The U.S. Food and Drug Administration (FDA) has taken an increasingly active role in regulating e-cigarettes, reflecting its dual mandate: reducing youth vaping and recognizing potential harm-reduction benefits for adult smokers.
Regulatory Authority and Premarket Review
Since the 2016 “deeming rule,” the FDA has classified e-cigarettes and other Electronic Nicotine Delivery Systems (ENDS) as tobacco products, bringing them under stringent regulation. Manufacturers must register, submit ingredient lists, marketing materials, and obtain premarket authorization through pathways like the Premarket Tobacco Product Application (PMTA) .
To remain on the market, products must receive marketing authorization, which hinges on a science-based evaluation of public health impact—factoring in risks and benefits to both users and non-users
Combatting Youth Vaping
The FDA has prioritized reducing youth access to e-cigarettes. Enforcement actions include warning letters, civil money penalties, and seizures in partnership with Customs and Border Protection—like the confiscation of 1.4 million unauthorized devices worth over $18 million
Additionally, social media Crystal Pro CP 10k marketing aimed at youth is closely monitored. In 2021, the FDA requested social media marketing data from major ENDS brands to assess exposure among adolescents
In 2025, the U.S. Supreme Court reaffirmed the FDA’s power to deny flavored e-cigarette products—ruling that rejecting certain youth-appealing flavors was not arbitrary or capricious .
Authorizations with Caution
While the FDA has launched tough enforcement, it has also allowed certain e-cigarette products to stay on the market when potential public health benefits are demonstrated. For example:
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In 2021, the FDA authorized R.J. Reynolds’s “Vuse” device, stating its aerosols are significantly less toxic than traditional cigarettes and could benefit adult smokers who switch
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More recently, in July 2025, the FDA authorized Juul’s tobacco- and menthol-flavored products to remain on the market, determining their potential to help adult smokers outweighs the risk to youth AP NewsThe Washington PostThe Wall Street Journal. Importantly, the FDA emphasized this is not an endorsement of safety and pledged ongoing monitoring and enforcement to minimize youth access AP News.
Strengthening Enforcement and Oversight
The FDA continues to scale up enforcement and policy transparency. In 2024 alone, it issued hundreds of warning letters and collaborated on federal injunctions against non-compliant companies. The agency is pursuing internal reforms to fast-track application reviews, improve guidance, and strengthen its Office of Science
Summary
In summary, the FDA’s stance on e-cigarettes can be described as risk-calibrated:
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The agency acknowledges that e-cigarettes may present less harm to adult smokers compared to combustible cigarettes—but only when backed by rigorous evidence and restricted to products unlikely to appeal to youth.
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It enforces strict rules to curb unauthorized sales and packaging that target children, while granting market access to select products that demonstrate net public health benefits.
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Courts have upheld the FDA’s authority to regulate flavors and deny marketing based on youth risk, reinforcing the agency’s legal foundation.
As the vaping landscape evolves, the FDA remains central to maintaining a balance between preventing new addictions in youth and offering regulated alternatives to adult smokers.