Flavored Electronic Nicotine Delivery Systems (ENDS) Premarket Applications—Considerations Related to Youth Risk - Draft Guidance for Industry

Geek Miracle (HK) Limited opposes the Draft Guidance because it introduces a higher evidentiary burden for specific flavor categories rather than maintaining a uniform "appropriate-for-the-protection-of-public-health" (APPH) standard. The company argues that the current regulatory framework is already effective at reducing youth vaping and that flavor-specific requirements will reduce legal supply, discourage compliant submissions, and expand the illicit market.

The Coalition for Safer Alternatives, a public health advocacy organization, opposes the Draft Guidance because it creates a flavor-tiered evidentiary burden without statutory authority and sets practically unachievable study requirements. They argue that the guidance relies on outdated youth use data, ignores the benefits of flavored ENDS for adult smokers, and risks expanding the illicit market by making the legal pathway for flavored products functionally unattainable.

The New York City Department of Health and Mental Hygiene argues that the draft guidance is insufficient because it fails to address the prevalence of unauthorized flavored ENDS and does not account for how youth behavior shifts when certain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.

ITG Brands, LLC, a manufacturer and distributor of nicotine and tobacco products, opposes the Draft Guidance because it imposes "unlawful, unduly burdensome, and unsound" requirements on manufacturers. They argue that the guidance relies on categorical presumptions rather than science-based, product-specific assessments and lacks sufficient detail regarding study designs and flavor risk categorization.

Researchers from the Yale Tobacco Center of Regulatory Science support the FDA's proposal to use non-use sensory methods to assess youth appeal of flavored ENDS. They recommend strengthening the guidance with specific methodological standards for smell-based testing and incorporating complementary evidence from use-based studies and behavioral measures.

The University of Southern California Tobacco Center of Regulatory Science (USC-TCORS) argues that the draft guidance is too narrow because it fails to account for the sensory attributes (like cooling and sweetness) of flavors such as menthol, mint, and coffee, which can increase appeal to youth and non-smokers. They propose that the FDA should require the industry to provide evidence on these sensory characteristics and use standardized assessment methods in PMTAs to better evaluate public health risks.

A law firm representing an anonymous industry stakeholder supports the FDA's efforts to address youth risk in flavored ENDS products but argues that the draft guidance lacks sufficient clarity regarding evidentiary expectations. They request specific benchmarks, study designs, and quantitative criteria to help applicants understand how to demonstrate "added benefit" to adult smokers relative to youth risk.

Mitchell Berger, commenting in a personal capacity, supports the draft guidance's balanced approach to flavored ENDS but suggests several improvements. He recommends that the FDA clarify the youth risk sliding scale, consider demographic subpopulations in sensory data, and include factors like device type and adult benefits in the risk assessment.