Letter to Stakeholders: Regulation of E-Cigarettes and Other Tobacco Products
Tuesday, April 26, 2011
Posted by: Natalia Gromov
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. 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:
More information on e-cigarettes:
Source: Center for Tobacco Products/FDA