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Rebecca Farley

Director, Policy & Advocacy, National Council for Behavioral Health

FDA Announces Move to Regulate E-Cigarettes

April 24, 2014 | Tobacco and Smoking | Comments
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The Food and Drug Administration today proposed a broad new regulation that will extend its regulatory authority to cover e-cigarettes and other nicotine products.

Under the Tobacco Control Act, the FDA already regulates cigarettes, cigarette tobacco, roll-your-own tobacco, and smokeless tobacco. Other nicotine products, such as electronic cigarettes,  are not subject to the same restrictions. As a result, little is known about their composition and health risks, and there are few protections in place for American consumers.

The new proposed rule presents two options for extending FDA’s regulatory reach over tobacco products.

  • Option 1 would deem electronic cigarettes, cigars, hookah tobacco, pipe tobacco, dissolvables, and gels as tobacco products subject to FDA regulatory control. These products already meet the statutory definition of a tobacco product, but are not yet regulated by FDA.
  • Option 2 is the same as Option 1, with the exception that it exempts premium cigars.

When finalized, this rule would subject these tobacco products to the same federal regulations that cigarettes and smokeless tobacco are subject to; for example: minimum age restrictions for purchase; required submission of ingredient listing and reporting of harmful and potentially harmful ingredients; health warnings for product packages and advertisements, and prohibition of vending machine sales.

“These actions would improve the public health by affording FDA critical information regarding the health risks of such products, preventing new products from entering the market if they are not appropriate for the protection of public health… and reducing the use of misleading claims and descriptors about the relative risk of tobacco products, which may lead consumers to initiate tobacco product use or continue using tobacco when they would otherwise quit,” FDA wrote in the proposed rule.

E-cigarettes are growing fast in popularity among American consumers. While some health experts have lauded them as a less dangerous alternative to traditional cigarettes, others caution that there is not yet enough information on their long-term health risks. In the absence of federal regulations governing e-cigarettes, many states have already moved to restrict their sales to minors, ban them from public areas, and even tax them.

FDA is seeking public comments for the next 75 days. In particular, the agency is seeking comments on how e-cigarettes should be regulated as part of the continuum of nicotine products and any health and behavioral data about the effects of using e-cigarettes.

The full text of the regulation is available here until April 25; at that time it will be published in the Federal Register.