The US FDA has issued a letter informing stakeholders that it will not appeal a December 2010 ruling by the US Court of Appeals for the DC Circuit that the agency has no authority to regulate electronic cigarettes as drug/device combinations unless the manufacturers marketed the products for “therapeutic” use.
According to the agency, it intends to take actions necessary to regulate the products under the Family Smoking Prevention and Tobacco Control Act of 2009, which “defines the term ‘tobacco product,’ in part, as any product ‘made or derived from tobacco’ that is not a ‘drug,’ ‘device,’ or combination product under the FD&C Act.”
In September 2010, the FDA had issued a warning letter to five manufacturers of e-cigarettes asserting that it had jurisdiction and that the products were unapproved drug/device combinations. A suit by Sottera, Inc. claiming that its Njoy e-cigarettes had no therapeutic use but were for enjoyment only resulted in the circuit court ruling.
The FDA also makes it clear that it will take a close look at the definition of “therapeutic” use, writing: “The Sottera decision states that products made or derived from tobacco can be regulated under the Tobacco Control Act unless they are ‘marketed for therapeutic purposes,’ in which case they are regulated as drugs and/or devices. The Agency is considering whether to issue a guidance and/or a regulation on ‘therapeutic’ claims.’”
On its web site, the FDA asserts, “Products that are marketed for therapeutic purposes will continue to be regulated as drugs and/or devices.”
Read the FDA letter.
