FDA to regulate e-cigarettes as "tobacco products"

FDA will not appeal the recent decision by the U.S. Court of Appeals for the D.C. Circuit in Sottera, Inc. v. 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.

Read an article published by US Today about the court decision

FDA 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. FDA 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.

Read the Letter to Stakeholders: http://www.fda.gov/NewsEvents/PublicHealthFocus/ucm252360.htm
More information on e-cigarettes: http://www.fda.gov/NewsEvents/PublicHealthFocus/ucm172906.htm