FDA proposes to extend its tobacco authority to additional tobacco products, including e-cigarettes



For Immediate Release: April 24, 2014 Media Inquiries: Jenny Haliski, 301-796-0776, jennifer.haliski@fda.hhs.gov  Consumer Inquiries: 888-INFO-FDA

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:

  • Register with the FDA and report product and ingredient listings;
  • Only market new tobacco products after FDA review;
  • Only make direct and implied claims of reduced risk if the FDA confirms that scientific evidence supports the claim and that marketing the product will benefit public health as a whole; and
  • Not distribute free samples.

In addition, under the proposed rule, the following provisions would apply to newly “deemed” tobacco products:

  • Minimum age and identification restrictions to prevent sales to underage youth;
  • Requirements to include health warnings; and
  • Prohibition of vending machine sales, unless in a facility that never admits youth.

“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:

  • The FDA recognizes that different tobacco products may have the potential for varying effects on public health and is proposing two options for the categories of cigars that would be covered by this rule. The FDA specifically seeks comment on whether all cigars should be subject to deeming, and which other provisions of the proposed rule may be appropriate or not appropriate for different kinds of cigars.
  • The FDA seeks answers to the many public health questions posed by products, such as e-cigarettes, that do not involve the burning of tobacco and inhalation of its smoke, as the agency develops an appropriate level of regulatory oversight for these products. The FDA seeks comment in this proposed rule as to how such products should be regulated.

For more information:

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.


#1 play@playacarmen on 04.24.14 at 2:17 PM

This is a schizo document — open season for 3 years or so (2 from implementation), followed by a draconian new product approval requirement nobody can meet for an e-cig. Just plain weird — years waiting for this?!?

#2 Candy Girl on 04.28.14 at 5:16 PM

The deeming regs are carefully drawn and cautiously presented, consistent with my predictions that the FDA would soft-peddle the regulatory schema the first go round in order to avoid litigation. There’s not much to litigate here as the previous commenter is correct, we could be waiting three years or more for the hammer to start to fall. But, sources tell me that litigation is being prepared – it’s a long shot, but it’s designed to get the FDA’s attention beyond the process of public comment and public hearings.

#3 play@playacarmen on 04.30.14 at 8:21 AM

No lawsuit is smarter than a bad lawsuit; getting tossed out of court will only help CTP to forget about Sottera.

#4 Candy Girl on 04.30.14 at 12:30 PM

The care and caution that was reflected in the deeming regs reflect the fact that CTP is now headed by a lawyer. Not sure that Zeller would have taken the steps that led to to Sottera decision; he certainly wouldn’t have allowed the same arguments to be made. In his telebriefing last week he asked for public comments as to whether or not concerned industry members thought that there were other ways that the CTP could interpret the FSPTCA. My FDA source suggests that his posture here was authentic- again seeking to avoid litigation early in this process. But even he is resigned to the fact that some litigation may be inevitable down the road. The CTP will not forget about Soterra- it’s defining the process and will continue to do so.

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