Flavored Electronic Nicotine Delivery Systems (ENDS) Premarket Applications—Considerations Related to Youth Risk - Draft Guidance for Industry

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.

Investigators from the Yale School of Medicine's Yale Tobacco Center of Regulatory Science argue that the FDA's draft guidance should be strengthened to address the combined impact of flavor, product design, and marketing on youth appeal. They specifically recommend implementing standardized packaging requirements and stricter oversight of marketing practices to better protect public health.

The Deputy Mayor of Health and Human Services for the City of New Orleans and the CEO of the Louisiana Public Health Institute urge the FDA to maintain a total prohibition on flavored electronic nicotine delivery systems (ENDS). They argue that flavored products are highly appealing to youth, distort risk perception, and contribute to a public health crisis that requires a complete ban rather than partial restrictions.

The International Tobacco Control (ITC) Policy Evaluation Project at the University of Waterloo submitted research findings from Canada to support the FDA's draft guidance. They argue that a comprehensive ban on flavored e-cigarettes in Quebec resulted in only limited reductions in flavored product use and did not significantly improve smoking cessation outcomes compared to provinces without such restrictions.

The Public Health Law Center opposes the FDA's consideration of device access restrictions (DARs) as a safeguard for flavored ENDS, arguing they are an ineffective and invasive public health policy. They contend that DARs create privacy risks, burden adult users with data collection, and fail to address the underlying issues of product availability and environmental harm.

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.

The Federal Law Enforcement Officers Association (FLEOA) opposes the draft guidance, arguing that it fails to address the existing illegal market for flavored e-cigarettes dominated by Chinese manufacturers. They contend that the guidance rewards foreign rule-breakers while burdening law enforcement with the task of policing an illicit market that lacks safety standards and poses national security risks.

Michael Pesko, a professor of economics at the University of Missouri, argues that flavored ENDS sales restrictions may lead to unintended public health consequences by causing users to substitute vaping with more lethal combustible cigarettes. He urges the FDA to consider these substitution effects and suggests targeting specific device types popular with youth rather than implementing blanket flavor bans.

The CDC Foundation submitted comments providing research data from their TEEN+ Study to support the FDA's draft guidance on flavored electronic nicotine delivery systems (ENDS). They argue that flavored e-cigarettes are highly appealing to youth and young adults, contribute to nicotine dependence, and that the FDA should consider these risks when reviewing marketing applications.

Lane County Health & Human Services, Public Health Division, opposes the FDA's draft guidance on authorizing flavored e-cigarettes. They argue that the proposed guidelines are not strict enough, could allow manufacturers to pivot to other youth-appealing flavors, and that device access technologies may provide a pathway for market expansion rather than true protection.