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Big Time Vapes, Inc. v. Food and Drug Administration

United States District Court, S.D. Mississippi, Southern Division

December 16, 2019

BIG TIME VAPES, INC. and UNITED STATES VAPING ASSOCIATION, INC. PLAINTIFFS
v.
FOOD AND DRUG ADMINISTRATION, et al. DEFENDANTS

          MEMORANDUM OPINION AND ORDER GRANTING DEFENDANTS' MOTION TO DISMISS AND DENYING PLAINTIFFS' MOTION FOR PRELIMINARY INJUNCTION

          LOUIS GUIROLA, JR. UNITED STATES DISTRICT JUDGE

         BEFORE THE COURT are the [15] Motion for Preliminary Injunction filed by the plaintiffs Big Time Vapes, Inc., and United States Vaping Association, Inc., and [24] Motion to Dismiss filed by the defendants Food and Drug Administration, Admiral Brett P. Giroir, M.D. in his official capacity as Acting Commissioner of Food and Drug Administration, and Alex M. Azar, II, in his official capacity as Secretary of Health and Human Services. The parties have fully briefed both Motions. The plaintiffs raise a constitutional delegation challenge to part of the Family Smoking Prevention and Tobacco Control Act (“TCA”), and the defendants counter that the plaintiffs have failed to state a plausible claim for relief. After reviewing the submissions of the parties, the record in this matter, and the applicable law, the Court finds that the defendants' Motion to Dismiss should be granted, and the plaintiffs' Motion for Preliminary Injunction should be denied.

         BACKGROUND

         In 2009, Congress amended the Federal Food, Drug, and Cosmetic Act to include the TCA, which vests the FDA with regulatory authority over the design, production, marketing, and advertising of tobacco products. Congress listed the following purposes of the Act:

(1) to provide authority to the Food and Drug Administration to regulate tobacco products under the Federal Food, Drug, and Cosmetic Act . . . by recognizing it as the primary Federal regulatory authority with respect to the manufacture, marketing, and distribution of tobacco products as provided for in this division . . .;
(2) to ensure that the Food and Drug Administration has the authority to address issues of particular concern to public health officials, especially the use of tobacco by young people and dependence on tobacco;
(3) to authorize the Food and Drug Administration to set national standards controlling the manufacture of tobacco products and the identity, public disclosure, and amount of ingredients used in such products;
(4) to provide new and flexible enforcement authority to ensure that there is effective oversight of the tobacco industry's efforts to develop, introduce, and promote less harmful tobacco products;
(5) to vest the Food and Drug Administration with the authority to regulate the levels of tar, nicotine, and other harmful components of tobacco products;
(6) in order to ensure that consumers are better informed, to require tobacco product manufacturers to disclose research which has not previously been made available, as well as research generated in the future, relating to the health and dependency effects or safety of tobacco products;
(7) to continue to permit the sale of tobacco products to adults in conjunction with measures to ensure that they are not sold or accessible to underage purchasers;
(8) to impose appropriate regulatory controls on the tobacco industry;
(9) to promote cessation to reduce disease risk and the social costs associated with tobacco-related diseases; and (10) to strengthen legislation against illicit trade in tobacco products.

Pub. L. No. 111-31, 123 Stat. 1778 (2009). Congress clarified, however, that the TCA is not intended to affect the growing, cultivation, ...


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