,The U.S. Food and Drug Administration (FDA) issued a draft guidance document to assist industry stakeholders in preparing Premarket Tobacco Product Applications (PMTAs) for Electronic Nicotine Delivery Systems (ENDS) under Section 910 of the Federal Food, Drug, and Cosmetic Act. The guidance outlines the FDA’s current recommendations for submitting PMTAs to improve the efficiency and clarity of the application and review process conducted by the FDA Center for Tobacco Products. However, the document is a draft and contains non-binding recommendations intended solely for comment and consultation. The FDA is accepting public comments on the draft guidance until May 11, 2026, under docket number FDA-2026-D-1817. Stakeholders may submit comments electronically or by mail to the FDA’s Dockets Management office. While the guidance provides insight into the FDA’s current regulatory expectations for ENDS PMTAs, final regulatory decisions will continue to be based on statutory requirements and implementing regulations under the FD&C Act. The agency also noted that insights gained from the implementation of this guidance and future PMTA reviews may inform additional rulemaking or guidance updates.
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