Flavored Electronic Nicotine Delivery Systems (ENDS) Premarket Applications—Considerations Related to Youth Risk - Draft Guidance for Industry

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of Nicotine (Regulate Smarter), representing U.S.-based manufacturers, distributors, and retailers, opposes the draft guidance because it maintains a flawed regulatory framework that they argue fosters a dangerous illicit market.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

The Vapor Technology Association (VTA) opposes the Draft Guidance, arguing that it fails to provide clear, actionable standards for bringing flavored ENDS products to market and instead maintains a de facto ban on most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 They contend that the guidance relies on outdated data regarding youth use and fails to account for the significant decline in youth vaping since 2019.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 Main Street Foundation’s Center for Regulatory Analysis and Engagement (CRAE) supports the FDA's efforts to develop a transparent, evidence-based framework for evaluating flavored ENDS applications to reduce youth access. However, they urge the FDA to ensure the final guidance avoids creating de facto prohibitions through excessive evidentiary burdens, considers comparative-risk tradeoffs (such as adult smoking cessation), and accounts for unintended consequences like illicit-market expansion.

Altria Client Services LLC, representing NJOY, LLC, opposes the Draft Guidance because it reinforces a prohibition-oriented framework that they argue ignores the growth of an illicit market and fails to provide adult consumers with regulated smoke-free alternatives. They argue the guidance is arbitrary and capricious, lacks sufficient scientific support regarding youth risk, and fails to meet legal requirements for a tobacco product standard.

The World Vapers' Alliance, representing adult consumers who have switched from smoking to nicotine alternatives, opposes the draft guidance because it frames flavored ENDS as a youth risk rather than a tool for adult smoking cessation. They argue that the guidance uses the wrong comparator (tobacco-flavored ENDS instead of combustible cigarettes), ignores the rise of illicit markets caused by flavor restrictions, and fails to recognize the public health benefits of flavored products in helping adults quit smoking.

A vapor business owner expresses extreme frustration over flavor bans and the financial ruin they cause for small businesses. The commenter argues that the current regulations are ineffective at stopping youth usage and suggests that the government is prioritizing the interests of big tobacco companies over small business owners.