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Sunday, July 10, 2011 3:15:05 PM
Electronic Cigarettes
On Monday, April 25, 2011, FDA announced in a letter to stakeholders that it 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.
Letter to Stakeholders: Regulation of E-Cigarettes and Other Tobacco Products (April 25, 2011)
On Thursday, September 9, 2010, the FDA announced that it had taken enforcement action against five electronic cigarette companies for violations of the Federal Food, Drug, and Cosmetic Act (FDCA), including unsubstantiated claims and poor manufacturing practices.
The FDA also sent a letter to the Electronic Cigarette Association stating that the agency intends to regulate electronic cigarette and related products in a manner consistent with its mission of protecting the public health.
Peter Michaels, CEO of Hop-on, "Since the FDA is going to regulate our products like Big Business Tobacco Companies, we are a US manufacturer and at the end of the day our products will say 'Made in the USA.' This will give us a distinct competitive advantage over foreign distributors."
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