FDA Rules Against Appeal Bid in Electronic Cigarette Case
In the case in question, Sottera Inc. v. Food & Drug Administration, the U.S. Court of Appeals for the District of Columbia Circuit ruled 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 Federal Drug and Cosmetic Act.
In a letter to its stakeholders, the FDA said that 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. 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."
On Dec. 7, 2010, a three-judge appellate panel ruled that the FDA should regulate e-cigarettes as tobacco products unless they are marketed with specific claims that the devices help smokers quit or provide other remedies, as CSNews Online previously reported. Two weeks later, on Dec. 20, the agency filed a request for the entire panel to hear the case.