Yes, e-cigarettes are Tobacco Products (Not Drugs/Devices)

December 9, 2010

By Ricardo Carvajal

The D.C. Circuit Court of Appeals upheld the D.C. District Court’s grant of an injunction that bars FDA's regulation of e-cigarettes as drug/device products absent claims of intended use to that effect (for our prior posting on the district court decision, see here). Finding that the breadth of FDA’s authority under the FDC Act (as opposed to the Family Smoking Prevention and Tobacco Control Act, or Tobacco Act) is governed by the Supreme Court’s decision in FDA v. Brown & Williamson, the appellate court interpreted that decision to preclude FDA from regulating all tobacco products as customarily marketed – not just those tobacco products that were the subject of federal legislation at the time Brown & Williamson was decided.

FDA argued to no avail that the appellate court’s interpretation of Brown & Williamson would hamper the agency’s efforts to address potential risks posed by e-cigarettes. The appellate court noted that "the Tobacco Act gives the FDA broad regulatory authority over tobacco products, including, for instance, authority to impose restrictions on their sale, and on the advertising and promotion of such products, to regulate the mode of manufacture of tobacco products, and to establish standards for tobacco products" (citations omitted). In summary, the court concluded:

Together, Brown & Williamson and the Tobacco Act establish that the FDA cannot regulate customarily marketed tobacco products under the FDCA’s drug/device provisions, that it can regulate tobacco products marketed for therapeutic purposes under those provisions, and that it can regulate customarily marketed tobacco products under the Tobacco Act.

FDA must now decide whether to continue its quest to regulate e-cigarettes (and possibly other less traditional products derived from tobacco) as drugs/devices, or to content itself with regulating them under the Tobacco Act.

Categories: Tobacco