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Sottera v. Food & Drug Administration

The FDA denied e-cigarette products from entry into the U.S. under the Food, Drug, and Cosmetic Act (FDCA).  Two companies, importers of e-cigarette products, challenged the FDA and won a preliminary injunction to release their products.  The companies argued that the FDA did not have authority to regulate their products under the FDCA.  In this case the appellate court agreed with the lower court, holding the FDA must regulate these products under the Family Smoking Prevention and Tobacco Control Act of 2009 (Tobacco Act) and upheld the injunction.  The concurring opinion of the appellate court highlighted the definition of “tobacco products” in the Tobacco Act to include e-cigarettes while the controlling authority, FDA v. Brown and Williamson, did not contain a similar definition.