Flavored Electronic Nicotine Delivery Systems (ENDS) Premarket Applications—Considerations Related to Youth Risk - Draft Guidance for Industry

Investigators from the Yale School of Medicine's Yale Tobacco Center of Regulatory Science argue that the FDA's draft guidance should be strengthened to address the combined impact of flavor, product design, and marketing on youth appeal.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The American Association for Cancer Research (AACR) supports the FDA's draft guidance on flavored ENDS but argues for more rigorous, science-backed standards.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.

The American Psychiatric Association (APA) supports the FDA's draft guidance, arguing that flavored electronic nicotine delivery systems (ENDS) pose a significant risk to youth and individuals with mental illness. They advocate for a rigorous premarket review process that requires manufacturers to prove that marketing these products does not harm public health.