A federal appeals court ruled yesterday that the FDA can only regulate electronic cigarettes (e-cigarettes) as tobacco products and not as drug-delivery products, and therefore cannot block their import. The ruling will allow e-cigarette maker Sottera Inc. to resume importing its NJOY products.
The FDA and other public health organizations had argued e-cigarettes should be regulated as drug-delivery devices. That would require proving that they are safe and effective as a stop-smoking aid using expensive clinical trials.
A three-judge panel of the U.S. Court of Appeals in Washington backed a lower court ruling that the devices should be considered under the agency's authority over tobacco. Congress passed the Tobacco Act in 2009 to give the FDA authority to regulate tobacco products -- but not to ban them.
"The liquid nicotine in each e-cigarette is derived from natural tobacco plants." Therefore the products are a "tobacco product" as defined by the Tobacco Act.
However, one of the three judges on the panel appeared to be willing to reconsider this issue again if the FDA were to issue its own interpretation of "tobacco product" through the rule making process. Also, the FDA may appeal this ruling in the Supreme Court. In the mean time, the ruling says that the FDA can only regulate e-cigarettes as tobacco products, provided that they do not make any drug or therapeutic claims.
The case is Sotera, Inc. v. FDA, case no. 10-5032. A copy of the opinion can be downloaded here.
