Flavored Electronic Nicotine Delivery Systems (ENDS) Premarket Applications—Considerations Related to Youth Risk - Draft Guidance for Industry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

The commenter opposes the proposed changes to vape regulations, expressing concern that fruit flavors appeal to youth and that the tobacco industry is influencing policy. They criticize the commercial sponsorship and argue that the move risks addicting young people to tobacco.

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.

Juul Labs, Inc. supports the proposed guidance but urges the FDA to adopt a framework that prioritizes the authorization of flavored ENDS to combat the illicit market. They argue that the FDA should incorporate "reach" (the proportion of smokers who adopt a product) into its public health impact analysis and streamline the PMTA review process to provide more authorized options for adult smokers.

Researchers from Duke University School of Medicine argue that the FDA's draft guidance is deficient because it fails to account for significant toxicological risks associated with mint- and spice-flavored ENDS.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The Hawaiʻi State Department of Health opposes the draft guidance because it would create a legal pathway for the sale of flavored electronic nicotine delivery systems (ENDS).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 Coalition for Smarter Regulation of Nicotine (Regulate Smarter), representing U.S.-based manufacturers, distributors, and retailers, opposes the draft guidance because it maintains a flawed regulatory framework that they argue fosters a dangerous illicit market. They urge the FDA to instead implement fundamental reforms, including the creation of clear product standards and stricter enforcement against illegal actors, to facilitate a legal marketplace for flavored e-cigarettes.

SkyX Group Inc. supports the FDA's move toward using Device Access Restriction (DAR) as a mechanism to allow flavored ENDS, but argues that the current Bluetooth-app model is flawed. They advocate for their own "Discrete Device Access Restriction" (D-DAR) technology, which uses NFC and on-device biometrics to provide more continuous, privacy-focused, and less friction-heavy age verification.