Key Takeaways
- FDA issued the draft guidance on March 11, 2026.
- The draft is titled Flavored Electronic Nicotine Delivery Systems (ENDS) Premarket Applications – Considerations Related to Youth Risk.
- The draft says applicants must show through appropriate studies that a flavored e-cigarette provides enough added benefit for adults who smoke, compared with a tobacco-flavored e-cigarette, to be found appropriate for the protection of public health.
- Topics discussed include youth use and initiation, a graduated risk-proportionate evaluation, evidence of adult switching or significant cigarette reduction, study approaches for youth risk, and novel device access restriction technology.
- Public comments may be submitted at regulations.gov under docket number FDA-2026-D-1817 until 11:59 p.m. EDT on May 11, 2026.
2Firsts, April 8, 2026
According to FDA CTP Newsroom, the U.S. Food and Drug Administration has opened a public comment period on a draft guidance related to flavored e-cigarette application reviews.
FDA issued the draft guidance on March 11
FDA said it issued the draft guidance on March 11, 2026, setting out the agency’s current thinking on how it assesses the risk to youth and the level of added benefit to adults needed to outweigh that risk when reviewing applications for flavored e-cigarettes.
The draft guidance, titled Flavored Electronic Nicotine Delivery Systems (ENDS) Premarket Applications – Considerations Related to Youth Risk, addresses in general how much added benefit, compared with a tobacco-flavored e-cigarette, an applicant must demonstrate through appropriate studies for a flavored e-cigarette to be found appropriate for the protection of the public health.
The draft covers youth risk, adult benefit, and access restriction technology
FDA said the draft guidance discusses several areas related to these types of application reviews, including the role of flavored e-cigarettes in youth use and initiation.
The draft also discusses a graduated risk-proportionate evaluation, including the 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, and novel device access restriction technology.
Public comments are due by May 11
FDA said that if finalized, the draft guidance will represent the agency’s current thinking on the topic. The public may submit comments at regulations.gov under docket number FDA-2026-D-1817.
The agency said comments should be submitted by 11:59 p.m. EDT on May 11, 2026, to ensure that FDA considers them before it begins work on the final version of the guidance.
Image source: FDA CTP Newsroom.
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