Open Public Comment Period: Draft Guidance on Applications for Flavored E-Cigarettes
On March 11, 2026, the U.S. Food and Drug Administration (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draft guidance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The public may submit comments on this draft guidance at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 PM ET on May 11, 2026. Read more
here.