Open Public Comment Period: Draft Guidance on Applications for Flavored E-Cigarettes
April 8, 2026
On March 11, 2026, FDA issued a draft guidance on the agency’s current thinking on assessing the risk to youth, and the added benefit to adults needed to outweigh that risk, when reviewing applications for flavored e-cigarettes.
“Flavored Electronic Nicotine Delivery Systems (ENDS) Premarket Applications – Considerations Related to Youth Risk” addresses in general how much of an added benefit – compared to a tobacco-flavored e-cigarette – an applicant must demonstrate, via appropriate studies, for a flavored e-cigarette to be found appropriate for the protection of the public health.
The draft guidance discusses several areas related to these types of application reviews, including:
- The role of flavored e-cigarettes in youth use and initiation
- A graduated risk-proportionate evaluation, including:
- Evidence needed to demonstrate sufficient benefit of flavored e-cigarettes for adults who smoke in switching behavior or significant reduction in cigarette use
- Potential study approaches to assessing the level of risk of youth initiation and use of flavored e-cigarettes
- Novel device access restriction technology
The draft guidance, if finalized, will represent the agency’s current thinking on this topic. The public may submit comments on this draft guidance at regulations.gov to docket number FDA-2026-D-1817. Comments should be submitted by 11:59 p.m. EDT on May 11, 2026, to ensure that the agency considers them before it begins work on the final version of the guidance.