Flavored Electronic Nicotine Delivery Systems (ENDS) Premarket Applications—Considerations Related to Youth Risk - Draft Guidance for Industry

Researchers from Duke University School of Medicine argue that the FDA's draft guidance is deficient because it fails to account for significant toxicological risks associated with mint- and spice-flavored ENDS.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 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 Non-Nicotine Promotion Organization (NNPO) expresses significant health concerns regarding the chemical additives and flavorings used in e-cigarettes, particularly their potential toxicity when heated and their risks to children. They argue that these products pose dangers such as DNA damage, microbiome disruption, and risks to pregnant women, thereby supporting stricter oversight or regulation of flavored ENDS.

The American Association for Cancer Research (AACR) supports the FDA's draft guidance on flavored ENDS but argues for more rigorous, science-backed standards.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.

Truth Initiative, a national nonprofit public health organization, supports the FDA's draft guidance on flavored ENDS but urges the agency to strengthen it.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 California Department of Public Health urges the FDA not to allow flavored electronic nicotine delivery systems (ENDS) to receive Premarket Tobacco Application (PMTA) approval. They argue that flavors are used by the tobacco industry to target youth and that these products do not meet the standard of being appropriate for the protection of public health.

Researchers from the Yale School of Medicine argue that the FDA should prioritize evidence of complete smoking abstinence rather than mere reduction when evaluating flavored e-cigarettes. They also express concern that many non-tobacco flavors appeal to youth and may pose toxicological risks, recommending stricter scrutiny of these products.

A coalition of 73 public health, medical, civil rights, and community organizations opposes the Draft Guidance, arguing that it creates a pathway for authorizing flavored ENDS products that pose substantial risks to youth. They specifically argue that the FDA's categorization of certain flavors like menthol and mint as "lower risk" is flawed because it fails to account for shifting youth preferences, the toxicity of flavors, and the history of menthol's appeal to young people.

Hayley Sanders, a public health nurse and tobacco treatment specialist, opposes the draft guidance because she argues that flavored ENDS provide no public health benefits and instead pose significant risks to youth and adults. She contends that flavors make quitting harder, that the health risks of nicotine are often underestimated, and that the guidance could be exploited by the tobacco industry to expand its market.

The Oncology Nursing Society (ONS) supports the FDA's draft guidance and advocates for stricter regulations on flavored electronic nicotine delivery systems (ENDS) to protect youth from nicotine addiction. They argue that flavors significantly increase youth initiation and urge the FDA to require product-specific evidence that any adult benefits outweigh the risks to minors before authorizing marketing.