The FDA now is developing a strategy to regulate electronic cigarettes as tobacco products.
On Monday, April 25, 2011, the FDA announced in a letter to stakeholders that is not appealing the recent decision by the U.S. Court of Appeals for the D.C. Circuit in Sottera Inc. vs. Food & Drug Administration, stating that e-cigarettes and other products are not drugs/devices unless they are marketed for therapeutic purposes, but that products “made or derived from tobacco” can be regulated as “tobacco products” under the FD&C Act.
The FDA noted it is aware that certain products made or derived from tobacco, such as electronic cigarettes, are not currently subject to pre-market review requirements of the Family Smoking Prevention and Tobacco Control Act. The FDA reported it is developing a strategy to regulate this emerging class of products as tobacco products under the Family Smoking Prevention and Tobacco Control Act. Products that are marketed for therapeutic purposes will continue to be regulated as drugs and/or devices.
To view the letter: