Yesterday (March 9), the U.S. Food and Drug Administration (FDA) issued a draft guidance outlining how it will evaluate flavored electronic nicotine delivery systems (ENDS) under the Premarket Tobacco Product Application (PMTA) process. The document clarifies the agency’s current thinking on determining whether such products are “appropriate for the protection of the public health” (APPH), the legal standard under the Federal Food, Drug, and Cosmetic Act. Although non-binding, the guidance emphasizes that applicants must demonstrate a net public health benefit, meaning any potential benefits to adult smokers, such as helping them switch from or reduce combustible cigarette use, must outweigh the risks to non-users, particularly youth.
The guidance adopts a “risk-proportionate” approach based on the level of youth appeal associated with different flavors. According to the FDA, high-risk flavors such as fruit, candy, dessert, and other sweet varieties face a particularly high evidentiary burden. They must demonstrate significant added benefits for adult smokers compared with tobacco-flavored products. Lower-risk flavors, including menthol, mint, and some novel flavors such as spices, may require a smaller demonstrated adult benefit to meet the APPH standard. Applicants are encouraged to provide scientifically valid evidence, including sensory perception studies, consumer response assessments, and population-level data, to evaluate both youth appeal and potential adult benefits.
The agency also addressed mitigation strategies designed to reduce youth access, including device access restrictions such as fingerprint authentication or geofencing. While these technologies may form part of a broader youth-prevention strategy, the FDA said they are generally insufficient on their own to offset the risks associated with highly youth-appealing flavors. The guidance reinforces the agency’s product-specific, evidence-based review process, with the most scrutiny applied to flavored products that present the greatest risk of youth initiation.
