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FDA warns e-cigarette distributors about poor manufacturing practices
Posted Sept. 20, 2010
The Food and Drug Administration issued warning letters to five electronic cigarette distributors Sept. 8 for violating the Federal Food, Drug, and Cosmetic Act. The violations include poor manufacturing practices and claims that the products help people quit smoking.
Under the law, a company cannot claim that its drug can treat or mitigate a disease, such as nicotine addiction, unless the product's safety and effectiveness have been proved, the FDA said. The agency said that such verification has not been made with e-cigarettes. The distributors had 15 days to respond to the FDA with steps they were taking to correct the violations.
At its Annual Meeting in June, the American Medical Association House of Delegates adopted policy recommending that e-cigarettes be classified as drug delivery devices subject to regulation by the FDA. The agency also wants the products regulated.
Note: This item originally appeared at http://www.ama-assn.org/amednews/2010/09/20/prbf0920.htm.
