NICOPURE v. FDA: NICOPURE LABS, LLC’s MOTION FOR SUMMARY JUDGMENT, July 8, 2016

July 11, 2016 5:39 pm by Gene Borio

The PDF is Here

EXCERPT:

The Court should enter summary judgment in Nicopure’s favor; declare that the Deeming Rule exceeds FDA’s statutory authority, is arbitrary, capricious, or an abuse of discretion, was promulgated with an unlawful cost-benefit analysis, and is contrary to the First Amendment; and vacate and set aside the Deeming Rule.

END EXCERPT

FULL TEXT:

Case 1:16-cv-00878-ABJ Document 20 Filed 07/08/16 Page 1 of 2

IN THE UNITED STATES DISTRICT COURT FOR THE DISTRICT OF COLUMBIA

NICOPURE LABS, LLC, et al.

Plaintiffs,

v.

FOOD AND DRUG ADMINISTRATION, et al.

Defendants.

Civ. No. 1:16-cv-0878-ABJ

NICOPURE LABS, LLC’s MOTION FOR SUMMARY JUDGMENT

Plaintiff Nicopure Labs, LLC moves for summary judgment against Defendants Food and Drug Administration; Robert Califf, M.D., Commissioner of Food and Drugs; and Sylvia Mathews Burwell, Secretary of Health and Human Services (collectively, “FDA”).

The Administrative Procedure Act requires the Court to set aside agency action that is arbitrary, capricious, or not in accordance with law. 5 U.S.C. § 706(2)(A). FDA’s rule published on May 10, 2016, deeming “vaping” products to be subject to FDA’s authority and the requirements of the Family Smoking Prevention and Tobacco Control Act, 81 Fed. Reg. 28,973, violates the APA because: (1) it exceeds FDA’s statutory authority in regulating non-nicotine-containing products such as batteries, software, tanks, and vaporizers; (2) it fails “hard look” APA scrutiny by purporting to regulate to advance a public health interest while conceding that it does not know the public health benefits of the rule, and by subjecting vaping prod

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Case 1:16-cv-00878-ABJ Document 20 Filed 07/08/16 Page 2 of 2

ucts to an insurmountable approval pathway while failing to consider reasonable alternatives; and (3) its unlawful cost-benefit analysis fails to quantify the Rule’s benefits and grossly understates its costs.

Additionally, the Rule violates the First Amendment because FDA has not met its burden in justifying the Rule’s ban of free samples of vaping products and its restrictions on making truthful, non-misleading statements about vaping products (such as that they do not contain tar, or ash, or that they are smokeless).

The Court should enter summary judgment in Nicopure’s favor; declare that the Deeming Rule exceeds FDA’s statutory authority, is arbitrary, capricious, or an abuse of discretion, was promulgated with an unlawful cost-benefit analysis, and is contrary to the First Amendment; and vacate and set aside the Deeming Rule.

In support of this Motion, Nicopure relies on the Administrative Record certified by FDA and the accompanying Memorandum of Points and Authorities and Declaration of Jeffrey Stamler. A proposed Order is attached.

Respectfully submitted,

/s/ Benjamin C. Block

(D.C. Bar No. 479705)

Kevin King

(D.C. Bar No. 1012403)

COVINGTON & BURLING LLP

One City Center

850 Tenth Street, NW

Washington, DC 20001-4956

(202) 662-5205 (Tel)

(202) 778-5205 (Fax)

bblock@cov.com

kking@cov.com

July 8, 2016 Counsel for Plaintiff Nicopure Labs, LLC

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