General Discussion
In reply to the discussion: Do smoking bans apply to e-cigarettes? [View all]pnwmom
(110,172 posts)And the answer is NONE.
http://www.fda.gov/NewsEvents/PublicHealthFocus/ucm252360.htm
Between 2008 and 2010, the FDA determined that certain electronic cigarettes (e-cigarettes) were unapproved drug/device combination products and detained and/or refused admission to those offered for import by Sottera, Inc. and other manufacturers. Sottera, Inc. challenged that determination in court.
The U.S. Court of Appeals for the D.C. Circuit, in Sottera, Inc. v. Food & Drug Administration, 627 F.3d 891 (D.C. Cir. 2010), recently issued a decision with regard to e-cigarettes and other products made or derived from tobacco and the jurisdictional line that should be drawn between tobacco products and drugs, devices, and combination products, as those terms are defined in the FD&C Act. The court held that e-cigarettes and other products made or derived from tobacco can be regulated as tobacco products under the Act and are not drugs/devices unless they are marketed for therapeutic purposes.
The government has decided not to seek further review of this decision, and FDA will comply with the jurisdictional lines established by Sottera.