Are E-Cigarettes Regulated by the FDA?

Updated May 2014

On April 25, 2014, the U.S. Food and Drug Administration (FDA) issued its proposed “deeming rule,” which would regulate e-cigarettes as tobacco products. If the rule is adopted as proposed, the deeming rule would extend FDA’s regulatory authority over a variety of tobacco products, including electronic cigarettes, cigars, pipe tobacco, and hookah tobacco. For example, these products would now be subject to the federal prohibition on sales to minors, the federal prohibition on free sampling, federal warning label requirements, and the requirement that tobacco manufacturers register with the FDA and seek the agency’s review of new tobacco products. However, until such time as the rule is adopted, the FDA’s Center for Tobacco Products does not have authority to regulate the sale or use of e-cigarettes as tobacco products. The FDA Center for Drug Evaluation and Research has limited authority to regulate e-cigarettes as drugs or devices, but only if they are marketed for therapeutic purposes.

The FDA’s proposed deeming rule must go through a public notice and comment process before the agency can implement the rule, and the FDA will likely make changes to the rule in response to this process. Given the large volume of comments the agency will receive, it will take at least a year, if not longer, for the FDA to implement the final rule. Thus, it is unclear when the FDA will release final regulations on e-cigarettes.

The FDA’s website on e-cigarettes is a good resource for following the agency’s next moves regarding e-cigarette regulation.

Even though the FDA has taken steps toward regulating e-cigarettes, local and state governments may still adopt laws regulating e-cigarettes, including restrictions on their sale or use. If you have any questions about the FDA’s proposed regulation of e-cigarettes, please submit your question to us.

For more information about legal limits on e-cigarettes, please see our associated FAQs “Are There Any Restrictions on How E-Cigarettes May Be Used or Sold?” and “FDA’s Proposed Tobacco Products Regulation: What Does the Deeming Rule Do?,” as well as our fact sheet “Electronic Cigarettes: How They Are – and Could Be – Regulated.”