NICOPURE v FDA: Brief of Amici Curiae Public Health Organizations, Aug 19, 2016

August 23, 2016 6:33 pm by Gene Borio

The PDF is Here

EXCERPT:

This brief is focused on a single issue that amici are particularly well-suited to address: whether the Deeming Rule advances the public health. The answer is indisputably yes.

Absent the Deeming Rule, the e-cigarette industry will continue to be the “Wild West.“ Currently, hundreds if not thousands of companies market many thousands of e-cigarette products that deliver nicotine in unregulated doses that can create and sustain addiction. These products present risks to the public health that may vary significantly in type and degree. The use of these products increased significantly between 2011 and 2014, especially among the young; because the industry is relatively new, information about the long-term effects of these products is limited. Yet, prior to the Deeming Rule, anyone could put such products on the market without meeting any regulatory requirement. In the Deeming Rule, FDA has identified numerous significant specific public health concerns about e-cigarettes and established a regulatory framework to ensure, for the first time, that these products do not expose their users to unnecessarily high levels of risk or increase the risk of youth tobacco initiation. The Deeming Rule will also enable FDA to acquire the information needed to answer the many unanswered questions about the health effects of these products and develop standards of product identity, design, manufacturing, packaging, and advertising. The stakes for the next generation are simply too high to allow the unregulated market to continue. The core of Plaintiffs‘ argument is that FDA‘s application of the Deeming Rule to e- cigarettes is arbitrary and capricious because: (1) there is evidence that exclusive e-cigarette use is less harmful to the individual than smoking cigarettes; and (2) FDA acknowledges that the long-term public health effects of e-cigarettes cannot currently be determined with certainty.

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DOCKET for NICOPURE LABS v. FDA et al, Aug 19-24, 2016

August 23, 2016 5:43 pm by Gene Borio

Date Filed # Docket Text

08/19/2016 45 AMICUS BRIEF by CAMPAIGN FOR TOBACCO-FREE KIDS, AMERICAN ACADEMY OF PEDIATRICS, AMERICAN CANCER SOCIETY CANCER ACTION NETWORK, AMERICAN HEART ASSOCIATION, AMERICAN LUNG ASSOCAITION, AMERICAN THORACIC SOCIETY, TOBACCO CONTROL LEGAL CONSORTIUM, TRUTH INITIATIVE. (Angulo, Carlos) Modified text on 8/19/2016 (td). Modified to add filers on 8/22/2016 (znmw). (Entered: 08/19/2016)

08/22/2016 MINUTE ORDER. The Clerk of Court is directed to add to the docket as additional amici the seven parties who have joined in the brief of the Campaign for Tobacco-Free Kids. See 45 Amicus Brief at iii n.1; see also Appendix A to 45 Amicus Brief. Signed by Judge Amy Berman Jackson on 8/22/2016. (lcabj3) (Entered: 08/22/2016)

08/24/2016 MINUTE ORDER. The parties shall file a joint appendix by September 16, 2016. See LCvR 7(n). SO ORDERED. Signed by Judge Amy Berman Jackson on 8/24/2016. (lcabj3) (Entered: 08/24/2016)

NICOPURE v FDA: DEFENDANTS’ CROSS-MOTION FOR SUMMARY JUDGMENT, Aug 17, 2016

August 18, 2016 3:50 pm by Gene Borio

The PDF is Here

EXCERPT:

Plaintiffs acknowledge none of these risks. Their briefs give no inkling that nicotine is highly addictive, that e-liquids often contain toxic chemicals, or that e-cigarettes can explode. Instead, Plaintiffs contend that e-cigarettes should not be regulated at all, because they are generally “safer” than conventional cigarettes—one of the deadliest products ever brought to market. But that is rather like saying that cars should not be regulated because they are safer than motorcycles. And it is no answer to the many risks of e-cigarettes that are known now, and that could be mitigated through FDA oversight.

The Court need not sift through this evidence, however, because Congress entrusted the decision whether to supervise tobacco products, including e-cigarettes, to the expert judgment of the FDA. There can be no doubt that “the FDA has authority under the Tobacco [Control] Act to regulate e-cigarettes,” as the D.C. Circuit held in Sottera, Inc. v. FDA, 627 F.3d 891, 897 (D.C. Cir. 2010), and Plaintiffs cannot escape that conclusion simply because their “open-system” e- cigarettes are refillable. It is equally clear that the FDA’s exercise of the deeming authority is committed to agency discretion, given that Congress authorized it to subject “any” tobacco product (except certain raw tobacco leaf) to the Tobacco Control Act as it “deems” fit. 21 U.S.C. § 387a(b). In any event, the FDA rationally explained why it deemed e-cigarettes subject to the Tobacco Control Act, given their many known risks, as well as why it rejected the regulatory alternatives that Plaintiffs prefer. While Plaintiffs fault the FDA for adopting a “onesize- fits-all” approach, the Tobacco Control Act makes deeming a necessary precondition to any regulation of e-cigarettes—including the age restrictions that Plaintiffs profess to support, Stamler Decl. ¶ 41—and Plaintiffs offer no statutory support for their alternative, à-la-carte approach.

There is likewise no basis to review the FDA’s cost-benefit analysis, as the Tobacco Control Act requires no such analysis, and the Executive Orders under which the agency acted expressly preclude judicial review of its conclusions. Regardless, the FDA reasonably found that the costs of the deeming rule—an estimated $2 per beneficiary per year—were justified by its benefits, including more accurate labels, effective health warnings, and improved product consistency. Similarly misplaced are Plaintiffs’ criticisms of the FDA’s regulatory flexibility analysis, as the agency fully complied with the purely procedural requirements of the Regulatory Flexibility Act.

Plaintiffs’ two First Amendment challenges—to the ban on the distribution of free samples, and to the premarket review of “modified risk” products—also lack merit. The free sample ban regulates conduct, not speech, and thus does not even implicate free speech concerns. And the premarket review of “modified risk” tobacco products is modeled after the premarket review of therapeutic drugs under the Federal Food, Drug, and Cosmetic Act (“FDCA”), which the D.C. Circuit has already upheld against First Amendment challenge. Moreover, both provisions would easily pass muster even if scrutinized as commercial speech, as they are narrowly tailored to prevent the harms that Congress foresaw.

Absent the deeming rule, the FDA cannot require e-cigarettes and e-liquids to have accurate labels. It cannot require warnings about their addictive potential. It cannot require that toxic and carcinogenic chemicals be reduced or eliminated. It cannot require that these products be made in accordance with good manufacturing practices. It cannot verify that purportedly “modified risk” products do, in fact, reduce risk. And it can do nothing to prevent risky products from falling into the hands of youth. The Court should reject Plaintiffs’ suggestion that e- cigarettes are somehow so unique among tobacco products that they should escape regulation of these known risks.

. . .

Indeed, cigarette companies have long manipulated these components or parts to affect the performance of their products. See, e.g., United States v. Philip Morris USA Inc.,

. . .

Even if the tobacco industry had no history of false and misleading statements about the relative health risk of their products, Congress’s determination that the government should ensure the accuracy and completeness of a manufacturer’s modified-risk claims through premarket FDA review when an addictive substance is at issue clearly advances the government’s substantial interest in protecting the public health. After-the-fact enforcement comes too late for the addicted consumer.

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DOCKET for NICOPURE LABS v. FDA et al, Aug 17, 2016

August 18, 2016 3:14 pm by Gene Borio

EXCERPT:

08/17/2016 43 Memorandum in opposition to re 21 MOTION for Summary Judgment , 20 MOTION for Summary Judgment filed by SYLVIA MATHEWS BURWELL, ROBERT CALIFF, FOOD AND DRUG ADMINISTRATION. (znmw) (Entered: 08/18/2016)

08/17/2016 44 MOTION for Summary Judgment by SYLVIA MATHEWS BURWELL, ROBERT CALIFF, FOOD AND DRUG ADMINISTRATION. (See Docket Entry 43 to view document). (znmw) (Entered: 08/18/2016)

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PHILIP MORRIS v FDA: MEMORANDUM OPINION, Aug 16, 2016

August 17, 2016 1:12 am by Gene Borio

The PDF is Here

EXCERPT:

Having concluded that one part of the Second SE Guidance—the labeling-change interpretation—conflicts with the TCA, but the other part—the quantity-change interpretation— does not, a question arises as to the proper remedy. “Whether an administrative agency’s order or regulation is severable, permitting a court to affirm it in part and reverse it in part, depends on the issuing agency’s intent.” North Carolina v. FERC, 730 F.2d 790, 795-96 (D.C. Cir. 1984). “Severance and affirmation of a portion of an administrative regulation is improper if there is ‘substantial doubt’ that the agency would have adopted the severed portion on its own.” Davis Cty. Solid Waste Mgmt. v. US EPA, 108 F.3d 1454, 1459 (D.C. Cir. 1997) (citations omitted). Here, the court harbors no doubt that the FDA would have adopted the product-quantity interpretation set forth in the Guidance separate and apart from the labeling-change interpretation. The court therefore vacates that portion of the Second SE Guidance relating to a labeling change, but affirms that portion relating to a product-quantity change.

V. CONCLUSION

For the reasons discussed above, Defendants’ Motion to Dismiss is denied. Defendants’ Motion for Summary Judgment and Plaintiffs’ Motion for Summary Judgment are granted in part and denied in part. This matter is remanded to the agency for further proceedings, as needed.

A separate Order accompanies this Memorandum Opinion.

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DOCKET FOR PHILIP MORRIS USA INC. et al v. FDA, Aug 16, 2016

August 17, 2016 12:55 am by Gene Borio

EXCERPT:

08/16/2016 43 MEMORANDUM OPINION re: 21 Plaintiffs’ Motion for Summary Judgment, and 29 Defendants’ Motion to Dismiss, or in the Alternative, for Summary Judgment. Signed by Judge Amit P. Mehta on 08/16/2016. (lcapm1) (Entered: 08/16/2016)

08/16/2016 44 ORDER. The court (1) denies 29 Defendants’ Motion to Dismiss, (2) grants in part and denies in part 29 Defendants’ Motion for Summary Judgment, and (3) grants in part and denies in part 21 Plaintiffs’ Motion for Summary Judgment. This matter is remanded to the United States Food and Drug Administration for further proceedings consistent with the court’s 43 Memorandum Opinion. See attached Order for further details. Signed by Judge Amit P. Mehta

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FORSYTH v MPAA: STIPULATION AND ORDER, Aug 9, 2016

August 9, 2016 5:29 pm by Gene Borio

The PDF is Here

EXCERPT:

1. Defendants’ special motion to strike Plaintiff’s action pursuant to California’s anti- SLAPP statute, in Code of Civil Procedure § 425.16, and Defendant’s motion to dismiss Plaintiff’s action pursuant to Federal Rule of Civil Procedure 12(b)(6), will be heard on October 27, 2016, at 13 1:30 p.m.;

2. Defendants’ Reply brief(s) is due on or before September 15, 2016, and shall not exceed 25 combined pages of text (exclusive of caption page and tables);

3. The case management conference currently scheduled for September 22, 2016, shall be continued to October 27, 2016, at 1:30 p.m.

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DOCKET for FORSYTH v MPAA, Aug 9, 2016

August 9, 2016 5:14 pm by Gene Borio

EXCERPT:

08/09/2016 47 STIPULATION AND ORDER Re: Defendants’ Reply in support of special motion to strike plaintiffs’ action pursuant to California’s Anti-Slapp statute and motion to dismiss, and hearing date for special motion to strike. . . .

08/09/2016 Reset Motion Hearing Re: [#31 and #33] Motion Hearing set for 10/27/2016 at 01:30 PM in Courtroom 3, 17th Floor, San Francisco

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NICOPURE v FDA: Notice of Errata by Clive Bates and Fifteen others, Aug 8, 2016

August 9, 2016 5:04 pm by Gene Borio

The PDF is Here

EXCERPT:

[Footnote 2]

The Amici are Philip Alcabes, Professor of Public Health College of Nursing and Public Health, Adelphi University, Garden City, New York; Edward Anselm MD, Assistant Professor of Medicine Icahn School of Medicine at Mount Sinai, New York. Senior Fellow, R Street Institute, Washington DC; Clive Bates (Lead author), Director Counterfactual. Former Director, ASH (UK); Ernest Drucker PhD, Research Scientist and Professor of Public Health, College of Global Public Health, New York University; Konstantinos Farsalinos, M.D. Research Scientist, Onassis Cardiac Surgery Center, Athens, University of Patras, Greece; William T. Godshall, MPH, Founder and Executive Director, Smokefree Pennsylvania; Jacques Le Houezec, Consultant in Public Health, Président SOVAPE, Paris, France; Bernd Mayer, PhD, Professor & Chair, Dept. Pharmacology, University of Graz, Austria; Jeff Nesbit, Executive Director, Climate Nexus, New York. Former Associate Commissioner, Food and Drug Administration; Joel L. Nitzkin, MD, MPH, DPA, Chief Executive Officer, JLN MD Associates, Senior Fellow for Tobacco Policy, R Street Institute, Washington, DC; Riccardo Polosa, MD, PhD, Full Professor of Internal Medicine, University of Catania; Gilbert L. Ross, MD, Diplomate, American Board of Internal Medicine Board-certified in Internal Medicine and Rheumatology. Jersey City, NJ; Sally L. Satel MD, Resident Scholar, American Enterprise Institute, Washington DC; Michael B. Siegel, MD, Professor, Community Health Sciences, Department of Community Health Sciences, Boston University School of Public Health. MA; Andrzej Sobczak PhD, Professor, Head of Department Chemical Hazards and Genetic Toxicology, Inst. Occupational Medicine and Environmental Health, Sosnowiec, Poland; David Sweanor, JD, Centre for Health Law, Policy and Ethics, University of Ottawa.

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NICOPURE v FDA: BRIEF OF AMICI CURIAE CLIVE BATES AND FIFTEEN OTHERS, Aug 8, 2016

August 9, 2016 4:33 pm by Gene Borio

The PDF is Here

EXCERPT:

A. ENDS Are An Alternative Way To Use Nicotine With A Risk To Health That Is Unlikely To Exceed Five Percent Of The Risk Of Smoking And Is Likely To Be Substantially Lower Than That Figure. If ENDS Substitute For Smoking, There Are Important Public Health Gains That Could Be Jeopardized By Poorly Designed Regulation

. . .

B. FDA Claims Five Main Benefits For The Deeming Rule, But These Are Weak Or Unsubstantiated And More Likely To Turn Out To Be Costs

. . .

C. FDA Has Failed To Consider The Likelihood That Its Own Intervention, Through The Deeming Rule, Will Have Harmful Unintended Consequences That Create Major Public Health Costs And These Have Not Been Assessed In The Cost-Benefit Or Breakeven Analysis.

. . .

Amici argue that the cost-benefit analysis for the Deeming Rule overstates benefits and ignores a major category of cost. The analysis is fundamentally flawed and not a sufficient justification for the Deeming Rule. It is the view of the Amici that applying the Deeming Rule to ENDS is likely to cause more harm to health than it prevents.

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