Does the FDA Regulate E-Cigarettes?

On May 5, 2016, the US Food and Drug Administration (FDA) issued its final “deeming rule,” which regulates electronic smoking devices in the same way it regulates other tobacco products. The deeming rule extends the FDA’s regulatory authority to all tobacco products, including electronic smoking devices, cigars, pipe tobacco, and hookah tobacco. These products are now 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, the FDA’s Center for Drug Evaluation and Research maintains its authority to regulate electronic smoking devices as drugs or devices if the devices are marketed for therapeutic purposes.

Many of the deeming rule’s requirements went into effect on August 8, 2016, including the prohibition on sales to minors, the prohibition on free sampling, and restrictions on tobacco product vending machines. Other requirements, such as those regarding warning labels, premarket review, tobacco product manufacturer registration, ingredient reporting, and restrictions on modified risk tobacco products, will go into effect between August 20, 2016, and May 10, 2018. For more information on these effective dates, please see the FDA document, Effective and Compliance Dates Applicable to Retailers, Manufacturers, Importers, and Distributors of Newly Deemed Tobacco Products.

Even though the FDA now regulates electronic smoking devices, local and state governments may still adopt laws regulating electronic smoking devices, including restrictions on their sale or use. If you have any questions about FDA regulation of electronic smoking devices, please submit your question to us.

For more information about legal restrictions on electronic smoking devices, please see our associated FAQs, Are There Any Restrictions on How Electronic Smoking Devices May Be Used or Sold? and FDA’s Tobacco Products Regulation: What Does the Deeming Rule Do?