General Discussion
In reply to the discussion: Do smoking bans apply to e-cigarettes? [View all]pnwmom
(108,955 posts)None of them have submitted any safety research to the FDA.
The only reason Njoy escaped regulation is because tobacco products have a special exemption that allows them to avoid normal FDA requirements, and e-cigarettes have now been classified as tobacco products.
http://www.fda.gov/NewsEvents/PublicHealthFocus/ucm172906.htm
As the safety and efficacy of e-cigarettes have not been fully studied, consumers of e-cigarette products currently have no way of knowing:
whether e-cigarettes are safe for their intended use,
how much nicotine or other potentially harmful chemicals are being inhaled during use, or
if there are any benefits associated with using these products.
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.