FDA to Regulate e-Cigarettes As a Tobacco Product

May 5, 2011 10:27 AM

Food and Drug Administration (FDA) recently issued a statement regarding the agency’s regulation of e-cigarettes in light of a recent court decision that concluded the products may be regulated as a tobacco product. As explained in the statement, the United States Court of Appeals for the D.C. Circuit, in Sottera, Inc v Food & Drug Administration, issued a decision with regard to e-cigarettes and other products “made or derived from tobacco” and the jurisdictional line that should be drawn between “tobacco products” and “drugs,” “devices,” and combination products, as those terms are defined in the Federal Food, Drug, and Cosmetic Act. The court held that e-cigarettes and other products made or derived from tobacco can be regulated as “tobacco products” under the act and are not drugs/devices unless they are marketed for therapeutic purposes. FDA notes that under the Family Smoking Prevention and Tobacco Control Act of 2009, “tobacco products” are subject to a number of controls, including registration, product listing, ingredient listing, good manufacturing practice requirements, user fees for certain products, adulteration and misbranding provisions, and premarket review which the agency intends to enforce. The statement describes how FDA will proceed to regulate e-cigarettes under this law. FDA notes that the agency is considering whether to issue a guidance and/or a regulation on “therapeutic” claims since the court decision states that tobacco products are regulated as drugs and/or devices under the Tobacco Control Act only if “marketed for therapeutic purposes.”