FDA Will Regulate E-Cigarettes as Tobacco

By Joyce Frieden, News Editor, MedPage Today
Published: April 26, 2011

WASHINGTON — The FDA will regulate electronic cigarettes the same way it regulates other tobacco products, the agency has announced.

The government has decided not to appeal a federal appeals court decision holding that e-cigarettes and other products made or derived from tobacco can be regulated as “tobacco products” under federal law “and are not drugs or devices unless they are marketed for therapeutic purposes,” Lawrence R. Deyton, MD, the director of the agency’s Center for Tobacco Products, and Janet Woodcock, MD, director of the Center for Drug Evaluation and Research, wrote in a letter to stakeholders.

E-cigarettes are battery-powered metallic tubes that resemble traditional cigarettes and are filled with a liquid nicotine mixture derived from tobacco, as well as flavors and other chemicals. The liquid is converted into a vapor that the user inhales.

Sottera, a Scottsdale, Ariz.-based manufacturer of e-cigarettes, sued the FDA in 2009 after the agency determined that its products were “unapproved drug/device combination products” and refused to allow the company to sell them in the U.S.

Under the federal Tobacco Control Act, tobacco products are subject to certain restrictions even though they are not considered drugs or devices, Deyton and Woodcock noted in the letter, which was released Monday. For instance, manufacturers are prohibited from marketing a “tobacco product” in combination with any other article or product regulated under the Food, Drug, and Cosmetic Act, such as a drug, biologic, food, cosmetic, medical device, or a dietary supplement.

The law also subjects new tobacco products — those first marketed or modified after Feb.15, 2007 — 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” — to premarket review.

Deyton and Woodcock wrote that the FDA now intends to propose a regulation that would extend the agency’s regulation of tobacco products to include “other categories of tobacco products that meet the statutory definition of ‘tobacco product'” as defined in the Tobacco Control Act — a group that presumably would 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.

The Sottera decision also states that products made or derived from tobacco can be regulated under the Tobacco Control Act unless they are “marketed for therapeutic purposes,” in which case they are regulated as drugs and/or devices. The agency is considering whether to issue a guidance and/or a regulation on “therapeutic” claims, Deyton and Woodcock noted.


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