Flavored Electronic Nicotine Delivery Systems (ENDS) Premarket Applications—Considerations Related to Youth Risk - Draft Guidance for Industry

The Tobacco Education and Research Oversight Committee (TEROC) expresses serious concern that flavored vape and nicotine products undermine efforts to reduce youth nicotine addiction. They urge the FDA to prioritize science over political pressure and call for a ban on the approval of flavored tobacco products to protect public health.

Researchers from the Addy Laboratory at Yale University argue that flavored and sweetened electronic nicotine delivery systems (ENDS) significantly increase nicotine palatability, reward, and preference, particularly among youth. They recommend that the FDA prohibit the expansion of marketing authorizations for flavored ENDS and ban the inclusion of added sugars and high-intensity sweeteners in all ENDS products.

The Hawaiʻi State Department of Health opposes the draft guidance because it would create a legal pathway for the sale of flavored electronic nicotine delivery systems (ENDS). The department argues that flavors lure youth into nicotine addiction and recommends a total prohibition on flavored tobacco products to protect public health.

A coalition of State Attorneys General opposes the Draft Guidance, arguing that it creates loopholes for flavored electronic nicotine delivery systems (ENDS) to enter the market. They contend that the proposed "lower risk" flavor categories are not scientifically supported and will be exploited by the industry to target youth.

The Deputy Mayor of Health and Human Services for the City of New Orleans and the CEO of the Louisiana Public Health Institute urge the FDA to maintain a total prohibition on flavored electronic nicotine delivery systems (ENDS). They argue that flavored products are highly appealing to youth, distort risk perception, and contribute to a public health crisis that requires a complete ban rather than partial restrictions.

The Coalition for a Tobacco-Free Hawai‘i, a program of the Hawai‘i Public Health Institute, argues that flavored e-cigarettes significantly attract and harm youth. They urge the FDA to finalize the draft guidance to restrict flavored e-cigarette products and refuse to grant marketing orders for additional flavors.

The Los Angeles County Department of Public Health opposes the draft guidance because it allows for select flavor exemptions in ENDS premarket applications. They urge the FDA to instead prohibit all flavor additives, including menthol and spice, to better prevent youth initiation of nicotine use.

Lane County Health & Human Services, Public Health Division, opposes the FDA's draft guidance on authorizing flavored e-cigarettes. They argue that the proposed guidelines are not strict enough, could allow manufacturers to pivot to other youth-appealing flavors, and that device access technologies may provide a pathway for market expansion rather than true protection.

Lane County Health & Human Services, Public Health Division, opposes the FDA's draft guidance on authorizing flavored e-cigarettes. They argue that the proposed guidelines are not strict enough, could allow manufacturers to pivot to other flavors appealing to youth, and that the proposed device access technologies may provide a pathway for market expansion rather than effective protection.

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.