FDA's Flavored e-Cigarette Approval: A Policy Reversal With Unresolved Risks

In an apparent departure from previous policy, the US Food and Drug Administration (FDA) recently authorized the marketing of four new flavored electronic nicotine-delivery systems, including mango and blueberry. In early 2020, the FDA prioritized enforcement against all unauthorized flavored cartridge-based electronic nicotine-delivery systems other than tobacco and menthol flavors in an effort to curb what the agency and the US Surgeon General had declared a youth vaping epidemic. The new approval effectively reverses that position, permitting flavors that were previously removed from the market specifically because of their appeal to young people.

The FDA's rationale for approval centers on a growing body of evidence supporting e-cigarettes as a tool for reducing combustible cigarette use among adults. A 2025 Cochrane systematic review found high-certainty evidence that electronic nicotine-delivery systems increase quit rates compared with nicotine replacement therapy. (An earlier version of this review was discussed in an FPIN Clinical Inquiry in American Family Physician.) Another meta-analysis of randomized controlled trials similarly reported that electronic nicotine-delivery systems were associated with significantly higher abstinence rates from conventional cigarettes than traditional cessation therapies (relative risk = 1.77; 95% CI, 1.29–2.44). These findings suggest that flavored products, which are preferred by most adult e-cigarette users, may play a role in facilitating the transition away from combustible tobacco. From that perspective, the FDA’s new authorization could be seen as a form of harm reduction for adult smokers.

However, the approval raises significant concerns about adolescent uptake. According to data from the 2023 National Youth Tobacco Survey, nearly 90% of adolescent ENDS users preferred flavored products. More importantly, a substantial proportion of adolescent electronic nicotine-delivery system users—more than 50%—have never smoked conventional cigarettes. In fact, a meta-analysis of longitudinal studies consistently shows an association between youth electronic nicotine-delivery system use and subsequent cigarette initiation. What was designed as a cessation tool becomes an initiation tool in the hands of young users.

The manufacturer of the recently approved electronic nicotine-delivery systems maintains that the new products have a thorough age and identity verification process to limit access to underage users. In-app periodic biometric confirmation is designed to limit product-sharing. The FDA’s challenge lies in balancing a legitimate cessation strategy for adult smokers against the well-documented risk of creating a new generation of nicotine-dependent adolescents. Whether the technological and age-verification requirements will be sufficient to prevent youth access to these newly authorized flavored products remains an open and urgent question.