NICOPURE v. FDA: NOTICE (Joint) by SYLVIA MATHEWS BURWELL, ROBERT CALIFF, FOOD AND DRUG ADMINISTRATION, Jun 8, 2017

June 13, 2017 3:19 am by Gene Borio

The PDF is Here

EXCERPT:

The parties respectfully notify the Court that the Food and Drug Administration (“FDA”) has announced that it is deferring enforcement of all future compliance deadlines under the Deeming Rule for three months . . .

Plaintiff Nicopure Labs, LLC believes that this deferral is not a reason for the Court to withhold its decision on the pending cross-motions for summary judgment. Plaintiffs Right To Be Smoke-Free Coalition et al. do not join Nicopure in this last point. Defendants take no position on this point.

END EXCERPT

FULL TEXT:

Case 1:16-cv-00878-ABJ Document 54 Filed 06/08/17 Page 1 of 3

IN THE UNITED STATES DISTRICT COURT FOR THE DISTRICT OF COLUMBIA

NICOPURE LABS, LLC,

Plaintiff,

v.

FOOD AND DRUG ADMINISTRATION; SCOTT GOTTLIEB, M.D., in his official capacity as Commissioner of Food and Drugs; and THOMAS E. PRICE, M.D., in his official capacity as Secretary of Health and Human Services,

Defendants.

RIGHT TO BE SMOKE–FREE COALITION, et al.,

Plaintiffs,

v.

FOOD AND DRUG ADMINISTRATION; SCOTT GOTTLIEB, M.D., in his official capacity as Commissioner of Food and Drugs; and THOMAS E. PRICE, M.D., in his official capacity as Secretary of Health and Human Services,1

Defendants.

Civil Action No. 16-878 (ABJ)

Civil Action No. 16-1210 (ABJ)

JOINT NOTICE

The parties respectfully notify the Court that the Food and Drug Administration (“FDA”) has announced that it is deferring enforcement of all future compliance deadlines under the

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1 Pursuant to Fed. R. Civ. P. 25(d), Dr. Scott Gottlieb and Dr. Thomas Price are substituted for their predecessors in office.

Case 1:16-cv-00878-ABJ Document 54 Filed 06/08/17 Page 2 of 3

Deeming Rule for three months, and has issued guidance to that effect. See www.fda.gov/ downloads/tobaccoproducts/labeling/rulesregulationsguidance/ucm557716.pdf.

As described in the guidance, this deferral affects a subset of compliance deadlines under the Deeming Rule, including those for the submission of manufacturer registrations; product listings; ingredient listings; substantial equivalence (“SE”) reports, SE exemption requests, and premarket tobacco product applications (“PMTAs”) for products on the market as of August 8, 2016; and modified risk tobacco product (“MRTP”) applications for products with the descriptors “light,” “mild,” or “low” or similar descriptors, among other deadlines. Defendants represent that the deferral is intended to give new leadership personnel at the Department of Health and Human Services and the FDA an opportunity to more fully consider the issues raised by the deeming rule, given the pendency of other challenges where briefing has not yet begun or is in its early stages.2

This deferral does not affect deadlines that have already passed, such as the ban on the distribution of free samples challenged in this case. See Nicopure Compl. ¶ 55; RSF Compl. ¶¶ 90–100.

Plaintiff Nicopure Labs, LLC believes that this deferral is not a reason for the Court to withhold its decision on the pending cross-motions for summary judgment. Plaintiffs Right To Be Smoke-Free Coalition et al. do not join Nicopure in this last point. Defendants take no position on this point.

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2 See Lost Art Liquids v. FDA, No. 16-3468 (C.D. Cal.); Sanchez Icaza v. FDA, No. 16-21967 (S.D. Fla.); Cyclops Vapor 2 v. FDA, No. 16-556 (M.D. Ala.); Cigar Ass’n of Am. v. FDA, No. 16-1460 (D.D.C.). In a sixth case, Defendants’ motion to dismiss for lack of jurisdiction is fully briefed. See Faircloth v. FDA, No. 16-5267 (S.D.W. Va.). Case 1:16-cv-00878-ABJ Document 54 Filed 06/08/17 Page 3 of 3

Dated: June 8, 2017

/s/ Benjamin Block

Benjamin C. Block (Bar No. 479705)

Kevin King (Bar No. 1012403)

Robert W. Jacques (Bar No. 1032591)

COVINGTON & BURLING LLP

OneCityCenter

850 Tenth Street NW

Washington, DC 20001-4956

(202) 662-6000

(202) 662-6291 (fax)

bblock@cov.com

kking@cov.com

rjacques@cov.com

Attorneys for Plaintiff Nicopure Labs, LLC

/s/ Eric Gotting

Eric P. Gotting (Bar No. 456406)

Azim Chowdhury (Bar No. 986331)

KELLER AND HECKMAN LLP

1001 G Street, N.W., Suite 500 West

Washington, D.C. 20001

(202) 434-4100

(202) 434-4646 (fax)

gotting@khlaw.com

chowdhury@khlaw.com

Attorneys for Plaintiffs Right to Be Smoke-Free Coalition et al.

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