Flavored Electronic Nicotine Delivery Systems (ENDS) Premarket Applications—Considerations Related to Youth Risk - Draft Guidance for Industry

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Researchers from Duke University School of Medicine argue that the FDA's draft guidance is deficient because it fails to account for significant toxicological risks associated with mint- and spice-flavored ENDS.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The National Association of Tobacco Outlets (NATO), a trade association representing retail tobacco stores, opposes the Draft Guidance because it fails to provide a clear path for authorizing a wide variety of flavored ENDS products. They argue that the current regulatory approach allows illicit products to flourish and that the FDA overestimates youth risk while downplaying the benefits of flavored products for adult smokers trying to quit combustible cigarettes.

The American Thoracic Society, a medical society representing healthcare professionals, supports the FDA's rigorous oversight of flavored ENDS products to prevent youth initiation. They argue that the FDA should prioritize removing illegal flavored products from the market, require robust evidence that new flavors do not pose toxicological risks or increase youth appeal, and mandate comprehensive post-market surveillance.

The National Hispanic Medical Association (NHMA) supports the FDA's graduated, risk-proportionate approach to evaluating flavored ENDS applications but urges the agency to make youth protection the primary threshold consideration. They advocate for the inclusion of health equity considerations for Latino and underserved communities, more rigorous scrutiny of industry-funded research, and the establishment of mandatory post-market surveillance and enforcement thresholds.

A coalition of State Attorneys General opposes the Draft Guidance, arguing that it creates loopholes for flavored electronic nicotine delivery systems (ENDS) to enter the market. They contend that the proposed "lower risk" flavor categories are not scientifically supported and will be exploited by the industry to target youth.

JTI LIGGETT LLC opposes the draft guidance, arguing that it fails to provide a clear, workable pathway for flavored ENDS authorizations and does not adequately account for the illicit market. The company argues that the guidance ignores the role of flavors in adult smoking cessation and lacks transparency regarding how the FDA evaluates flavor-related risks and device access restriction (DAR) technologies.

Truth Initiative, a national nonprofit public health organization, supports the FDA's draft guidance on flavored ENDS but urges the agency to strengthen it. They argue for stricter requirements regarding product-specific evidence of adult switching, toxicity assessments of flavoring chemicals, and the consideration of marketing and packaging cues in youth risk evaluations.

The commenters, representing several Minnesota-based community and youth organizations, argue that the Draft Guidance fails to sufficiently prioritize youth protection over adult harm reduction. They urge the FDA to prohibit all flavors in ENDS products except for tobacco flavor, citing data that shows flavored products are a primary driver of nicotine addiction among youth.