Court Rules FDA Lacks Authority to Regulate Electronic Cigarettes as Drugs or Devices

Publish Date: 
December 9, 2010

A U.S. Court of Appeals in Washington recently ruled that the FDA can only regulate e-cigarettes as a tobacco product and not as a drug or device.  Basically, the Court ruled that as long as the e-cigarette is not promoted as a treatment for a disease or a smoking cessation device, the FDA cannot regulate these products under the federal Food, Drug and Cosmetic Act (FDCA) and cannot block the importation of these products.

The court indicated that while Congress did not grant the FDA jurisdiction to regulate tobacco products as drug-delivery devices under the FDCA, Congress could decide to make changes to the law to allow such regulation.