually explicit.” Id. at 651–52. The label was to be applied only to games “‘that the average person, applying contemporary community standards would find, with respect to minors, is designed to appeal or pander to the prurient interest.’” Id. at 643. That definition incorporated “widely divergent local standards” of offensiveness, id. at 650, making it “subjective and highly controversial” and therefore subject to strict scrutiny, id. at 652.

The Seventh Circuit, id. at 651–52, distinguished these subjective warnings from the Vermont statute upheld by the Second Circuit in National Electrical Manufacturers Ass’n v. Sorrell, 272 F.3d 104, 107 (2d Cir. 2001), which required manufacturers to label products containing mercury and to inform consumers that these products should be recycled or disposed of as hazardous waste. The Second Circuit applied the Zauderer standard, noting that “the compelled disclosure at issue . . . was not intended to prevent ‘consumer confusion or deception’ per se, but rather to better inform consumers about the products they purchase.” Id. at 115 (citations omitted). The court stressed that requiring “commercial actors [to] disclose commercial information ordinarily does not offend the important utilitarian and individual liberty interests that lie at the heart of the First Amendment,” and that such requirements will withstand judicial scrutiny as long as there is “a rational connection between the purpose of a commercial disclosure requirement and the means

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employed to realize that purpose.” Id. at 114–15 (citing Zauderer, 471 U.S. at 651).12

2.

The Health Warnings Convey Risks of Addiction and Smoking that Are Not Adequately Appreciated by Consumers Generally and Adolescents in Particular.

The second prong of plaintiffs’ argument is their insistence that no valid purpose can by served by changing the format of the current warnings because “Americans, young and old alike, are well aware of the health risks of smoking.” Pl. S.J. Br. 14. In this vein they assert that “the health risks of smoking have already been ‘disseminated to and absorbed by an overwhelmingly high percentage of the population’ through the familiar Surgeon General’s warnings and numerous other means.” Ibid. (citation omitted).

Such claims are particularly ironic in light of the tobacco industry’s fifty-year enterprise to deceive the American public about the dangers and addictiveness of smoking and to discredit the Surgeon General’s reports of health risks. Philip Morris, 566 F.3d 1095. Their arguments about the dissemination of the message of the adverse health consequences of smoking and the consequent lack of need for any further warnings were decisively rejected by the district court in Philip Morris and are no more convincing here.

Plaintiffs’ arguments ignore judicial findings and the vast literature regarding perception of the health risks associated with smoking, and rely, instead, on the declaration of their expert, Dr. W.

12 Plaintiffs’ reliance on Brown v. Entertainment Merchants Ass’n, 131 S. Ct. 2729 (2011), is likewise misplaced. See Pl. S.J. Br. 28. The Court in that case considered the validity of a law that prohibited the sale or rental of violent video games to minors. As a content-based restriction on protected speech, the Court subjected the law to strict scrutiny, and concluded that it was not narrowly tailored. 131 S. Ct. at 2738. As already explained, the disclosure requirements here at issue are not subject to strict scrutiny. Just as they have nothing in common with the compelled ideological speech at issue in Wooley, theyare readily distinguishable from the restrictions on access to video games addressed in Brown. Nor do plaintiffs advance their argument by relying on Pacific Gas & Electric Co. v. Public Utilities Commission, 475 U.S. 1, 8–9 (1986), where the Supreme Court specifically held that the speech at issue was not commercial speech.

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Kip Viscusi, who admitted at trial in Philip Morris that his research was commissioned by tobacco industry law firms for use in litigation. Trial Tr. vol. 88, 17930 (Apr. 6, 2005) (filed as R. 98-1 at A16, Commonwealth Brands, No. 1:09-cv-117 (W.D. Ky.)). Myriad independent studies contradict Dr. Viscusi’s position. The Institute of Medicine explained in 2007 that “adolescents misperceive the magnitude of smoking harms and the addictive properties of tobacco and fail to appreciate the long-term dangers of smoking, especially when they apply the dangers to their own behavior.” IOM Report at 93. Although adolescents overestimate certain risks, such as the statistical risk of lung cancer, they underestimate the degree to which smoking can shorten life and the likelihood that they will suffer tobacco-related disease. Id. at 89-90. Both adolescent and adult smokers were more than twice as likely as nonsmokers to doubt that tobacco use, even for a period of 30 to 40 years, would cause death. Id. at 90. Adolescents fail to recognize that smoking causes more deaths than gunshots, car accidents, alcohol, and the use of other drugs. Ibid. And they “typically underestimate the tenacity of nicotine addiction and overestimate their ability to stop smoking when they choose.” President’s Cancer Panel, Promoting Healthy Lifestyles, at 64 (2007).

Dr. Viscusi disregards this body of investigation, and his limited discussion of scientific studies is inaccurate. For example, Dr. Viscusi invokes the research of Drs. Weinstein and Slovic to support his claim that “young people overestimate the dangers of smoking to an even greater degree [than adult smokers].” Comment Letter exh. A, Statement of W. Kip Viscusi (“Viscusi Statement”), at 28. Drs. Weinstein and Slovic were experts for the government in United States v. Philip Morris, and what they actually found is that “most people have only a superficial awareness that smoking is dangerous,” 449 F. Supp. 2d at 578 (citing Slovic); “individuals have little knowledge of the reality of the pain, suffering, and despair of those with lung cancer, emphysema, congestive heart failure, and other smoking related diseases,” ibid. (citing Weinstein & Slovic);

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“[m]ore than 70% of adults and 80% of adolescents overestimated the likelihood that lung cancer is curable,” ibid. (citing Weinstein & Slovic); “adolescents not only underestimate the harm that results from smoking cigarettes, but are overly optimistic about their ability to quit smoking,” ibid.

(citing Weinstein); and “[m]ost smokers only begin to think of risk after they have started to smoke regularly and have already become addicted,” id. at 576 (citing Slovic). Summarizing, the Philip Morris court explained that “the research and expert testimony demonstrate that most youth, at a time when they are deciding whether to start smoking, have a very inadequate understanding of the medical consequences, physical pain, and emotional suffering which results from smoking and the unlikelihood of their being able to quit smoking at some future time.” Id. at 579–80. Plaintiffs would have the Court ignore these well-established facts.

3.

The Constitutionality of the Required Warnings Does Not Require a Statistical Determination Regarding the Extent to Which the Decline in Smoking Rates in Canada Should Be Attributed to the Introduction of New Health Warnings There.

To bolster their contention that the revised health warnings do not advance the government’s public health interests, plaintiffs argue that the warnings will “have no material impact” on smoking rates. See Pl. S.J. Br. 7; see also id. at 39 (urging that the administrative record is “devoid of evidence” that the rule will “convinc[e] smokers [to] reduce their smoking, make an attempt to quit, or quit altogether” (internal quotation marks and citation omitted)).

This argument reflects plaintiffs fundamental misunderstanding of the nature and purpose of the warnings. As mandated by Congress, the purpose of the warnings is “to effectively convey the negative health consequences of smoking on cigarette packages and in advertisements.” 76 Fed. Reg. at 36,697; see also Commonwealth Brands, 678 F. Supp. 2d at 530 (“[T]he government’s goal is . . . to ensure that the health risk message is actually seen by consumers in the first instance.”).

Congress concluded, and the FDA affirmed, that the revised warning format does more effectively

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convey information about health risks to consumers and potential consumers than text-only warnings. Plaintiffs’ focus on smoking rates, rather than the conveyance of information, misapprehends relevant constitutional concerns. See generally Nat’l Elec. Mfrs. Ass’n, 272 F.3d at 115 (upholding requirement that products containing mercury be labeled with a recommendation that they be recycled or disposed of as hazardous waste, without requiring any showing by the state that the disclosure actually caused consumers to recycle or dispose of the labeled products in the suggested manner, because it is sufficient for First Amendment purposes that the compelled disclosure “better inform[s] consumers about the products they purchase”).

In any event, the evidence does not indicate that the format required by Congress will have no material impact on smoking rates. Both the World Health Organization and the Institute of Medicine, after examining the full body of scientific research on graphic warnings, concluded that such warnings would reduce smoking rates. 75 Fed. Reg. at 69,531 (discussing Institute of Medicine report concluding that “larger, graphic health warnings would promote greater public knowledge of the health risks of using tobacco and would help reduce consumption”); ibid. (discussing WHO report finding that “taken as a whole, the research on graphic health warnings show that they are . . .

associated with increased motivation to quit”). Other studies reinforce that conclusion. For example, in one Canadian study, twenty-six percent of smokers who quit after the introduction of graphic warnings reported that the “graphic warnings on cigarette packages helped them remain abstinent.” Id. at 69,532.

A surveyof Australian youth found that “adolescents who were experimenting with smoking or were established smokers indicated that they thought more about forgoing cigarettes after graphic warnings appeared on cigarette packages in 2006.” Ibid. Summarizing the results of fifteen studies, a more recent review concluded that “significant proportions of adult and youth smokers report that

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large text and pictorial health warnings have reduced their consumption levels, increased their likelihood of quitting, increased their motivation to quit and increased the likelihood of remaining abstinent following a quit attempt.” David Hammond, Health Warnings Messages On Tobacco Products: A Review, 20 Tobacco Control 327, 331 (2011).

Several studies also demonstrated that the introduction of graphic warnings prevented smokers from smoking as much as they normally would, and made smokers abstain from exposing others to secondhand smoke. 75 Fed. Reg. at 69,534. A survey of Canadian smokers indicated that “21 percent of smokers reported that on one or more occasions they chose not to smoke a cigarette due to the warnings on cigarette packages,” and that “27 percent of participants reported that the then-new graphic warnings motivated them to smoke less inside their homes.” Id. at 69,532.

Another study of young Canadian smokers found that “22.6 percent of current male smokers and 26.6 percent of current female smokers reported that in the past month, noticing the warning on cigarette packages led them to decide not to have a cigarette.” Ibid.

As discussed in greater detail below, the FDA did not, as plaintiffs claim, conclude that the new format would have no impact on smoking rates. See infra 46–49. FDA noted, after the introduction of graphic warnings in Canada, that smoking rates in that country dropped steeply. 76 Fed. Reg. at 36,710 (explaining that “Canada’s smoking rate has decreased by around seven percentage points . . . since the implementation of graphic warning labels”). FDA’s regulatory impact analysis concluded only that it could not determine in a statistically significant way the extent to which the decline in Canadian smoking rates was attributable to the introduction of new warnings as opposed to other measures. FDA’s lack of certainty as to the causes of the drop in Canadian smoking rates cannot properly be understood as an admission that the warnings here will not reduce smoking rates.

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Similarly, Dr. David Hammond recently concluded that, as compared to text-only warnings, “pictorial warnings are more likely to be noticed and read by smokers, [and] are associated with stronger beliefs about the health risks of smoking, as well as increased motivation to quit smoking.” Hammond, 20 Tobacco Control at 330. Plaintiffs nevertheless cite the same publication to insist that Dr. Hammond believes that pictorial warnings are ineffective. See P.I. Reply 11 n.12; P.I. Hr’g Tr. 73, 76–77. In the passage quoted by plaintiffs, Dr. Hammond notes the difficulties inherent in determining the extent to which pictorial warnings accounted for the documented decline in Canadian smoking rates following their introduction, noting that the decline may also have been influenced by other public health measures. See 20 Tobacco Control at 331.

III.

FDA Adopted Images to Accompany the Text of the Health Warnings that Accurately Convey the Extraordinary Risks of Smoking Consistent with the First Amendment and the APA.

A.

The Images Selected By FDA Raise No First Amendment Concerns.

1.

FDA Properly Considered the “Salience” of the Proposed Warnings, i.e., the Extent to Which Consumers Will Notice and Process the Warnings Over Time.

As discussed in Part II, plaintiffs assert that Congress could not, consistent with the First Amendment, require inclusion of images depicting the negative consequences of smoking of the kind already mandated in Canada, Australia, Great Britain and approximately 30 other countries.

Thus, in plaintiffs’ view, none of the 36 images considered by the FDA in its rulemaking would pass constitutional muster. The only acceptable form of image in plaintiffs’ view is a graph. P.I. Hr’g Tr. 16. As we have demonstrated, no principle of First Amendment law precludes Congress from requiring images to accompanying the text of the health warnings.

Plaintiffs’ challenge to the images selected by FDA to accompany the text of the nine warnings is likewise flawed. In selecting the nine images, FDA reviewed extensive scientific

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literature, the experience of other countries, and over a thousand comments. See 76 Fed. Reg. at 36,629. FDA also conducted a study to measure consumer responses to the 36 warnings submitted for comment in the proposed rulemaking. That study divided 18,000 participants into three study groups: adult smokers (age 25 or older), young adult smokers (aged 18 to 24), and youth (aged 13 to 17) who currently smoke or who are susceptible to smoking. Id. at 36,637. The study randomly exposed study participants to a cigarette package or an advertisement containing one of the prospective warnings proposed by FDA or a control set of text-only warnings. FDA Study Report at 1-3; 4-1. The study then asked each participant to answer a series of questions about the warning.

Id. at 1-3. These questions were designed to elicit participants’ immediate reactions to the warnings.

These “salience” measures include cognitive responses (e.g., belief that the warnings were, for instance, informative, meaningful, or difficult to look at) and emotional responses (e.g., worry, disgust, etc.). Id. app. A, at A-3.

FDA recognized, based on the substantial body of scientific literature discussed above, that such cognitive and emotional responses reliably predict the likelihood that consumers would understand and appreciate the warnings’ messages. Id. at 4-1. The study also attempted to assess whether the warnings would enhance recall of the warning statement, change the self-reported beliefs about the health risks of smoking, or impact the participants’ intentions to quit or initiate smoking. Id. at 1-3; 76 Fed. Reg. at 36,638; see infra 37–44 (discussing study results).

Plaintiffs fundamentallymisunderstand “salience,” which theycharacterize as “a euphemism for shock value.” P.I. Hr’g Tr. 12. FDA repeatedly explained that the “emotional” reactions of consumers are germane because they predict the likelihood that viewers will notice and process the information contained in the text. See FDA Study Report at 1-2, 4-1 (citing studies); 76 Fed. Reg at 36,639 (same). The agency explained that “[t]he overall body of scientific evidence indicates that

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health warnings that evoke strong emotional responses enhance an individual’s ability to process the warning information, leading to increased knowledge and thoughts about the harms of cigarettes and the extent to which the individual could personally experience a smoking-related disease.” Id. at 36,641. The images selected “were designed to correlate with [the] warning statements,” and the “available evidence base highlights the value of the text and images in graphic health warnings relating to one another in a meaningful way.” Id. at 36,637 (citations omitted).

FDA noted that some comments criticized specific images as “disturbing” or “eliciting emotions.” Id. at 36,696. These included the image “depicting a man smoking through a tracheostomy opening,” the image “depicting healthy lungs juxtaposed with lungs damaged by smoking,” the image “depicting a lesion consistent with that caused by oral cancer,” and the image “depicting a man with an autopsy scar.” Ibid. The comments “did not assert, however, that the effects shown in the images are false, i.e., that they are not manifestations of negative health consequences of smoking, such as throat, lung, and oral cancer, and death.” Ibid. (emphasis added).

The agency emphasized: “The fact that the images are disturbing or evoke emotion does not mean that they are not factual representations of the effects of smoking. . . . As such, it is not surprising that the warnings regarding the negative health consequences of smoking would evoke emotions such as fear of being stricken with life-threatening cancer or disgust at what it might be like to have that happen.” Ibid. The images do not, as plaintiffs claim, “exaggerate the effects of sickness and disease.” Pl. S.J. Br. 21. FDA explained that, although “some of the photographs were technologically modified to depict the negative health consequences of smoking, the effects shown in the photographs are, in fact, accurate depictions of the effects of sickness and disease caused by smoking, and the comments did not dispute this fact.” 76 Fed. Reg. at 36,696.

Ultimately, plaintiffs’ objection is not that these images are false but that they are true: they

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accurately communicate that smoking causes disease and death. As we have already discussed, see supra 23–29, plaintiffs’ attempt to characterize these warnings a controversial, ideological “antismoking message” is without basis.

2.

Plaintiffs Have Waived Any Challenge to the Specific Warnings Selected by FDA, Which Accurately Convey Consequences of Smoking.

As noted, plaintiffs’ argument does not differentiate among the images considered or selected. Their pleadings offer scattered observations about some of the images chosen by the agency; but they do not contend that these warnings are any more or less constitutionally suspect than the other images reviewed or adopted in the rulemaking. Plaintiffs have thus waived any argument that the Court should hold specific images invalid if it does not accept their contention that all the images offend First Amendment constraints.

FDA did respond, at length, to other commenters whose comments with respect to specific images, explained why, in their view, some of the proposed graphics were more effective or less appropriate than others. We therefore address each of the images selected by FDA to accompany the text of the health warnings as well as the general objections advanced by plaintiffs. This section elaborates the previous discussion at 17–20 regarding the interaction of pictorial and text content in conveying the warnings’ messages.

“WARNING: Cigarettes are addictive.” FDA selected the image of a man smoking through a tracheostomy hole in his throat. 76 Fed. Reg. at 36,649. Plaintiffs do not deny that this image is a factual and accurate depiction of a health consequence of smoking. As FDA explained, “[t]he image effectively and concretely communicates the negative health consequences of smoking,” and “clearly portrays the addictive nature of cigarettes, depicting a man who is still smoking despite prior evidence (a stoma in his neck) of surgery for cancer.” Ibid. Indeed, smoking rates are “particularly high” even among those who have already been diagnosed with and are being

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treated for head and neck cancer; for example, two studies found that “55–69% of head and neck cancer patients are current smokers.” Robert A. Schnoll & Caryn Lerman, Smoking Behavior and Smoking Cessation among Head and Neck Cancer Patients, in HEAD AND NECK CANCER: EMERGING PERSPECTIVES 185, 187 (John F. Ensley ed. 2003) (citing studies).

The image also performed particularly well in FDA’s consumer study: the image “had a

13

significant effect (p<0.001)[ ] on all salience measures” across “all three study populations.” 76Fed. Reg. at 36,649. The image also “had a significant impact (p<0.05) on adult beliefs about the health risks of smoking for smokers and a significant impact (p<0.05) on adult beliefs about the health risks of secondhand smoke exposure for nonsmokers, relative to the text-only control.” Ibid.

Although the image was associated with “lower statement recall at one week follow-up,” FDA explained that “recall of the statement was generally high for the image,” and concluded that “repetitive viewing of the required warning is likely to increase recall.” Ibid. Furthermore, many comments—including those from “public health advocacygroups, academics, State and local public health agencies, and health care professionals”—supported use of this image. Ibid. FDA was amply warranted in rejecting a comment that “the image would only have a one-time shock value,” explaining that “the research literature suggests that more vivid warnings are more likely to retain their salience over time.” Ibid.

“WARNING: Tobacco Smoke Can Harm Your Children.” FDA selected the image of smoke approaching a baby for this warning statement. Ibid. Plaintiffs urge that this image does not “even purport to describe, as a factual matter, the health consequences of exposing children to

13 The consumer study reported the “p-values”—the significance levels—of each of its findings. For findings that were significant at the 0.001 confidence level (p<0.001), “there is less than one chance in a thousand that the finding happened by coincidence.” 76 Fed. Reg. at 36,648.

And for findings that were significant at the 0.05 confidence level (p<0.05), there is less than a 5% chance that the finding was a coincidence. Ibid.

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second-hand smoke,” P.I. Reply 6, echoing comments that “the child does not appear to be suffering harms to his health” and “looks too healthy,” id. at 36,650. But as FDA explained, “[g]raphic depictions of the visible effects of disease are not the only way of communicating the health risks of second hand smoke for children, some of which (such as impaired lung growth), are not necessarily visible in a photograph of a child exposed to secondhand smoke.” Id. at 36,650. The chosen image also performed well in the consumer study, showing a significant effect on all the salience measures in all three study populations. Id. at 36,649–50. Moreover, the image “had a statistically significant effect (p<0.05) on youth intentions to not smoke in the next year, with 71.6 percent of youth viewing the image reporting that they would not be likely to smoke in the next year, compared to 56.9 percent in the text only control.” Id. at 36,650. Thus, as FDA concluded, the warning “depicts the health consequences of secondhand smoke exposure in a manner that has an impact on both smokers and potential smokers.” Id. at 36,650–51.

“WARNING: Cigarettes Cause Fatal Lung Disease.” FDA selected the image comparing healthy and diseased lungs to accompany this warning statement. Id. at 36,651. Plaintiffs do not deny that this image is a factual and accurate depiction of a health consequence of smoking. In FDA’s consumer study, the image “had a significant effect (p<0.001) on all the salience measures . . . in all three study populations” as compared to the text-only control, and “showed some of the largest effect sizes for image recall (at baseline and at 1 week follow-up) in adults and youth across the images proposed for use with this warning statement.” Ibid.

“WARNING: Cigarettes Cause Cancer.” FDA selected the image showing a cancerous lesion on a lip. Ibid. Plaintiffs do not deny that this image is a factual and accurate depiction of a health consequence of smoking. FDA received “a large number of comments supporting the use of [this] image” including comments from “public health advocacy groups, a medical organization,

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academics, State and local public health agencies, and health care professionals.” Id. at 36,652.

Several of those comments noted that the image “has a very high potential to reach consumers and positively influence their behavior.” Ibid. Other comments “addressed the benefits of using an image that shows the public that cigarettes cause oral cancers, noting that public awareness of this negative health consequence is low, and that many smokers and nonsmokers only relate cigarettes to lung cancer.” Ibid.

FDA also found that “the selected image . . . is likely to have particular relevance for youth,” because “the research literature suggests that youth are likely to relate to and be susceptible to cigarette warnings depicting the negative short-term impacts of smoking on their personal appearance, including their lips and teeth.” Ibid. FDA’s consumer study indicated that the image had “a significant effect (p<0.001) on all the salience measures . . . in all three study populations,” and the “numerically largest effects of the images proposed for use with this warning statement on the emotional reaction scale and had the numerically largest effects on the cognitive reaction scale in young adults and youth.” Id. at 36,651.

“WARNING: Cigarettes Cause Strokes and Heart Disease.” FDA selected the image depicting a man with an oxygen mask on his face. Id. at 36,652. Plaintiffs do not deny that this image is a factual and accurate depiction of a health consequence of smoking. FDA selected this image in part because “the person shown in this image is an older man,” while other images “show younger people.” Id. at 36,653. FDA explained that this image thus helped fulfill the goal of “selecting a set of required warnings that includes a diversity of . . . human images (e.g., race, gender, age),” such that “the nine selected required warnings will effectively communicate to a wide range of consumers, including both young and older smokers.” Ibid. Moreover, in FDA’s consumer study the image “had a significant effect (p<0.001) on all the salience measures . . . in all three study

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populations (adults, young adults, and youth).” Id. at 36,652. The image “also showed some of the largest effect sizes for image recall (at baseline and 1 week follow-up) in adults and youth across the images proposed for use with this warning statement.” Id. at 36,653. The image was identified by public health groups as “the best image for use with this warning statement.” Ibid.

“WARNING: Smoking During Pregnancy Can Harm Your Baby.” FDA selected a graphic illustration of a baby in an incubator. Plaintiffs criticize this image as a “non-factual cartoon drawing[],” Pl. S.J. Br. 21, but do not contend that a graphic illustration cannot convey factual and accurate information. FDA correctly noted that “[t]he style of the depiction—here, a graphic illustration—does not make it less factual,” id. at 36,696, and further explained that “the importance of selecting a set of required warnings that includes a diversity of styles (e.g., photographic versus illustrative),” is demonstrated by the experience of other countries, id. at 36,653.

More important, plaintiffs suggest no respect in which the use of the image contained in the FDA warning fails to convey the health risks described in the undisputed accompanying text.

Cigarette manufacturers maintained for decades that smoking during pregnancy would have no adverse impact long after they knew the contrary to be true. See Philip Morris, 449 F. Supp. 2d at 194. At this point, however, plaintiffs no longer dispute that “smoking during pregnancy has negative effects, including increasing rates of preterm delivery and shortened gestation.” 76 Fed. Reg. at 36,696. Nor do they offer any basis for setting aside the agency’s conclusion that the image “accurately depicts the health consequences smoking during pregnancy can have for infants born to mothers who smoke.” Ibid.

FDA’s consumer research study showed that this image “had a significant effect (p<0.001) on all the salience measures . . . in all three study populations (adults, young adults, and youth).” Id. at 36,653. Those effects were the “numerically largest” among of the “images proposed for use

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with this warning statement.” Ibid. The image also had significant effects on recall of the warning statement as compared to the text-only baseline in all three study populations. Ibid. Although the image also had a significant effect on the beliefs about the risks of smoking among adults, it was associated with a decreased awareness of health risks for youth smokers. Ibid. But, “given the strength of the effects observed for this image on the salience measures,” which FDA found to be the most relevant metric, FDA found that the warning is “is likely to increase awareness of the health risks of smoking and increase the likelihood that smokers will reduce their smoking, make an attempt to quit, or quit altogether.” Ibid.

“WARNING: Smoking Can Kill You.” FDA selected the image depicting a man on an autopsy table with an autopsy scar. Id. at 36,654. Plaintiffs claim that this image is inaccurate because “autopsies [are not] a common result of cigarette smoking.” Pl. S.J. Br. 21. Plaintiffs do not dispute, however, that smoking kills 443,000 Americans each year, id. at 36,629, or that, among children that become regular smokers, “about half eventually will die from a disease caused by tobacco use,” Promoting Healthy Lifestyles, supra, at 64 (emphasis added). As FDA explained, “[v]iewers will understand that the image shows someone who has died from a smoking-related cause,” particularly because “the image is not used in isolation, but accompanies the textual warning statement, which provides additional context for what is shown.” 76 Fed. Reg. at 36,655. The autopsy image thus underscores the factual, non-controversial information contained in the warning statement, and is a good deal less “disturbing” than photographs of the most common ravages of the diseases caused by plaintiffs’ products.

FDA’s consumer study indicated “that viewers from all age groups understood and reacted to this image in desirable ways.” Ibid. The image had “a significant effect (p<0.001) on all the salience measures . . . in all three study populations (adults, young adults, and youth).” Id. at

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36,654. The image was also “associated with higher intentions to quit smoking compared to the text-only control (p<0.05) in adults.” Ibid.

“WARNING: Tobacco Smoke Causes Fatal Lung Disease In Nonsmokers.” FDA selected the image of a woman crying to accompany this warning statement. Id. at 36,655.

Plaintiffs do not dispute FDA’s conclusion that “the image is a realistic portrayal of how the negative health consequences caused by exposure to secondhand smoke can affect people.” Id. at 36,656. FDA explained that “the negative health consequences caused by secondhand smoke exposure, including fatal lung disease, have many dimensions, including emotional suffering,” and that the selected image “highlights that dimension.” Ibid. Moreover, as FDA explained “the image is not used in isolation, but accompanies the textual warning statement, which provides additional context for what is shown.” Ibid. The image performed well in FDA’s consumer study: it had significant effects across the salience metrics in all three study populations, and “a significant impact (p<0.05) on beliefs about the health risks of smoking for smokers in young adults.” Id. at 36,655.

“WARNING: Quitting Smoking Now Greatly Reduces Serious Risks To Your Health.” FDA selected the image of a man wearing a t-shirt that says “I Quit” to accompany the warning statement. Id. at 36,656. Plaintiffs urge that this image “says absolutely nothing about the risks of smoking or the benefits of quitting.” P.I. Reply 6. FDA explained that research indicates “that warnings that focus on the benefits of quitting are effective at encouraging cessation, and suggests that positive, self-efficacy messages can be used effectively as one component of graphic health warnings to increase smokers’ motivations and confidence about quitting.” 76 Fed. Reg. at 36,656.

The agency observed that “[t]he research literature also highlights the importance of including one or more warnings that provide solutions, such as the ‘man I Quit t-shirt’ required warning, in a set of warnings conveying the negative health consequences of smoking.” Ibid. Thus, “the literature

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recommends that, in addition to communicating the health risks of smoking, some warnings should also provide information on how to avoid these risks (i.e., by quitting), in order to optimize the effectiveness of the overall set of warning messages.” Ibid. The image showed significant effects in FDA’s consumer study: it had a significant impact in the cognitive reaction scale in all three study populations, and “showed the largest effect sizes for image recall (at baseline and 1 week follow-up) in adults, young adults, and youth across the images proposed for this warning statement.” Ibid.

In sum, individually and as a group, the warnings combine text and image to convey accurate information of the consequences of smoking.

3.

The Inclusion of a Phone Number for a Smoking Cessation Resource Raises No First Amendment Concerns.

Plaintiffs do not advance their argument by insisting that inclusion of a telephone number for a nationally recognized smoking cessation resource—1-800-QUIT-NOW—in the health warnings violates the First Amendment. FDA explained (and it is not disputed) that studies have found that “health warnings are more effective if they are combined with cessation-related information.” 76 Fed. Reg. at 36,681. Indeed, because of the powerfully addictive nature of plaintiffs’ products, the overwhelming majority of smokers who try to quit fail in their efforts in any given quit attempt. Id. at 36,700.

The phone number plaintiffs complain about is that of the preexisting “National Network of Tobacco Cessation Quitlines (Network), which uses the telephone portal 1-800-QUIT-NOW” provided by the National Cancer Institute. Id. at 36,681. Based on the caller’s area code, the Network “routes calls to the appropriate State quitline.” Ibid. These state quitlines receive “significant support and oversight” from the Centers for Disease Control and Prevention, which will now require that these quitlines comply with all the requirements set out in the final rule. Ibid.

Plaintiffs’ sole objection is that this smoking-cessation resource uses the telephone number

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“1-800-QUIT-NOW.” See Pl. S.J. Br. 23. The use of dashes and the fact that it begins with “1-800” makes plain to any reasonable reader that it is a telephone number to call, and the fact that the number is in an easy-to-remember form does not make it a “subjective policy message.” Ibid. At most, the telephone number conveys that quitting smoking is beneficial, which is plainly permissible. One of the textual warnings, which the tobacco companies “do not challenge” because it contains “purely factual information,” id. at 20, states: “WARNING: Quitting smoking now greatly reduces serious risks to your health.” 15 U.S.C. § 1333 Note.

Plaintiffs’ arguments recapitulate their contention that the warnings reflect a government “ideology,” a contention wholly without merit. See supra 23–29. As discussed, plaintiffs’ own websites conveythe samewarnings and, indeed, Lorillard’s web site instructs consumers who follow that advice to call the same phone number that plaintiffs challenge here on constitutional grounds: “For help in quitting smoking call 1-800-QUITNOW (TTY 1-800-322-8615), which is a 24-hour toll-free number to the National Network of Tobacco Cessation Quitlines.”14

B.

Plaintiffs’ APA Challenge Reduces to the Contention that the Agency Should Have Declined to Implement the Statutory Mandate.

Plaintiffs’ quarrel is not with the FDA but with Congress. They asserted in the rulemaking, and continue to maintain, that the only constitutionally acceptable course for the agency would be to require warnings that include the new text mandated by Congress but that appear in precisely “the same manner in which the Surgeon General’s warnings have successfully been displayed for decades.” Comment Letter 24. Plaintiffs’ comments necessarily acknowledged that the statute precluded this course of action, but made the extraordinary suggestion that the agency should assert the Executive Branch’s constitutional duty to take care that the law shall be faithfully executed “to

14 www.lorillard.com/respons….

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eliminate constitutional and other infirmities.” Ibid.

It is thus unsurprising that plaintiffs’ APA arguments challenging the rulemaking add nothing to their constitutional claim that the size and placement of the health warnings, as well as the inclusion of images, violate the First Amendment. Plaintiffs’ objections to the rulemaking generally condemn the agency for faithfully implementing the statute or for not amassing additional evidence in support of the judgment already made by Congress.

1. The Regulatory Impact Statement

The errors besetting plaintiffs’ analysis are epitomized in their discussion of the regulatory impact statement conducted pursuant to Executive Orders 12,866 and 13,563. They urge that FDA should not have implemented the statutorily mandated warnings because the regulatory impact statement did not demonstrate to a statistical certainty that the new warnings will reduce the rate of smoking. Pl. S.J. Br. 7–10, 25.

This argument has no bearing on the validity of the regulation. Congress did not ask FDA to determine the costs and benefits of including warnings of a particular size and format with specified text and accompanying graphics—Congress itself had made that judgment, and, as discussed above, had ample basis for doing so. FDA had no authority to second-guess that legislative determination, and was statutorily precluded from accepting plaintiffs’ recommendation to order that the Act’s “new textual warnings be displayed in the same manner in which the Surgeon General’s warnings have been displayed for years.” Comment Letter 3-4. In contrast, the decisions on which plaintiffs rely involved statutes that specifically directed an agency to consider costs and benefits in determining whether to promulgate a regulation. See, e.g., Pub. Citizen v. Fed. Motor Carrier Safety Admin., 374 F.3d 1209, 1212 (D.C. Cir. 2004) (considering rule promulgated under a statute that mandated that “[b]efore prescribing or revising any . . . requirement, [the agency] shall

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consider the costs and benefits of the requirement” (quoting 49 U.S.C. § 31506(d)).

The Executive Orders that require a regulatoryimpact analysis do not permit FDA to second- guess congressional judgments. The orders apply generally to all federal rulemaking and are designed to “improve the internal management of the Federal Government.” Executive Order 12,866, § 10, 58 Fed. Reg. 51,735, 51,744 (1993). They include the requirement that agency rulemaking be accompanied by a regulatory impact statement, but they explicitly declare that they do “not create any right or benefit, substantive or procedural, enforceable at law or equity by a party against the United States, its agencies or instrumentalities, its officers or employees, or any other person.” Ibid.; see also Executive Order 13,563, § 7(d), 76 Fed. Reg. 3821, 3823 (2011) (similar language). Plaintiffs’ misunderstanding of the purpose of the impact statement is illustrated by their assertion that FDA’s statement in this instance improperly failed to account for the “the healthcare, social security, and other cost increases caused by increased longevity.” Compl. ¶ 46. For the limited purpose of complying with the Executive Orders, FDA did consider the rule’s indirect effects on such costs. See 76 Fed. Reg. at 36,714. But that analysis is irrelevant to the issues before the Court. Congress legislated on the premise that keeping people alive is a good thing. The Constitution does not require Congress to adopt plaintiffs’ accounting standards and to treat the achievement of that goal as a “cost” rather than a “benefit.”

Plaintiffs’ discussion of the Regulatory Impact Statement also provides no support for their constitutional claims. First, as already discussed, supra 31–34, the constitutionality of the statute does not turn on statistical predictions of the impact of warnings on national smoking rates. Second, the impact analysis does not, in fact, predict that the new warnings will have little if any impact on smoking rates. The impact analysis compared data from Canada for the years 2000 to 2009 with data from the United States for the same period. Between 2000 (prior to the effective date of the

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Canadian warnings) and 2010, the smoking rate dropped 7 percentage points, from 24 percent to 17 percent. Over the same period, the smoking rate in the United States dropped less than 3 percentage points, from 23 percent to 20.5 percent. 76 Fed. Reg. at 36,720.

The impact statement observed that it could not be assumed that “the introduction of graphic warning labels in the United States will cause the U.S. smoking rate to fall by seven, or even the three percentage points needed to reach the Canadian rate.” Ibid. The reasons for some uncertainty are evident. The federal and state governments, as well as public health organizations, have taken a variety of measures to increase public awareness of the risks of tobacco use. Attempting to quantify the extent to which any one measure, acting alone, will contribute to a decline, or avoid an increase, in smoking rates poses major challenges. Thus, although the impact statement sought to “isolate the impact of graphic warning labels on the Canadian smoking rate,” it recognized that its analysis was no more than a “rudimentary approach” that “may be producing results that are off by one or more orders of magnitude.” Ibid.15

With these major caveats, the impact statement estimated that the updated warnings will have the effect of reducing the United States’ adult smoking population by more than 200,000 people, an 0.088-percentage-point drop in the smoking rate from what could be expected without the updated warnings. Id. at 36,721.

Plaintiffs repeatedly quote the sentence fragment that this estimate is “not statistically distinguishable from zero,” without reference to the rest of the sentence in which that statement

15 Plaintiffs point out that FDA could not account for certain “confounding factors” other than the presence of graphic warnings that contributed to the trends in smoking rates in the United States and Canada. Pl. S.J. Br. 9–10. As FDA explained, the effects of these factors were difficult to quantify, and plaintiffs suggest no means of doing so. Moreover, accounting for some such factors would tend to increase the estimate of the effect of the warnings while others would tend to decrease it, and thus FDA’s “estimates could as easily be underestimates as overestimates.” 76 Fed. Reg. at 36,711. Plaintiffs offer no response to this conclusion.

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appears. See, e.g., Pl. S.J. Br. 8, 24, 33; Comment Letter exh. B, Statement of Robert S. Maness, at 2. The sentence does not declare that the likely impact on smoking rates is zero. It is, instead, an acknowledgment that the parameters of the economic analysis required by the Executive Orders inject enormous uncertainty into its quantitative conclusions. The full sentence declares: “Although both of the estimation methods” discussed in the statement “lead to the conclusion that graphic warning labels will reduce smoking rates, FDA has had access to very small data sets, so our effectiveness estimates are in general not statistically distinguishable from zero; we therefore cannot reject, in a statistical sense, the possibility that the rule will not change the U.S. smoking rate.” 76 Fed. Reg. at 36,776. The agency explained that the proper approach to uncertain estimates is not to “set[] estimates of effects equal to zero when their estimates are statistically insignificant,” but rather to present the best estimate along with an analysis of the uncertainty. Id. at 36,712.

2. The Consumer Research Study

Plaintiffs offer various criticisms of the study of 18,000 consumers that FDA conducted in to determine the relative effectiveness of the proposed warnings. These criticisms are both inaccurate and immaterial.

Plaintiffs note that, as to some of the warnings, the study did not find “a statistically significant effect on consumers’ awareness of smoking risks.” Pl. S.J. Br. 7. The study was not designed to make an assessment of the kind suggested by plaintiffs. Instead, as FDA explained, the study simply provided one means of assessing the relative impact of different pictorial warnings based on participants’ exposure to one warning on one occasion. 76 Fed. Reg. at 36,639. The warning did so by comparing the effects of images on several different variables—including the salience metrics discussed above. As explained, supra 34–37, these salience metrics provided an appropriate basis for distinguishing among potential images because they predict the likelihood that

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viewers will notice and process the information contained in the text. See FDA Study Report at 1-2, 4-1 (citing studies); 76 Fed. Reg at 36,639 (same). And, of course, plaintiffs themselves have never suggested that some warnings have greater salience than others or that any would, in their view, be constitutionally permissible.

Moreover, the impact of warnings on consumer awareness results not from a single viewing, as in FDA’s study, but from repeated exposure to multiple warnings over an extended time. FDA emphasized that a pack-a-day smoker will be exposed to a package warning “more than 7,000 times per year.” 76 Fed. Reg. at 36,682. In recognition of this fact, the study specified that it was not intended to furnish conclusions about “longer-term outcomes” that will be achieved by multiple viewings of the warnings. FDA Study Report at 1-2. As explained above, studies that have examined the long-term impact of pictorial warnings concluded that such warnings increase consumers’ understanding of the health effects of smoking. See supra 16–18.

Plaintiffs are equally wide of the mark in claiming that the survey design—in which FDA studied the reactions of three different populations to the 36 prospective pictorial health warnings—created the likelihood that the study results were the result of “random error.” Pl. S.J. Br. 13–14. The study was designed in this manner because scientific research demonstrated that the “effectiveness of health warnings in communicating the health risks of smoking may vary according to the audience” and that “[a] variety of health warnings facilitates better targeting of specific groups whose primary concerns about smoking tend to vary.” 75 Fed. Reg. at 69,534. Because FDA considered a finding to be statistically significant if there was only a 5% chance that it was coincidence, 76 Fed. Reg. at 36,648, by definition, one would expect only 5% of the total number of findings to be statistically significant if random error were the only contributing factor. As the data from the study demonstrates, however, the actual number of significant findings was greater

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by an order of magnitude. See generally FDA Study Report, app. C, at C-1. In addition, many of the findings were significant at the .001 confidence level, meaning that “there is less than one chance in a thousand that the finding happened by coincidence.” 76 Fed. Reg. at 36,648.

Plaintiffs also argue that the consumer study (as well as other studies in the record) “suffer from the methodological flaw of ‘social desirability bias,’” because survey participants systematically over-report their intention to quit smoking. Pl. S.J. Br. 12–13, 27. FDA directly addressed that point during the rulemaking, explaining that “[t]he more recent scientific literature shows that statements by smokers concerning their intentions to quit smoking are predictive of their making subsequent quit attempts.” 75 Fed. Reg. 52,352, 52,354 (Aug. 25, 2010). Plaintiffs offer no basis for finding this conclusion to be arbitrary or capricious.

3. Other APA Challenges

Plaintiffs summarize their APA claims as follows: “(1) the stated purpose of the Rule—to decrease smoking—is not supported by the administrative record; (2) FDA’s cost-benefit analysis exaggerated the Rule’s benefits while ignoring obvious costs; (3) FDA rejected comments based on the absence of empirical support even though it ignored a similar lack of empirical support in favor of the Rule; (4) FDA failed to assess numerous less burdensome alternatives . . .; and (5) FDA failed to disclose numerous studies and other data on which the Rule is predicated.” P.I. Reply 17.

We have already addressed many of these arguments. First, plaintiffs’ arguments regarding the warnings’ likely impact on smoking rates is incorrect and offers no basis for setting aside the rule. See supra 31–34. Second, the cost-benefit calculations in FDA’s regulatory impact analysis were not meant to justify the graphic warnings requirement, and plaintiffs’ claims regarding supposed errors in those calculations are irrelevant to any APA challenge. See supra 46–49. Third, plaintiffs’ claim that FDA “failed to assess numerous less burdensome alternatives” to the mandated

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warnings fails to appreciate that it was Congress, not FDA, that required the inclusion of images with the warning statements. See supra 21.

Plaintiffs’ remaining arguments require little discussion. Plaintiffs fault the FDA for rejecting a comment that some of the graphic images would cause a so-called “rebound” or “boomerang” effect, i.e., they would “increase cigarette use by causing consumers to avoid the warnings or increasing the appeal of cigarettes to some young people.” Pl. S.J. Br. 40. But as FDA explained, the companies relied on studies that were dated and that “did not specifically address graphic warnings on cigarette packages and advertisements.” 76 Fed. Reg. at 36,634. Recent empirical research studying graphic warnings in other countries has found no such “boomerang” effect. Ibid. (citing studies). Nor did FDA apply a “different standard[] of analysis” to comments addressing studies that supported the proposed pictorial warnings. Pl. S.J. Br. 39–40. Unlike the evidence presented by the tobacco companies, these comments were not directly contradicted by newer scientific research. See 76 Fed. Reg. at 36,645–46.

Nor can plaintiffs plausibly claim on this record that FDA “failed to provide a meaningful opportunity to comment” on the proposed rule by failing to disclose certain internal studies and reports. Pl. S.J. Br. 41–42. FDA went to great lengths to ensure that the rule was subject to exhaustive public notice and comment. Eight months after the passage of the Tobacco Control Act (a full sixteen months before the congressionally mandated deadline for issuing pictorial warnings), FDA issued a notice describing the design of its consumer research study and seeking public comment. See 75 Fed. Reg. 7,604 (Feb. 22, 2010). The agency responded to those comments on August 25, 2010, and sought further comment. See 75 Fed. Reg. 52,352. Then on November 12, 2010, FDA issued its notice of proposed rulemaking, unveiling 36 prospective warning images and a preliminary regulatory impact analysis. See 75 Fed. Reg. 69,524. Following issuance of the

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proposed rule, FDA placed the results of its consumer study on the public docket of the pending rulemaking, and announced that fact in a Federal Register notice to allow public comment on the results. See 75 Fed. Reg. 75,936 (Dec. 7, 2010). In these circumstances, there is no basis for plaintiffs’ claim that they were not afforded a “reasonable opportunity to participate in the rulemaking process.” WJG Tel. Co., Inc. v. FCC, 675 F.2d 386, 389 (D.C. Cir. 1982).

In any event, the information that plaintiffs identify as missing from the record did not in any respect prevent plaintiffs from commenting on matters before the agency. Plaintiffs’ claim that FDA “failed to disclose key technical data and assumptions it used” in the regulatory impact analysis is incorrect and, in any event, beside the point. As explained above, FDA’s cost-benefit analysis played no role in justifying the rule, and so there is no reason why plaintiffs would have needed this information. Dr. Viscusi’s assertion that FDA “neglected to describe . . . in meaningful detail” the process by which FDA selected the warning text and the 36 prospective images is similarly mistaken. Pl. S.J. Br. 42 (quoting Viscusi Statement at 37–38). The warning text was required by Congress, and plaintiffs do not explain why knowledge of the process by which the prospective images were selected would have aided their ability to participate in the rulemaking: once FDA revealed the prospective images, plaintiffs were free to (and did) comment on them before FDA promulgated its final rule.

IV.

There Is No Authority To Issue an Injunction that Would Delay Enforcement of the Warning Requirements Established by Statute.

The effective date of the updated health warnings was established by Congress in the Tobacco Control Act. Congress provided that, “[n]ot later than 24 months after June 22, 2009, the Secretary shall issue regulations that require color graphics depicting the negative health consequences of smoking to accompany the label statements specified in the statute.” 15 U.S.C. § 1333 Note. Congress further provided that the Act’s amendment to the pre-existing warning

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requirements “shall take effect 15 months after the issuance of the regulations.” Ibid. Consistent with Congress’s directive, FDA issued its graphics regulations on June 22, 2011. See 76 Fed. Reg. 36,628. Accordingly, the updated health warnings will take effect on September 22, 2012.

In their motion for a preliminary injunction, plaintiffs asked the Court to delay the effective date for 15 months if it rejects their challenges. We explained in our opposition to that motion that this relief cannot properly be awarded as a “preliminary injunction,” and there would likewise be no basis for issuing final judgment sustaining the validity of the statute and regulation but postponing the effective date established by Congress.

Plaintiffs’ summary judgment motion does not argue that the Court could disregard the effective date established byCongress if their challenge to the warning requirements is unsuccessful.

Instead, they ask the Court to issue a “declaration invalidating and setting aside the Rule,” Pl. S.J. Mot. iii ¶ 1, and, further, to enjoin FDA from enforcing the warning requirements established by statute “until 15 months after issuance by FDA of regulations . . . that are substantively and procedurally valid and permissible.” See id. ¶¶ 2, 3.

Because plaintiffs’ challenge to the rule has no merit, their request for further relief is moot.

Even assuming, however, that some aspect of the rule were ultimately declared invalid, there would be no basis for the relief that plaintiffs seek. Plaintiffs’ assertion that Congress itself foreclosed “multiple . . . overhauls of their packaging and advertising” (Pl. S.J. Br. 44-45) is belied by the plain terms of the Tobacco Control Act, which expressly authorizes the Secretary to make further adjustments to the warning requirements through rulemaking. See 15 U.S.C. § 1333(b)(4) (authorizing the Secretary to “adjust the format and type sizes for the label statements”); see also 21 U.S.C. § 387f(d)(1) (authorizing restrictions on advertising and promotion of tobacco products to protect public health). Thus, Congress expressly contemplated that there would be multiple

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rounds of changes to the warnings.

Assuming arguendo that some aspect of the rule were ultimately declared invalid, the proper course would be a remand to FDA to determine in the first instance whether the particular provision is severable from other warning requirements, whether additional rule-making proceedings are necessary or appropriate, and when any revised rule should take effect. In any such rulemaking, plaintiffs and other interested parties would have the opportunity to submit their views regarding the revised rule as well as its effective date, and plaintiffs could attempt to show that an additional lengthy delayis appropriate even though they implemented the Canadian warning requirements over the course of 180 days. See Tobacco Products Information Regulations, SOR/2000-272 (Can.).16

FDA’s final determinations on such matters would be subject to judicial review on the basis of the administrative record. The APA authorizes judicial review of final agency action, see 5 U.S.C. § 706; it does not permit a court to address in advance the contours or effective date of action not yet taken by an agency. Cf. Nat’l Petrochemical & Refiners Ass’n v. EPA, 630 F.3d 145, 164 (D.C. Cir. 2010) (“when Congress has delegated ‘a determination of policy or judgment which the agency alone is authorized to make and which it has not made, a judicial judgment cannot be made to do service for an administrative judgment”) (quoting SEC v. Chenery Corp., 318 U.S. 80, 88, 63 S.Ct. 454, 87 L.Ed. 626 (1943) (emphasis in Nat’l Petrochemical)).

CONCLUSION

For the foregoing reasons, plaintiffs’ motion for summary judgment should be denied, and the government’s motion for summary judgment should be granted.

16 www.canlii.org/en/ca/laws….

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Dated: October 21, 2011

Of Counsel:

WILLIAM B. SCHULTZ

Acting General Counsel

ELIZABETH H. DICKINSON

Acting Associate General Counsel

Food and Drug Division

ERIC M. BLUMBERG

Deputy Chief Counsel, Litigation

KAREN E. SCHIFTER

Senior Counsel

U.S. Department of Health & Human Services

Office of the General Counsel

10903 New Hampshire Ave.

Silver Spring, MD 20993-0002

Respectfully submitted,

TONY WEST

Assistant Attorney General

BETH S. BRINKMANN

Deputy Assistant Attorney General

MAAME EWUSI-MENSAH FRIMPONG

Acting Deputy Assistant Attorney General

________/s/________________

DRAKE CUTINI

DANIEL K. CRANE-HIRSCH

Attorneys, Consumer Protection Branch

PO Box 386

Washington, DC 20044

202-307-0044 (Cutini)

drake.cutini@usdoj.gov

________/s/_________________

MARK B STERN

ALISA B. KLEIN

SARANG V. DAMLE

DANIEL TENNY

LINDSEY POWELL

Attorneys, Appellate Staff

Civil Division, Room 7217

U.S. Department of Justice

950 Pennsylvania Ave., NW

Washington, DC 20530

202-514–5735 (Damle)

Fax: 202-514-9405

sarang.damle@usdoj.gov

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Index to References and Memos in Proposed and Final Rule, “Required Warnings for Cigarette Packages and Advertisements”, Docket No. FDA-2010-N-0568, 75 Fed. Reg. 69524 (November 12, 2010), 76 Fed. Reg. 36628 (June 22, 2011)

Name Title Bates

Proposed Rule References

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Reference 14

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Chen, J. and Millar, W, “Age of Smoking Initiation: Implications for Quitting,” Health Reports (Statistics Canada, Catalogue 82-003-XPB), 9(4); 39-46, 1998. 002704-002711

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Hammond, D., “Tobacco Labelling & Packaging Toolkit: A guide to FCTC Article 11,” Feb. 2009, available at www.tobaccolabels.ca/ download/tobaccolab/iuatldtook?attachment=1. 005015-005146

Reference 28

Hammond, D., Fong, G.T., and McDonald, P.W., et al., “Impact of the Graphic Canadian Warning Labels on Adult Smoking Behaviour,” Tobacco Control, 12; 391-5, 2003. 005147-005151

Reference 29

Hammond, D., McDonald, P.W., and Fong, G.T., et al. “The Impact of Cigarette Warning Labels and Smoke-free Bylaws on Smoking Cessation–Evidence from Former Smokers,” Canadian Journal of Public Health/Revue Canadienne de Sante Publique, 95(3); 201-204, May-June

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Reference 30

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Reference 31

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Reference 33

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Reference 34

Robinson, T.N. Killen, J.D., “Do Cigarette Warning Labels Reduce Smoking?: Paradoxical Effects Among Adolescents,” Archives of Pediatrics & Adolescent Medicine, 151(3); 267-72, 1997. 005214-005220

Reference 35

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Reference 36

Hammond, D., Fong, G.T., and Borland, R., et al., “Text and Graphic Warnings on Cigarette Packages: Findings from the International Tobacco Control Four Country Study,” American Journal of Preventive Medicine, 32(3); 202-209, 2007. 005226-005233

Reference 37

Hammond, D., Fong, G.T. and McNeill, A., et al., “Effectiveness of Cigarette Warning Labels in Informing Smokers about the Risks of Smoking: Findings from the International Tobacco Control (ITC) Four Country Survey,” Tobacco Control, 15(III); iii19-iii25, 2006, available at http://tc. bmjjournals.com/cgi/ content/full/15/suppl_3/iii19. 005234-005241

Reference 38

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Reference 39

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Reference 40

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Reference 41

Millar, W.J., “Reaching Smokers with Lower Educational Attainment,” Health Reports (Statistics Canada), 8(2); 11-19, 1996. 005943-005951

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Fong, G.T., Hammond, D., and Hitchman, S.C., “The Impact of Pictures on the Effectiveness of Tobacco Warnings,” Bulletin of the World Health Organization, 87; 640-43, 2009, available at www.who.int/bulletin/volumes/87/8/09-069575.pdf. 005952-005955

Reference 43

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Reference 44

Morrison, W., Doucet, C., and Diener, A., “Knowledge of Health Risks,” Health Canada, 2002 Youth Smoking Survey-Technical Report; 197-228, 2004, available at www.hc-sc.gc.ca/hc-ps/pub… index-eng.php. 006022-006369

Reference 45

Koval, J.J., Aubut, J.A., et al., “The Potential Effectiveness of Warning Labels on Cigarette Packages: The Perceptions of Young Adult Canadians,” Canadian Journal of Public Health/Revue Canadienne de Sante Publique, 96(5); 353-6, 2005. 006370-006373

Reference 46

Borland, R., Wilson, N., et al., “Impact of Graphic and Text Warnings on Cigarette Packs: Findings from Four Countries over Five Years,” Tobacco Control, 18(5); 358-364, 2009. 006374-006381

Reference 47

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Reference 48

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Reference 49

Kempf, D.S. and Harmon, S.K., “Examining the Effectiveness of Proposed Cigarette Package Warning Labels with Graphic Images Among U.S. College Students,” Academy of Marketing Studies Journal, 10(2); 77-93, 2006. 006458-006474

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O’Hegarty, M., Pederson, L.L., et al., “Young Adults’ Perceptions of Cigarette Warning Labels in the United States and Canada,” Preventing Chronic Disease, 4(2); 1-9, 2007. 006475-006483

Reference 51

Hammond, D., Fong, G.T., et al., “Graphic Canadian Cigarette Warning Labels and Adverse Outcomes: Evidence from Canadian Smokers,” American Journal of Public Health, 94(8); 1442-5, 2004. 006484-006487

Reference 52

Shanahan, P. and Elliot, D., “Evaluation of the Effectiveness of the Graphic Health Warnings on Tobacco Product Packaging 2008,” Canberra: Australian Government Department of Health and Ageing,

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Reference 53

Miller, C.L., Hill, D.J., Quester, P.G., et al., “Response of Mass Media, Tobacco Industry and Smokers to the Introduction of Graphic Cigarette Pack Warnings in Australia,” European Journal of Public Health, 19(6); 644-49, 2009. 006730-006735

Reference 54

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Markowitz, S., “Where There’s Smoking, There’s Fire: The Effects of Smoking Policies on the Incidence of Fires in the United States,” National Bureau of Economic Research, Working Paper 16625, December 2010, available at www.nber.org/papers/w1662…. 0200059-0200096 Reference 145 National Fire Protection Association, News Release, July 16, 2004. 0200097-0200098

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Muth, M.K., Gledhill, E.C., and Karns, S.A., “FDA Labeling Cost Model,” Research Triangle Park, NC: Research Triangle Institute (RTI), January

2003. 020700-020832

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Braithwaite, R.S., Meltzer, D.O., King, J.T., et al., “What Does the Value of Modern Medicine Say About the $50,000 per Quality-Adjusted Life- Year Decision Rule?,” Medical Care, 46(4); 349-56, April 2008. 020925-020932

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U.S. Census Bureau, American FactFinder, “2006 Annual Survey of Manufacturers,” 2008, available at factfinder.census.gov/ser… IBQTable?_bm=y&-ds_name=AM0631GS101. 020933-020935

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U.S. Department of Agriculture, “2007 Census of Agriculture: United States Summary and State Data: Volume 1, Geographic Area Series, Part 51,” December 2009, available at www.agcensus.usda.gov/ Publications/2007/Full_Report/usv1.pdf. 020936-021674

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Miscellaneous Memos

Memo to File: Required Warnings for Cigarette Packages and Advertisements Final Rule – Electronic Files for Images. 022330

NEPA Memo: Required Warnings for Cigarette Packages and Advertisements Proposed Regulation. 022331-022334

Memo to File: Tribal Consultation and the Proposed Rule “Required Warnings for Cigarette Packages and Advertisements”. 022335-022337 Nielsen Updated Weekly Scanner Data. 022338-022339

Page 20 of 20

Case 1:11-cv-01482-RJL Document 35-1 Filed 10/21/11 Page 23 of 61

Index to Comments on Proposed Rule,”Required Warnings for Cigarette Packages and Advertisements,” Docket No. FDA-2010-N-0568, 75 Fed. Reg. 69524 (November 12, 2010)

Document ID Title Date

Received Phase

PUBLIC SUBMISSIONS

FDA-2010-N-0568-DRAFT-0004 Anonymous - Comment 11/12/2010 DoNotPost

FDA-2010-N-0568-DRAFT-0005 Anonymous - Comment 11/12/2010 DoNotPost

FDA-2010-N-0568-DRAFT-0006 Norman Beck - Comment 11/12/2010 DoNotPost

FDA-2010-N-0568-DRAFT-0007 Vanessa Payne - Comment 11/12/2010 DoNotPost

FDA-2010-N-0568-DRAFT-0008 Denise Morrissette - Comment 11/12/2010 DoNotPost

FDA-2010-N-0568-DRAFT-0009 Craig Hibner - Comment 11/12/2010 DoNotPost

FDA-2010-N-0568-DRAFT-0010 Anonymous - Comment 11/12/2010 DoNotPost

FDA-2010-N-0568-DRAFT-0011 B. R. - Comment 11/12/2010 DoNotPost

FDA-2010-N-0568-DRAFT-0012 Anonymous - Comment 11/12/2010 DoNotPost

FDA-2010-N-0568-DRAFT-0013 Herman Todd - Comment 11/12/2010 DoNotPost

FDA-2010-N-0568-DRAFT-0014 Meagan - Comment 11/12/2010 DoNotPost

FDA-2010-N-0568-DRAFT-0015 Rachel Mahon Bosman - Comment 11/12/2010 DoNotPost

FDA-2010-N-0568-DRAFT-0016 Laura Culp - Comment 11/12/2010 DoNotPost

FDA-2010-N-0568-DRAFT-0017 Marco Schad - Comment 11/12/2010 DoNotPost

FDA-2010-N-0568-DRAFT-0018 Anonymous - Comment 11/12/2010 DoNotPost

FDA-2010-N-0568-DRAFT-0019 Mark Maxwell - Comment 11/12/2010 DoNotPost

FDA-2010-N-0568-DRAFT-0020 William Todd Gunter - Comment 11/12/2010 DoNotPost

FDA-2010-N-0568-DRAFT-0022 Cameron Dekany - Comment 11/12/2010 DoNotPost

FDA-2010-N-0568-DRAFT-0023 Amy - Comment 11/12/2010 DoNotPost

FDA-2010-N-0568-DRAFT-0024 William M. McManus - Comment 11/12/2010 DoNotPost

FDA-2010-N-0568-DRAFT-0028 James Bryan Mason - Comment 11/12/2010 DoNotPost

FDA-2010-N-0568-DRAFT-0030 James T. Simmon - Comment 11/12/2010 DoNotPost

FDA-2010-N-0568-DRAFT-0031 Philip William Young - Comment 11/12/2010 DoNotPost

FDA-2010-N-0568-DRAFT-0032 Sonya Walters - Comment 11/12/2010 DoNotPost

FDA-2010-N-0568-DRAFT-0033 Anonymous - Comment 11/12/2010 DoNotPost

FDA-2010-N-0568-DRAFT-0035 Deborah Moran - Comment 11/12/2010 DoNotPost

FDA-2010-N-0568-DRAFT-0036 Suanne Sines - Comment 11/12/2010 DoNotPost

FDA-2010-N-0568-DRAFT-0039 Sara Jordan - Comment 11/12/2010 DoNotPost

FDA-2010-N-0568-DRAFT-0040 R. Recla - Comment 11/12/2010 DoNotPost

FDA-2010-N-0568-DRAFT-0041 Charles Ward - Comment 11/12/2010 DoNotPost

FDA-2010-N-0568-DRAFT-0045 Anonymous - Comment 11/12/2010 DoNotPost

FDA-2010-N-0568-DRAFT-0047 Ted Steichen - Comment 11/12/2010 DoNotPost

FDA-2010-N-0568-DRAFT-0051 William V. - Comment 11/12/2010 DoNotPost

FDA-2010-N-0568-DRAFT-0052 Kristie Nauman - Comment 11/12/2010 DoNotPost

FDA-2010-N-0568-DRAFT-0053 Bridget Townsley - Comment 11/12/2010 DoNotPost

FDA-2010-N-0568-DRAFT-0056 Anonymous - Comment 11/12/2010 DoNotPost

FDA-2010-N-0568-DRAFT-0057 Kevin J O’Conner - Comment 11/12/2010 DoNotPost

FDA-2010-N-0568-DRAFT-0058 Jonathan David - Comment 11/12/2010 DoNotPost

FDA-2010-N-0568-DRAFT-0059 A.R. - Comment 11/12/2010 DoNotPost

FDA-2010-N-0568-DRAFT-0060 James Robert Farmer - Comment 11/12/2010 DoNotPost

FDA-2010-N-0568-DRAFT-0061 Douglas Paul Huffaker - Comment 11/12/2010 DoNotPost

FDA-2010-N-0568-DRAFT-0062 Anthony B. McClure - Comment 11/12/2010 DoNotPost

FDA-2010-N-0568-DRAFT-0063 Carol Louise Hardin - Comment 11/12/2010 DoNotPost

FDA-2010-N-0568-DRAFT-0066 Kim Anne Schechter - Comment 11/12/2010 DoNotPost

FDA-2010-N-0568-DRAFT-0070 Adriane Beatrice Miller - Comment 11/12/2010 DoNotPost

FDA-2010-N-0568-DRAFT-0071 Theresa Verret -Comment 11/12/2010 DoNotPost

FDA-2010-N-0568-DRAFT-0072 Mary Louise Hirzel - Comment 11/12/2010 DoNotPost

Page 1 of 39

Case 1:11-cv-01482-RJL Document 35-1 Filed 10/21/11 Page 24 of 61

Document ID Title Date

Received Phase

FDA-2010-N-0568-DRAFT-0073 Jim Wilson - Comment 11/12/2010 DoNotPost

FDA-2010-N-0568-DRAFT-0074 Patricia Waugh - Comment 11/12/2010 DoNotPost

FDA-2010-N-0568-DRAFT-0075 Cheri L Brown - Comment 11/12/2010 DoNotPost

FDA-2010-N-0568-DRAFT-0076 James Oliver Henry Niermann, Junior 11/12/2010 DoNotPost

- Comment

FDA-2010-N-0568-DRAFT-0077 Yvonne Watts - Comment 11/12/2010 DoNotPost

FDA-2010-N-0568-DRAFT-0078 Jamie Elizabeth Perkins - Comment 11/12/2010 DoNotPost

FDA-2010-N-0568-DRAFT-0079 Robert Ray Gabriel - Comment 11/12/2010 DoNotPost

FDA-2010-N-0568-DRAFT-0080 Elinor Schwartz - Comment 11/12/2010 DoNotPost

FDA-2010-N-0568-DRAFT-0081 Paul Jarrod Blonsky - Comment 11/12/2010 DoNotPost

FDA-2010-N-0568-DRAFT-0082 Dana A. Pintago - Comment 11/12/2010 DoNotPost

FDA-2010-N-0568-DRAFT-0083 Thomas Krepshaw - Comment 11/12/2010 DoNotPost

FDA-2010-N-0568-DRAFT-0084 Cameron W. Schnur - Comment 11/12/2010 DoNotPost

FDA-2010-N-0568-DRAFT-0086 Charles Lineberg Jr. - Comment 11/12/2010 DoNotPost

FDA-2010-N-0568-DRAFT-0087 Debra Nester - Comment 11/12/2010 DoNotPost

FDA-2010-N-0568-DRAFT-0088 Howard C. Brown - Comment 11/12/2010 DoNotPost

FDA-2010-N-0568-DRAFT-0090 Martha Cifuentes - Comment 11/12/2010 DoNotPost

FDA-2010-N-0568-DRAFT-0091 Joseph Edward Stringer - Comment 11/12/2010 DoNotPost

FDA-2010-N-0568-DRAFT-0092 Jamison Loos - Comment 11/12/2010 DoNotPost

FDA-2010-N-0568-DRAFT-0093 Anonymous - Comment 11/12/2010 DoNotPost

FDA-2010-N-0568-DRAFT-0094 Kimberly Kirsten Gregersen -11/12/2010 DoNotPost

Comment

FDA-2010-N-0568-DRAFT-0097 Matt Althage - Comment 11/12/2010 DoNotPost

FDA-2010-N-0568-DRAFT-0098 David Arthur Nelson - Comment 11/12/2010 DoNotPost

FDA-2010-N-0568-DRAFT-0099 Jacquelynne - Comment 11/12/2010 DoNotPost

FDA-2010-N-0568-DRAFT-0100 Al Cates - Comment 11/12/2010 DoNotPost

FDA-2010-N-0568-DRAFT-0101 Bill Burtt - Comment 11/12/2010 DoNotPost

FDA-2010-N-0568-DRAFT-0102 Stephen H Smith - Comment 11/12/2010 DoNotPost

FDA-2010-N-0568-DRAFT-0103 Anonymous - Comment 11/12/2010 DoNotPost

FDA-2010-N-0568-DRAFT-0104 Wendy Hays - Comment 11/12/2010 DoNotPost

FDA-2010-N-0568-DRAFT-0107 Jim Funk - Comment 11/12/2010 DoNotPost

FDA-2010-N-0568-DRAFT-0109 Edward Charles Middleton -11/12/2010 DoNotPost

Comment

FDA-2010-N-0568-DRAFT-0111 James Arthur Gould - Comment 11/12/2010 DoNotPost

FDA-2010-N-0568-DRAFT-0112 Jason Merrell - Comment 11/12/2010 DoNotPost

FDA-2010-N-0568-DRAFT-0113 Lisa A. Porter - Comment 11/12/2010 DoNotPost

FDA-2010-N-0568-DRAFT-0114 Christine E. Leitham - Comment 11/12/2010 DoNotPost

FDA-2010-N-0568-DRAFT-0119 Anonymous - Comment 11/12/2010 DoNotPost

FDA-2010-N-0568-DRAFT-0120 David Paul Shrader - Comment 11/12/2010 DoNotPost

FDA-2010-N-0568-DRAFT-0122 Scott D. - Comment 11/12/2010 DoNotPost

FDA-2010-N-0568-DRAFT-0124 Linda Britton - Comment 11/12/2010 DoNotPost

FDA-2010-N-0568-DRAFT-0125 John Mark Florence - Comment 11/12/2010 DoNotPost

FDA-2010-N-0568-DRAFT-0126 E.K. Cobb - Comment 11/12/2010 DoNotPost

FDA-2010-N-0568-DRAFT-0128 Lily Jun Betz - Comment 11/12/2010 DoNotPost

FDA-2010-N-0568-DRAFT-0129 Anonymous - Comment 11/13/2010 DoNotPost

FDA-2010-N-0568-DRAFT-0130 Shirley A. Bryant - Comment 11/13/2010 DoNotPost

FDA-2010-N-0568-DRAFT-0131 Maggie - Comment 11/13/2010 DoNotPost

FDA-2010-N-0568-DRAFT-0132 John Lewis Lostetter II - Comment 11/13/2010 DoNotPost

FDA-2010-N-0568-DRAFT-0134 Barry Lynn Townsend - Comment 11/13/2010 DoNotPost

FDA-2010-N-0568-DRAFT-0135 David R. Stephens - Comment 11/13/2010 DoNotPost

Page 2 of 39

Case 1:11-cv-01482-RJL Document 35-1 Filed 10/21/11 Page 25 of 61

Document ID Title Date

Received Phase

FDA-2010-N-0568-DRAFT-0136 Karen Janeen Jersvig - Comment 11/13/2010 DoNotPost

FDA-2010-N-0568-DRAFT-0137 Brian Odonoghue - Comment 11/13/2010 DoNotPost

FDA-2010-N-0568-DRAFT-0138 Harry Dennis - Comment 11/13/2010 DoNotPost

FDA-2010-N-0568-DRAFT-0139 Michael Timothy Rodgers - Comment 11/13/2010 DoNotPost

FDA-2010-N-0568-DRAFT-0140 Dan Tepper - Comment 11/13/2010 DoNotPost

FDA-2010-N-0568-DRAFT-0143 Anonymous - Comment 11/13/2010 DoNotPost

FDA-2010-N-0568-DRAFT-0145 Susan Varner - Comment 11/13/2010 DoNotPost

FDA-2010-N-0568-DRAFT-0147 Erin Janoso - Comment 11/13/2010 DoNotPost

FDA-2010-N-0568-DRAFT-0148 Eric Newlon - Comment 11/13/2010 DoNotPost

FDA-2010-N-0568-DRAFT-0150 Brian Eugene Dixon - Comment 11/13/2010 DoNotPost

FDA-2010-N-0568-DRAFT-0151 Charles H. Smith - Comment 11/13/2010 DoNotPost

FDA-2010-N-0568-DRAFT-0152 Anonymous - Comment 11/13/2010 DoNotPost

FDA-2010-N-0568-DRAFT-0154 Gary Hall - Comment 11/13/2010 DoNotPost

FDA-2010-N-0568-DRAFT-0155 R.S. - Comment 11/13/2010 DoNotPost

FDA-2010-N-0568-DRAFT-0157 Richard C. Tyll - Comment 11/13/2010 DoNotPost

FDA-2010-N-0568-DRAFT-0158 Timothy Van Harlin - Comment 11/13/2010 DoNotPost

FDA-2010-N-0568-DRAFT-0159 Richard Franklin - Comment 11/13/2010 DoNotPost

FDA-2010-N-0568-DRAFT-0160 Sarah Rudeen - Comment 11/13/2010 DoNotPost

FDA-2010-N-0568-DRAFT-0161 Anonymous - Comment 11/13/2010 DoNotPost

FDA-2010-N-0568-DRAFT-0163 Hannah Leigh Young - Comment 11/13/2010 DoNotPost

FDA-2010-N-0568-DRAFT-0166 Dan Locklair - Comment 11/13/2010 DoNotPost

FDA-2010-N-0568-DRAFT-0167 Gloria Jean Pierce - Comment 11/13/2010 DoNotPost

FDA-2010-N-0568-DRAFT-0168 Edward J. Farrell - Comment 11/13/2010 DoNotPost

FDA-2010-N-0568-DRAFT-0170 Hiltrud Jones - Comment 11/13/2010 DoNotPost

FDA-2010-N-0568-DRAFT-0171 Therese Martin - Comment 11/13/2010 DoNotPost

FDA-2010-N-0568-DRAFT-0173 Cheryl A. Merrill - Comment 11/13/2010 DoNotPost

FDA-2010-N-0568-DRAFT-0174 Janet Ditzer - Comment 11/13/2010 DoNotPost

FDA-2010-N-0568-DRAFT-0176 William Landgraf, Jr. - Comment 11/13/2010 DoNotPost

FDA-2010-N-0568-DRAFT-0177 Anonymous - Comment 11/13/2010 DoNotPost

FDA-2010-N-0568-DRAFT-0178 Sue Chance - Comment 11/14/2010 DoNotPost

FDA-2010-N-0568-DRAFT-0179 Anonymous - Comment 11/14/2010 DoNotPost

FDA-2010-N-0568-DRAFT-0181 W. John Martius Jr. - Comment 11/14/2010 DoNotPost

FDA-2010-N-0568-DRAFT-0182 Andrea G. Leonardi - Comment 11/14/2010 DoNotPost

FDA-2010-N-0568-DRAFT-0184 Gail Maureen Delaney - Comment 11/14/2010 DoNotPost

FDA-2010-N-0568-DRAFT-0185 Cindi Williamson - Comment 11/14/2010 DoNotPost

FDA-2010-N-0568-DRAFT-0186 John B. - Comment 11/14/2010 DoNotPost

FDA-2010-N-0568-DRAFT-0187 Amber Stivers - Comment 11/14/2010 DoNotPost

FDA-2010-N-0568-DRAFT-0188 Anonymous - Comment 11/14/2010 DoNotPost

FDA-2010-N-0568-DRAFT-0189 Lynn T. Henagan - Comment 11/14/2010 DoNotPost

FDA-2010-N-0568-DRAFT-0191 Michael T. Jones - Comment 11/14/2010 DoNotPost

FDA-2010-N-0568-DRAFT-0192 Robert L. Texidor - Comment 11/14/2010 DoNotPost

FDA-2010-N-0568-DRAFT-0194 Dianne A. Hays - Comment 11/14/2010 DoNotPost

FDA-2010-N-0568-DRAFT-0196 Randal M. Vicars - Comment 11/14/2010 DoNotPost

FDA-2010-N-0568-DRAFT-0197 Johnny Neil Hays - Comment 11/14/2010 DoNotPost

FDA-2010-N-0568-DRAFT-0198 Michael L. Bauchan - Comment 11/14/2010 DoNotPost

FDA-2010-N-0568-DRAFT-0199 John Jay Lyon - Comment 11/14/2010 DoNotPost

FDA-2010-N-0568-DRAFT-0201 Susan R. Stolburg - Comment 11/14/2010 DoNotPost

FDA-2010-N-0568-DRAFT-0202 Anonymous - Comment 11/14/2010 DoNotPost

FDA-2010-N-0568-DRAFT-0203 Robert Scott - Comment 11/14/2010 DoNotPost

Page 3 of 39

Case 1:11-cv-01482-RJL Document 35-1 Filed 10/21/11 Page 26 of 61

Document ID Title Date

Received Phase

FDA-2010-N-0568-DRAFT-0204 Kelly Ebel - Comment 11/14/2010 DoNotPost

FDA-2010-N-0568-DRAFT-0205 Leonard Rapoport - Comment 11/14/2010 DoNotPost

FDA-2010-N-0568-DRAFT-0206 James Sidney Ketchum - Comment 11/14/2010 DoNotPost

FDA-2010-N-0568-DRAFT-0207 Anonymous - Comment 11/14/2010 DoNotPost

FDA-2010-N-0568-DRAFT-0208 Donia D. Cullison - Comment 11/14/2010 DoNotPost

FDA-2010-N-0568-DRAFT-0209 A. Combs - Comment 11/14/2010 DoNotPost

FDA-2010-N-0568-DRAFT-0210 Mary Hatch - Comment 11/14/2010 DoNotPost

FDA-2010-N-0568-DRAFT-0211 Hoffman - Comment 11/14/2010 DoNotPost

FDA-2010-N-0568-DRAFT-0213 Peter Murray - Comment 11/14/2010 DoNotPost

FDA-2010-N-0568-DRAFT-0215 Susan June Felter - Comment 11/14/2010 DoNotPost

FDA-2010-N-0568-DRAFT-0217 Michael Joseph Boone - Comment 11/14/2010 DoNotPost

FDA-2010-N-0568-DRAFT-0218 Ryan Jacob Lederman - Comment 11/14/2010 DoNotPost

FDA-2010-N-0568-DRAFT-0219 Daniel Bethoney - Comment 11/14/2010 DoNotPost

FDA-2010-N-0568-DRAFT-0220 Julian S. West - Comment 11/14/2010 DoNotPost

FDA-2010-N-0568-DRAFT-0221 Heather Ann Smithson - Comment 11/14/2010 DoNotPost

FDA-2010-N-0568-DRAFT-0223 Mary Lee Cole - Comment 11/14/2010 DoNotPost

FDA-2010-N-0568-DRAFT-0224 James W. Schmus - Comment 11/14/2010 DoNotPost

FDA-2010-N-0568-DRAFT-0225 Erik Folch - Comment 11/14/2010 DoNotPost

FDA-2010-N-0568-DRAFT-0226 Anonymous - Comment 11/14/2010 DoNotPost

FDA-2010-N-0568-DRAFT-0227 John - Comment 11/14/2010 DoNotPost

FDA-2010-N-0568-DRAFT-0228 Dave Ferree - Comment 11/14/2010 DoNotPost

FDA-2010-N-0568-DRAFT-0229 Sherry Levitt - Comment 11/14/2010 DoNotPost

FDA-2010-N-0568-DRAFT-0230 Nora Marie McDowell - Comment 11/14/2010 DoNotPost

FDA-2010-N-0568-DRAFT-0231 Kevin Mulholland - Comment 11/14/2010 DoNotPost

FDA-2010-N-0568-DRAFT-0232 Dick Lang - Comment 11/14/2010 DoNotPost

FDA-2010-N-0568-DRAFT-0233 Daniel Jaimes - Comment 11/14/2010 DoNotPost

FDA-2010-N-0568-DRAFT-0234 Margierose Salerno - Comment 11/14/2010 DoNotPost

FDA-2010-N-0568-DRAFT-0235 Louise Fulton - Comment 11/14/2010 DoNotPost

FDA-2010-N-0568-DRAFT-0236 Gregory Robert Howard - Comment 11/14/2010 DoNotPost

FDA-2010-N-0568-DRAFT-0237 Sandy J. Floyd - Comment 11/14/2010 DoNotPost

FDA-2010-N-0568-DRAFT-0238 Beverly Karen Spencer - Comment 11/14/2010 DoNotPost

FDA-2010-N-0568-DRAFT-0239 Michael Foust - Comment 11/14/2010 DoNotPost

FDA-2010-N-0568-DRAFT-0240 Marilyn J. Carver - Comment 11/14/2010 DoNotPost

FDA-2010-N-0568-DRAFT-0242 Harry Edward Baird, Jr. - Comment 11/14/2010 DoNotPost

FDA-2010-N-0568-DRAFT-0243 Judy Suarez - Comment 11/14/2010 DoNotPost

FDA-2010-N-0568-DRAFT-0244 Anthony Joseph Sanders - Comment 11/14/2010 DoNotPost

FDA-2010-N-0568-DRAFT-0246 Anonymous - Comment 11/14/2010 DoNotPost

FDA-2010-N-0568-DRAFT-0247 Robert Douglas Jones - Comment 11/14/2010 DoNotPost

FDA-2010-N-0568-DRAFT-0250 John Brown - Comment 11/14/2010 DoNotPost

FDA-2010-N-0568-DRAFT-0251 Steven Ray Croy - Comment 11/14/2010 DoNotPost

FDA-2010-N-0568-DRAFT-0252 Carl T. Raff - Comment 11/14/2010 DoNotPost

FDA-2010-N-0568-DRAFT-0253 Scott M Wiesman - Comment 11/14/2010 DoNotPost

FDA-2010-N-0568-DRAFT-0254 Lee Dale Smith - Comment 11/14/2010 DoNotPost

FDA-2010-N-0568-DRAFT-0255 Glenn Russell Smith - Comment 11/14/2010 DoNotPost

FDA-2010-N-0568-DRAFT-0256 Thomas H. Smallwood, Sr. -11/14/2010 DoNotPost

Comment

FDA-2010-N-0568-DRAFT-0257 Varun Sastry - Comment 11/14/2010 DoNotPost

FDA-2010-N-0568-DRAFT-0259 Sheryl - Comment 11/14/2010 DoNotPost

FDA-2010-N-0568-DRAFT-0260 Steve - Comment 11/14/2010 DoNotPost

Page 4 of 39

Case 1:11-cv-01482-RJL Document 35-1 Filed 10/21/11 Page 27 of 61

Document ID Title Date

Received Phase

FDA-2010-N-0568-DRAFT-0261 Sherry Black - Comment 11/14/2010 DoNotPost

FDA-2010-N-0568-DRAFT-0262 Anonymous - Comment 11/14/2010 DoNotPost

FDA-2010-N-0568-DRAFT-0263 Laurie Jean Grina - Comment 11/14/2010 DoNotPost

FDA-2010-N-0568-DRAFT-0265 Anonymous - Comment 11/15/2010 DoNotPost

FDA-2010-N-0568-DRAFT-0266 Cheryl Driscoll - Comment 11/15/2010 DoNotPost

FDA-2010-N-0568-DRAFT-0267 Derek Suchard - Comment 11/15/2010 DoNotPost

FDA-2010-N-0568-DRAFT-0268 Christina M. Licina - Comment 11/15/2010 DoNotPost

FDA-2010-N-0568-DRAFT-0269 Ron Roskos - Comment 11/15/2010 DoNotPost

FDA-2010-N-0568-DRAFT-0273 Mary George - Comment 11/15/2010 DoNotPost

FDA-2010-N-0568-DRAFT-0274 Diane Paul - Comment 11/15/2010 DoNotPost

FDA-2010-N-0568-DRAFT-0275 Anonymous - Comment 11/15/2010 DoNotPost

FDA-2010-N-0568-DRAFT-0278 Angela M. Hoedt - Comment 11/15/2010 DoNotPost

FDA-2010-N-0568-DRAFT-0279 Tracie - Comment 11/15/2010 DoNotPost

FDA-2010-N-0568-DRAFT-0288 Jacinda - Comment 11/15/2010 DoNotPost

FDA-2010-N-0568-DRAFT-0289 Anonymous - Comment 11/15/2010 DoNotPost

FDA-2010-N-0568-DRAFT-0291 Linda Luciano - Comment 11/15/2010 DoNotPost

FDA-2010-N-0568-DRAFT-0292 Anonymous - Comment 11/15/2010 DoNotPost

FDA-2010-N-0568-DRAFT-0294 Scott Ronald Haese - Comment 11/15/2010 DoNotPost

FDA-2010-N-0568-DRAFT-0295 V.M. Oakley - Comment 11/15/2010 DoNotPost

FDA-2010-N-0568-DRAFT-0296 Terry L. Hammett - Comment 11/15/2010 DoNotPost

FDA-2010-N-0568-DRAFT-0297 Patricia Anne Stewart - Comment 11/15/2010 DoNotPost

FDA-2010-N-0568-DRAFT-0298 Sheral A. Thomas - Comment 11/15/2010 DoNotPost

FDA-2010-N-0568-DRAFT-0299 Carma Simmons Wise - Comment 11/15/2010 DoNotPost

FDA-2010-N-0568-DRAFT-0301 Caile E. Spear - Comment 11/15/2010 DoNotPost

FDA-2010-N-0568-DRAFT-0303 John Vinson - Comment 11/15/2010 DoNotPost

FDA-2010-N-0568-DRAFT-0306 Michael Renaldo Pedro - Comment 11/15/2010 DoNotPost

FDA-2010-N-0568-DRAFT-0307 Debbie Byrd - Comment 11/15/2010 DoNotPost

FDA-2010-N-0568-DRAFT-0308 l. Jamison - Comment 11/15/2010 DoNotPost

FDA-2010-N-0568-DRAFT-0310 Mark J. Kovasity - Comment 11/15/2010 DoNotPost

FDA-2010-N-0568-DRAFT-0311 Timothy Allen Urban - Comment 11/15/2010 DoNotPost

FDA-2010-N-0568-DRAFT-0312 Rick Brovelli - Comment 11/15/2010 DoNotPost

FDA-2010-N-0568-DRAFT-0313 Don Adams - Comment 11/12/2010 DoNotPost

FDA-2010-N-0568-DRAFT-0315 Jean Brook - Comment 11/15/2010 DoNotPost

FDA-2010-N-0568-DRAFT-0317 John Myers - Comment 11/15/2010 DoNotPost

FDA-2010-N-0568-DRAFT-0318 Roger D. Hale - Comment 11/12/2010 DoNotPost

FDA-2010-N-0568-DRAFT-0320 Anonymous - Comment 11/15/2010 DoNotPost

FDA-2010-N-0568-DRAFT-0322 Elaine Rebecca Hinchee - Comment 11/15/2010 DoNotPost

FDA-2010-N-0568-DRAFT-0324 Jane Savides - Comment 11/15/2010 DoNotPost

FDA-2010-N-0568-DRAFT-0326 Elaine Yasenia Hernandez Wilson -11/15/2010 DoNotPost

Comment

FDA-2010-N-0568-DRAFT-0328 Sky Christopherson - Comment 11/15/2010 DoNotPost

FDA-2010-N-0568-DRAFT-0329 Jennifer L. McArdle - Comment 11/15/2010 DoNotPost

FDA-2010-N-0568-DRAFT-0330 Anonymous - Comment 11/15/2010 DoNotPost

FDA-2010-N-0568-DRAFT-0332 Anonymous - Comment 11/15/2010 DoNotPost

FDA-2010-N-0568-DRAFT-0333 Anonymous - Comment 11/15/2010 DoNotPost

FDA-2010-N-0568-DRAFT-0336 Erik Bryer - Comment 11/15/2010 DoNotPost

FDA-2010-N-0568-DRAFT-0337 Anonymous - Comment 11/15/2010 DoNotPost

FDA-2010-N-0568-DRAFT-0340 Carolyn Durbin - Comment 11/15/2010 DoNotPost

FDA-2010-N-0568-DRAFT-0343 Miche’le G. Lipari - Comment 11/15/2010 DoNotPost

FDA-2010-N-0568-DRAFT-0344 Sandra L. Grasley - Comment 11/15/2010 DoNotPost

Page 5 of 39

Case 1:11-cv-01482-RJL Document 35-1 Filed 10/21/11 Page 28 of 61

Document ID Title Date

Received Phase

FDA-2010-N-0568-DRAFT-0345 Anonymous - Comment 11/15/2010 DoNotPost

FDA-2010-N-0568-DRAFT-0346 Jackie Ann Puvalowski - Comment 11/15/2010 DoNotPost

FDA-2010-N-0568-DRAFT-0347 Randall Stephens - Comment 11/15/2010 DoNotPost

FDA-2010-N-0568-DRAFT-0348 Filippo C. Vitale - Comment 11/15/2010 DoNotPost

FDA-2010-N-0568-DRAFT-0353 Felicia Barnes - Comment 11/16/2010 DoNotPost

FDA-2010-N-0568-DRAFT-0354 Jesse Derouen - Comment 11/16/2010 DoNotPost

FDA-2010-N-0568-DRAFT-0355 Charles Lynn Grubbs - Comment 11/16/2010 DoNotPost

FDA-2010-N-0568-DRAFT-0356 Matthew Hancock - Comment 11/16/2010 DoNotPost

FDA-2010-N-0568-DRAFT-0357 James Elwood Quinn - Comment 11/16/2010 DoNotPost

FDA-2010-N-0568-DRAFT-0358 Marlene Cartaina - Comment 11/12/2010 DoNotPost

FDA-2010-N-0568-DRAFT-0360 Katherine Rosch - Comment 11/16/2010 DoNotPost

FDA-2010-N-0568-DRAFT-0362 Gwen Miller, RN, COHN - Comment 11/12/2010 DoNotPost

FDA-2010-N-0568-DRAFT-0363 Marty Horton Ramirez - Comment 11/12/2010 DoNotPost

FDA-2010-N-0568-DRAFT-0365 Jena Nylec - Comment 11/12/2010 DoNotPost

FDA-2010-N-0568-DRAFT-0366 Peggy J. Morris - Comment 11/12/2010 DoNotPost

FDA-2010-N-0568-DRAFT-0367 Stacy K. Williams - Comment 11/12/2010 DoNotPost

FDA-2010-N-0568-DRAFT-0368 Kevin McCullough - Comment 11/12/2010 DoNotPost

FDA-2010-N-0568-DRAFT-0369 Daniel Barth - Comment 11/12/2010 DoNotPost

FDA-2010-N-0568-DRAFT-0370 Karen B. Hortman - Comment 11/16/2010 DoNotPost

FDA-2010-N-0568-DRAFT-0372 C.M. Springer - Comment 11/16/2010 DoNotPost

FDA-2010-N-0568-DRAFT-0373 Kevin Fruchey - Comment 11/16/2010 DoNotPost

FDA-2010-N-0568-DRAFT-0374 Shawn Robert Gertken - Comment 11/16/2010 DoNotPost

FDA-2010-N-0568-DRAFT-0376 Nancy Hinsdale Poole - Comment 11/16/2010 DoNotPost

FDA-2010-N-0568-DRAFT-0377 Anonymous - Comment 11/16/2010 DoNotPost

FDA-2010-N-0568-DRAFT-0379 Elizabeth Trapp - Comment 11/15/2010 DoNotPost

FDA-2010-N-0568-DRAFT-0380 Bob Rudd - Comment 11/16/2010 DoNotPost

FDA-2010-N-0568-DRAFT-0383 Anonymous - Comment 11/16/2010 DoNotPost

FDA-2010-N-0568-DRAFT-0386 Karen Stump - Comment 11/16/2010 DoNotPost

FDA-2010-N-0568-DRAFT-0387 Anonymous - Comment 11/16/2010 DoNotPost

FDA-2010-N-0568-DRAFT-0388 David Strunk - Comment 11/16/2010 DoNotPost

FDA-2010-N-0568-DRAFT-0392 Anonymous - Comment 11/16/2010 DoNotPost

FDA-2010-N-0568-DRAFT-0393 Anonymous - Comment 11/16/2010 DoNotPost

FDA-2010-N-0568-DRAFT-0394 Anonymous - Comment 11/16/2010 DoNotPost

FDA-2010-N-0568-DRAFT-0395 Anonymous - Comment 11/16/2010 DoNotPost

FDA-2010-N-0568-DRAFT-0396 Anonymous - Comment 11/16/2010 DoNotPost

FDA-2010-N-0568-DRAFT-0397 Anonymous - Comment 11/16/2010 DoNotPost

FDA-2010-N-0568-DRAFT-0399 Anonymous - Comment 11/16/2010 DoNotPost

FDA-2010-N-0568-DRAFT-0400 Anonymous - Comment 11/16/2010 DoNotPost

FDA-2010-N-0568-DRAFT-0401 Anonymous - Comment 11/16/2010 DoNotPost

FDA-2010-N-0568-DRAFT-0402 Anonymous - Comment 11/16/2010 DoNotPost

FDA-2010-N-0568-DRAFT-0403 Anonymous - Comment 11/16/2010 DoNotPost

FDA-2010-N-0568-DRAFT-0404 Anonymous - Comment 11/16/2010 DoNotPost

FDA-2010-N-0568-DRAFT-0405 Anonymous - Comment 11/16/2010 DoNotPost

FDA-2010-N-0568-DRAFT-0406 Anonymous - Comment 11/16/2010 DoNotPost

FDA-2010-N-0568-DRAFT-0407 Calvin Quigley Cerrone - Comment 11/16/2010 DoNotPost

FDA-2010-N-0568-DRAFT-0410 Anonymous - Comment 11/16/2010 DoNotPost

FDA-2010-N-0568-DRAFT-0411 Anonymous - Comment 11/16/2010 DoNotPost

FDA-2010-N-0568-DRAFT-0412 Anonymous - Comment 11/16/2010 DoNotPost

FDA-2010-N-0568-DRAFT-0413 Anonymous - Comment 11/16/2010 DoNotPost

FDA-2010-N-0568-DRAFT-0414 Anonymous - Comment 11/16/2010 DoNotPost

Page 6 of 39

Case 1:11-cv-01482-RJL Document 35-1 Filed 10/21/11 Page 29 of 61

Document ID Title Date

Received Phase

FDA-2010-N-0568-DRAFT-0415 Anonymous - Comment 11/16/2010 DoNotPost

FDA-2010-N-0568-DRAFT-0416 Tria Vang - Comment 11/16/2010 DoNotPost

FDA-2010-N-0568-DRAFT-0417 Anonymous - Comment 11/16/2010 DoNotPost

FDA-2010-N-0568-DRAFT-0421 Jean Barilla - Comment 11/16/2010 DoNotPost

FDA-2010-N-0568-DRAFT-0426 Charles A. Carlsen - Comment 11/16/2010 DoNotPost

FDA-2010-N-0568-DRAFT-0427 Martha A. Stamper - Comment 11/16/2010 DoNotPost

FDA-2010-N-0568-DRAFT-0430 Anonymous - Comment 11/16/2010 DoNotPost

FDA-2010-N-0568-DRAFT-0431 Marianne Alpha Schroer - Comment 11/16/2010 DoNotPost

FDA-2010-N-0568-DRAFT-0433 Barbara Lynn FRancesco - Comment 11/16/2010 DoNotPost

FDA-2010-N-0568-DRAFT-0434 John G. Ellis - Comment 11/16/2010 DoNotPost

FDA-2010-N-0568-DRAFT-0435 Jenna Cline - Comment 11/16/2010 DoNotPost

FDA-2010-N-0568-DRAFT-0436 Jenna Cline - Comment 11/16/2010 DoNotPost

FDA-2010-N-0568-DRAFT-0438 Christie Lynne Goodman - Comment 11/16/2010 DoNotPost

FDA-2010-N-0568-DRAFT-0439 James R. Kane - Comment 11/16/2010 DoNotPost

FDA-2010-N-0568-DRAFT-0440 Erin Theisen - Comment 11/16/2010 DoNotPost

FDA-2010-N-0568-DRAFT-0442 Patricia J. McDulin - Comment 11/16/2010 DoNotPost

FDA-2010-N-0568-DRAFT-0444 Anonymous - Comment 11/17/2010 DoNotPost

FDA-2010-N-0568-DRAFT-0447 Michele Renaud - Comment 11/17/2010 DoNotPost

FDA-2010-N-0568-DRAFT-0448 Vicki Reed - Comment 11/17/2010 DoNotPost

FDA-2010-N-0568-DRAFT-0450 Betty Jean Robinson - Comment 11/17/2010 DoNotPost

FDA-2010-N-0568-DRAFT-0453 Linda - Comment 11/17/2010 DoNotPost

FDA-2010-N-0568-DRAFT-0454 Hannah Walker - Comment 11/17/2010 DoNotPost

FDA-2010-N-0568-DRAFT-0459 George Eric Forsen - Comment 11/17/2010 DoNotPost

FDA-2010-N-0568-DRAFT-0462 Anonymous - Comment 11/17/2010 DoNotPost

FDA-2010-N-0568-DRAFT-0463 Robert Joseph Spellman - Comment 11/17/2010 DoNotPost

FDA-2010-N-0568-DRAFT-0464 Marilyn Elder - Comment 11/17/2010 DoNotPost

FDA-2010-N-0568-DRAFT-0465 J.W. - Comment 11/17/2010 DoNotPost

FDA-2010-N-0568-DRAFT-0468 Jan Alkire - Comment 11/17/2010 DoNotPost

FDA-2010-N-0568-DRAFT-0469 Jennifer Harrell - Comment 11/17/2010 DoNotPost

FDA-2010-N-0568-DRAFT-0470 Adam Miller - Comment 11/17/2010 DoNotPost

FDA-2010-N-0568-DRAFT-0472 Robert E. Morton, Jr. - Comment 11/17/2010 DoNotPost

FDA-2010-N-0568-DRAFT-0474 T.A. Cover - Comment 11/17/2010 DoNotPost

FDA-2010-N-0568-DRAFT-0475 Emily Orlikowski - Comment 11/17/2010 DoNotPost

FDA-2010-N-0568-DRAFT-0478 Barbara Slack - Comment 11/17/2010 DoNotPost

FDA-2010-N-0568-DRAFT-0479 Anas Brown - Comment 11/17/2010 DoNotPost

FDA-2010-N-0568-DRAFT-0480 Charles Dolder - Comment 11/17/2010 DoNotPost

FDA-2010-N-0568-DRAFT-0520 Danielle - Comment 11/18/2010 DoNotPost

FDA-2010-N-0568-DRAFT-0521 Danielle - Comment 11/18/2010 DoNotPost

FDA-2010-N-0568-DRAFT-0522 Ayla Marquez - Comment 11/18/2010 DoNotPost

FDA-2010-N-0568-DRAFT-0523 Stephen McMillen - Comment 11/18/2010 DoNotPost

FDA-2010-N-0568-DRAFT-0524 Meagan Sierens - Comment 11/18/2010 DoNotPost

FDA-2010-N-0568-DRAFT-0525 Jessica Cook - Comment 11/18/2010 DoNotPost

FDA-2010-N-0568-DRAFT-0526 James Fish - Comment 11/18/2010 DoNotPost

FDA-2010-N-0568-DRAFT-0527 Richard Reis - Comment 11/16/2010 DoNotPost

FDA-2010-N-0568-DRAFT-0528 William Santagata - Comment 11/16/2010 DoNotPost

FDA-2010-N-0568-DRAFT-0529 Michael Pallack - Comment 11/16/2010 DoNotPost

FDA-2010-N-0568-DRAFT-0530 Anne F. Long - Comment 11/16/2010 DoNotPost

FDA-2010-N-0568-DRAFT-0531 Ann Holterman - Comment 11/18/2010 DoNotPost

Page 7 of 39

Case 1:11-cv-01482-RJL Document 35-1 Filed 10/21/11 Page 30 of 61

Document ID Title Date

Received Phase

FDA-2010-N-0568-DRAFT-0532 Judith Cornelius - Comment 11/16/2010 DoNotPost

FDA-2010-N-0568-DRAFT-0533 Nedra Dokes - Comment 11/16/2010 DoNotPost

FDA-2010-N-0568-DRAFT-0534 Anonymous - Comment 11/15/2010 DoNotPost

FDA-2010-N-0568-DRAFT-0535 Mary Baker - Comment 11/18/2010 DoNotPost

FDA-2010-N-0568-DRAFT-0536 Clarence D. Bowers - Comment 11/15/2010 DoNotPost

FDA-2010-N-0568-DRAFT-0548 Chris Stauber - Comment 11/17/2010 DoNotPost

FDA-2010-N-0568-DRAFT-0550 Barbara Oberman - Comment 11/18/2010 DoNotPost

FDA-2010-N-0568-DRAFT-0551 Corey Barron - Comment 11/18/2010 DoNotPost

FDA-2010-N-0568-DRAFT-0552 Richard Edmund Ferry - Comment 11/18/2010 DoNotPost

FDA-2010-N-0568-DRAFT-0553 Anonymous - Comment 11/18/2010 DoNotPost

FDA-2010-N-0568-DRAFT-0554 Katie Fulks - Comment 11/18/2010 DoNotPost

FDA-2010-N-0568-DRAFT-0558 Anonymous - Comment 11/18/2010 DoNotPost

FDA-2010-N-0568-DRAFT-0562 Jenna Cline - Comment 11/18/2010 DoNotPost

FDA-2010-N-0568-DRAFT-0563 Joseph Conley - Comment 11/18/2010 DoNotPost

FDA-2010-N-0568-DRAFT-0564 Aaron Faw - Comment 11/18/2010 DoNotPost

FDA-2010-N-0568-DRAFT-0569 Shontia Griffin - Comment 11/18/2010 DoNotPost

FDA-2010-N-0568-DRAFT-0573 Paul Lewis - Comment 11/18/2010 DoNotPost

FDA-2010-N-0568-DRAFT-0577 Bronte Root - Comment 11/18/2010 DoNotPost

FDA-2010-N-0568-DRAFT-0581 Brent Ray - Comment 11/18/2010 DoNotPost

FDA-2010-N-0568-DRAFT-0582 Lauren Ambrozic - Comment 11/18/2010 DoNotPost

FDA-2010-N-0568-DRAFT-0583 Thomas Foeller - Comment 11/18/2010 DoNotPost

FDA-2010-N-0568-DRAFT-0584 David Hagen - Comment 11/18/2010 DoNotPost

FDA-2010-N-0568-DRAFT-0585 Annymous - Comment 11/18/2010 DoNotPost

FDA-2010-N-0568-DRAFT-0586 Anonymous - Comment 11/18/2010 DoNotPost

FDA-2010-N-0568-DRAFT-0588 Anonymous - Comment 11/18/2010 DoNotPost

FDA-2010-N-0568-DRAFT-0589 Sue Sayne - Comment 11/18/2010 DoNotPost

FDA-2010-N-0568-DRAFT-0590 Tim Dougherty - Comment 11/18/2010 DoNotPost

FDA-2010-N-0568-DRAFT-0591 Anonymous - Comment 11/18/2010 DoNotPost

FDA-2010-N-0568-DRAFT-0594 Angel Studebaker - Comment 11/18/2010 DoNotPost

FDA-2010-N-0568-DRAFT-0595 Heather Cowen-Wilson - Comment 11/18/2010 DoNotPost

FDA-2010-N-0568-DRAFT-0596 David Hasenauer - Comment 11/18/2010 DoNotPost

FDA-2010-N-0568-DRAFT-0598 Justin Robertson - Comment 11/18/2010 DoNotPost

FDA-2010-N-0568-DRAFT-0599 Nora Ferguson - Comment 11/18/2010 DoNotPost

FDA-2010-N-0568-DRAFT-0600 Anonymous - Comment 11/18/2010 DoNotPost

FDA-2010-N-0568-DRAFT-0602 Anonymous - Comment 11/18/2010 DoNotPost

FDA-2010-N-0568-DRAFT-0603 Kassie Kronenberger - Comment 11/18/2010 DoNotPost

FDA-2010-N-0568-DRAFT-0604 Morgan Lederman - Comment 11/18/2010 DoNotPost

FDA-2010-N-0568-DRAFT-0605 Awais Hussain - Comment 11/18/2010 DoNotPost

FDA-2010-N-0568-DRAFT-0606 Amber Shipman - Comment 11/18/2010 DoNotPost

FDA-2010-N-0568-DRAFT-0608 Alex Meffert - Comment 11/18/2010 DoNotPost

FDA-2010-N-0568-DRAFT-0609 Anonymous - Comment 11/18/2010 DoNotPost

FDA-2010-N-0568-DRAFT-0610 Ben Weiman - Comment 11/18/2010 DoNotPost

FDA-2010-N-0568-DRAFT-0611 Beth Bland - Comment 11/18/2010 DoNotPost

FDA-2010-N-0568-DRAFT-0612 Chris Fletcher - Comment 11/18/2010 DoNotPost

FDA-2010-N-0568-DRAFT-0613 Judy Sarayda Shapiro - Comment 11/19/2010 DoNotPost

FDA-2010-N-0568-DRAFT-0614 Christina Carter - Comment 11/19/2010 DoNotPost

FDA-2010-N-0568-DRAFT-0616 Clarence D. Bowers - Comment 11/18/2010 DoNotPost

FDA-2010-N-0568-DRAFT-0617 Scott Wohlers - Comment 11/18/2010 DoNotPost

FDA-2010-N-0568-DRAFT-0618 Karie Newman - Comment 11/19/2010 DoNotPost

FDA-2010-N-0568-DRAFT-0621 Mary Ann Hartnett - Comment 11/19/2010 DoNotPost

Page 8 of 39

Case 1:11-cv-01482-RJL Document 35-1 Filed 10/21/11 Page 31 of 61

Document ID Title Date

Received Phase

FDA-2010-N-0568-DRAFT-0622 Steve Stout - Comment 11/19/2010 DoNotPost

FDA-2010-N-0568-DRAFT-0623 Marjorie Carter - Comment 11/19/2010 DoNotPost

FDA-2010-N-0568-DRAFT-0626 Jennifer Wathen - Comment 11/19/2010 DoNotPost

FDA-2010-N-0568-DRAFT-0628 Porche Franklin - Comment 11/19/2010 DoNotPost

FDA-2010-N-0568-DRAFT-0630 Stephanie Steel - Comment 11/19/2010 DoNotPost

FDA-2010-N-0568-DRAFT-0635 Mary Boyd - Comment 11/19/2010 DoNotPost

FDA-2010-N-0568-DRAFT-0636 Jane O’Toole - Comment 11/19/2010 DoNotPost

FDA-2010-N-0568-DRAFT-0637 Colin Rigsby - Comment 11/19/2010 DoNotPost

FDA-2010-N-0568-DRAFT-0638 Joan Woodcock - Comment 11/19/2010 DoNotPost

FDA-2010-N-0568-DRAFT-0640 Lindsey Bein - Comment 11/19/2010 DoNotPost

FDA-2010-N-0568-DRAFT-0641 Gino Rampolla - Comment 11/19/2010 DoNotPost

FDA-2010-N-0568-DRAFT-0643 Anonymous - Comment 11/19/2010 DoNotPost

FDA-2010-N-0568-DRAFT-0644 Sara Gonzalez - Comment 11/19/2010 DoNotPost

FDA-2010-N-0568-DRAFT-0646 Shon Hathcock - Comment 11/19/2010 DoNotPost

FDA-2010-N-0568-DRAFT-0647 McKenzie Walker - Comment 11/19/2010 DoNotPost

FDA-2010-N-0568-DRAFT-0648 Robin Moon - Comment 11/19/2010 DoNotPost

FDA-2010-N-0568-DRAFT-0650 Shelley Nasello - Comment 11/19/2010 DoNotPost

FDA-2010-N-0568-DRAFT-0652 Sheyda Irani - Comment 11/20/2010 DoNotPost

FDA-2010-N-0568-DRAFT-0653 Grace E Ekstrom - Comment 11/20/2010 DoNotPost

FDA-2010-N-0568-DRAFT-0656 T. - Comment 11/20/2010 DoNotPost

FDA-2010-N-0568-DRAFT-0657 Martin Minemier - Comment 11/20/2010 DoNotPost

FDA-2010-N-0568-DRAFT-0658 Linda Roberts - Comment 11/20/2010 DoNotPost

FDA-2010-N-0568-DRAFT-0659 Alan Quackenbush - Comment 11/20/2010 DoNotPost

FDA-2010-N-0568-DRAFT-0663 Anonymous - Comment 11/20/2010 DoNotPost

FDA-2010-N-0568-DRAFT-0664 Anonymous - Comment 11/20/2010 DoNotPost

FDA-2010-N-0568-DRAFT-0665 Cherlyn - Comment 11/20/2010 DoNotPost

FDA-2010-N-0568-DRAFT-0666 Dianne McNally - Comment 11/20/2010 DoNotPost

FDA-2010-N-0568-DRAFT-0667 Sherri Bayer - Comment 11/20/2010 DoNotPost

FDA-2010-N-0568-DRAFT-0668 Edward Merrell - Comment 11/20/2010 DoNotPost

FDA-2010-N-0568-DRAFT-0670 Gloria J Williams - Comment 11/20/2010 DoNotPost

FDA-2010-N-0568-DRAFT-0671 Nicole Wagoner - Comment 11/20/2010 DoNotPost

FDA-2010-N-0568-DRAFT-0672 Anonymous - Comment 11/20/2010 DoNotPost

FDA-2010-N-0568-DRAFT-0673 Barbara Jones - Comment 11/20/2010 DoNotPost

FDA-2010-N-0568-DRAFT-0674 Anonymous - Comment 11/20/2010 DoNotPost

FDA-2010-N-0568-DRAFT-0675 Fernando Almeida - Comment 11/20/2010 DoNotPost

FDA-2010-N-0568-DRAFT-0676 Charlene Dolos - Comment 11/21/2010 DoNotPost

FDA-2010-N-0568-DRAFT-0677 Kenneth Sutherland III - Comment 11/21/2010 DoNotPost

FDA-2010-N-0568-DRAFT-0679 William Cunningham Jr - Comment 11/21/2010 DoNotPost

FDA-2010-N-0568-DRAFT-0680 Anonymous - Comment 11/21/2010 DoNotPost

FDA-2010-N-0568-DRAFT-0681 Donna Ipema - Comment 11/21/2010 DoNotPost

FDA-2010-N-0568-DRAFT-0682 Lindsey - Comment L 11/21/2010 DoNotPost

FDA-2010-N-0568-DRAFT-0683 Kelley Briggs - Comment 11/21/2010 DoNotPost

FDA-2010-N-0568-DRAFT-0684 Roberto Luciano - Comment 11/21/2010 DoNotPost

FDA-2010-N-0568-DRAFT-0686 Ronald Schoenherr - Comment 11/21/2010 DoNotPost

FDA-2010-N-0568-DRAFT-0687 Anonymous - Comment 11/21/2010 DoNotPost

FDA-2010-N-0568-DRAFT-0688 Marilyn Sanders - Comment 11/21/2010 DoNotPost

FDA-2010-N-0568-DRAFT-0690 Sheena Tomar - Comment 11/21/2010 DoNotPost

FDA-2010-N-0568-DRAFT-0691 Ronald Henry - Comment 11/21/2010 DoNotPost

FDA-2010-N-0568-DRAFT-0694 Ronald Rombough - Comment 11/21/2010 DoNotPost

FDA-2010-N-0568-DRAFT-0695 Terry Pentz - Comment 11/21/2010 DoNotPost

Page 9 of 39

Case 1:11-cv-01482-RJL Document 35-1 Filed 10/21/11 Page 32 of 61

Document ID Title Date

Received Phase

FDA-2010-N-0568-DRAFT-0696 Bibi Prindle - Comment 11/21/2010 DoNotPost

FDA-2010-N-0568-DRAFT-0697 Mark Pinson - Comment 11/21/2010 DoNotPost

FDA-2010-N-0568-DRAFT-0699 Tanya Wyatt - Comment 11/21/2010 DoNotPost

FDA-2010-N-0568-DRAFT-0700 Anonymous - Comment 11/21/2010 DoNotPost

FDA-2010-N-0568-DRAFT-0703 Anne Field - Comment 11/22/2010 DoNotPost

FDA-2010-N-0568-DRAFT-0707 Gina Livorsi - Comment 11/22/2010 DoNotPost

FDA-2010-N-0568-DRAFT-0708 Linda Treglia - Comment 11/22/2010 DoNotPost

FDA-2010-N-0568-DRAFT-0709 Anonymous - Comment 11/22/2010 DoNotPost

FDA-2010-N-0568-DRAFT-0710 Jeff Slattery - Comment 11/22/2010 DoNotPost

FDA-2010-N-0568-DRAFT-0711 Emily Gorenson - Comment 11/22/2010 DoNotPost

FDA-2010-N-0568-DRAFT-0712 Josie Ceselski - Comment 11/22/2010 DoNotPost

FDA-2010-N-0568-DRAFT-0713 Theresa Welt - Comment 11/22/2010 DoNotPost

FDA-2010-N-0568-DRAFT-0714 Vickie Brown - Comment 11/22/2010 DoNotPost

FDA-2010-N-0568-DRAFT-0716 Jennifer Roche - Comment 11/22/2010 DoNotPost

FDA-2010-N-0568-DRAFT-0718 Rachel Ciccarone - Comment 11/22/2010 DoNotPost

FDA-2010-N-0568-DRAFT-0719 Gary Keene - Comment 11/22/2010 DoNotPost

FDA-2010-N-0568-DRAFT-0720 Nancy Hadley - Comment 11/22/2010 DoNotPost

FDA-2010-N-0568-DRAFT-0721 Joyce Faltis - Comment 11/22/2010 DoNotPost

FDA-2010-N-0568-DRAFT-0722 Devon Sanders - Comment 11/22/2010 DoNotPost

FDA-2010-N-0568-DRAFT-0723 Karen Thompson - Comment 11/22/2010 DoNotPost

FDA-2010-N-0568-DRAFT-0724 Molly Marks - Comment 11/22/2010 DoNotPost

FDA-2010-N-0568-DRAFT-0725 Kenyetta Watkins - Comment 11/22/2010 DoNotPost

FDA-2010-N-0568-DRAFT-0726 Samantha Ross - Comment 11/22/2010 DoNotPost

FDA-2010-N-0568-DRAFT-0728 Jordan Kantner - Comment 11/22/2010 DoNotPost

FDA-2010-N-0568-DRAFT-0729 James Smith - Comment 11/22/2010 DoNotPost

FDA-2010-N-0568-DRAFT-0730 Teddy Sloan - Comment 11/22/2010 DoNotPost

FDA-2010-N-0568-DRAFT-0731 Anonymous - Comment 11/22/2010 DoNotPost

FDA-2010-N-0568-DRAFT-0732 Anonymous - Comment 11/22/2010 DoNotPost

FDA-2010-N-0568-DRAFT-0735 Anonymous - Comment 11/22/2010 DoNotPost

FDA-2010-N-0568-DRAFT-0736 Ian Durkee - Comment 11/22/2010 DoNotPost

FDA-2010-N-0568-DRAFT-0740 Joseph Stelzer - Comment 11/22/2010 DoNotPost

FDA-2010-N-0568-DRAFT-0741 Alec McKenna - Comment 11/22/2010 DoNotPost

FDA-2010-N-0568-DRAFT-0742 Carolyn Hilde - Comment 11/22/2010 DoNotPost

FDA-2010-N-0568-DRAFT-0743 Marta Kowal - Comment 11/22/2010 DoNotPost

FDA-2010-N-0568-DRAFT-0745 Miranda Linco - Comment 11/22/2010 DoNotPost

FDA-2010-N-0568-DRAFT-0746 Jasmine Paige - Comment 11/22/2010 DoNotPost

FDA-2010-N-0568-DRAFT-0747 Jack Church - Comment 11/22/2010 DoNotPost

FDA-2010-N-0568-DRAFT-0750 Mary Bryant - Comment 11/22/2010 DoNotPost

FDA-2010-N-0568-DRAFT-0751 Deanna Cooley - Comment 11/23/2010 DoNotPost

FDA-2010-N-0568-DRAFT-0753 Linda Hawkins - Comment 11/23/2010 DoNotPost

FDA-2010-N-0568-DRAFT-0755 Gregg Cayce - Comment 11/23/2010 DoNotPost

FDA-2010-N-0568-DRAFT-0756 Diana Verdick - Comment 11/23/2010 DoNotPost

FDA-2010-N-0568-DRAFT-0757 Lauren Kostrzeski - Comment 11/23/2010 DoNotPost

FDA-2010-N-0568-DRAFT-0758 Andrew Miller - Comment 11/23/2010 DoNotPost

FDA-2010-N-0568-DRAFT-0760 Thomas Gabriel - Comment 11/23/2010 DoNotPost

FDA-2010-N-0568-DRAFT-0761 Yamini Patel - Comment 11/23/2010 DoNotPost

FDA-2010-N-0568-DRAFT-0762 Kay Adefuye - Comment 11/23/2010 DoNotPost

FDA-2010-N-0568-DRAFT-0763 Juliet Dlugokecki - Comment 11/23/2010 DoNotPost

FDA-2010-N-0568-DRAFT-0765 Matt Nadzam - Comment 11/23/2010 DoNotPost

FDA-2010-N-0568-DRAFT-0767 Keturah Nowak - Comment 11/23/2010 DoNotPost

Page 10 of 39

Case 1:11-cv-01482-RJL Document 35-1 Filed 10/21/11 Page 33 of 61

Document ID Title Date

Received Phase

FDA-2010-N-0568-DRAFT-0768 Fuwad Ogunedina - Comment 11/23/2010 DoNotPost

FDA-2010-N-0568-DRAFT-0769 Logan Thompson - Comment 11/23/2010 DoNotPost

FDA-2010-N-0568-DRAFT-0770 Nathan Reynolds - Comment 11/23/2010 DoNotPost

FDA-2010-N-0568-DRAFT-0772 Anonymous - Comment 11/23/2010 DoNotPost

FDA-2010-N-0568-DRAFT-0777 Garrett Potterton - Comment 11/23/2010 DoNotPost

FDA-2010-N-0568-DRAFT-0778 Kelly Bitsilly - Comment 11/23/2010 DoNotPost

FDA-2010-N-0568-DRAFT-0779 Mark Luger - Comment 11/23/2010 DoNotPost

FDA-2010-N-0568-DRAFT-0780 Mark Luger - Comment 11/24/2010 DoNotPost

FDA-2010-N-0568-DRAFT-0784 Marissa Villaluna - Comment 11/24/2010 DoNotPost

FDA-2010-N-0568-DRAFT-0788 Jennie Rhoades - Comment 11/24/2010 DoNotPost

FDA-2010-N-0568-DRAFT-0791 Anonymous - Comment 11/24/2010 DoNotPost

FDA-2010-N-0568-DRAFT-0792 Meredith Lindsay Milewicz -11/24/2010 DoNotPost

Comment

FDA-2010-N-0568-DRAFT-0793 Helen Ogden - Comment 11/25/2010 DoNotPost

FDA-2010-N-0568-DRAFT-0794 Anonymous - Comment 11/25/2010 DoNotPost

FDA-2010-N-0568-DRAFT-0795 Todd Burnell Settle - Comment 11/26/2010 DoNotPost

FDA-2010-N-0568-DRAFT-0796 Sarah B. Semon - Comment 11/26/2010 DoNotPost

FDA-2010-N-0568-DRAFT-0797 Richard Draper - Comment 11/26/2010 DoNotPost

FDA-2010-N-0568-DRAFT-0798 Vickie Susan Barrett - Comment 11/26/2010 DoNotPost

FDA-2010-N-0568-DRAFT-0799 Michelle L Sykes - Comment 11/26/2010 DoNotPost

FDA-2010-N-0568-DRAFT-0801 Eileen Bowen - Comment 11/27/2010 DoNotPost

FDA-2010-N-0568-DRAFT-0803 Jeffrey Todd Kinkle - Comment 11/27/2010 DoNotPost

FDA-2010-N-0568-DRAFT-0805 Bennett Myron Spence - Comment 11/27/2010 DoNotPost

FDA-2010-N-0568-DRAFT-0806 Anonymous - Comment 11/27/2010 DoNotPost

FDA-2010-N-0568-DRAFT-0807 Anonymous - Comment 11/28/2010 DoNotPost

FDA-2010-N-0568-DRAFT-0810 Anonymous - Comment 11/28/2010 DoNotPost

FDA-2010-N-0568-DRAFT-0811 Anonymous - Comment 11/28/2010 DoNotPost

FDA-2010-N-0568-DRAFT-0812 Anonymous - Comment 11/28/2010 DoNotPost

FDA-2010-N-0568-DRAFT-0813 Anonymous - Comment 11/28/2010 DoNotPost

FDA-2010-N-0568-DRAFT-0814 Anonymous - Comment 11/28/2010 DoNotPost

FDA-2010-N-0568-DRAFT-0815 Christine Lisiecki - Comment 11/28/2010 DoNotPost

FDA-2010-N-0568-DRAFT-0816 Michelle Chang - Comment 11/28/2010 DoNotPost

FDA-2010-N-0568-DRAFT-0817 Jack H. - Comment 11/28/2010 DoNotPost

FDA-2010-N-0568-DRAFT-0818 Anonymous - Comment 11/28/2010 DoNotPost

FDA-2010-N-0568-DRAFT-0819 Jamie Mustful - Comment 11/28/2010 DoNotPost

FDA-2010-N-0568-DRAFT-0820 Anonymous - Comment 11/28/2010 DoNotPost

FDA-2010-N-0568-DRAFT-0821 Anonymous - Comment 11/28/2010 DoNotPost

FDA-2010-N-0568-DRAFT-0822 Anonymous - Comment 11/28/2010 DoNotPost

FDA-2010-N-0568-DRAFT-0824 Anonymous - Comment 11/28/2010 DoNotPost

FDA-2010-N-0568-DRAFT-0826 Anonymous - Comment 11/28/2010 DoNotPost

FDA-2010-N-0568-DRAFT-0827 Anonymous - Comment 11/28/2010 DoNotPost

FDA-2010-N-0568-DRAFT-0829 Anonymous - Comment 11/28/2010 DoNotPost

FDA-2010-N-0568-DRAFT-0830 Anonymous - Comment 11/28/2010 DoNotPost

FDA-2010-N-0568-DRAFT-0831 Lane Foster Mobley - Comment 11/28/2010 DoNotPost

FDA-2010-N-0568-DRAFT-0832 Alexander Meffert-Nelson - Comment 11/29/2010 DoNotPost

FDA-2010-N-0568-DRAFT-0833 Anonymous - Comment 11/29/2010 DoNotPost

FDA-2010-N-0568-DRAFT-0836 Lee Vogtman - Comment 11/29/2010 DoNotPost

FDA-2010-N-0568-DRAFT-0837 Cathy T Moore - Comment 11/29/2010 DoNotPost

FDA-2010-N-0568-DRAFT-0843 Lorien Smyer - Comment 11/29/2010 DoNotPost

Page 11 of 39

Case 1:11-cv-01482-RJL Document 35-1 Filed 10/21/11 Page 34 of 61

Document ID Title Date

Received Phase

FDA-2010-N-0568-DRAFT-0845 Cal D. Rains - Comment 11/29/2010 DoNotPost

FDA-2010-N-0568-DRAFT-0848 Tierrilee Adrienne Robb - Comment 11/29/2010 DoNotPost

FDA-2010-N-0568-DRAFT-0849 Dennis Radecky - Comment 11/29/2010 DoNotPost

FDA-2010-N-0568-DRAFT-0851 B.H. - Comment 11/29/2010 DoNotPost

FDA-2010-N-0568-DRAFT-0852 Bovy - Comment 11/29/2010 DoNotPost

FDA-2010-N-0568-DRAFT-0853 Sobette Anna Sissi - Comment 11/29/2010 DoNotPost

FDA-2010-N-0568-DRAFT-0854 Sophie Sissi - Comment 11/29/2010 DoNotPost

FDA-2010-N-0568-DRAFT-0855 Anonymous - Comment 11/29/2010 DoNotPost

FDA-2010-N-0568-DRAFT-0856 Anonymous - Comment 11/29/2010 DoNotPost

FDA-2010-N-0568-DRAFT-0857 Thoms Rhoades - Comment 11/29/2010 DoNotPost

FDA-2010-N-0568-DRAFT-0859 James Edward Arntz - Comment 11/29/2010 DoNotPost

FDA-2010-N-0568-DRAFT-0861 Anonymous - Comment 11/30/2010 DoNotPost

FDA-2010-N-0568-DRAFT-0862 Anonymous - Comment 11/30/2010 DoNotPost

FDA-2010-N-0568-DRAFT-0868 Anonymous - Comment 11/30/2010 DoNotPost

FDA-2010-N-0568-DRAFT-0869 Anonymous - Comment 11/30/2010 DoNotPost

FDA-2010-N-0568-DRAFT-0870 Anonymous - Comment 11/30/2010 DoNotPost

FDA-2010-N-0568-DRAFT-0873 Tim Pishdad - Comment 12/1/2010 DoNotPost

FDA-2010-N-0568-DRAFT-0876 Kathy E. Figiel - Comment 11/22/2010 DoNotPost

FDA-2010-N-0568-DRAFT-0877 Amber Brister - Comment 11/22/2010 DoNotPost

FDA-2010-N-0568-DRAFT-0878 Mami Dittmar - Comment 11/22/2010 DoNotPost

FDA-2010-N-0568-DRAFT-0881 Dee Bura - Comment 12/1/2010 DoNotPost

FDA-2010-N-0568-DRAFT-0883 Anonymous - Comment 12/1/2010 DoNotPost

FDA-2010-N-0568-DRAFT-0884 Spencer M. - Comment 12/1/2010 DoNotPost

FDA-2010-N-0568-DRAFT-0885 Wade Austin Perry - Comment 12/1/2010 DoNotPost

FDA-2010-N-0568-DRAFT-0886 Anonymous - Comment 12/1/2010 DoNotPost

FDA-2010-N-0568-DRAFT-0888 Anonymous - Comment 12/1/2010 DoNotPost

FDA-2010-N-0568-DRAFT-0893 Richard Edmund Ferry - Comment 11/23/2010 DoNotPost

FDA-2010-N-0568-DRAFT-0894 Nikquan Lewis - Comment 11/23/2010 DoNotPost

FDA-2010-N-0568-DRAFT-0895 Carla Johnson - Comment 11/23/2010 DoNotPost

FDA-2010-N-0568-DRAFT-0896 Mike Harrison - Comment 11/24/2010 DoNotPost

FDA-2010-N-0568-DRAFT-0901 James Allen Zorns - Comment 12/2/2010 DoNotPost

FDA-2010-N-0568-DRAFT-0903 Lynda Wilson, R.N. - Comment 11/29/2010 DoNotPost

FDA-2010-N-0568-DRAFT-0904 Unknown - Comment 11/29/2010 DoNotPost

FDA-2010-N-0568-DRAFT-0905 Ronald T. Schoenherr - Comment 11/29/2010 DoNotPost

FDA-2010-N-0568-DRAFT-0906 J.P. Cochran - Comment 12/1/2010 DoNotPost

FDA-2010-N-0568-DRAFT-0907 Patrick Ewalt - Comment 12/3/2010 DoNotPost

FDA-2010-N-0568-DRAFT-0908 J.F. Somers - Comment 12/1/2010 DoNotPost

FDA-2010-N-0568-DRAFT-0909 Tammy Larson - Comment 12/1/2010 DoNotPost

FDA-2010-N-0568-DRAFT-0912 Amy Roberts - Comment 12/3/2010 DoNotPost

FDA-2010-N-0568-DRAFT-0913 Anonymous - Comment 12/3/2010 DoNotPost

FDA-2010-N-0568-DRAFT-0917 Courtney Elbert - Comment 12/3/2010 DoNotPost

FDA-2010-N-0568-DRAFT-0918 Anonymous - Comment 12/3/2010 DoNotPost

FDA-2010-N-0568-DRAFT-0920 Jack Marrion - Comment 12/4/2010 DoNotPost

FDA-2010-N-0568-DRAFT-0921 Gary Lyndon Simons - Comment 12/4/2010 DoNotPost

FDA-2010-N-0568-DRAFT-0922 Sean Robert Desrochers - Comment 12/4/2010 DoNotPost

FDA-2010-N-0568-DRAFT-0924 Robin L. Bettencourt - Comment 12/5/2010 DoNotPost

FDA-2010-N-0568-DRAFT-0930 Keli Marie Hall - Comment 12/6/2010 DoNotPost

FDA-2010-N-0568-DRAFT-0932 Anonymous - Comment 12/6/2010 DoNotPost

FDA-2010-N-0568-DRAFT-0933 Megan Multack - Comment 12/6/2010 DoNotPost

FDA-2010-N-0568-DRAFT-0942 Shea Marie Evans - Comment 12/6/2010 DoNotPost

Page 12 of 39

Case 1:11-cv-01482-RJL Document 35-1 Filed 10/21/11 Page 35 of 61

Document ID Title Date

Received Phase

FDA-2010-N-0568-DRAFT-0944 Richard J. Smith III - Comment 12/6/2010 DoNotPost

FDA-2010-N-0568-DRAFT-0952 Marlet Jones - Comment 12/6/2010 DoNotPost

FDA-2010-N-0568-DRAFT-0955 George Perry Hoskin - Comment 12/6/2010 DoNotPost

FDA-2010-N-0568-DRAFT-0958 Samuel C. Ingraham - Comment 12/6/2010 DoNotPost

FDA-2010-N-0568-DRAFT-0963 Danielle S. Mills - Comment 12/7/2010 DoNotPost

FDA-2010-N-0568-DRAFT-0966 Anonymous - Comment 12/7/2010 DoNotPost

FDA-2010-N-0568-DRAFT-0974 Anonymous - Comment 12/7/2010 DoNotPost

FDA-2010-N-0568-DRAFT-0982 Marnie Schilken - Comment 12/7/2010 DoNotPost

FDA-2010-N-0568-DRAFT-0991 Yolanda Dixon - Comment 12/7/2010 DoNotPost

FDA-2010-N-0568-DRAFT-0992 Sven E. Rodenbeck - Comment 12/7/2010 DoNotPost

FDA-2010-N-0568-DRAFT-0995 Amanda Yong - Comment 12/7/2010 DoNotPost

FDA-2010-N-0568-DRAFT-1001 Pamela Kathleen Reynolds -12/8/2010 DoNotPost

Comment

FDA-2010-N-0568-DRAFT-1004 Anonymous - Comment 12/8/2010 DoNotPost

FDA-2010-N-0568-DRAFT-1005 Anonymous - Comment 12/8/2010 DoNotPost

FDA-2010-N-0568-DRAFT-1006 Janice Mercer - Comment 12/8/2010 DoNotPost

FDA-2010-N-0568-DRAFT-1010 Daniel Taharlev - Comment 12/9/2010 DoNotPost

FDA-2010-N-0568-DRAFT-1013 Julie J. Kessler - Comment 12/9/2010 DoNotPost

FDA-2010-N-0568-DRAFT-1019 David Steinmetz, No Butts About It 12/10/2010 DoNotPost

Litter Campaign - Comment

FDA-2010-N-0568-DRAFT-1020 Samuel Ikenberry - Comment 12/10/2010 DoNotPost

FDA-2010-N-0568-DRAFT-1026 Anonymous - Comment 12/10/2010 DoNotPost

FDA-2010-N-0568-DRAFT-1031 Dominick Splendorio - Comment 12/12/2010 DoNotPost

FDA-2010-N-0568-DRAFT-1034 Alan W. Siemering - Comment 12/12/2010 DoNotPost

FDA-2010-N-0568-DRAFT-1035 Victor Isarraraz - Comment 12/12/2010 DoNotPost

FDA-2010-N-0568-DRAFT-1036 Victor Isarraraz - Comment 12/12/2010 DoNotPost

FDA-2010-N-0568-DRAFT-1038 Antoinette Kelleher-Raynes -12/13/2010 DoNotPost

Comment

FDA-2010-N-0568-DRAFT-1047 Sachin Desai - Comment 12/13/2010 DoNotPost

FDA-2010-N-0568-DRAFT-1048 Nirdesh K. Gupta - Comment 12/13/2010 DoNotPost

FDA-2010-N-0568-DRAFT-1051 David Steinmetz, No Butts About It 12/13/2010 DoNotPost

Litter Campaign - Comment

FDA-2010-N-0568-DRAFT-1052 Jeff Murray - Comment 12/14/2010 DoNotPost

FDA-2010-N-0568-DRAFT-1057 Mitchell Glass - Comment 12/14/2010 DoNotPost

FDA-2010-N-0568-DRAFT-1058 Lisa Delaney - Comment 12/14/2010 DoNotPost

FDA-2010-N-0568-DRAFT-1059 Madeline Jean Akeley - Comment 12/14/2010 DoNotPost

FDA-2010-N-0568-DRAFT-1060 Karen R. Hinkle - Comment 12/15/2010 DoNotPost

FDA-2010-N-0568-DRAFT-1061 Kristine Marie Villanueva - Comment 12/15/2010 DoNotPost

FDA-2010-N-0568-DRAFT-1066 Jacqueline M. Vanier - Comment 12/15/2010 DoNotPost

FDA-2010-N-0568-DRAFT-1071 Jonathan Matthew Holland -12/16/2010 DoNotPost

Comment

FDA-2010-N-0568-DRAFT-1072 Jeffery Don House - Comment 12/16/2010 DoNotPost

FDA-2010-N-0568-DRAFT-1073 Lovely M. Bayani - Comment 12/16/2010 DoNotPost

FDA-2010-N-0568-DRAFT-1074 William Taylor - Comment 12/16/2010 DoNotPost

FDA-2010-N-0568-DRAFT-1076 Susan Stein, Ph.D. - Comment 12/17/2010 DoNotPost

FDA-2010-N-0568-DRAFT-1082 Malu Misilao - Comment 12/17/2010 DoNotPost

FDA-2010-N-0568-DRAFT-1087 Barbara Lou Rushmore - Comment 12/18/2010 DoNotPost

FDA-2010-N-0568-DRAFT-1089 L. Aguilar - Comment 12/19/2010 DoNotPost

FDA-2010-N-0568-DRAFT-1090 Jeffry Larson - Comment 12/19/2010 DoNotPost

FDA-2010-N-0568-DRAFT-1091 Kristen Carteret - Comment 12/19/2010 DoNotPost

Page 13 of 39

Case 1:11-cv-01482-RJL Document 35-1 Filed 10/21/11 Page 36 of 61

Document ID Title Date

Received Phase

FDA-2010-N-0568-DRAFT-1092 Corwin D. Strong - Comment 12/19/2010 DoNotPost

FDA-2010-N-0568-DRAFT-1099 Charles Joseph Alley III - Comment 12/20/2010 DoNotPost

FDA-2010-N-0568-DRAFT-1103 Samantha - Comment 12/21/2010 DoNotPost

FDA-2010-N-0568-DRAFT-1104 Anonymous - Comment 12/21/2010 DoNotPost

FDA-2010-N-0568-DRAFT-1105 Anonymous - Comment 12/21/2010 DoNotPost

FDA-2010-N-0568-DRAFT-1106 Justice D. - Comment 12/21/2010 DoNotPost

FDA-2010-N-0568-DRAFT-1107 Samantha - Comment 12/21/2010 DoNotPost

FDA-2010-N-0568-DRAFT-1108 Kylee Hetherington - Comment 12/21/2010 DoNotPost

FDA-2010-N-0568-DRAFT-1109 Anonymous - Comment 12/21/2010 DoNotPost

FDA-2010-N-0568-DRAFT-1110 Samantha - Comment 12/21/2010 DoNotPost

FDA-2010-N-0568-DRAFT-1111 Anonymous - Comment 12/21/2010 DoNotPost

FDA-2010-N-0568-DRAFT-1112 Jason Daniel Bond - Comment 12/21/2010 DoNotPost

FDA-2010-N-0568-DRAFT-1113 Anonymous - Comment 12/21/2010 DoNotPost

FDA-2010-N-0568-DRAFT-1114 Samantha - Comment 12/21/2010 DoNotPost

FDA-2010-N-0568-DRAFT-1115 Austin - Comment 12/21/2010 DoNotPost

FDA-2010-N-0568-DRAFT-1116 Kendra H. - Comment 12/21/2010 DoNotPost

FDA-2010-N-0568-DRAFT-1117 Samantha - Comment 12/21/2010 DoNotPost

FDA-2010-N-0568-DRAFT-1118 Samantha - Comment 12/21/2010 DoNotPost

FDA-2010-N-0568-DRAFT-1119 Anonymous - Comment 12/21/2010 DoNotPost

FDA-2010-N-0568-DRAFT-1120 Alexander - Comment 12/21/2010 DoNotPost

FDA-2010-N-0568-DRAFT-1121 Noah - Comment 12/21/2010 DoNotPost

FDA-2010-N-0568-DRAFT-1122 Rebecca C. - Comment 12/21/2010 DoNotPost

FDA-2010-N-0568-DRAFT-1123 Samantha - Comment 12/21/2010 DoNotPost

FDA-2010-N-0568-DRAFT-1124 Anonymous - Comment 12/21/2010 DoNotPost

FDA-2010-N-0568-DRAFT-1125 Trevor - Comment 12/21/2010 DoNotPost

FDA-2010-N-0568-DRAFT-1126 Anonymous - Comment 12/21/2010 DoNotPost

FDA-2010-N-0568-DRAFT-1127 Austin - Comment 12/21/2010 DoNotPost

FDA-2010-N-0568-DRAFT-1128 Anonymous - Comment 12/21/2010 DoNotPost

FDA-2010-N-0568-DRAFT-1129 Anonymous - Comment 12/21/2010 DoNotPost

FDA-2010-N-0568-DRAFT-1130 Anonymous - Comment 12/21/2010 DoNotPost

FDA-2010-N-0568-DRAFT-1131 Brandon - Comment 12/21/2010 DoNotPost

FDA-2010-N-0568-DRAFT-1134 Rick - Comment 12/21/2010 DoNotPost

FDA-2010-N-0568-DRAFT-1135 Joshua - Comment 12/21/2010 DoNotPost

FDA-2010-N-0568-DRAFT-1136 Colin - Comment 12/21/2010 DoNotPost

FDA-2010-N-0568-DRAFT-1137 Taylor - Comment 12/21/2010 DoNotPost

FDA-2010-N-0568-DRAFT-1138 Teal - Comment 12/21/2010 DoNotPost

FDA-2010-N-0568-DRAFT-1139 Suzie Ryder - Comment 12/21/2010 DoNotPost

FDA-2010-N-0568-DRAFT-1140 Aaron - Comment 12/21/2010 DoNotPost

FDA-2010-N-0568-DRAFT-1141 Derek - Comment 12/21/2010 DoNotPost

FDA-2010-N-0568-DRAFT-1142 Jahzaya - Comment 12/21/2010 DoNotPost

FDA-2010-N-0568-DRAFT-1143 Andrew - Comment 12/21/2010 DoNotPost

FDA-2010-N-0568-DRAFT-1144 Tanner - Comment 12/21/2010 DoNotPost

FDA-2010-N-0568-DRAFT-1145 Amber - Comment 12/21/2010 DoNotPost

FDA-2010-N-0568-DRAFT-1146 Elias - Comment 12/21/2010 DoNotPost

FDA-2010-N-0568-DRAFT-1147 Joshua Mickle Ryan - Comment 12/21/2010 DoNotPost

FDA-2010-N-0568-DRAFT-1148 Brenda - Comment 12/21/2010 DoNotPost

FDA-2010-N-0568-DRAFT-1150 Kenneth Woodard - Comment 12/21/2010 DoNotPost

FDA-2010-N-0568-DRAFT-1151 Anonymous - Comment 12/21/2010 DoNotPost

FDA-2010-N-0568-DRAFT-1152 Ronald Adam Zdrojewski - Comment 12/21/2010 DoNotPost

Page 14 of 39

Case 1:11-cv-01482-RJL Document 35-1 Filed 10/21/11 Page 37 of 61

Document ID Title Date

Received Phase

FDA-2010-N-0568-DRAFT-1153 Anonymous - Comment 12/22/2010 DoNotPost

FDA-2010-N-0568-DRAFT-1154 David - Comment 12/22/2010 DoNotPost

FDA-2010-N-0568-DRAFT-1155 Ben Blasier - Comment 12/22/2010 DoNotPost

FDA-2010-N-0568-DRAFT-1156 Paul - Comment 12/22/2010 DoNotPost

FDA-2010-N-0568-DRAFT-1157 Joe Gardner - Comment 12/22/2010 DoNotPost

FDA-2010-N-0568-DRAFT-1158 David - Comment 12/22/2010 DoNotPost

FDA-2010-N-0568-DRAFT-1159 Shantel - Comment 12/22/2010 DoNotPost

FDA-2010-N-0568-DRAFT-1160 Demi - Comment 12/22/2010 DoNotPost

FDA-2010-N-0568-DRAFT-1161 Danielle - Comment 12/22/2010 DoNotPost

FDA-2010-N-0568-DRAFT-1162 Travis - Comment 12/22/2010 DoNotPost

FDA-2010-N-0568-DRAFT-1163 Peyton - Comment 12/22/2010 DoNotPost

FDA-2010-N-0568-DRAFT-1164 Timothy Plaza - Comment 12/22/2010 DoNotPost

FDA-2010-N-0568-DRAFT-1165 Emmyz Bean - Comment 12/22/2010 DoNotPost

FDA-2010-N-0568-DRAFT-1166 Ashley - Comment 12/22/2010 DoNotPost

FDA-2010-N-0568-DRAFT-1167 Monica Wlodarski - Comment 12/22/2010 DoNotPost

FDA-2010-N-0568-DRAFT-1168 Matayaa - Comment 12/22/2010 DoNotPost

FDA-2010-N-0568-DRAFT-1169 Demi - Comment 12/22/2010 DoNotPost

FDA-2010-N-0568-DRAFT-1170 Molly - Comment 12/22/2010 DoNotPost

FDA-2010-N-0568-DRAFT-1171 Megan - Comment 12/22/2010 DoNotPost

FDA-2010-N-0568-DRAFT-1172 Lexer - Comment 12/22/2010 DoNotPost

FDA-2010-N-0568-DRAFT-1173 MIra - Comment 12/22/2010 DoNotPost

FDA-2010-N-0568-DRAFT-1175 Austin - Comment 12/22/2010 DoNotPost

FDA-2010-N-0568-DRAFT-1176 Anonymous - Comment 12/22/2010 DoNotPost

FDA-2010-N-0568-DRAFT-1178 Anonymous - Comment 12/22/2010 DoNotPost

FDA-2010-N-0568-DRAFT-1179 Shannon Ann Mary S. - Comment 12/22/2010 DoNotPost

FDA-2010-N-0568-DRAFT-1180 Josh - Comment 12/22/2010 DoNotPost

FDA-2010-N-0568-DRAFT-1181 Amanda - Comment 12/22/2010 DoNotPost

FDA-2010-N-0568-DRAFT-1182 Josh - Comment 12/22/2010 DoNotPost

FDA-2010-N-0568-DRAFT-1183 Nick - Comment 12/22/2010 DoNotPost

FDA-2010-N-0568-DRAFT-1184 Josh - Comment 12/22/2010 DoNotPost

FDA-2010-N-0568-DRAFT-1185 Sarah Ketchup Mustard - Comment 12/22/2010 DoNotPost

FDA-2010-N-0568-DRAFT-1186 Alexander Douglas Hammer -12/22/2010 DoNotPost

Comment

FDA-2010-N-0568-DRAFT-1187 Brent - Comment 12/22/2010 DoNotPost

FDA-2010-N-0568-DRAFT-1188 John - Comment 12/22/2010 DoNotPost

FDA-2010-N-0568-DRAFT-1189 Ember - Comment 12/22/2010 DoNotPost

FDA-2010-N-0568-DRAFT-1190 Lizzie - Comment 12/22/2010 DoNotPost

FDA-2010-N-0568-DRAFT-1191 Trey - Comment 12/22/2010 DoNotPost

FDA-2010-N-0568-DRAFT-1192 Lilly - Comment 12/22/2010 DoNotPost

FDA-2010-N-0568-DRAFT-1193 Rachael - Comment 12/22/2010 DoNotPost

FDA-2010-N-0568-DRAFT-1194 Hunter - Comment 12/22/2010 DoNotPost

FDA-2010-N-0568-DRAFT-1195 Hunter - Comment 12/22/2010 DoNotPost

FDA-2010-N-0568-DRAFT-1196 Nathan - Comment 12/22/2010 DoNotPost

FDA-2010-N-0568-DRAFT-1197 Breana - Comment 12/22/2010 DoNotPost

FDA-2010-N-0568-DRAFT-1198 Christian Prior - Comment 12/22/2010 DoNotPost

FDA-2010-N-0568-DRAFT-1199 Shelby Lee Buffham - Comment 12/22/2010 DoNotPost

FDA-2010-N-0568-DRAFT-1203 Anonymous - Comment 12/23/2010 DoNotPost

FDA-2010-N-0568-DRAFT-1204 Stephen Ulbricht - Comment 12/22/2010 DoNotPost

FDA-2010-N-0568-DRAFT-1205 Celia Gooch - Comment 12/22/2010 DoNotPost

FDA-2010-N-0568-DRAFT-1206 Michael Shaw - Comment 12/23/2010 DoNotPost

Page 15 of 39

Case 1:11-cv-01482-RJL Document 35-1 Filed 10/21/11 Page 38 of 61

Document ID Title Date

Received Phase

FDA-2010-N-0568-DRAFT-1207 Anonymous - Comment 12/23/2010 DoNotPost

FDA-2010-N-0568-DRAFT-1208 Anne Kisly - Comment 12/23/2010 DoNotPost

FDA-2010-N-0568-DRAFT-1211 Christy Ann Onufer - Comment 12/26/2010 DoNotPost

FDA-2010-N-0568-DRAFT-1212 Edward Greene - Comment 12/26/2010 DoNotPost

FDA-2010-N-0568-DRAFT-1213 Cameron Lowell Palmer - Comment 12/26/2010 DoNotPost

FDA-2010-N-0568-DRAFT-1214 Anonymous - Comment 12/27/2010 DoNotPost

FDA-2010-N-0568-DRAFT-1215 Joan Blackwood Davis - Comment 12/27/2010 DoNotPost

FDA-2010-N-0568-DRAFT-1217 Jonathan Mark Ball - Comment 12/28/2010 DoNotPost

FDA-2010-N-0568-DRAFT-1218 Carol McNamara - Comment 12/28/2010 DoNotPost

FDA-2010-N-0568-DRAFT-1222 Catherine Ann Champion - Comment 12/29/2010 DoNotPost

FDA-2010-N-0568-DRAFT-1223 Jaime Marie Price - Comment 12/29/2010 DoNotPost

FDA-2010-N-0568-DRAFT-1225 Ann Keysor - Comment 12/30/2010 DoNotPost

FDA-2010-N-0568-DRAFT-1227 Anonymous - Comment 12/31/2010 DoNotPost

FDA-2010-N-0568-DRAFT-1228 Nick Mancini - Comment 1/1/2011 DoNotPost

FDA-2010-N-0568-DRAFT-1229 Patricia Broderick - Comment 1/1/2011 DoNotPost

FDA-2010-N-0568-DRAFT-1230 Kim L. Byers - Comment 1/1/2011 DoNotPost

FDA-2010-N-0568-DRAFT-1234 Stephen Helfer - Comment 1/3/2011 DoNotPost

FDA-2010-N-0568-DRAFT-1236 Bruce Turner - Comment 12/22/2010 DoNotPost

FDA-2010-N-0568-DRAFT-1237 Diane Rudebock - Comment 12/22/2010 DoNotPost

FDA-2010-N-0568-DRAFT-1238 Harvey Hild - Comment 12/22/2010 DoNotPost

FDA-2010-N-0568-DRAFT-1239 Wayne Truax - Comment 12/22/2010 DoNotPost

FDA-2010-N-0568-DRAFT-1240 Jennifer Watson - Comment 12/22/2010 DoNotPost

FDA-2010-N-0568-DRAFT-1241 Thomas Tenner - Comment 12/22/2010 DoNotPost

FDA-2010-N-0568-DRAFT-1242 Alma Sahli - Comment 12/22/2010 DoNotPost

FDA-2010-N-0568-DRAFT-1243 Bob Elling - Comment 12/22/2010 DoNotPost

FDA-2010-N-0568-DRAFT-1244 Christine Lisiecki - Comment 12/22/2010 DoNotPost

FDA-2010-N-0568-DRAFT-1245 James Swan - Comment 12/22/2010 DoNotPost

FDA-2010-N-0568-DRAFT-1246 Bill Daly - Comment 12/22/2010 DoNotPost

FDA-2010-N-0568-DRAFT-1247 Molly Henderson - Comment 12/22/2010 DoNotPost

FDA-2010-N-0568-DRAFT-1248 Judy Mahaffey - Comment 12/22/2010 DoNotPost

FDA-2010-N-0568-DRAFT-1249 Shely Taylor - Comment 12/22/2010 DoNotPost

FDA-2010-N-0568-DRAFT-1250 Richard Adams - Comment 12/22/2010 DoNotPost

FDA-2010-N-0568-DRAFT-1251 Pamela Woodard - Comment 12/22/2010 DoNotPost

FDA-2010-N-0568-DRAFT-1252 Anthony Capobianco - Comment 12/22/2010 DoNotPost

FDA-2010-N-0568-DRAFT-1253 Denee D. Chmiel - Comment 12/22/2010 DoNotPost

FDA-2010-N-0568-DRAFT-1254 Allan Figot - Comment 12/22/2010 DoNotPost

FDA-2010-N-0568-DRAFT-1255 Alison Beck - Comment 12/22/2010 DoNotPost

FDA-2010-N-0568-DRAFT-1256 Valorie Snyder - Comment 12/22/2010 DoNotPost

FDA-2010-N-0568-DRAFT-1258 Coletta Barrett - Comment 12/22/2010 DoNotPost

FDA-2010-N-0568-DRAFT-1259 John Harvey - Comment 12/22/2010 DoNotPost

FDA-2010-N-0568-DRAFT-1261 Martha Vennes - Comment 12/22/2010 DoNotPost

FDA-2010-N-0568-DRAFT-1262 Tony Elliott - Comment 12/22/2010 DoNotPost

FDA-2010-N-0568-DRAFT-1263 James Ottinger - Comment 12/22/2010 DoNotPost

FDA-2010-N-0568-DRAFT-1264 Paula Gjerstad - Comment 12/22/2010 DoNotPost

FDA-2010-N-0568-DRAFT-1265 Rosalie Sudowski - Comment 12/22/2010 DoNotPost

FDA-2010-N-0568-DRAFT-1266 Corey E. Olsen - Comment 12/22/2010 DoNotPost

FDA-2010-N-0568-DRAFT-1267 Lilly Keller - Comment 12/22/2010 DoNotPost

FDA-2010-N-0568-DRAFT-1268 Cherish Hart - Comment 12/22/2010 DoNotPost

Page 16 of 39

Case 1:11-cv-01482-RJL Document 35-1 Filed 10/21/11 Page 39 of 61

Document ID Title Date

Received Phase

FDA-2010-N-0568-DRAFT-1269 Doug Bogan - Comment 12/22/2010 DoNotPost

FDA-2010-N-0568-DRAFT-1270 Marilyn Ritsky - Comment 12/22/2010 DoNotPost

FDA-2010-N-0568-DRAFT-1271 Christine Marquette - Comment 12/22/2010 DoNotPost

FDA-2010-N-0568-DRAFT-1272 Sharleen Ackley - Comment 12/22/2010 DoNotPost

FDA-2010-N-0568-DRAFT-1273 Nel Curtiss - Comment 12/22/2010 DoNotPost

FDA-2010-N-0568-DRAFT-1275 Jessica Kraskian - Comment 12/22/2010 DoNotPost

FDA-2010-N-0568-DRAFT-1276 James Dunford - Comment 12/22/2010 DoNotPost

FDA-2010-N-0568-DRAFT-1277 Roy Coleman - Comment 12/22/2010 DoNotPost

FDA-2010-N-0568-DRAFT-1278 Eugene Shaffer - Comment 12/22/2010 DoNotPost

FDA-2010-N-0568-DRAFT-1279 Norm Petrik - Comment 12/22/2010 DoNotPost

FDA-2010-N-0568-DRAFT-1280 Delwin Goss - Comment 12/22/2010 DoNotPost

FDA-2010-N-0568-DRAFT-1281 Mark Olson - Comment 12/22/2010 DoNotPost

FDA-2010-N-0568-DRAFT-1282 Nicole Orr - Comment 12/22/2010 DoNotPost

FDA-2010-N-0568-DRAFT-1283 Lillian Billingsley - Comment 12/22/2010 DoNotPost

FDA-2010-N-0568-DRAFT-1284 Betty Matthews - Comment 12/22/2010 DoNotPost

FDA-2010-N-0568-DRAFT-1286 Rebecca C. Knight - Comment 1/4/2011 DoNotPost

FDA-2010-N-0568-DRAFT-1288 Mark Reback - Comment 12/22/2010 DoNotPost

FDA-2010-N-0568-DRAFT-1289 Deborah Stucklen - Comment 12/22/2010 DoNotPost

FDA-2010-N-0568-DRAFT-1290 Angela Clark - Comment 12/22/2010 DoNotPost

FDA-2010-N-0568-DRAFT-1294 Stephen Helfer - Comment 1/4/2011 DoNotPost

FDA-2010-N-0568-DRAFT-1295 Maureen Margaret - Comment 1/4/2011 DoNotPost

FDA-2010-N-0568-DRAFT-1300 Mary Anna Evans - Comment 1/4/2011 DoNotPost

FDA-2010-N-0568-DRAFT-1303 Anna M. Todd - Comment 1/4/2011 DoNotPost

FDA-2010-N-0568-DRAFT-1306 Kim Golden - Comment 12/22/2010 DoNotPost

FDA-2010-N-0568-DRAFT-1307 Renee Verspoor - Comment 12/22/2010 DoNotPost

FDA-2010-N-0568-DRAFT-1308 Janice Reagan - comment 12/22/2010 DoNotPost

FDA-2010-N-0568-DRAFT-1309 Joleen Chambers - Comment 12/22/2010 DoNotPost

FDA-2010-N-0568-DRAFT-1310 Phillip Crabill - Comment 12/22/2010 DoNotPost

FDA-2010-N-0568-DRAFT-1311 Miriam Iosupovici - Comment 12/22/2010 DoNotPost

FDA-2010-N-0568-DRAFT-1312 Marge Walsh - Comment 12/22/2010 DoNotPost

FDA-2010-N-0568-DRAFT-1313 Susan Hons - Comment 12/22/2010 DoNotPost

FDA-2010-N-0568-DRAFT-1314 Sylvia Watson-Chambers - Comment 12/22/2010 DoNotPost

FDA-2010-N-0568-DRAFT-1315 Mary Wells - Comment 12/22/2010 DoNotPost

FDA-2010-N-0568-DRAFT-1316 Kathleen Marble - Comment 12/22/2010 DoNotPost

FDA-2010-N-0568-DRAFT-1317 Claire Gayley - Comment 12/22/2010 DoNotPost

FDA-2010-N-0568-DRAFT-1318 Tim Hayes - Comment 12/22/2010 DoNotPost

FDA-2010-N-0568-DRAFT-1319 Amy Figot - Comment 12/22/2010 DoNotPost

FDA-2010-N-0568-DRAFT-1320 Judy Richards - Comment 12/22/2010 DoNotPost

FDA-2010-N-0568-DRAFT-1321 Dennis Ledden - Comment 12/22/2010 DoNotPost

FDA-2010-N-0568-DRAFT-1323 Katie Taylor - Comment 12/22/2010 DoNotPost

FDA-2010-N-0568-DRAFT-1325 Lawrence Abramson - Comment 12/22/2010 DoNotPost

FDA-2010-N-0568-DRAFT-1326 Sandra Pieschel - Comment 12/22/2010 DoNotPost

FDA-2010-N-0568-DRAFT-1327 Sharon Goodwin - Comment 12/22/2010 DoNotPost

FDA-2010-N-0568-DRAFT-1328 George Waterhouse - Comment 12/22/2010 DoNotPost

FDA-2010-N-0568-DRAFT-1329 Jacqueline Morales - Comment 12/22/2010 DoNotPost

FDA-2010-N-0568-DRAFT-1330 John Viacrucis - Comment 12/22/2010 DoNotPost

FDA-2010-N-0568-DRAFT-1331 Beverly Davis - Comment 12/22/2010 DoNotPost

FDA-2010-N-0568-DRAFT-1332 Ruby Foster - Comment 12/22/2010 DoNotPost

FDA-2010-N-0568-DRAFT-1333 Miriam Plitt - Comment 12/22/2010 DoNotPost

Page 17 of 39

Case 1:11-cv-01482-RJL Document 35-1 Filed 10/21/11 Page 40 of 61

Document ID Title Date

Received Phase

FDA-2010-N-0568-DRAFT-1334 John Galindo - Comment 12/22/2010 DoNotPost

FDA-2010-N-0568-DRAFT-1335 Anne Devillier - Comment 12/22/2010 DoNotPost

FDA-2010-N-0568-DRAFT-1336 Dan Eposito - Comment 12/22/2010 DoNotPost

FDA-2010-N-0568-DRAFT-1337 Flo Morgenstein - Comment 12/22/2010 DoNotPost

FDA-2010-N-0568-DRAFT-1338 Matthew Palo - Comment 1/5/2011 DoNotPost

FDA-2010-N-0568-DRAFT-1340 Chris Ellis - Comment 12/22/2010 DoNotPost

FDA-2010-N-0568-DRAFT-1342 Rita Taylor - Comment 12/23/2010 DoNotPost

FDA-2010-N-0568-DRAFT-1344 Yvette M. Jones - Comment 1/5/2011 DoNotPost

FDA-2010-N-0568-DRAFT-1345 Ronald Douglas Davis - Comment 1/5/2011 DoNotPost

FDA-2010-N-0568-DRAFT-1347 Dirk Rogers - Comment 12/23/2010 DoNotPost

FDA-2010-N-0568-DRAFT-1348 Linda Yates - Comment 12/23/2010 DoNotPost

FDA-2010-N-0568-DRAFT-1349 Pam Massey - Comment 12/23/2010 DoNotPost

FDA-2010-N-0568-DRAFT-1351 Robert Dorman - Comment 12/23/2010 DoNotPost

FDA-2010-N-0568-DRAFT-1352 William Lee Kohler - Comment 12/23/2010 DoNotPost

FDA-2010-N-0568-DRAFT-1353 Katherine Repanich - Comment 12/23/2010 DoNotPost

FDA-2010-N-0568-DRAFT-1355 Heather Lopardo - Comment 12/23/2010 DoNotPost

FDA-2010-N-0568-DRAFT-1357 G. Preuss - Comment 12/23/2010 DoNotPost

FDA-2010-N-0568-DRAFT-1358 Linda Kay Bourne - Comment 1/5/2011 DoNotPost

FDA-2010-N-0568-DRAFT-1360 Donna M. FSM - Comment 12/27/2010 DoNotPost

FDA-2010-N-0568-DRAFT-1362 Write-In Campaign 2 - [Multiple 12/22/2010 DoNotPost

Submitters=381] - Form Letter

Comment

FDA-2010-N-0568-DRAFT-1363 Shelon Barker - Comment 12/27/2010 DoNotPost

FDA-2010-N-0568-DRAFT-1366 William Kimber - Comment 12/29/2010 DoNotPost

FDA-2010-N-0568-DRAFT-1367 Mary Boutain - Comment 12/30/2010 DoNotPost

FDA-2010-N-0568-DRAFT-1368 Ball - Comment 1/3/2011 DoNotPost

FDA-2010-N-0568-DRAFT-1369 Ceil Ann Sperzel - Comment 1/5/2011 DoNotPost

FDA-2010-N-0568-DRAFT-1371 Laura Elizaeth Reed - Comment 1/5/2011 DoNotPost

FDA-2010-N-0568-DRAFT-1373 Ian Brooks - Comment 12/22/2010 DoNotPost

FDA-2010-N-0568-DRAFT-1374 Regina Wilkerson - Comment 1/3/2011 DoNotPost

FDA-2010-N-0568-DRAFT-1375 Anonymous - Comment 1/3/2011 DoNotPost

FDA-2010-N-0568-DRAFT-1379 Reuben Bahar - Comment 1/5/2011 DoNotPost

FDA-2010-N-0568-DRAFT-1382 Lori Greenstein Bremner - Comment 1/5/2011 DoNotPost

FDA-2010-N-0568-DRAFT-1383 Danila Oder - Comment 1/5/2011 DoNotPost

FDA-2010-N-0568-DRAFT-1390 Nancy Green - Comment 1/5/2011 DoNotPost

FDA-2010-N-0568-DRAFT-1400 Amber Marko - Comment 1/6/2011 DoNotPost

FDA-2010-N-0568-DRAFT-1406 Elizabeth Dubravcic - Comment 1/6/2011 DoNotPost

FDA-2010-N-0568-DRAFT-1408 Willie Ericson - Comment 1/6/2011 DoNotPost

FDA-2010-N-0568-DRAFT-1409 Marissa Amy Wilkin - Comment 1/6/2011 DoNotPost

FDA-2010-N-0568-DRAFT-1410 Deb Campbell - Comment 1/6/2011 DoNotPost

FDA-2010-N-0568-DRAFT-1411 Whitney Bowman - Comment 1/6/2011 DoNotPost

FDA-2010-N-0568-DRAFT-1412 Randi Denice McIntyre - Comment 1/6/2011 DoNotPost

FDA-2010-N-0568-DRAFT-1413 Eric James Moser - Comment 1/6/2011 DoNotPost

FDA-2010-N-0568-DRAFT-1414 Heather Prince - Comment 1/6/2011 DoNotPost

FDA-2010-N-0568-DRAFT-1415 Carrie King - Comment 1/6/2011 DoNotPost

FDA-2010-N-0568-DRAFT-1416 Bonnie Fried - Comment 1/6/2011 DoNotPost

FDA-2010-N-0568-DRAFT-1419 Jodi Kenworthy - Comment 1/6/2011 DoNotPost

FDA-2010-N-0568-DRAFT-1420 Francis Louis Wootton - Comment 1/6/2011 DoNotPost

FDA-2010-N-0568-DRAFT-1421 Bob Holder - Comment 1/6/2011 DoNotPost

FDA-2010-N-0568-DRAFT-1422 David E. Gott, Esq. - Comment 1/6/2011 DoNotPost

Page 18 of 39

Case 1:11-cv-01482-RJL Document 35-1 Filed 10/21/11 Page 41 of 61

Document ID Title Date

Received Phase

FDA-2010-N-0568-DRAFT-1423 Ruth Carlin - Comment 1/6/2011 DoNotPost

FDA-2010-N-0568-DRAFT-1424 Terrence F. Sinclair - Comment 1/6/2011 DoNotPost

FDA-2010-N-0568-DRAFT-1425 Norman Wasserman - Comment 1/6/2011 DoNotPost

FDA-2010-N-0568-DRAFT-1427 Paulette Cecile Martinez - Comment 1/6/2011 DoNotPost

FDA-2010-N-0568-DRAFT-1429 Anonymous - Comment 1/6/2011 DoNotPost

FDA-2010-N-0568-DRAFT-1430 B.B. - Comment 1/6/2011 DoNotPost

FDA-2010-N-0568-DRAFT-1431 Patricia Salenius - Comment 1/6/2011 DoNotPost

FDA-2010-N-0568-DRAFT-1432 Anonymous - Comment 1/6/2011 DoNotPost

FDA-2010-N-0568-DRAFT-1433 Evelyn S. Heller - Comment 1/6/2011 DoNotPost

FDA-2010-N-0568-DRAFT-1434 Mary Katherine Kates - Comment 1/6/2011 DoNotPost

FDA-2010-N-0568-DRAFT-1435 Scott Benford - Comment 1/6/2011 DoNotPost

FDA-2010-N-0568-DRAFT-1436 Andree J. Wells - Comment 1/6/2011 DoNotPost

FDA-2010-N-0568-DRAFT-1437 Tedi Siminowsky - Comment 1/6/2011 DoNotPost

FDA-2010-N-0568-DRAFT-1438 Thomas Michael Heller - Comment 1/6/2011 DoNotPost

FDA-2010-N-0568-DRAFT-1441 E. Michael D. Scott - Comment 1/6/2011 DoNotPost

FDA-2010-N-0568-DRAFT-1442 Andrew G. Cano - Comment 1/6/2011 DoNotPost

FDA-2010-N-0568-DRAFT-1443 Sarah Quinn Rowland - Comment 1/6/2011 DoNotPost

FDA-2010-N-0568-DRAFT-1446 Sharon Golden - Comment 1/6/2011 DoNotPost

FDA-2010-N-0568-DRAFT-1447 Jeffrey Simon - Comment 1/6/2011 DoNotPost

FDA-2010-N-0568-DRAFT-1448 Tammy Phillips - Comment 1/6/2011 DoNotPost

FDA-2010-N-0568-DRAFT-1450 Mark L. Ryckman - Comment 1/6/2011 DoNotPost

FDA-2010-N-0568-DRAFT-1452 Sabina Zolot - Comment 1/6/2011 DoNotPost

FDA-2010-N-0568-DRAFT-1453 Lani K. Welborn - Comment 1/6/2011 DoNotPost

FDA-2010-N-0568-DRAFT-1454 Doris M. Berko - Comment 1/6/2011 DoNotPost

FDA-2010-N-0568-DRAFT-1456 Kenneth Lloyd Stone - Comment 1/6/2011 DoNotPost

FDA-2010-N-0568-DRAFT-1457 Nancy Rogers Lindsey - Comment 1/6/2011 DoNotPost

FDA-2010-N-0568-DRAFT-1458 Anita Greenlee - Comment 1/6/2011 DoNotPost

FDA-2010-N-0568-DRAFT-1460 Donna L. Webb - Comment 1/6/2011 DoNotPost

FDA-2010-N-0568-DRAFT-1462 Charlotte Koppe - Comment 1/6/2011 DoNotPost

FDA-2010-N-0568-DRAFT-1464 Edward Merrell - Comment 1/6/2011 DoNotPost

FDA-2010-N-0568-DRAFT-1465 Tara Ann Lange - Comment 1/6/2011 DoNotPost

FDA-2010-N-0568-DRAFT-1466 Judith C Anderson - Comment 1/6/2011 DoNotPost

FDA-2010-N-0568-DRAFT-1467 Marilyn S. Prehm - Comment 1/6/2011 DoNotPost

FDA-2010-N-0568-DRAFT-1468 Barbara C. C. Holladay-Vernon -1/7/2011 DoNotPost

Comment

FDA-2010-N-0568-DRAFT-1469 Anonymous - Comment 1/7/2011 DoNotPost

FDA-2010-N-0568-DRAFT-1470 James Robert Bailey - Comment 1/7/2011 DoNotPost

FDA-2010-N-0568-DRAFT-1473 Carol Lee Collins - Comment 1/7/2011 DoNotPost

FDA-2010-N-0568-DRAFT-1474 Chip Henneman - Comment 1/7/2011 DoNotPost

FDA-2010-N-0568-DRAFT-1475 Bobbie Dee Flowers - Comment 1/7/2011 DoNotPost

FDA-2010-N-0568-DRAFT-1476 Charles J. McCall - Comment 1/7/2011 DoNotPost

FDA-2010-N-0568-DRAFT-1477 Rael Nidess, M.D. - Comment 1/7/2011 DoNotPost

FDA-2010-N-0568-DRAFT-1478 Donn Walter Leatherman - Comment 1/7/2011 DoNotPost

FDA-2010-N-0568-DRAFT-1479 Hank - Comment 1/7/2011 DoNotPost

FDA-2010-N-0568-DRAFT-1484 C. Kleymeyer - Comment 1/7/2011 DoNotPost

FDA-2010-N-0568-DRAFT-1485 John S. McPeek - Comment 1/7/2011 DoNotPost

FDA-2010-N-0568-DRAFT-1488 Rachel Lindstrom - Comment 1/7/2011 DoNotPost

FDA-2010-N-0568-DRAFT-1490 Anne Schulthess - Comment 1/7/2011 DoNotPost

FDA-2010-N-0568-DRAFT-1491 Jill Manske - Comment 1/7/2011 DoNotPost

Page 19 of 39

Case 1:11-cv-01482-RJL Document 35-1 Filed 10/21/11 Page 42 of 61

Document ID Title Date

Received Phase

FDA-2010-N-0568-DRAFT-1492 Sriram Madhusoodanan - Comment 1/7/2011 DoNotPost

FDA-2010-N-0568-DRAFT-1494 Anthony Angelo Capobianco -1/7/2011 DoNotPost

Comment

FDA-2010-N-0568-DRAFT-1496 Paul Moss - Comment 1/7/2011 DoNotPost

FDA-2010-N-0568-DRAFT-1497 Diane Hart - Comment 1/7/2011 DoNotPost

FDA-2010-N-0568-DRAFT-1499 Lee Stanfield - Comment 1/7/2011 DoNotPost

FDA-2010-N-0568-DRAFT-1500 Gregory Esteve - Comment 1/7/2011 DoNotPost

FDA-2010-N-0568-DRAFT-1501 Philip Lewis Joffe - Comment 1/7/2011 DoNotPost

FDA-2010-N-0568-DRAFT-1502 Jennifer DeLeeuw Lindquist -1/7/2011 DoNotPost

Comment

FDA-2010-N-0568-DRAFT-1503 Aaron Ucko - Comment 1/7/2011 DoNotPost

FDA-2010-N-0568-DRAFT-1504 Deb Brown - Comment 1/7/2011 DoNotPost

FDA-2010-N-0568-DRAFT-1505 Anthony David Albert - Comment 1/7/2011 DoNotPost

FDA-2010-N-0568-DRAFT-1506 Melissa Vatterott - Comment 1/7/2011 DoNotPost

FDA-2010-N-0568-DRAFT-1507 Mary Leitch - Comment 1/7/2011 DoNotPost

FDA-2010-N-0568-DRAFT-1508 Dorothy C. Chamberlin - Comment 1/7/2011 DoNotPost

FDA-2010-N-0568-DRAFT-1509 Leah Margulies, Esq. - Comment 1/7/2011 DoNotPost

FDA-2010-N-0568-DRAFT-1511 Thomas Tizard - Comment 1/7/2011 DoNotPost

FDA-2010-N-0568-DRAFT-1512 Sally Small - Comment 1/7/2011 DoNotPost

FDA-2010-N-0568-DRAFT-1514 Kathleen H Hayes - Comment 1/7/2011 DoNotPost

FDA-2010-N-0568-DRAFT-1515 Robert Rose - Comment 1/7/2011 DoNotPost

FDA-2010-N-0568-DRAFT-1518 Maradel K Gale - Comment 1/7/2011 DoNotPost

FDA-2010-N-0568-DRAFT-1520 Meredith Alexander - Comment 1/7/2011 DoNotPost

FDA-2010-N-0568-DRAFT-1521 Janet A. Holden - Comment 1/7/2011 DoNotPost

FDA-2010-N-0568-DRAFT-1522 Bob Segal - Comment 1/7/2011 DoNotPost

FDA-2010-N-0568-DRAFT-1524 Lucille Teresa Boss - Comment 1/7/2011 DoNotPost

FDA-2010-N-0568-DRAFT-1525 Lucille Teresa Boss - Comment 1/7/2011 DoNotPost

FDA-2010-N-0568-DRAFT-1526 Lucille Teresa Boss - Comment 1/7/2011 DoNotPost

FDA-2010-N-0568-DRAFT-1527 Lucille Teresa Boss - Comment 1/7/2011 DoNotPost

FDA-2010-N-0568-DRAFT-1528 Brad Jones - Comment 1/7/2011 DoNotPost

FDA-2010-N-0568-DRAFT-1529 Alex Woolery - Comment 1/7/2011 DoNotPost

FDA-2010-N-0568-DRAFT-1530 Chris M. Candell - Comment 1/7/2011 DoNotPost

FDA-2010-N-0568-DRAFT-1531 Jason G. Berteotti - Comment 1/7/2011 DoNotPost

FDA-2010-N-0568-DRAFT-1532 Melissa McCool - Comment 1/7/2011 DoNotPost

FDA-2010-N-0568-DRAFT-1535 Ralph Louis Shenker - Comment 1/7/2011 DoNotPost

FDA-2010-N-0568-DRAFT-1536 Paul - Comment 1/7/2011 DoNotPost

FDA-2010-N-0568-DRAFT-1537 Sarah Woodside Gallagher -1/7/2011 DoNotPost

Comment

FDA-2010-N-0568-DRAFT-1538 Dirk Faegre - Comment 1/7/2011 DoNotPost

FDA-2010-N-0568-DRAFT-1540 Mary L. Mutch - Comment 1/7/2011 DoNotPost

FDA-2010-N-0568-DRAFT-1541 Elaine Becker - Comment 1/7/2011 DoNotPost

FDA-2010-N-0568-DRAFT-1542 Brian Allen Houser - Comment 1/7/2011 DoNotPost

FDA-2010-N-0568-DRAFT-1544 Harriet C. McCleary - Comment 1/7/2011 DoNotPost

FDA-2010-N-0568-DRAFT-1545 Carla - Comment 1/7/2011 DoNotPost

FDA-2010-N-0568-DRAFT-1546 Laurie Ann de Jong - Comment 1/7/2011 DoNotPost

FDA-2010-N-0568-DRAFT-1547 Anonymous - Comment 1/7/2011 DoNotPost

FDA-2010-N-0568-DRAFT-1548 William Schmidt - Comment 1/7/2011 DoNotPost

FDA-2010-N-0568-DRAFT-1550 Bill Anderson - Comment 1/7/2011 DoNotPost

FDA-2010-N-0568-DRAFT-1551 Mark Reback - Comment 1/7/2011 DoNotPost

FDA-2010-N-0568-DRAFT-1552 Francis Hagan - Comment 1/7/2011 DoNotPost

Page 20 of 39

Case 1:11-cv-01482-RJL Document 35-1 Filed 10/21/11 Page 43 of 61

Document ID Title Date

Received Phase

FDA-2010-N-0568-DRAFT-1553 Dudley & Candace Campbell -1/7/2011 DoNotPost

Comment

FDA-2010-N-0568-DRAFT-1555 Leslie Marie Sheridan - Comment 1/7/2011 DoNotPost

FDA-2010-N-0568-DRAFT-1556 Sherri J. Carlson - Comment 1/7/2011 DoNotPost

FDA-2010-N-0568-DRAFT-1557 Ron J. McGill - Comment 1/7/2011 DoNotPost

FDA-2010-N-0568-DRAFT-1558 Holly Kukkonen - Comment 1/7/2011 DoNotPost

FDA-2010-N-0568-DRAFT-1559 Megan Rising - Comment 1/7/2011 DoNotPost

FDA-2010-N-0568-DRAFT-1560 Stephen W. Couche - Comment 1/7/2011 DoNotPost

FDA-2010-N-0568-DRAFT-1561 Allan B. Jones - Comment 1/7/2011 DoNotPost

FDA-2010-N-0568-DRAFT-1562 Gabriel Steinfeld - Comment 1/7/2011 DoNotPost

FDA-2010-N-0568-DRAFT-1563 Mark M. Giese - Comment 1/7/2011 DoNotPost

FDA-2010-N-0568-DRAFT-1564 Harold T. Hodes - Comment 1/7/2011 DoNotPost

FDA-2010-N-0568-DRAFT-1565 Ephraim Olani - Comment 1/7/2011 DoNotPost

FDA-2010-N-0568-DRAFT-1566 Corey E. Olsen - Comment 1/7/2011 DoNotPost

FDA-2010-N-0568-DRAFT-1567 Holly Garland - Comment 1/7/2011 DoNotPost

FDA-2010-N-0568-DRAFT-1568 Brenda Page Troup - Comment 1/7/2011 DoNotPost

FDA-2010-N-0568-DRAFT-1570 James Schall - Comment 1/7/2011 DoNotPost

FDA-2010-N-0568-DRAFT-1571 Jim Flynn - Comment 1/7/2011 DoNotPost

FDA-2010-N-0568-DRAFT-1573 Justin Sweet - Comment 1/7/2011 DoNotPost

FDA-2010-N-0568-DRAFT-1575 Misty T. - Comment 1/7/2011 DoNotPost

FDA-2010-N-0568-DRAFT-1576 Maura Kelly Leib - Comment 1/7/2011 DoNotPost

FDA-2010-N-0568-DRAFT-1579 M.E. Buckner - Comment 1/7/2011 DoNotPost

FDA-2010-N-0568-DRAFT-1580 Mary Suda - Comment 1/7/2011 DoNotPost

FDA-2010-N-0568-DRAFT-1581 Mike Hansen - Comment 1/7/2011 DoNotPost

FDA-2010-N-0568-DRAFT-1582 Nancy Wall - Comment 1/7/2011 DoNotPost

FDA-2010-N-0568-DRAFT-1583 Connie K Raper - Comment 1/7/2011 DoNotPost

FDA-2010-N-0568-DRAFT-1584 Lynn Elliott - Comment 1/7/2011 DoNotPost

FDA-2010-N-0568-DRAFT-1585 Ruth Elaine Smith - Comment 1/7/2011 DoNotPost

FDA-2010-N-0568-DRAFT-1586 Simon Jonsson - Comment 1/7/2011 DoNotPost

FDA-2010-N-0568-DRAFT-1590 N. Refes - Comment 1/7/2011 DoNotPost

FDA-2010-N-0568-DRAFT-1593 Douglas C. Estes - Comment 1/7/2011 DoNotPost

FDA-2010-N-0568-DRAFT-1594 Mike Vanlandingham - Comment 1/7/2011 DoNotPost

FDA-2010-N-0568-DRAFT-1595 Ari Meyer - Comment 1/7/2011 DoNotPost

FDA-2010-N-0568-DRAFT-1599 Larry Andrews - Comment 1/7/2011 DoNotPost

FDA-2010-N-0568-DRAFT-1600 Norman Conrad - Comment 1/7/2011 DoNotPost

FDA-2010-N-0568-DRAFT-1601 Doug Landau - Comment 1/7/2011 DoNotPost

FDA-2010-N-0568-DRAFT-1602 Debra J. Saude - Comment 1/7/2011 DoNotPost

FDA-2010-N-0568-DRAFT-1603 Martha White - Comment 1/7/2011 DoNotPost

FDA-2010-N-0568-DRAFT-1604 Gerritt and Elizabeth Baker-Smith -1/7/2011 DoNotPost

Comment

FDA-2010-N-0568-DRAFT-1605 Diana Lisa Andres - Comment 1/7/2011 DoNotPost

FDA-2010-N-0568-DRAFT-1606 Denise Romesburg - Comment 1/7/2011 DoNotPost

FDA-2010-N-0568-DRAFT-1607 Edith G. Montgomery - Comment 1/7/2011 DoNotPost

FDA-2010-N-0568-DRAFT-1608 Gordon John Gerbitz - Comment 1/7/2011 DoNotPost

FDA-2010-N-0568-DRAFT-1609 Anonymous - Comment 1/7/2011 DoNotPost

FDA-2010-N-0568-DRAFT-1610 Marcia J. Bailey - Comment 1/7/2011 DoNotPost

FDA-2010-N-0568-DRAFT-1611 Greg Sells - Comment 1/7/2011 DoNotPost

FDA-2010-N-0568-DRAFT-1612 Evelyn Stern - Comment 1/7/2011 DoNotPost

FDA-2010-N-0568-DRAFT-1613 Mannon Hubbard - Comment 1/7/2011 DoNotPost

FDA-2010-N-0568-DRAFT-1614 Art Hanson - Comment 1/7/2011 DoNotPost

Page 21 of 39

Case 1:11-cv-01482-RJL Document 35-1 Filed 10/21/11 Page 44 of 61

Document ID Title Date

Received Phase

FDA-2010-N-0568-DRAFT-1615 Mary K. Mataja - Comment 1/7/2011 DoNotPost

FDA-2010-N-0568-DRAFT-1616 Patricia - Comment 1/7/2011 DoNotPost

FDA-2010-N-0568-DRAFT-1617 Anthony Martin - Comment 1/8/2011 DoNotPost

FDA-2010-N-0568-DRAFT-1618 Cheryl Ann Dzubak - Comment 1/8/2011 DoNotPost

FDA-2010-N-0568-DRAFT-1619 Natalie Hanson - Comment 1/8/2011 DoNotPost

FDA-2010-N-0568-DRAFT-1620 Lynne M. Taylor - Comment 1/8/2011 DoNotPost

FDA-2010-N-0568-DRAFT-1621 Lisa Anthony - Comment 1/8/2011 DoNotPost

FDA-2010-N-0568-DRAFT-1622 Betsy A. Aller - Comment 1/8/2011 DoNotPost

FDA-2010-N-0568-DRAFT-1623 Deborah Reynolds Pendrey -1/8/2011 DoNotPost

Comment

FDA-2010-N-0568-DRAFT-1625 Karen McNay Bauerle - Comment 1/8/2011 DoNotPost

FDA-2010-N-0568-DRAFT-1626 Linda K. Clarey - Comment 1/8/2011 DoNotPost

FDA-2010-N-0568-DRAFT-1627 Marian Claire di Piazza - Comment 1/8/2011 DoNotPost

FDA-2010-N-0568-DRAFT-1628 Mary Lou Mortimer - Comment 1/8/2011 DoNotPost

FDA-2010-N-0568-DRAFT-1629 Eric Scheihagen - Comment 1/8/2011 DoNotPost

FDA-2010-N-0568-DRAFT-1630 Alicia Campbell - Comment 1/8/2011 DoNotPost

FDA-2010-N-0568-DRAFT-1631 Frank D. FitzPatrick - Comment 1/8/2011 DoNotPost

FDA-2010-N-0568-DRAFT-1633 Carol Rosskam - Comment 1/8/2011 DoNotPost

FDA-2010-N-0568-DRAFT-1634 Gene Ulmer - Comment 1/8/2011 DoNotPost

FDA-2010-N-0568-DRAFT-1638 Laura Anne Meek - Comment 1/8/2011 DoNotPost

FDA-2010-N-0568-DRAFT-1641 Michael W Evans - Comment 1/8/2011 DoNotPost

FDA-2010-N-0568-DRAFT-1642 Angelo J. Feldkamp - Comment 1/9/2011 DoNotPost

FDA-2010-N-0568-DRAFT-1643 Sharon A. Mulgrwe - Comment 1/9/2011 DoNotPost

FDA-2010-N-0568-DRAFT-1644 Joshua Bud Maizel - Comment 1/9/2011 DoNotPost

FDA-2010-N-0568-DRAFT-1645 Anonymous - Comment 1/9/2011 DoNotPost

FDA-2010-N-0568-DRAFT-1647 Janet E. McIver - Comment 1/9/2011 DoNotPost

FDA-2010-N-0568-DRAFT-1648 Patricia A. Young - Comment 1/9/2011 DoNotPost

FDA-2010-N-0568-DRAFT-1649 Hollie Rinoul - Comment 1/9/2011 DoNotPost

FDA-2010-N-0568-DRAFT-1650 Barbara Jean Stewart - Comment 1/9/2011 DoNotPost

FDA-2010-N-0568-DRAFT-1651 Kristiana Dahl - Comment 1/9/2011 DoNotPost

FDA-2010-N-0568-DRAFT-1653 James C. Roberts - Comment 1/9/2011 DoNotPost

FDA-2010-N-0568-DRAFT-1654 J. Lasahn - Comment 1/9/2011 DoNotPost

FDA-2010-N-0568-DRAFT-1656 Valerie Foy - Comment 1/9/2011 DoNotPost

FDA-2010-N-0568-DRAFT-1657 Durango Mendoza - Comment 1/9/2011 DoNotPost

FDA-2010-N-0568-DRAFT-1658 Francisco Jose Costa - Comment 1/10/2011 DoNotPost

FDA-2010-N-0568-DRAFT-1659 Carol Danoff - Comment 1/10/2011 DoNotPost

FDA-2010-N-0568-DRAFT-1660 Ben Zachary Heller - Comment 1/10/2011 DoNotPost

FDA-2010-N-0568-DRAFT-1664 Clayton Vern Griffith - Comment 1/10/2011 DoNotPost

FDA-2010-N-0568-DRAFT-1666 Pat and Gary Gover - Comment 1/10/2011 DoNotPost

FDA-2010-N-0568-DRAFT-1667 Erika E. DeCarlo - Comment 1/10/2011 DoNotPost

FDA-2010-N-0568-DRAFT-1672 Christine Sparks - Comment 1/10/2011 DoNotPost

FDA-2010-N-0568-DRAFT-1676 Emanuel Magid - Comment 1/10/2011 DoNotPost

FDA-2010-N-0568-DRAFT-1677 Anonymous - Comment 1/10/2011 DoNotPost

FDA-2010-N-0568-DRAFT-1680 Belinda J. Isham - Comment 1/10/2011 DoNotPost

FDA-2010-N-0568-DRAFT-1682 Donna M. Ayerst - Comment 1/10/2011 DoNotPost

FDA-2010-N-0568-DRAFT-1686 Richard Charles Wheeler - Comment 1/10/2011 DoNotPost

FDA-2010-N-0568-DRAFT-1688 Ronald Baltzer Brooks - Comment 1/10/2011 DoNotPost

FDA-2010-N-0568-DRAFT-1689 Diane - Comment 1/10/2011 DoNotPost

FDA-2010-N-0568-DRAFT-1691 Karen Bernhardt - Comment 1/10/2011 DoNotPost

Page 22 of 39

Case 1:11-cv-01482-RJL Document 35-1 Filed 10/21/11 Page 45 of 61

Document ID Title Date

Received Phase

FDA-2010-N-0568-DRAFT-1692 Sarah Michele Vassello - Comment 1/10/2011 DoNotPost

FDA-2010-N-0568-DRAFT-1693 Keith Andrew Fry - Comment 1/10/2011 DoNotPost

FDA-2010-N-0568-DRAFT-1694 Keith Andrew Fry - Comment 1/10/2011 DoNotPost

FDA-2010-N-0568-DRAFT-1695 Keith Andew Fry - Comment 1/10/2011 DoNotPost

FDA-2010-N-0568-DRAFT-1696 Keith Andrew Fry - Comment 1/10/2011 DoNotPost

FDA-2010-N-0568-DRAFT-1698 Keith and Kyle Fluegge - Comment 1/10/2011 DoNotPost

FDA-2010-N-0568-DRAFT-1700 Charles Otter McSweeney -1/11/2011 DoNotPost

Comment

FDA-2010-N-0568-DRAFT-1701 Jacqueline Nalls - Comment 1/7/2011 DoNotPost

FDA-2010-N-0568-DRAFT-1704 Ryan Arruda - Comment 1/11/2011 DoNotPost

FDA-2010-N-0568-DRAFT-1705 George Gaffney, M.D. - Comment 1/11/2011 DoNotPost

FDA-2010-N-0568-DRAFT-1713 Milbrey E. - Comment 1/11/2011 DoNotPost

FDA-2010-N-0568-DRAFT-1717 Richard Paul Fehr - Comment 1/11/2011 DoNotPost

FDA-2010-N-0568-DRAFT-1723 Victoria F. Warren - Comment 1/11/2011 DoNotPost

FDA-2010-N-0568-DRAFT-1757 Christopher Lish - Comment 1/11/2011 DoNotPost

FDA-2010-N-0568-DRAFT-1758 Christopher Lish - Comment 1/11/2011 DoNotPost

FDA-2010-N-0568-DRAFT-1759 Elaine Barbara Lubetsky - Comment 1/11/2011 DoNotPost

FDA-2010-N-0568-DRAFT-1760 Monica McQueen - Comment 1/11/2011 DoNotPost

FDA-2010-N-0568-DRAFT-1761 Sachi Uyesugi - Comment 1/11/2011 DoNotPost

FDA-2010-N-0568-DRAFT-1770 Anonymous - Comment 1/11/2011 DoNotPost

FDA-2010-N-0568-DRAFT-1776 Mary P. Farley, R.N., M.N. -1/11/2011 DoNotPost

Comment

FDA-2010-N-0568-DRAFT-1790 Theresa Eckstein - Comment 1/6/2011 DoNotPost

FDA-2010-N-0568-DRAFT-1791 Carla Compton - Comment 1/6/2011 DoNotPost

FDA-2010-N-0568-DRAFT-1792 Marianne Duke - Comment 1/6/2011 DoNotPost

FDA-2010-N-0568-DRAFT-1793 Christine Shelley - Comment 1/5/2011 DoNotPost

FDA-2010-N-0568-DRAFT-1794 Holly Thompson - Comment 1/5/2011 DoNotPost

FDA-2010-N-0568-DRAFT-1795 Margo Perkins - Comment 1/5/2011 DoNotPost

FDA-2010-N-0568-DRAFT-1796 Cresha Auck - Comment 1/7/2011 DoNotPost

FDA-2010-N-0568-DRAFT-1797 Cynthia Shambley - Comment 1/7/2011 DoNotPost

FDA-2010-N-0568-DRAFT-1798 Cathy Savage - Comment 1/7/2011 DoNotPost

FDA-2010-N-0568-DRAFT-1801 Terry Sunderlin - Comment 1/13/2011 DoNotPost

FDA-2010-N-0568-DRAFT-1805 Keltcie Delamar - Comment 1/13/2011 DoNotPost

FDA-2010-N-0568-DRAFT-1806 Lorie McKellar - Comment 1/14/2011 DoNotPost

FDA-2010-N-0568-DRAFT-1817 Charlotte Fellers, et al - Comment 3/8/2011 DoNotPost

FDA-2010-N-0568-0004 Life or Death Playing Cards, Mickey 11/12/2010 Posted

Weedon - Comment

FDA-2010-N-0568-0005 Julia McFarlane [Vancouver Island 11/17/2010 Posted

Health Authority] - Comment

FDA-2010-N-0568-0010 Christopher Saldivar (108 6th Grade 12/3/2010 Posted

Students From Ralston Middle

School) - Comment

FDA-2010-N-0568-0011 George Cromer, III., Aleuttans East 11/23/2010 Posted

Borough School District (AEBSD)

Sand Point School - Commenr

FDA-2010-N-0568-0012 Gail Ellis; Health & Physical 12/10/2010 Posted

Education Educator - (45, 10th Grade

Students, Jasper-Troupsburg Central

School) - Comment

Page 23 of 39

Case 1:11-cv-01482-RJL Document 35-1 Filed 10/21/11 Page 46 of 61

Document ID Title Date

Received Phase

FDA-2010-N-0568-0013 Wayne Keene, R.N., B.S.N., MS., 12/9/2010 Posted

Northern Navajo Medical Center -

Comment

FDA-2010-N-0568-0014 Bianca Aniski, Ethel Jacobsen 11/12/2010 Posted

Elernentaiy School - Comment

FDA-2010-N-0568-0015 Sharon Jarchin, Jarchin Group, Inc. -11/12/2010 Posted

Comment

FDA-2010-N-0568-0016 Anje Van Berckelaer, M.D., MS., 11/12/2010 Posted

Robert Wood Johnson Clinical

Scholars, University of Pennsylvania -

Comment

FDA-2010-N-0568-0018 Arlington Citizen for Clean Air -11/15/2010 Posted

Comment

FDA-2010-N-0568-0019 Stanislaus County TOPS (Tobacco12/

23/2010 Posted

Control Outreach and Prevention

Services) - Comment

FDA-2010-N-0568-0020 McConnell Heart Health Center Ohio 1/3/2011 Posted

Health - Comment

FDA-2010-N-0568-0021 California Family Health Council, Inc. 1/3/2011 Posted

(CFHC) - Comment

FDA-2010-N-0568-0022 Troy School District Troy Community 11/17/2010 Posted

Coalition - Comment

FDA-2010-N-0568-0023 Traci Galinsky - Comment 12/1/2010 Posted

FDA-2010-N-0568-0024 Ronald Hall - Comment 12/1/2010 Posted

FDA-2010-N-0568-0025 Sacred Heart Rehabilitation Center -12/20/2010 Posted

Comment

FDA-2010-N-0568-0026 National Latino Tobacco Control 1/11/2011 Posted

Network (NLTCN) - Comment

FDA-2010-N-0568-0027 Albert Ortiz (Artist) - Comment 11/22/2010 Posted

FDA-2010-N-0568-0028 Clallam County Board of Health -1/4/2011 Posted

Comment

FDA-2010-N-0568-0029 Johns Hopkins Bloomberg School of 1/5/2011 Posted

Public Health (JHSPH) - Comment

FDA-2010-N-0568-0030 Ohio Department of Health Tobacco 1/5/2011 Posted

Program - Comment

FDA-2010-N-0568-0031 Clark County Tobacco Prevention 1/5/2011 Posted

and Cessation Coalition - Comment

FDA-2010-N-0568-0032 University of Detroit Mercy School of 1/6/2011 Posted

Dentistry - Comment

FDA-2010-N-0568-0033 Penn State University College of 1/6/2011 Posted

Medicine - Comment

FDA-2010-N-0568-0034 S.A.F.E. Smokefree Air for Everyone 1/

6/2011 Posted

Comment

FDA-2010-N-0568-0035 Bladder Cancer Advocacy Network 1/6/2011 Posted

(BCAN) - comment

FDA-2010-N-0568-0036 ClearWay Minnesota - Comment 1/7/2011 Posted

FDA-2010-N-0568-0037 University of Massachusetts Medical 1/7/2011 Posted

School - Comment

FDA-2010-N-0568-0038 Nebraska Department of Health and 11/15/2010 Posted

Human Services - Comment

Page 24 of 39

Case 1:11-cv-01482-RJL Document 35-1 Filed 10/21/11 Page 47 of 61

Document ID Title Date

Received Phase

FDA-2010-N-0568-0039 Tobacco Control & Prevention 11/10/2010 Posted

Program - Comment

FDA-2010-N-0568-0040 Anonymous - Comment 11/12/2010 Posted

FDA-2010-N-0568-0041 Write-In Campaign 1 - (Surgeon 12/6/2010 Posted

General’s Warning) - [Multiple

Submitters Total Count=69 - Form

Letter Comment

FDA-2010-N-0568-0042 Action on Smoking and Health (ASH) 1/

10/2011 Posted

Comment

FDA-2010-N-0568-0043 La Clinica de Raza, Inc. - Comment 1/10/2011 Posted

FDA-2010-N-0568-0044 Allison Johnson, United General 1/11/2011 Posted

Hospital - Comment

FDA-2010-N-0568-0045 Democracy Institute - Comment 1/11/2011 Posted

FDA-2010-N-0568-0046 Association of National Advertisers, 1/11/2011 Posted

Inc., and American Advertising

Federation (AAF), (Davis Wright

Tremaine, LLP) - Comment

FDA-2010-N-0568-0047 Dosal Tobacco Corporation -1/11/2011 Posted

Comment

FDA-2010-N-0568-0048 NATO - Comment 1/12/2011 Posted

FDA-2010-N-0568-0049 Pasadena Tobacco Prevention 1/12/2011 Posted

Coalition - Comment

FDA-2010-N-0568-0050 Wendy Max, Institute for Health & 1/12/2011 Posted

Aging, University of California, San

Francisco - Comment

FDA-2010-N-0568-0051 Jessica Apodaca, Office of Student 1/12/2011 Posted

Wellness, Santa Fe Public Schools -

Comment

FDA-2010-N-0568-0052 Canadian Cancer Society - Comment 1/12/2011 Posted

FDA-2010-N-0568-0059 California Department of Public 1/12/2011 Posted

Health (CDPH) - Comment

FDA-2010-N-0568-0060 University of California San Francisco 1/13/2011 Posted

- Comment

FDA-2010-N-0568-0061 Peripheral Arterial Disease (PAD) -1/14/2011 Posted

Comment

FDA-2010-N-0568-0062 Canadian Cancer Society - Comment 1/18/2011 Posted

FDA-2010-N-0568-0063 Association of National Advertisers, 1/19/2011 Posted

Inc., (ANA) and American Advertising

Federation (AAF) - Comment

FDA-2010-N-0568-0064 State of California-Health and Human 1/19/2011 Posted

Services Agency California

Department of Health - Comment

FDA-2010-N-0568-0065 American Wholesale Marketers 2/4/2011 Posted

Association (AWMA) - Comment

FDA-2010-N-0568-0066 Pennsylvania Department of Health -1/21/2011 Posted

Comment

Page 25 of 39

Case 1:11-cv-01482-RJL Document 35-1 Filed 10/21/11 Page 48 of 61

Document ID Title Date

Received Phase

FDA-2010-N-0568-0067 Kathryn Keister and Prashant Patel -2/23/2011 Posted

Comment

FDA-2010-N-0568-0068 George Croomer, III., (Sand Point 2/23/2011 Posted

School) - Comment

FDA-2010-N-0568-0069 Rodney D Barekman - Comment 11/12/2010 Posted

FDA-2010-N-0568-0070 Jim Elsesser - Comment 11/12/2010 Posted

FDA-2010-N-0568-0071 Evette Marie Olszyk - Comment 11/12/2010 Posted

FDA-2010-N-0568-0072 Sam Phillips - Comment 11/12/2010 Posted

FDA-2010-N-0568-0073 Dale Klabacha - Comment 11/12/2010 Posted

FDA-2010-N-0568-0074 Kathi K. Elkins - Comment 11/12/2010 Posted

FDA-2010-N-0568-0075 Michael G. Sell - Comment 11/12/2010 Posted

FDA-2010-N-0568-0076 Mariela Gonzalez - Comment 11/12/2010 Posted

FDA-2010-N-0568-0077 Kay M. Kreklau - Comment 11/12/2010 Posted

FDA-2010-N-0568-0078 Madeline Ronne - Comment 11/12/2010 Posted

FDA-2010-N-0568-0079 Amanda Halford - Comment 11/12/2010 Posted

FDA-2010-N-0568-0080 Holly M-Z - Comment 11/12/2010 Posted

FDA-2010-N-0568-0081 Erin G. Johnson - Comment 11/12/2010 Posted

FDA-2010-N-0568-0082 Teresa Ann Toombs - Comment 11/12/2010 Posted

FDA-2010-N-0568-0083 Sharon marie Day - Comment 11/12/2010 Posted

FDA-2010-N-0568-0084 Daniel Robert Pea - Comment 11/12/2010 Posted

FDA-2010-N-0568-0085 Anonymous - Comment 11/12/2010 Posted

FDA-2010-N-0568-0086 Nicole Marie Kogowski - Comment 11/12/2010 Posted

FDA-2010-N-0568-0087 Andrew Scott - Comment 11/12/2010 Posted

FDA-2010-N-0568-0088 Deena Jean Martin - Comment 11/12/2010 Posted

FDA-2010-N-0568-0089 Arlene K. Stoller - Comment 11/12/2010 Posted

FDA-2010-N-0568-0090 Marcia Brown-Machen - Comment 11/12/2010 Posted

FDA-2010-N-0568-0091 Reggie J. Labat - Comment 11/12/2010 Posted

FDA-2010-N-0568-0092 Juan Antonio Flores - Comment 11/12/2010 Posted

FDA-2010-N-0568-0093 Gavin Brown - Comment 11/12/2010 Posted

FDA-2010-N-0568-0094 David Berry - Comment 11/12/2010 Posted

FDA-2010-N-0568-0095 Eric Hansen - Comment 11/12/2010 Posted

FDA-2010-N-0568-0096 Raymond Rose - Comment 11/12/2010 Posted

FDA-2010-N-0568-0097 JoAnne Zito-Brause - Comment 11/12/2010 Posted

FDA-2010-N-0568-0098 Kristina - Comment 11/12/2010 Posted

FDA-2010-N-0568-0099 JoAnne Zito-Brause - Comment 11/12/2010 Posted

FDA-2010-N-0568-0100 Michelle Jeanette-Toupin Bielecki -11/12/2010 Posted

Comment

FDA-2010-N-0568-0101 Lauren Kelsey - Comment 11/12/2010 Posted

FDA-2010-N-0568-0102 Charlotte Marie Aborn - Comment 11/12/2010 Posted

FDA-2010-N-0568-0103 Zoe Melisa Kipping - Comment 11/12/2010 Posted

FDA-2010-N-0568-0104 Joshua Dyme - Comment 11/13/2010 Posted

FDA-2010-N-0568-0106 Regina Marie Moore - Comment 11/13/2010 Posted

FDA-2010-N-0568-0107 Charles Yingling - Comment 11/13/2010 Posted

FDA-2010-N-0568-0108 Lauren Frances LaBelle - Comment 11/13/2010 Posted

FDA-2010-N-0568-0109 Denise Raphaelle Eavers - Comment 11/13/2010 Posted

FDA-2010-N-0568-0110 Bre-Ann Slay - Comment 11/13/2010 Posted

FDA-2010-N-0568-0111 Mary Barba - Comment 11/13/2010 Posted

FDA-2010-N-0568-0112 Rachel E Mossey - Comment 11/13/2010 Posted

FDA-2010-N-0568-0113 Henry Carole Hambel - Comment 11/13/2010 Posted

Page 26 of 39

Case 1:11-cv-01482-RJL Document 35-1 Filed 10/21/11 Page 49 of 61

Document ID Title Date

Received Phase

FDA-2010-N-0568-0114 Deborah Leader - Comment 11/13/2010 Posted

FDA-2010-N-0568-0115 Anonymous - Comment 11/13/2010 Posted

FDA-2010-N-0568-0116 Joseph Bonneau - Comment 11/13/2010 Posted

FDA-2010-N-0568-0117 Alex Linenberger - Comment 11/13/2010 Posted

FDA-2010-N-0568-0118 Matthew S. White - Comment 11/13/2010 Posted

FDA-2010-N-0568-0119 Larry Lamarr Jordan - Comment 11/14/2010 Posted

FDA-2010-N-0568-0120 Patricia Joan Taylor - Comment 11/14/2010 Posted

FDA-2010-N-0568-0121 Susan Joan Forton - Comment 11/14/2010 Posted

FDA-2010-N-0568-0122 Steve J. Rohosky - Comment 11/14/2010 Posted

FDA-2010-N-0568-0123 Erric Crum - Comment 11/14/2010 Posted

FDA-2010-N-0568-0124 Margie Katherine Barry - Comment 11/14/2010 Posted

FDA-2010-N-0568-0125 William Balcer - Comment 11/14/2010 Posted

FDA-2010-N-0568-0126 Bridgette Collado - Comment 11/14/2010 Posted

FDA-2010-N-0568-0127 Patricia Ann Pelham - Comment 11/14/2010 Posted

FDA-2010-N-0568-0128 Sima Parsai - Comment 11/14/2010 Posted

FDA-2010-N-0568-0129 Ferris Sydney Whitfield - Comment 11/14/2010 Posted

FDA-2010-N-0568-0130 Paul Mayer - Comment 11/14/2010 Posted

FDA-2010-N-0568-0131 Cory Hunt - Comment 11/14/2010 Posted

FDA-2010-N-0568-0132 Samantha Jo Beck - Comment 11/14/2010 Posted

FDA-2010-N-0568-0133 Anonymous - Comment 11/14/2010 Posted

FDA-2010-N-0568-0134 Legacy - Comment 1/11/2011 Posted

FDA-2010-N-0568-0135 Michele N. Vaught - Comment 11/15/2010 Posted

FDA-2010-N-0568-0136 Chris Novrocki - Comment 11/15/2010 Posted

FDA-2010-N-0568-0137 Cheryl Uzdarwin - Comment 11/15/2010 Posted

FDA-2010-N-0568-0138 Tony Perez - Comment 11/15/2010 Posted

FDA-2010-N-0568-0139 Robert L. Daly - Comment 11/15/2010 Posted

FDA-2010-N-0568-0140 Erica A. Danos - Comment 11/15/2010 Posted

FDA-2010-N-0568-0141 Suzanne Mary Binau - Comment 11/15/2010 Posted

FDA-2010-N-0568-0142 Wendy Crespi Morgan - Comment 11/15/2010 Posted

FDA-2010-N-0568-0143 Pamela Minx Pollard - Comment 11/15/2010 Posted

FDA-2010-N-0568-0144 R.K. Teague - Comment 11/15/2010 Posted

FDA-2010-N-0568-0145 Becky L. Lamb - Comment 11/15/2010 Posted

FDA-2010-N-0568-0146 Stacy Marie Harris - Comment 11/15/2010 Posted

FDA-2010-N-0568-0147 Florence Dallo - Comment 11/15/2010 Posted

FDA-2010-N-0568-0148 Denise Catherine Zock - Comment 11/15/2010 Posted

FDA-2010-N-0568-0149 Kathryn L. Mitchell-Healey -11/15/2010 Posted

Comment

FDA-2010-N-0568-0150 Lora Stott - Comment 11/15/2010 Posted

FDA-2010-N-0568-0151 Crystal Samantha Kherkher -11/15/2010 Posted

Comment

FDA-2010-N-0568-0152 Kim M. Downing - Comment 11/15/2010 Posted

FDA-2010-N-0568-0153 Ryan Claire Reikowsky - Comment 11/15/2010 Posted

FDA-2010-N-0568-0154 Chris Hollenback - Comment 11/15/2010 Posted

FDA-2010-N-0568-0155 Karen S. Thompson - Comment 11/15/2010 Posted

FDA-2010-N-0568-0156 Veronica Maldonado - Comment 11/15/2010 Posted

FDA-2010-N-0568-0157 Rose Marie Davis - Comment 11/15/2010 Posted

FDA-2010-N-0568-0158 Nancy Jo Sauerman - Comment 11/15/2010 Posted

FDA-2010-N-0568-0159 Jen Brown - Comment 11/15/2010 Posted

FDA-2010-N-0568-0160 Tim J. Nelson - Comment 11/15/2010 Posted

Page 27 of 39

Case 1:11-cv-01482-RJL Document 35-1 Filed 10/21/11 Page 50 of 61

Document ID Title Date

Received Phase

FDA-2010-N-0568-0161 Laurena Leigh-Charlotte White -11/15/2010 Posted

Comment

FDA-2010-N-0568-0162 Joyce Nelle Adkins - Comment 11/15/2010 Posted

FDA-2010-N-0568-0163 Gayle Davidson - Comment 11/15/2010 Posted

FDA-2010-N-0568-0164 Debbie McDonald - Comment 11/15/2010 Posted

FDA-2010-N-0568-0165 Amanda - Comment 11/15/2010 Posted

FDA-2010-N-0568-0166 Anonymous - Comment 11/15/2010 Posted

FDA-2010-N-0568-0167 Jane Branscomb - Comment 11/15/2010 Posted

FDA-2010-N-0568-0168 Amanda - Comment 11/15/2010 Posted

FDA-2010-N-0568-0169 Casey K. Oskey - Comment 11/15/2010 Posted

FDA-2010-N-0568-0170 Anonymous - Comment 11/15/2010 Posted

FDA-2010-N-0568-0171 Aisatou Diallo - Comment 11/16/2010 Posted

FDA-2010-N-0568-0172 Nicolas Alexander Mauro - Comment 11/16/2010 Posted

FDA-2010-N-0568-0173 Erica L Smith - Comment 11/16/2010 Posted

FDA-2010-N-0568-0174 Michael Scott Steves - Comment 11/16/2010 Posted

FDA-2010-N-0568-0175 Anonymous - Comment 11/16/2010 Posted

FDA-2010-N-0568-0176 Daniel C. Rutz - Comment 11/16/2010 Posted

FDA-2010-N-0568-0177 Christina Marie Hamilton - Comment 11/16/2010 Posted

FDA-2010-N-0568-0178 Brian TenHopen - Comment 11/16/2010 Posted

FDA-2010-N-0568-0179 Carol - Comment 11/16/2010 Posted

FDA-2010-N-0568-0180 Robin Ellis - Comment 11/16/2010 Posted

FDA-2010-N-0568-0181 Elizabeth Bryanna Crose - Comment 11/16/2010 Posted

FDA-2010-N-0568-0182 Muhammad Thaakier Salie -11/16/2010 Posted

Comment

FDA-2010-N-0568-0183 Anonymous - Comment 11/16/2010 Posted

FDA-2010-N-0568-0184 Jordyn Lempert - Comment 11/16/2010 Posted

FDA-2010-N-0568-0185 Dennis James Martin - Comment 11/16/2010 Posted

FDA-2010-N-0568-0186 Derek Brett Sulpizio - Comment 11/16/2010 Posted

FDA-2010-N-0568-0187 Danielle Sylvester - Comment 11/16/2010 Posted

FDA-2010-N-0568-0188 Jake Harlick - Comment 11/16/2010 Posted

FDA-2010-N-0568-0189 Matt E. Phelan - Comment 11/16/2010 Posted

FDA-2010-N-0568-0190 Rebecca Rene Keating - Comment 11/16/2010 Posted

FDA-2010-N-0568-0191 Tyler James Bryant - Comment 11/16/2010 Posted

FDA-2010-N-0568-0192 Jim T. Funk - Comment 11/16/2010 Posted

FDA-2010-N-0568-0193 Amanda Mazurek - Comment 11/16/2010 Posted

FDA-2010-N-0568-0194 Lauren Nicole Stakey - Comment 11/16/2010 Posted

FDA-2010-N-0568-0195 Rachel H. Watson - Comment 11/16/2010 Posted

FDA-2010-N-0568-0196 Anonymous - Comment 11/17/2010 Posted

FDA-2010-N-0568-0197 Renee Hoffinger - Comment 11/17/2010 Posted

FDA-2010-N-0568-0198 Jenny R. Ostien - Comment 11/17/2010 Posted

FDA-2010-N-0568-0199 Linda Cahn - Comment 11/17/2010 Posted

FDA-2010-N-0568-0200 Kim Randell Aanderud - Comment 11/17/2010 Posted

FDA-2010-N-0568-0201 Shirley Kathleen Chaney - Comment 11/17/2010 Posted

FDA-2010-N-0568-0202 Dori Khakpour - Comment 11/17/2010 Posted

FDA-2010-N-0568-0203 Mary Ann Martin - Comment 11/17/2010 Posted

FDA-2010-N-0568-0204 Anonymous - Comment 11/17/2010 Posted

Page 28 of 39

Case 1:11-cv-01482-RJL Document 35-1 Filed 10/21/11 Page 51 of 61

Document ID Title Date

Received Phase

FDA-2010-N-0568-0205 Beverly J. Tafoya-Dominguez -11/17/2010 Posted

Comment

FDA-2010-N-0568-0206 Beverly Tafoya-Dominguez -11/17/2010 Posted

Comment

FDA-2010-N-0568-0207 Dr. Sam Schwartz - Comment 4/14/2011 Posted

FDA-2010-N-0568-0208 BIC Corporation - Comment 4/26/2011 Posted

FDA-2010-N-0568-0209 Anthony Lamont - Comment 11/17/2010 Posted

FDA-2010-N-0568-0210 Chris Morin - Comment 11/17/2010 Posted

FDA-2010-N-0568-0211 Julie A. Marders - Comment 11/17/2010 Posted

FDA-2010-N-0568-0212 Laura Culp - Comment 11/17/2010 Posted

FDA-2010-N-0568-0213 Adriana Christina Badalamenti -11/17/2010 Posted

Comment

FDA-2010-N-0568-0214 Nicholas Reusch - Comment 11/18/2010 Posted

FDA-2010-N-0568-0215 Judith Anne Labdik - Comment 11/18/2010 Posted

FDA-2010-N-0568-0216 Richard Spiegel - Comment 11/18/2010 Posted

FDA-2010-N-0568-0217 Victor Manzon - Comment 11/18/2010 Posted

FDA-2010-N-0568-0218 Anthony Scott Kostrzewa - Comment 11/18/2010 Posted

FDA-2010-N-0568-0219 Sandra Farley - Comment 11/18/2010 Posted

FDA-2010-N-0568-0220 Aubrey K. - Comment 11/18/2010 Posted

FDA-2010-N-0568-0221 Rita Shapiro - Comment 11/18/2010 Posted

FDA-2010-N-0568-0222 Sage - Comment 11/18/2010 Posted

FDA-2010-N-0568-0223 Wendy Smith - Comment 11/18/2010 Posted

FDA-2010-N-0568-0224 Janel Meriam Ayar - Comment 11/18/2010 Posted

FDA-2010-N-0568-0225 Christopher James Lounsbery -11/18/2010 Posted

Comment

FDA-2010-N-0568-0226 Freya Andrukitas Zork - Comment 11/18/2010 Posted

FDA-2010-N-0568-0227 Kara Ann Grauf - Comment 11/18/2010 Posted

FDA-2010-N-0568-0228 Lauren S. Kallabat - Comment 11/18/2010 Posted

FDA-2010-N-0568-0229 Nathan S. Zachar - Comment 11/18/2010 Posted

FDA-2010-N-0568-0230 Symone Sterling - Comment 11/18/2010 Posted

FDA-2010-N-0568-0231 Reed Hall - Comment 11/18/2010 Posted

FDA-2010-N-0568-0232 Jessica Lauren Minicuci - Comment 11/18/2010 Posted

FDA-2010-N-0568-0233 Amanda M. Fernandez - Comment 11/18/2010 Posted

FDA-2010-N-0568-0234 Ariel Cason - Comment 11/18/2010 Posted

FDA-2010-N-0568-0235 Dennis James Martin - Comment 11/18/2010 Posted

FDA-2010-N-0568-0236 Casey Lynn Curnutte - Comment 11/18/2010 Posted

FDA-2010-N-0568-0237 Reosha’ Renee Pope - Comment 11/18/2010 Posted

FDA-2010-N-0568-0238 Chris James Lounsbery - Comment 11/18/2010 Posted

FDA-2010-N-0568-0239 Zachary Frederick Sexton - Comment 11/18/2010 Posted

FDA-2010-N-0568-0240 Ellin Johnson - Comment 11/18/2010 Posted

FDA-2010-N-0568-0241 Chelsea Messina Salkeld - Comment 11/18/2010 Posted

FDA-2010-N-0568-0242 Lauren Marie Etta - Comment 11/18/2010 Posted

FDA-2010-N-0568-0243 Richard Steven Bello - Comment 11/18/2010 Posted

FDA-2010-N-0568-0244 Michael Mendelson - Comment 11/18/2010 Posted

FDA-2010-N-0568-0245 Willow McVeigh - Comment 11/18/2010 Posted

FDA-2010-N-0568-0246 Chris - Comment 11/18/2010 Posted

FDA-2010-N-0568-0247 Rana M. Parker - Comment 11/18/2010 Posted

Page 29 of 39

Case 1:11-cv-01482-RJL Document 35-1 Filed 10/21/11 Page 52 of 61

Document ID Title Date

Received Phase

FDA-2010-N-0568-0248 Wafeeza Bacchus - Comment 11/18/2010 Posted

FDA-2010-N-0568-0249 Anonymous - Comment 11/19/2010 Posted

FDA-2010-N-0568-0250 University of Wisconsin-Center for 1/7/2011 Posted

Tobacco Research and Intervention

(UW-CTRI) - Comment

FDA-2010-N-0568-0267 Linda Cooperstock - Comment 11/19/2010 Posted

FDA-2010-N-0568-0268 Andy Reinhard - Comment 11/19/2010 Posted

FDA-2010-N-0568-0269 Holly Martin - Comment 11/19/2010 Posted

FDA-2010-N-0568-0270 Deborah Ruth Noyes - Comment 11/19/2010 Posted

FDA-2010-N-0568-0271 Danielle Morgan Kubly - Comment 11/19/2010 Posted

FDA-2010-N-0568-0272 Walton Sumner - Comment 11/19/2010 Posted

FDA-2010-N-0568-0273 L. Wright - Comment 11/19/2010 Posted

FDA-2010-N-0568-0274 Josh - Comment 11/19/2010 Posted

FDA-2010-N-0568-0275 Jim - Comment 11/19/2010 Posted

FDA-2010-N-0568-0276 Andy Reinhard - Comment 11/19/2010 Posted

FDA-2010-N-0568-0277 Sharon Marks - Comment 11/19/2010 Posted

FDA-2010-N-0568-0278 Wanda Armstrong - Comment 11/19/2010 Posted

FDA-2010-N-0568-0279 Matt Finn - Comment 11/19/2010 Posted

FDA-2010-N-0568-0280 Mary Ann Magaw - Comment 11/19/2010 Posted

FDA-2010-N-0568-0281 Betty L Martini - Comment 11/19/2010 Posted

FDA-2010-N-0568-0282 Thurman Allen Merritt - Comment 11/20/2010 Posted

FDA-2010-N-0568-0283 Pamela Rae Welsing - Comment 11/20/2010 Posted

FDA-2010-N-0568-0284 Barbara Cindric - Comment 11/20/2010 Posted

FDA-2010-N-0568-0285 lorraine Ruppe - Comment 11/20/2010 Posted

FDA-2010-N-0568-0286 Virginia Frances Stegall - Comment 11/20/2010 Posted

FDA-2010-N-0568-0287 Madeline Arkin - Comment 11/20/2010 Posted

FDA-2010-N-0568-0288 Sasha W. - Comment 11/21/2010 Posted

FDA-2010-N-0568-0289 Charles Bina - Comment 11/21/2010 Posted

FDA-2010-N-0568-0290 Michael Hart - Comment 11/21/2010 Posted

FDA-2010-N-0568-0291 Arnold H. Herman - Comment 11/21/2010 Posted

FDA-2010-N-0568-0292 Cliff William Rustia - Comment 11/21/2010 Posted

FDA-2010-N-0568-0293 Chiquita Cole - Comment 11/21/2010 Posted

FDA-2010-N-0568-0294 James Scott Lachapelle - Comment 11/21/2010 Posted

FDA-2010-N-0568-0295 David Ehrlich - Comment 11/22/2010 Posted

FDA-2010-N-0568-0296 Chris Peralta - Comment 11/22/2010 Posted

FDA-2010-N-0568-0297 James L. Williams - Comment 11/22/2010 Posted

FDA-2010-N-0568-0298 Gregg L. Ruppel - Comment 11/22/2010 Posted

FDA-2010-N-0568-0299 Alexander Zubenko - Comment 11/22/2010 Posted

FDA-2010-N-0568-0300 Rhonda Jane Drain - Comment 11/22/2010 Posted

FDA-2010-N-0568-0301 Nora Elizabeth Coulter - Comment 11/22/2010 Posted

FDA-2010-N-0568-0302 Bernice Gerig Carver - Comment 11/22/2010 Posted

FDA-2010-N-0568-0303 Marty L. Eckrem - Comment 11/22/2010 Posted

FDA-2010-N-0568-0304 Susan K. Bergquist - Comment 11/22/2010 Posted

FDA-2010-N-0568-0305 Andrew J. Woodruff - Comment 11/22/2010 Posted

FDA-2010-N-0568-0306 Paula J. Martel - Comment 11/22/2010 Posted

FDA-2010-N-0568-0307 Anonymous - Comment 11/22/2010 Posted

FDA-2010-N-0568-0308 Ashley V. Dzingle - Comment 11/22/2010 Posted

FDA-2010-N-0568-0309 Lynda Anne Nesbitt - Comment 11/22/2010 Posted

FDA-2010-N-0568-0310 Nick A. Mauro - Comment 11/23/2010 Posted

FDA-2010-N-0568-0311 Mary Ann Aregood - Comment 11/23/2010 Posted

Page 30 of 39

Case 1:11-cv-01482-RJL Document 35-1 Filed 10/21/11 Page 53 of 61

Document ID Title Date

Received Phase

FDA-2010-N-0568-0312 Jacqueline L. Webb - Comment 11/23/2010 Posted

FDA-2010-N-0568-0313 Beth Lisa Haley - Comment 11/23/2010 Posted

FDA-2010-N-0568-0314 Troy Michael Doetch - Comment 11/23/2010 Posted

FDA-2010-N-0568-0315 Joni Jones - Comment 11/23/2010 Posted

FDA-2010-N-0568-0316 Anonymous - Comment 11/23/2010 Posted

FDA-2010-N-0568-0317 Anonymous - Comment 11/23/2010 Posted

FDA-2010-N-0568-0318 Barbara A Armstrong - Comment 11/23/2010 Posted

FDA-2010-N-0568-0319 MSIntelligence - Comment 11/24/2010 Posted

FDA-2010-N-0568-0320 Isabel Truong - Comment 11/24/2010 Posted

FDA-2010-N-0568-0321 Patricia Lundrigan - Comment 11/24/2010 Posted

FDA-2010-N-0568-0322 Justin Daniel Hassenfeld - Comment 11/24/2010 Posted

FDA-2010-N-0568-0323 Dara Sheinker - Comment 11/24/2010 Posted

FDA-2010-N-0568-0324 Brandon John Bloom - Comment 11/24/2010 Posted

FDA-2010-N-0568-0325 Jonathan K Rash - Comment 11/24/2010 Posted

FDA-2010-N-0568-0326 Glenn D. Cormier - Comment 11/24/2010 Posted

FDA-2010-N-0568-0327 David T. - Comment 11/27/2010 Posted

FDA-2010-N-0568-0328 James R. Damon - Comment 11/27/2010 Posted

FDA-2010-N-0568-0329 Wesley Eden Helms - Comment 11/27/2010 Posted

FDA-2010-N-0568-0330 Nitteya Thompson - Comment 11/28/2010 Posted

FDA-2010-N-0568-0331 William P. Williams - Comment 11/28/2010 Posted

FDA-2010-N-0568-0332 Frank Lukas Birt - Comment 11/28/2010 Posted

FDA-2010-N-0568-0333 Anonymous - Comment 11/28/2010 Posted

FDA-2010-N-0568-0334 Natalie Grace Ringham - Comment 11/28/2010 Posted

FDA-2010-N-0568-0335 Lanell M. Perkins - Comment 11/29/2010 Posted

FDA-2010-N-0568-0336 Betty C. Jung - Comment 11/29/2010 Posted

FDA-2010-N-0568-0337 Diane Ouellette Barnaby - Comment 11/29/2010 Posted

FDA-2010-N-0568-0338 Larry P. East - Comment 11/29/2010 Posted

FDA-2010-N-0568-0339 Keri Reyburn - Comment 11/29/2010 Posted

FDA-2010-N-0568-0340 Bob Wit Jeb - Comment 11/29/2010 Posted

FDA-2010-N-0568-0341 Schnee Nicole - Comment 11/29/2010 Posted

FDA-2010-N-0568-0342 Alan W. Palmer - Comment 11/29/2010 Posted

FDA-2010-N-0568-0343 Sally Ann Dutson - Comment 11/29/2010 Posted

FDA-2010-N-0568-0344 Bill Ramsaur - Comment 11/29/2010 Posted

FDA-2010-N-0568-0345 Timothy Ashton Alexander -11/29/2010 Posted

Comment

FDA-2010-N-0568-0346 Jo DeBuhr - Comment 11/29/2010 Posted

FDA-2010-N-0568-0347 Eric Campbell - Comment 11/30/2010 Posted

FDA-2010-N-0568-0348 Shylo Dennison - Comment 11/30/2010 Posted

FDA-2010-N-0568-0349 Angel Nace - Comment 11/30/2010 Posted

FDA-2010-N-0568-0350 Aleta R. Carpenter - Comment 11/30/2010 Posted

FDA-2010-N-0568-0351 Angela Maria Martinelli - Comment 11/30/2010 Posted

FDA-2010-N-0568-0352 Vicki Barron - Comment 11/30/2010 Posted

FDA-2010-N-0568-0353 Jason Lee Ambrosino - Comment 11/30/2010 Posted

FDA-2010-N-0568-0354 Tiffany Humphrey - Comment 11/30/2010 Posted

FDA-2010-N-0568-0355 Constance Elaine Cephus - Comment 12/1/2010 Posted

FDA-2010-N-0568-0356 Denise Woods - Comment 12/1/2010 Posted

FDA-2010-N-0568-0357 Deborah Dawn Colwell - Comment 12/1/2010 Posted

FDA-2010-N-0568-0358 Ryan Barbieri - Comment 12/1/2010 Posted

FDA-2010-N-0568-0359 Jesus Perez - Comment 12/1/2010 Posted

Page 31 of 39

Case 1:11-cv-01482-RJL Document 35-1 Filed 10/21/11 Page 54 of 61

Document ID Title Date

Received Phase

FDA-2010-N-0568-0360 Abby Lynn McElligott - Comment 12/1/2010 Posted

FDA-2010-N-0568-0361 Anonymous - Comment 12/1/2010 Posted

FDA-2010-N-0568-0362 Anonymous - Comment 12/2/2010 Posted

FDA-2010-N-0568-0363 Aaron - Comment 12/2/2010 Posted

FDA-2010-N-0568-0364 Ann Quinn-Zobeck - Comment 12/2/2010 Posted

FDA-2010-N-0568-0365 Hollie Dawn Garrison - Comment 12/2/2010 Posted

FDA-2010-N-0568-0366 Anonymous - Comment 12/2/2010 Posted

FDA-2010-N-0568-0367 Dani Roesler - Comment 12/2/2010 Posted

FDA-2010-N-0568-0368 Gina Rae Ryg - Comment 12/3/2010 Posted

FDA-2010-N-0568-0369 Amy McQueen - Comment 12/3/2010 Posted

FDA-2010-N-0568-0370 Tina M. Lavy - Comment 12/3/2010 Posted

FDA-2010-N-0568-0371 Diana S. Blythe - Comment 12/4/2010 Posted

FDA-2010-N-0568-0372 Xenia A. - Comment 12/5/2010 Posted

FDA-2010-N-0568-0373 Calleagh Cecelia Brown - Comment 12/5/2010 Posted

FDA-2010-N-0568-0374 Erin M. Swaller - Comment 12/5/2010 Posted

FDA-2010-N-0568-0375 Lucille Rathier - Comment 12/5/2010 Posted

FDA-2010-N-0568-0376 Christie Pua’ala Hussey - Comment 12/6/2010 Posted

FDA-2010-N-0568-0377 Christie Pua’ala Hussey - Comment 12/6/2010 Posted

FDA-2010-N-0568-0378 Malllory Jane McPherson - Comment 12/6/2010 Posted

FDA-2010-N-0568-0379 Lauren C. Lackey - Comment 12/6/2010 Posted

FDA-2010-N-0568-0380 Brittany Keener - Comment 12/6/2010 Posted

FDA-2010-N-0568-0381 Jeff Shrifter - Comment 12/6/2010 Posted

FDA-2010-N-0568-0382 Alicia S. Hoard - Comment 12/6/2010 Posted

FDA-2010-N-0568-0383 John M. Golden - Comment 12/6/2010 Posted

FDA-2010-N-0568-0384 Jonnie D. Purify, Jr. - Comment 12/6/2010 Posted

FDA-2010-N-0568-0385 Shary M. Jones - Comment 12/6/2010 Posted

FDA-2010-N-0568-0386 Steven Randolf Tidwell - Comment 12/6/2010 Posted

FDA-2010-N-0568-0387 Shani Smith - Comment 12/6/2010 Posted

FDA-2010-N-0568-0388 Patrick C. Harper - Comment 12/6/2010 Posted

FDA-2010-N-0568-0389 Mark Miller - Comment 12/6/2010 Posted

FDA-2010-N-0568-0390 Arlan Lee Rosenbloom - Comment 12/6/2010 Posted

FDA-2010-N-0568-0391 Patricia Davison Mail - Comment 12/6/2010 Posted

FDA-2010-N-0568-0392 Dale King - Comment 12/6/2010 Posted

FDA-2010-N-0568-0393 CAPT Jooh J Bartko - Comment 12/6/2010 Posted

FDA-2010-N-0568-0394 C.K. Olson - Comment 12/6/2010 Posted

FDA-2010-N-0568-0395 Anonymous - Comment 12/6/2010 Posted

FDA-2010-N-0568-0396 Eva McLanahan - Comment 12/6/2010 Posted

FDA-2010-N-0568-0397 Ferdinand R Hassler - Comment 12/6/2010 Posted

FDA-2010-N-0568-0398 Anonymous - Comment 12/6/2010 Posted

FDA-2010-N-0568-0399 Erica Frahm - Comment 12/6/2010 Posted

FDA-2010-N-0568-0400 Alberto Moreno - Comment 12/6/2010 Posted

FDA-2010-N-0568-0401 LTJG Rebecca L. Hampton -12/7/2010 Posted

Comment

FDA-2010-N-0568-0402 Connor Steele - Comment 12/7/2010 Posted

FDA-2010-N-0568-0403 Mary F. Rossi-Coajou - Comment 12/7/2010 Posted

FDA-2010-N-0568-0404 Erin Grasso - Comment 12/7/2010 Posted

FDA-2010-N-0568-0405 Jeremy Sobel - Comment 12/7/2010 Posted

FDA-2010-N-0568-0406 Jill Hammond - Comment 12/7/2010 Posted

FDA-2010-N-0568-0407 Laura Gieraltowski - Comment 12/7/2010 Posted

Page 32 of 39

Case 1:11-cv-01482-RJL Document 35-1 Filed 10/21/11 Page 55 of 61

Document ID Title Date

Received Phase

FDA-2010-N-0568-0408 Rob Lyerla - Comment 12/7/2010 Posted

FDA-2010-N-0568-0409 Austin Lee Nichols - Comment 12/7/2010 Posted

FDA-2010-N-0568-0410 Kimberly Ruth Crocker - Comment 12/7/2010 Posted

FDA-2010-N-0568-0411 Silvia Benincaso - Comment 12/7/2010 Posted

FDA-2010-N-0568-0412 Mark A. Chen - Comment 12/7/2010 Posted

FDA-2010-N-0568-0413 Richard Michael Davidson -12/7/2010 Posted

Comment

FDA-2010-N-0568-0414 Richard Michael Davidson -12/7/2010 Posted

Comment

FDA-2010-N-0568-0415 Jolene M. Caselli - Comment 12/7/2010 Posted

FDA-2010-N-0568-0416 Laura A. Meller - Comment 12/7/2010 Posted

FDA-2010-N-0568-0417 LCDR Deborah Dee - Comment 12/7/2010 Posted

FDA-2010-N-0568-0418 Richard John Calvert - Comment 12/7/2010 Posted

FDA-2010-N-0568-0419 Nadine Marie Simons - Comment 12/7/2010 Posted

FDA-2010-N-0568-0420 Ronald Arthur Berry - Comment 12/7/2010 Posted

FDA-2010-N-0568-0421 Sara Beth Newman - Comment 12/7/2010 Posted

FDA-2010-N-0568-0422 Frank - Comment 12/7/2010 Posted

FDA-2010-N-0568-0423 Sarah Bernett - Comment 12/7/2010 Posted

FDA-2010-N-0568-0424 Charles Helmick - Comment 12/7/2010 Posted

FDA-2010-N-0568-0425 Cameron Seth Lorbiecki - Comment 12/8/2010 Posted

FDA-2010-N-0568-0426 Anonymous - Comment 12/8/2010 Posted

FDA-2010-N-0568-0427 Nicole king - Comment 12/8/2010 Posted

FDA-2010-N-0568-0428 Monique M. Connor - Comment 12/8/2010 Posted

FDA-2010-N-0568-0429 Janet Keysser - Comment 12/8/2010 Posted

FDA-2010-N-0568-0430 Lori Sugiyama - Comment 12/8/2010 Posted

FDA-2010-N-0568-0431 Amy Ray Fisher - Comment 12/9/2010 Posted

FDA-2010-N-0568-0432 Eric S. Armbrecht - Comment 12/9/2010 Posted

FDA-2010-N-0568-0433 Andrea Bankoski - Comment 12/9/2010 Posted

FDA-2010-N-0568-0434 Patricia Nye - Comment 12/9/2010 Posted

FDA-2010-N-0568-0435 Nadine Marie Simons - Comment 12/9/2010 Posted

FDA-2010-N-0568-0436 Anonymous - Comment 12/9/2010 Posted

FDA-2010-N-0568-0437 Ashley - Comment 12/9/2010 Posted

FDA-2010-N-0568-0438 David Kristopher Glabe - Comment 12/10/2010 Posted

FDA-2010-N-0568-0439 Isabel Auerbach - Comment 12/10/2010 Posted

FDA-2010-N-0568-0440 Robert C. Williams - Comment 12/10/2010 Posted

FDA-2010-N-0568-0441 Jason McLean - Comment 12/10/2010 Posted

FDA-2010-N-0568-0442 Latoya Nicola Belgrave - Comment 12/10/2010 Posted

FDA-2010-N-0568-0443 Latonia Ford - Comment 12/10/2010 Posted

FDA-2010-N-0568-0444 Andrea Barrus - Comment 12/10/2010 Posted

FDA-2010-N-0568-0445 Caleb Hopwood - Comment 12/11/2010 Posted

FDA-2010-N-0568-0446 Alan Stuart Echt - Comment 12/11/2010 Posted

FDA-2010-N-0568-0447 Gary William Bangs - Comment 12/12/2010 Posted

FDA-2010-N-0568-0448 John T. Majewski - Comment 12/12/2010 Posted

FDA-2010-N-0568-0449 Anonymous - Comment 12/12/2010 Posted

FDA-2010-N-0568-0450 Sherry Burrer - Comment 12/12/2010 Posted

FDA-2010-N-0568-0451 Anonymous - Comment 12/13/2010 Posted

FDA-2010-N-0568-0452 Dylan Selterman - Comment 12/13/2010 Posted

FDA-2010-N-0568-0453 Cynthia Keely - Comment 12/13/2010 Posted

FDA-2010-N-0568-0454 Kevin Matthew Kunard - Comment 12/13/2010 Posted

FDA-2010-N-0568-0455 Rachelle Leong - Comment 12/13/2010 Posted

Page 33 of 39

Case 1:11-cv-01482-RJL Document 35-1 Filed 10/21/11 Page 56 of 61

Document ID Title Date

Received Phase

FDA-2010-N-0568-0456 Anonymous - Comment 12/13/2010 Posted

FDA-2010-N-0568-0457 Stephen Isaacs - Comment 12/13/2010 Posted

FDA-2010-N-0568-0458 Mitchell Wada - Comment 12/14/2010 Posted

FDA-2010-N-0568-0459 Jobana L. Perez - Comment 12/14/2010 Posted

FDA-2010-N-0568-0460 Anonymous - Comment 12/13/2010 Posted

FDA-2010-N-0568-0461 Megan Mattingly - Comment 12/14/2010 Posted

FDA-2010-N-0568-0462 Barry Sanders - Comment 12/14/2010 Posted

FDA-2010-N-0568-0463 Ashley J. Burns - Comment 12/14/2010 Posted

FDA-2010-N-0568-0464 Michelle E. Poindexter - Comment 12/15/2010 Posted

FDA-2010-N-0568-0465 Donna Sue Peros - Comment 12/15/2010 Posted

FDA-2010-N-0568-0466 Emily Nichole Stark - Comment 12/15/2010 Posted

FDA-2010-N-0568-0467 Kelly J. Jarrell - Comment 12/15/2010 Posted

FDA-2010-N-0568-0468 Alexis Bartolome Vea - Comment 12/15/2010 Posted

FDA-2010-N-0568-0469 Eric William Bradford - Comment 12/15/2010 Posted

FDA-2010-N-0568-0470 Mark Goldstein - Comment 12/16/2010 Posted

FDA-2010-N-0568-0471 Kate Heim - Comment 12/16/2010 Posted

FDA-2010-N-0568-0472 Marie Davantes - Comment 12/17/2010 Posted

FDA-2010-N-0568-0473 Claudine Samanic - Comment 12/17/2010 Posted

FDA-2010-N-0568-0474 Susan Utegg - Comment 12/17/2010 Posted

FDA-2010-N-0568-0475 Adele M. Spegman - Comment 12/17/2010 Posted

FDA-2010-N-0568-0476 Dana L. Hall - Comment 12/17/2010 Posted

FDA-2010-N-0568-0477 Marty Celis Borja - Comment 12/17/2010 Posted

FDA-2010-N-0568-0478 Al D. Paet - Comment 12/17/2010 Posted

FDA-2010-N-0568-0479 Luciano Nunes Duro - Comment 12/17/2010 Posted

FDA-2010-N-0568-0480 Thurman Allen Allen Merritt M.D., 12/18/2010 Posted

MHA - Comment

FDA-2010-N-0568-0481 Anonymous - Comment 12/18/2010 Posted

FDA-2010-N-0568-0482 Lyzette Czarina Abalos - Comment 12/18/2010 Posted

FDA-2010-N-0568-0483 Mark Kane Goldstein - Comment 12/19/2010 Posted

FDA-2010-N-0568-0484 Kathryn S. Kreimer - Comment 12/19/2010 Posted

FDA-2010-N-0568-0485 Anonymous - Comment 12/19/2010 Posted

FDA-2010-N-0568-0486 Lisa D. Wallace - Comment 12/20/2010 Posted

FDA-2010-N-0568-0487 Dorothea Moll - Comment 12/20/2010 Posted

FDA-2010-N-0568-0488 Connie Lynne Bruce - Comment 12/20/2010 Posted

FDA-2010-N-0568-0489 Anonymous - Comment 12/21/2010 Posted

FDA-2010-N-0568-0490 Dan - Comment 12/21/2010 Posted

FDA-2010-N-0568-0491 Joni A. Jensen - Comment 12/21/2010 Posted

FDA-2010-N-0568-0492 Anonymous - Comment 12/21/2010 Posted

FDA-2010-N-0568-0493 American Association for Respiratory 12/22/2010 Posted

Care (AARC) - Comment

FDA-2010-N-0568-0494 American Academy of Family 12/22/2010 Posted

Physicians - Comment

FDA-2010-N-0568-0495 Zach Lomba Monsto - Comment 12/22/2010 Posted

FDA-2010-N-0568-0496 John E. Kroneck - Comment 12/22/2010 Posted

FDA-2010-N-0568-0497 Judith M. Metzger - Comment 12/25/2010 Posted

FDA-2010-N-0568-0498 Liatte Krueger - Comment 12/28/2010 Posted

FDA-2010-N-0568-0499 Jochim Hansen - Comment 12/29/2010 Posted

FDA-2010-N-0568-0500 Anonymous - Comment 12/29/2010 Posted

FDA-2010-N-0568-0501 Dan Werle - Comment 12/30/2010 Posted

Page 34 of 39

Case 1:11-cv-01482-RJL Document 35-1 Filed 10/21/11 Page 57 of 61

Document ID Title Date

Received Phase

FDA-2010-N-0568-0502 Christopher Gibbons - Comment 12/30/2010 Posted

FDA-2010-N-0568-0503 Margie R. Arnett - Comment 1/3/2011 Posted

FDA-2010-N-0568-0504 Penny Denise Green - Comment 12/23/2010 Posted

FDA-2010-N-0568-0505 Timothy Michael Lape - Comment 1/4/2011 Posted

FDA-2010-N-0568-0506 Linn Allen Morrill - Comment 1/4/2011 Posted

FDA-2010-N-0568-0507 Robert Andersn - Comment 1/4/2011 Posted

FDA-2010-N-0568-0508 Jeremy Kees et al - Comment 1/4/2011 Posted

FDA-2010-N-0568-0509 Lynn Rose Antil - Comment 1/4/2011 Posted

FDA-2010-N-0568-0510 Vivian Lasley-Bibbs - Comment 1/4/2011 Posted

FDA-2010-N-0568-0511 Lisa Miller - Comment 1/4/2011 Posted

FDA-2010-N-0568-0512 Jane L. Jones - Comment 1/4/2011 Posted

FDA-2010-N-0568-0513 Donald J. Breece - Comment 1/4/2011 Posted

FDA-2010-N-0568-0514 Robin M. Scott - Comment 1/4/2011 Posted

FDA-2010-N-0568-0515 Stephanie M. Steinberg - Comment 1/4/2011 Posted

FDA-2010-N-0568-0516 Marsha Lynn Laflamme - Comment 1/4/2011 Posted

FDA-2010-N-0568-0517 Anonymous - Comment 1/4/2011 Posted

FDA-2010-N-0568-0518 Tracy R. Spencer - Comment 1/4/2011 Posted

FDA-2010-N-0568-0519 Edgar Lopez - Comment 1/4/2011 Posted

FDA-2010-N-0568-0520 Marvin L. Vinson - Comment 1/4/2011 Posted

FDA-2010-N-0568-0521 Robert William Ling - Comment 1/4/2011 Posted

FDA-2010-N-0568-0522 Jerry Zee - Comment 1/5/2011 Posted

FDA-2010-N-0568-0523 Jean Kelahan - Comment 1/5/2011 Posted

FDA-2010-N-0568-0524 Diana Meyers - Comment 1/5/2011 Posted

FDA-2010-N-0568-0525 Tobacco Prevention and Cessation 1/5/2011 Posted

Program, Arkansas Department of

Health - Comment

FDA-2010-N-0568-0526 Michael Placona - Comment 1/5/2011 Posted

FDA-2010-N-0568-0527 Linda Salzman - Comment 1/5/2011 Posted

FDA-2010-N-0568-0528 Cassandra Contreras - Comment 1/5/2011 Posted

FDA-2010-N-0568-0529 James Darrel Gregory - Comment 1/5/2011 Posted

FDA-2010-N-0568-0530 Veronica Merrell - Comment 1/5/2011 Posted

FDA-2010-N-0568-0531 catherine A mcdonald - Comment 1/5/2011 Posted

FDA-2010-N-0568-0532 Erin Lea Fletcher - Comment 1/5/2011 Posted

FDA-2010-N-0568-0533 Johnelle Claire Lamarque - Comment 1/5/2011 Posted

FDA-2010-N-0568-0534 Gabriel Arthur Cardenas - Comment 1/5/2011 Posted

FDA-2010-N-0568-0535 Rick David Watson - Comment 1/5/2011 Posted

FDA-2010-N-0568-0536 Nancy Thomas - Comment 1/5/2011 Posted

FDA-2010-N-0568-0537 Donna Repaty, CTTS - Comment 1/5/2011 Posted

FDA-2010-N-0568-0538 Kathy Spruce Garrett - Comment 1/5/2011 Posted

FDA-2010-N-0568-0539 Christine Weiss - Comment 1/5/2011 Posted

FDA-2010-N-0568-0540 Lisa Nicole Houston - Comment 1/5/2011 Posted

FDA-2010-N-0568-0541 Sandra Schulthies - Comment 1/5/2011 Posted

FDA-2010-N-0568-0542 Kirby R. Avila - Comment 1/5/2011 Posted

FDA-2010-N-0568-0543 Karlee - Comment 1/5/2011 Posted

FDA-2010-N-0568-0544 Adam T. Bramwell - Comment 1/5/2011 Posted

FDA-2010-N-0568-0545 Bob Doyle - Comment 1/6/2011 Posted

FDA-2010-N-0568-0546 Pat Moeder - Comment 1/6/2011 Posted

FDA-2010-N-0568-0547 Anonymous - Comment 1/6/2011 Posted

Page 35 of 39

Case 1:11-cv-01482-RJL Document 35-1 Filed 10/21/11 Page 58 of 61

Document ID Title Date

Received Phase

FDA-2010-N-0568-0548 Jordan D. Mathis - Comment 1/6/2011 Posted

FDA-2010-N-0568-0549 David Joseph Neville - Comment 1/6/2011 Posted

FDA-2010-N-0568-0550 Jean Marie Calomeni - Comment 1/6/2011 Posted

FDA-2010-N-0568-0551 Melissa Kuhn - Comment 1/6/2011 Posted

FDA-2010-N-0568-0552 Partnership for Prevention -1/6/2011 Posted

Comment

FDA-2010-N-0568-0553 American Medical Association (AMA) 1/

6/2011 Posted

Comment

FDA-2010-N-0568-0554 Lisa Wright - Comment 1/6/2011 Posted

FDA-2010-N-0568-0555 Te van Phan - Comment 1/6/2011 Posted

FDA-2010-N-0568-0556 Jonathan E. Rosenberg - Comment 1/6/2011 Posted

FDA-2010-N-0568-0557 Kathy Heitkamp - Comment 1/6/2011 Posted

FDA-2010-N-0568-0558 Mary Ann Aregood - Comment 1/6/2011 Posted

FDA-2010-N-0568-0559 David G. Smart - Comment 1/6/2011 Posted

FDA-2010-N-0568-0560 Kenneth B. McCoppen - Comment 1/6/2011 Posted

FDA-2010-N-0568-0561 Paul Rene Knoll - Comment 1/6/2011 Posted

FDA-2010-N-0568-0562 Maddie Williams - Comment 1/6/2011 Posted

FDA-2010-N-0568-0563 Mary H. Korte - Comment 1/6/2011 Posted

FDA-2010-N-0568-0564 Carol Ann Reed - Comment 1/6/2011 Posted

FDA-2010-N-0568-0565 M.F. Petersen - Comment 1/6/2011 Posted

FDA-2010-N-0568-0566 Sandra S. Tucker - Comment 1/6/2011 Posted

FDA-2010-N-0568-0567 Cindy Quick - Comment 1/6/2011 Posted

FDA-2010-N-0568-0568 Emily Doutre - Comment 1/7/2011 Posted

FDA-2010-N-0568-0569 A. Bonvouloir - Comment 1/7/2011 Posted

FDA-2010-N-0568-0570 Mark S. Artis - Comment 1/7/2011 Posted

FDA-2010-N-0568-0571 Ray Cage - Comment 1/7/2011 Posted

FDA-2010-N-0568-0572 Joan Budd - Comment 1/7/2011 Posted

FDA-2010-N-0568-0573 Howard Rau Christofersen, MD -1/7/2011 Posted

Comment

FDA-2010-N-0568-0574 Katie Johnson - Comment 1/7/2011 Posted

FDA-2010-N-0568-0575 Michael Lahey - Comment 1/7/2011 Posted

FDA-2010-N-0568-0576 Erin G. Fitzgerald - Comment 1/7/2011 Posted

FDA-2010-N-0568-0577 Julia M. Penn, LCSW - Comment 1/7/2011 Posted

FDA-2010-N-0568-0578 Susan Peirce - Comment 1/7/2011 Posted

FDA-2010-N-0568-0579 RevAntoinette Wilhemina Pezet -1/7/2011 Posted

Comment

FDA-2010-N-0568-0580 Wayne J. Stroessner - Comment 1/7/2011 Posted

FDA-2010-N-0568-0581 Todd Snyder - Comment 1/7/2011 Posted

FDA-2010-N-0568-0582 Franklin Joseph Kapustka - Comment 1/7/2011 Posted

FDA-2010-N-0568-0583 Matthew Swyers - Comment 1/7/2011 Posted

FDA-2010-N-0568-0584 Jonathon J. Singleton - Comment 1/7/2011 Posted

FDA-2010-N-0568-0585 Sarah Hafer - Comment 1/7/2011 Posted

FDA-2010-N-0568-0586 Mary Krebs - Comment 1/7/2011 Posted

FDA-2010-N-0568-0587 Frederic W. Grannis - Comment 1/7/2011 Posted

FDA-2010-N-0568-0588 Marc Pilisuk - Comment 1/7/2011 Posted

FDA-2010-N-0568-0589 Commissioned Officers Assn. of the 1/7/2011 Posted

U.S. Public Health Service -

Comment

FDA-2010-N-0568-0590 Rainbow Health Initiative - Comment 1/7/2011 Posted

Page 36 of 39

Case 1:11-cv-01482-RJL Document 35-1 Filed 10/21/11 Page 59 of 61

Document ID Title Date

Received Phase

FDA-2010-N-0568-0591 Alex Lessin - Comment 1/7/2011 Posted

FDA-2010-N-0568-0592 Diego Itzjak Shmuels - Comment 1/7/2011 Posted

FDA-2010-N-0568-0593 Jill Ransom, RN - Comment 1/7/2011 Posted

FDA-2010-N-0568-0594 C. Everett Koop, et al. - Comment 1/7/2011 Posted

FDA-2010-N-0568-0595 LA Tobacco Control Program -1/7/2011 Posted

Comment

FDA-2010-N-0568-0596 LA Tobacco Control Program -1/7/2011 Posted

Comment

FDA-2010-N-0568-0597 Ann Manion Watters - Comment 1/7/2011 Posted

FDA-2010-N-0568-0598 Anonymous - Comment 1/7/2011 Posted

FDA-2010-N-0568-0599 Matt Slade - Comment 1/7/2011 Posted

FDA-2010-N-0568-0600 Pennsylvania Department of Health -1/7/2011 Posted

Comment

FDA-2010-N-0568-0601 Barbara Cohan - Comment 1/8/2011 Posted

FDA-2010-N-0568-0602 Marilyn Hawrylik - Comment 1/8/2011 Posted

FDA-2010-N-0568-0603 Rachel Manning - Comment 1/8/2011 Posted

FDA-2010-N-0568-0604 Gregory Marc Bentley - Comment 1/8/2011 Posted

FDA-2010-N-0568-0605 Stephen Lorin Hamann - Comment 1/8/2011 Posted

FDA-2010-N-0568-0606 Don Lee Lamm - Comment 1/8/2011 Posted

FDA-2010-N-0568-0607 Robert New - Comment 1/8/2011 Posted

FDA-2010-N-0568-0608 Tim Paul Strong - Comment 1/9/2011 Posted

FDA-2010-N-0568-0609 Guru Sonpavde - Comment 1/9/2011 Posted

FDA-2010-N-0568-0610 Michael A. O’Donnell - Comment 1/9/2011 Posted

FDA-2010-N-0568-0611 Ellen Peters - Comment 1/10/2011 Posted

FDA-2010-N-0568-0612 Anonymous - Comment 1/10/2011 Posted

FDA-2010-N-0568-0613 Stanton A. Glantz - Comment 1/10/2011 Posted

FDA-2010-N-0568-0614 Helen Sharon Campbell - Comment 1/10/2011 Posted

FDA-2010-N-0568-0615 NC Division of Public Health -1/10/2011 Posted

Comment

FDA-2010-N-0568-0616 Cheryl T. Lee - Comment 1/10/2011 Posted

FDA-2010-N-0568-0617 Walter Mulican Whineright -1/10/2011 Posted

Comment

FDA-2010-N-0568-0618 Carol Sexy Murphy - Comment 1/10/2011 Posted

FDA-2010-N-0568-0619 Micheal Brian Dutra - Comment 1/10/2011 Posted

FDA-2010-N-0568-0620 Erik Lewis - Comment 1/10/2011 Posted

FDA-2010-N-0568-0621 Jeff Bertucci - Comment 1/10/2011 Posted

FDA-2010-N-0568-0622 Martha Rose Regalado - Comment 1/10/2011 Posted

FDA-2010-N-0568-0623 Lawson A. Moyer III MD - Comment 1/10/2011 Posted

FDA-2010-N-0568-0624 Tyler Lee Long - Comment 1/10/2011 Posted

FDA-2010-N-0568-0625 Heather - Comment 1/10/2011 Posted

FDA-2010-N-0568-0626 Free & Clear - Comment 1/10/2011 Posted

FDA-2010-N-0568-0627 Public Health - Seattle & King County 1/10/2011 Posted

- Comment

FDA-2010-N-0568-0628 American College of Physicians 1/10/2011 Posted

(ACP) - Comment

FDA-2010-N-0568-0629 Anonymous - Comment 1/10/2011 Posted

FDA-2010-N-0568-0630 Marion R. Gaffney - Comment 1/10/2011 Posted

FDA-2010-N-0568-0631 University of South Carolina -1/11/2011 Posted

Comment

Page 37 of 39

Case 1:11-cv-01482-RJL Document 35-1 Filed 10/21/11 Page 60 of 61

Document ID Title Date

Received Phase

FDA-2010-N-0568-0632 Christopher Keith Haddock -1/11/2011 Posted

Comment

FDA-2010-N-0568-0633 World Lung Foundation - Comment 1/11/2011 Posted

FDA-2010-N-0568-0634 National Association of County and 1/11/2011 Posted

City Health Officials (NACCHO) -

Comment

FDA-2010-N-0568-0635 Corporate Accountability International 1/11/2011 Posted

- Comment

FDA-2010-N-0568-0636 Altria Client Services - Comment 1/11/2011 Posted

FDA-2010-N-0568-0637 Lorillard Tobacco Company -1/11/2011 Posted

Comment

FDA-2010-N-0568-0638 Annenberg Public Policy Center, 1/11/2011 Posted

University of Pennsylvania -

Comment

FDA-2010-N-0568-0639 Roswell Park Cancer Institute -1/11/2011 Posted

Comment

FDA-2010-N-0568-0640 Chris R. Doster - Comment 1/11/2011 Posted

FDA-2010-N-0568-0641 Marra Williams - Comment 1/11/2011 Posted

FDA-2010-N-0568-0642 Laura Elizabeth Crook - Comment 1/11/2011 Posted

FDA-2010-N-0568-0643 NYC Department of Health and 1/11/2011 Posted

Mental Hygiene - Comment

FDA-2010-N-0568-0644 GlaxoSmithKline Consumer 1/11/2011 Posted

Healthcare - Comment

FDA-2010-N-0568-0645 Anonymous - Comment 1/11/2011 Posted

FDA-2010-N-0568-0646 Elizabeth Manteuffel - Comment 1/11/2011 Posted

FDA-2010-N-0568-0647 Dosal Tobacco Corp. - Comment 1/11/2011 Posted

FDA-2010-N-0568-0648 American College of Cardiology -1/11/2011 Posted

Comment

FDA-2010-N-0568-0649 WomenHeart - Comment 1/11/2011 Posted

FDA-2010-N-0568-0650 Gloria Beth Soliz - Comment 1/11/2011 Posted

FDA-2010-N-0568-0651 COPD Foundation - Comment 1/11/2011 Posted

FDA-2010-N-0568-0652 Shelbey Miller - Comment 1/11/2011 Posted

FDA-2010-N-0568-0653 Bay County Health Dept. Tobacco 1/11/2011 Posted

Prevention Program - Comment

FDA-2010-N-0568-0654 Japan Tobacco International U.S.A. -1/11/2011 Posted

Comment

FDA-2010-N-0568-0655 WomenHeart - Comment 1/11/2011 Posted

FDA-2010-N-0568-0656 WomenHeart - Comment 1/11/2011 Posted

FDA-2010-N-0568-0657 WomenHeart - Comment 1/11/2011 Posted

FDA-2010-N-0568-0658 R.J. Reynolds Tobacco Company, 1/11/2011 Posted

Lorillard Tobacco Company, and

Commonwealth Brands, Inc. -

Comment

FDA-2010-N-0568-0659 American Cancer Society Cancer 1/11/2011 Posted

Action Network, the American Heart

Association, Campaign for Tobacco-

Free Kids, American Lung

Association, & the American

Academy of Pediatrics - Comment

Page 38 of 39

Case 1:11-cv-01482-RJL Document 35-1 Filed 10/21/11 Page 61 of 61

Document ID Title Date

Received Phase

FDA-2010-N-0568-0660 Goodhue County Health and Human 1/11/2011 Posted

Services - Comment

FDA-2010-N-0568-0661 Lisa Marie Wind - Comment 1/11/2011 Posted

FDA-2010-N-0568-0662 Dalys Wright - Comment 1/11/2011 Posted

FDA-2010-N-0568-0663 Gwendolyn Stewart - Comment 1/11/2011 Posted

FDA-2010-N-0568-0664 North American Quitline Consortium -1/11/2011 Posted

Comment

FDA-2010-N-0568-0665 National Association of Tobacco 1/11/2011 Posted

Outlets, Inc. (NATO) - Comment

FDA-2010-N-0568-0666 TobaccoHarmReduction.org -1/11/2011 Posted

Comment

FDA-2010-N-0568-0667 Tobacco Control Legal Consortium -1/11/2011 Posted

Comment

FDA-2010-N-0568-0668 J. Naumiec - Comment 1/11/2011 Posted

FDA-2010-N-0568-0669 Altria Client Services, on behalf of 1/11/2011 Posted

Philip Morris USA - Comment

FDA-2010-N-0568-0670 Centro Campesino - Comment 1/11/2011 Posted

FDA-2010-N-0568-0671 Narayanan Iyer - Comment 1/11/2011 Posted

FDA-2010-N-0568-0672 Virginia Foundation for Healthy Youth 1/11/2011 Posted

(Y Street) - Comment

FDA-2010-N-0568-0673 Jessica Apodaca - Comment 1/11/2011 Posted

FDA-2010-N-0568-0674 Sandra L. Johnson - Comment 1/11/2011 Posted

FDA-2010-N-0568-0675 Kristina Ann Clark - Comment 1/11/2011 Posted

FDA-2010-N-0568-0676 University of California at Merced -1/11/2011 Posted

Comment

FDA-2010-N-0568-0677 Denise Ayana Stiassny - Comment 1/11/2011 Posted

FDA-2010-N-0568-0678 Robert Wood Johnson Foundation -1/11/2011 Posted

Comment

FDA-2010-N-0568-0679 California Smokers’ 1/11/2011 Posted

Helpline/University of California San

Diego - Comment

FDA-2010-N-0568-0680 American Association for Cancer 1/11/2011 Posted

Research - Comment

FDA-2010-N-0568-0681 University of Waterloo & International 1/11/2011 Posted

Tobacco Control Policy Evaluation

Project - Comment

FDA-2010-N-0568-0682 American Association for Cancer 1/11/2011 Posted

Research - Comment

FDA-2010-N-0568-0683 Council of Independent Tobacco 1/11/2011 Posted

Manufacturers of America (CITMA) -

Comment

FDA-2010-N-0568-0684 University of Waterloo - Comment 1/11/2011 Posted

FDA-2010-N-0568-0685 University of Waterloo - Comment 1/11/2011 Posted

FDA-2010-N-0568-0686 Frank Joseph Chaloupka - Comment 1/11/2011 Posted

FDA-2010-N-0568-0687 Food Marketing Institute (FMI) -1/11/2011 Posted

Comment

FDA-2010-N-0568-0747 Benjamin Toll - Comment 12/21/2010 Posted

Page 39 of 39

Case 1:11-cv-01482-RJL Document 35-2 Filed 10/21/11 Page 1 of 1

UNITED STATES DISTRICT COURT FOR THE DISTRICT OF COLUMBIA

R.J. REYNOLDS TOBACCO

COMPANY, et al.,

Plaintiffs,

v.

UNITED STATES FOOD AND

DRUG ADMINISTRATION, et al.,

Defendants.

No. 1:11-cv-1482 (RJL)

ORDER

The Court having considered plaintiffs’ motion for summary judgment, defendants’ motion for summary judgment, both parties’ memoranda of law, and the record herein, it is hereby

ORDERED that plaintiffs’ motion is DENIED and defendants’ motion is GRANTED.

JUDGMENT is hereby granted in defendants’ favor, and plaintiffs shall take nothing.

Dated: _______________________ ________________________

RICHARD J. LEON

United States District Judge

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