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FDA extends tobacco authority to e-cigarettes

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In 2009, the Family Smoking Prevention and Tobacco Control Act was signed into law. On April 24, as part of its implementation, the Food and Drug Administration (FDA) proposed a new rule that would extend the agency’s tobacco authority to cover additional tobacco products, including e-cigarettes. The proposed rules address the manufacture and sale of e-cigarettes; however, they do not contain recommendations regarding whether e-cigarettes should have similar or less stringent restriction as to where they can be smoked. Currently, when one “vapes” in a non-smoking area, the legality is murky.

Other products that would fall under the proposed ruling are those that meet the legal definition of a tobacco product, including currently unregulated products available in the marketplace, such as cigars, pipe tobacco, nicotine gels, water pipe (or hookah) tobacco, and dissolvables not already under the FDA’s authority. At present, the agency regulates cigarettes, cigarette tobacco, roll-your-own tobacco, and smokeless tobacco. The proposed rule will be available for public comment for 75 days.

“This proposed rule is the latest step in our efforts to make the next generation tobacco-free,” noted Health and Human Services Kathleen Sebelius. Under the proposed rules, manufacturers of e-cigarettes and other currently regulated products would be subject to similar requirements as currently regulated tobacco products, including: registration with the FDA and reporting 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 to the foregoing, the proposed rule contains the following provisions for the currently unregulated 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 minors.

FDA Commissioner Margaret A. Hamburg, M.D. explained, “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. 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.” Mitch Zeller, director of the FDA’s Center for Tobacco Products, added, “Tobacco-related disease and death is one of the most critical public health challenges before the FDA,” said. “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 has proposed different compliance dates for the various provisions of the rules so that all regulated entities, including small businesses, will have adequate time to comply with the rule’s requirements. In addition, tobacco products that are marketed for therapeutic purposes will continue to be regulated as medical products under the agency’s existing drug and device authorities in the Food, Drug &Cosmetic Act.

Take home message:

The proposed rulings are a step in the right direction for clarifying the murky legal status of e-cigarettes; however, state and local governments need to take a stand regarding their use in public areas. In my opinion, they should fall under the same provisions as regular cigarettes. The vapor from e-cigarettes contains nicotine and propylene glycol. Nicotine is a drug that constricts blood vessels; thus, it can raise blood pressure and reduce blood flow. This effect could result in cardiovascular problems such as heart attack or stroke. Studies are lacking on the health impact of inhaled propylene glycol vapor.