FDA Issues Draft Guidance on Tobacco Harm Reduction Products

The Food and Drug Administration (FDA) announced draft guidance for premarket tobacco product applications (PMTAs) for electronic delivery systems (ENDS) that modifies the agency’s consideration of flavored products.  The March 9, 2026, proposal states that a flavored ENDS product application must show that the benefits outweigh the risks to meet the standard of “appropriate for the protection of public health.”  The amount of the benefit will vary depending on the flavor, and there are no changes in the higher burden of proof required for flavored ENDS products intended for youth than adults.

While the FDA has approved tobacco- and menthol-flavored ENDS products, the agency has never approved a flavored product.  The guidance states that the strong youth appeal of flavored products, especially candy, fruit, and other sweet flavors, means that applicants have a “heightened evidentiary burden to demonstrate that marketing such products would result in a net benefit to the population as a whole.”  While those flavors are still unlikely to be approved for anyone, the evaluation of risk, which is based on the appeal of a flavor category to youth, could lead to flavors like mint, spices, coffee, or tea meeting the “appropriate for the protection of public health” (APPH) standard for approval for adults.  While the FDA recognizes the benefits of tobacco harm reduction products, it has approved only 39 ENDS products.

The FDA is requiring PMTAs to be based on research that include studies of consumer preferences, tests of different flavors, patterns of switching and ceasing use of products, and studies that review outcomes.  The decision on each PMTA will be based on all of the evidence, not a single survey or study.

The draft guidance is another welcome decision after President Trump announced on January 21, 2025, that the FDA was withdrawing the Biden administration’s menthol cigarette ban.

While it may appear to open the door to approval of flavored ENDS products, the draft guidance still makes it difficult for them to be authorized.  The FDA will still prioritize the risk to youth while allowing manufacturers to demonstrate that flavored products meet the APPH standard for adult smokers.

The FDA’s lack of approval of flavored e-cigarettes restricts tobacco harm reduction products for Americans who are attempting to ditch their smoking habit.  By making it somewhat less burdensome to approve “adult” flavors, the FDA can expand consumer choice and make it easier for Americans to finally give up smoking.