Flavored Electronic Nicotine Delivery Systems (ENDS) Premarket Applications—Considerations Related to Youth Risk - Draft Guidance for Industry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

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of Nicotine (Regulate Smarter), representing U.S.-based manufacturers, distributors, and retailers, opposes the draft guidance because it maintains a flawed regulatory framework that they argue fosters a dangerous illicit market.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.

The National Association of Tobacco Outlets (NATO), a trade association representing retail tobacco stores, opposes the Draft Guidance because it fails to provide a clear path for authorizing a wide variety of flavored ENDS products.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.

IKE Tech, LLP, a technology company specializing in identity and age verification, supports the FDA's draft guidance and advocates for the use of point-of-use age-gating technology. They argue that robust technological barriers to youth access should obviate the need for complex, subjective analyses of flavor appeal, thereby facilitating the authorization of flavored ENDS for adult smokers.

The Vapor Technology Association (VTA) opposes the Draft Guidance, arguing that it fails to provide clear, actionable standards for bringing flavored ENDS products to market and instead maintains a de facto ban on most flavors. They contend that the guidance relies on outdated data regarding youth use and fails to account for the significant decline in youth vaping since 2019.

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.

The American Association for Cancer Research (AACR) supports the FDA's draft guidance on flavored ENDS but argues for more rigorous, science-backed standards. They specifically call for clearer definitions of "low" vs. "high" risk, more robust post-market surveillance for youth appeal, and stricter requirements for evaluating the carcinogenicity of flavor additives.

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.