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Sottera, Inc. v. FDA, No. 10-5032

By FindLaw Staff on December 08, 2010 11:26 AM

Action to Enjoin FDA From Regulating Electronic Cigarettes

In Sottera, Inc. v. FDA, No. 10-5032, an action seeking to enjoin the FDA from regulating electronic cigarettes under the Federal Food, Drug, and Cosmetic Act In (FDCA), the court affirmed a preliminary injunction in favor of plaintiffs where the FDCA and the Family Smoking Prevention and Tobacco Control Act (Tobacco Act), properly read in light of the Supreme Court's decision in FDA v. Brown & Williamson, 529 U.S. 120 (2000), located the product under the Tobacco Act.


As the court wrote:  "Sottera, Inc., which does business as NJOY, is an importer and distributor of "electronic cigarettes" or "e-cigarettes," a product that enables users to inhale vaporized nicotine. The question before us is whether Congress has authorized the Food and Drug Administration ("FDA") to regulate e-cigarettes under the drug/device provisions of the Federal Food, Drug, and Cosmetic Act ("FDCA"), 21 U.S.C. § 351 et seq., or under the Family Smoking Prevention and Tobacco Control Act of 2009 (the "Tobacco Act"), Pub. L. 111-31, 123 Stat. 1776."

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