Flavored Electronic Nicotine Delivery Systems (ENDS) Premarket Applications—Considerations Related to Youth Risk - Draft Guidance for Industry

The Tobacco Education and Research Oversight Committee (TEROC) expresses serious concern that flavored vape and nicotine products undermine efforts to reduce youth nicotine addiction. They urge the FDA to prioritize science over political pressure and call for a ban on the approval of flavored tobacco products to protect public health.

Researchers from the Addy Laboratory at Yale University argue that flavored and sweetened electronic nicotine delivery systems (ENDS) significantly increase nicotine palatability, reward, and preference, particularly among youth. They recommend that the FDA prohibit the expansion of marketing authorizations for flavored ENDS and ban the inclusion of added sugars and high-intensity sweeteners in all ENDS products.

Researchers from Duke University School of Medicine argue that the FDA's draft guidance is deficient because it fails to account for significant toxicological risks associated with mint- and spice-flavored ENDS. They provide evidence that these flavors contain toxic cooling agents, carcinogens, and other chemicals that pose severe health risks and may increase nicotine dependence.

The Hawaiʻi State Department of Health opposes the draft guidance because it would create a legal pathway for the sale of flavored electronic nicotine delivery systems (ENDS). The department argues that flavors lure youth into nicotine addiction and recommends a total prohibition on flavored tobacco products to protect public health.

The Parents Against Vaping Parent Advisory Board opposes the FDA's authorization of flavored electronic nicotine delivery systems (ENDS), arguing that flavors significantly increase youth appeal and nicotine addiction. They urge the FDA to reverse current authorizations, implement strict post-market surveillance, and require manufacturers to prove that these products do not pose a risk to minors.

The Non-Nicotine Promotion Organization (NNPO) expresses significant health concerns regarding the chemical additives and flavorings used in e-cigarettes, particularly their potential toxicity when heated and their risks to children. They argue that these products pose dangers such as DNA damage, microbiome disruption, and risks to pregnant women, thereby supporting stricter oversight or regulation of flavored ENDS.

The Coalition for a Tobacco-Free Hawai‘i, a program of the Hawai‘i Public Health Institute, argues that flavored e-cigarettes significantly attract and harm youth. They urge the FDA to finalize the draft guidance to restrict flavored e-cigarette products and refuse to grant marketing orders for additional flavors.

The New York City Department of Health and Mental Hygiene argues that the draft guidance is insufficient because it fails to address the prevalence of unauthorized flavored ENDS and does not account for how youth behavior shifts when certain flavors are restricted. They recommend that the FDA focus more on enforcement and adjust study benchmarks to compare proposed flavors only against those that already have marketing authorization.

Researchers from the Yale Tobacco Center of Regulatory Science argue that the FDA should adopt stricter regulations on "smart" vaping technology to prevent youth addiction and protect consumer privacy. They recommend prohibiting engagement-enhancing features like gamification and advocating for a centralized, government-managed digital age-verification system.