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ASAM and several other public health, medical, and community organizations have raised concerns that new draft guidance from the Food and Drug Administration (FDA) could lead to the authorization of more flavored products that have historically appealed to youth.  

In March, the FDA issued draft guidance titled “Flavored Electronic Nicotine Delivery Systems (ENDS) Premarket Applications – Considerations Related to Youth Risk.” The guidance is intended to inform marketing applications submitted by manufacturers of electronic nicotine delivery systems (ENDS). To receive marketing authorization, federal law requires the FDA to determine that a product is “appropriate for the protection of public health.” For flavored e-cigarettes, applicants must show robust evidence demonstrating that the product’s benefits of helping adults stop tobacco use outweigh potential risks to youth.  

The coalition’s concerns come as FDA recently authorized the marketing of four new products, including its first authorization of non-tobacco and non-menthol ENDS products. FDA cited, among other factors, device-based access restrictions intended to limit use by individuals under age 21. However, the draft guidance itself acknowledges that such restrictions may have limitations in preventing youth access and use. 

A chief concern with the new draft guidance is that it categorizes certain flavors, such as mint, as “lower risk” to youth, which may lead to improperly authorized e-cigarette products that could harm public health. Categorizing certain flavors as “lower risk” fails to recognize that youth preferences change over time, including in response to government actions.  

Read the full comment letter