On March 9, 2026, the U.S. Food and Drug Administration (FDA) issued a draft guidance to assist companies in submitting Pre-Market Tobacco Applications (PMTAs) for electronic cigarette products. The draft guidance is titled “Flavored Electronic Nicotine Delivery Systems (ENDS) Premarket Applications: Considerations Related to Youth Risk.” A draft guidance is not legally binding and describes the FDA’s current thinking on a specific topic and should only be viewed as recommendations. The public may submit comments on the draft guidance to the FDA on or before May 8, 2026, at which time the agency will review comments and finalize the draft guidance.

The draft guidance focuses on another question that arises during the review of a PMTA for a flavored e-cigarette, namely, how much of an added benefit compared to a tobacco-flavored e-cigarette must a manufacturer demonstrate for the FDA to find that a flavored e-cigarette meets the APPH standard. The FDA’s position is that an e-cigarette, which has a fruit, candy, dessert or other sweet flavors, is a substantial public health risk to attracting youth usage and, for this reason, has a high evidentiary burden to demonstrate that the benefits to adult smokers in terms of quitting or reducing cigarette smoking outweigh the risks of youth usage.

Read the full article here.

Read the full draft guidance document, which includes instructions on where and how to submit comments, here.