The FDA will regulate electronic cigarettes in the same way as other tobacco products, the agency announced this week.
E-cigarettes are rechargeable battery operated metallic tubes made to look like traditional smoking products. The e-cigarette contains a liquid cartridge with nicotine and other chemicals that, when heated, is converted to a vapor that can be inhaled.
The announcement comes following a decision from the D.C. Circuit U.S. Court of Appeals in which the court ruled that e-cigarettes should not be classified as drugs or devices unless they are marketed for therapeutic purposes.
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In 2009, Sottera, an e-cigarette manufacturer based in Scottsdale, Ariz., sued the FDA after the agency deemed its products were “unapproved drug/device combination products” and refused to allow the company to sell them in the U.S.
The FDA is currently debating whether to issue guidance and/or a regulation that explicitly defines a “therapeutic” claim, Janet Woodcock, MD, director of the FDA’s Center for Drug Evaluation and Research, and Lawrence R. Deyton, MSPH, MD, director of the Center for Tobacco Products, wrote in a letter to stakeholders.
Under the current Tobacco Control Act, e-cigarettes will be subjected to a number of controls, Woodcock and Deyton explained. For example, the act prohibits tobacco products from being marketed in combination with other products regulated by the Food Drug & Cosmetics Act, including any other drug, biologic, food, cosmetic, medical device or dietary supplement.
Other provisions of the act specify that any tobacco product and “modified risk tobacco products” — those that are “sold or distributed for use to reduce harm or the risk of tobacco-related disease associated with commercially marketed tobacco products” — first marketed or modified after February 15, 2007 must undergo premarket review.
Additionally, the FDA plans to propose a regulation that will extend the agency’s ability to control “other categories of tobacco products,” and will presumably include e-cigarettes.
“The additional tobacco product categories would be subject to general controls, such as registration, product listing, ingredient listing, good manufacturing practice requirements, user fees for certain products, and the adulteration and misbranding provisions, as well as to the premarket review requirements for new tobacco products and modified risk tobacco products,” they wrote.
