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.

Sottera, Inc. v. FDA, et. al., 627 F.3d 891 (D.C. Cir. 2010)

  • United States
  • Dec 7, 2010
  • U.S. Court of Appeal, District of Columbia Circuit

Parties

Plaintiff Sottera, Inc. dba NJOY

Defendant Food and Drug Administration

Legislation Cited

Related Documents

Type of Litigation

Tobacco Control Topics

Substantive Issues

Type of Tobacco Product

"Brown & Williamson therefore did not preclude the FDA from regulating only those products for which Congress had passed specific statutes. Rather, it recognized that Congress had consciously developed a statutory scheme for tobacco and health that distinguished tobacco products as customarily marketed from ones marketed for therapeutic purposes. "Thus, what Congress ratified was the FDA's plain and resolute position that the FDCA gives the agency no authority to regulate tobacco products as customarily marketed." Id. at 159, 120 S.Ct. 1291.At oral argument the FDA observed with some justice that the regulatory scheme before the Court in Brown & Williamson addressed only cigarettes and smokeless tobacco; it would have us infer that the Court used the incessantly repeated phrase "tobacco products" as a shorthand, confined to the products before the Court (supplemented by whatever additional products were reached by the six statutes). We find no evidence of any such restrictive intent; certainly the Court did not use the familiar economizing form: "cigarettes and smokeless tobacco ('tobacco products')." The Tobacco Act is wholly consistent with this reading of Brown & Williamson. Written to address the regulatory gap that the case identified, the Tobacco Act provides the FDA with regulatory authority over tobacco products without requiring therapeutic claims. Besides leaving the FDA's authority under the drug/device provisions of the FDCA undisturbed, see 21 U.S.C. § 321(rr)(2) & § 387a(c)(1), the act broadly defines tobacco products as extending to " any product made or derived from tobacco," 21 U.S.C. § 321(rr)(1) (emphasis added). To be sure, this definition could align with a variety of interpretations of Brown & Williamson 's scope (including the one FDA proffers here), but our reading is squarely within that range."