From Our 2014 Archives
FDA Proposes to Extend Its Tobacco Authority to Additional Tobacco Products, Including E-cigarettes
As part of its implementation of the Family Smoking Prevention and Tobacco Control Act signed by the President in 2009, the U.S. Food and Drug Administration today proposed a new rule that would extend the agency's tobacco authority to cover additional tobacco products.
Products that would be "deemed" to be subject to FDA regulation are those that meet the statutory definition of a tobacco product, including currently unregulated marketed products, such as electronic cigarettes (e-cigarettes), cigars, pipe tobacco, nicotine gels, waterpipe (or hookah) tobacco, and dissolvables not already under the FDA's authority. The FDA currently regulates cigarettes, cigarette tobacco, roll-your-own tobacco, and smokeless tobacco.
"This proposed rule is the latest step in our efforts to make the next generation tobacco-free," said HHS Secretary Kathleen Sebelius.
Consistent with currently regulated tobacco products, under the proposed rule, makers of newly deemed tobacco products would, among other requirements:
In addition, under the proposed rule, the following provisions would apply to newly "deemed" tobacco products:
"Tobacco remains the leading cause of death and disease in this country. This is an important moment for consumer protection and a significant proposal that if finalized as written would bring FDA oversight to many new tobacco products," said FDA Commissioner Margaret A. Hamburg, M.D. "Science-based product regulation is a powerful form of consumer protection that can help reduce the public health burden of tobacco use on the American public, including youth."
"Tobacco-related disease and death is one of the most critical public health challenges before the FDA," said Mitch Zeller, director of the FDA's Center for Tobacco Products. "The proposed rule would give the FDA additional tools to protect the public health in today's rapidly evolving tobacco marketplace, including the review of new tobacco products and their health-related claims."
The FDA proposes different compliance dates for various provisions so that all regulated entities, including small businesses, will have adequate time to comply with the requirements of the proposed rule.
Products that are marketed for therapeutic purposes will continue to be regulated as medical products under the FDA's existing drug and device authorities in the Food, Drug & Cosmetic Act.
The proposed rule will be available for public comment for 75 days. While all comments, data, research, and other information submitted to the docket will be considered, the FDA is requesting comments in certain areas, including:
SOURCE: FDA, April 24, 2014
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