Enforcement Priorities for Certain New Tobacco Products Marketed Without Premarket Authorization May 2026

GUIDANCE DOCUMENT

• Docket Number: FDA-2026-D-5083
• Issued by: Center for Tobacco Products

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The docket to submit public comments on this guidance is scheduled to open on May 12, 2026. Until then, the docket link will return an error message.

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This guidance document describes certain enforcement policies with regard to the marketing of certain electronic nicotine delivery systems and oral nicotine pouch products that do not have premarket authorization.

FDA’s guidance documents, including this guidance, do not establish legally enforceable responsibilities. Instead, guidances describe the Agency’s current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word should in Agency guidances means that something is suggested or recommended, but not required.

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Submit Comments

Submit Comments Online

You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))

If unable to submit comments online, please mail written comments to:

Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852

All written comments should be identified with this document's docket number: FDA-2026-D-5083.

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