{"abstract":"The Food and Drug Administration (FDA, Agency, or we) is announcing the availability of a final guidance for industry entitled \"Enforcement Priorities for Certain New Tobacco Products Marketed Without Premarket Authorization.\" 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.","action":"Notice of availability.","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN SERVICES","name":"Health and Human Services Department","id":221,"url":"https://www.federalregister.gov/agencies/health-and-human-services-department","json_url":"https://www.federalregister.gov/api/v1/agencies/221","parent_id":null,"slug":"health-and-human-services-department"},{"raw_name":"Food and Drug Administration","name":"Food and Drug Administration","id":199,"url":"https://www.federalregister.gov/agencies/food-and-drug-administration","json_url":"https://www.federalregister.gov/api/v1/agencies/199","parent_id":221,"slug":"food-and-drug-administration"}],"body_html_url":"https://www.federalregister.gov/documents/full_text/html/2026/05/12/2026-09368.html","cfr_references":[],"citation":"91 FR 25892","comment_url":null,"comments_close_on":null,"correction_of":null,"corrections":[],"dates":"The announcement of the guidance is published in the Federal Register on May 12, 2026.","disposition_notes":null,"docket_ids":["Docket No. FDA-2026-D-5083"],"dockets":[{"supporting_documents":[{"title":"FINAL Enforcement Priorities For ENDS Guidance Withdrawal","document_id":"FDA-2026-D-5083-0003"}],"agency_name":"FDA","documents":[{"comment_count":0,"comment_start_date":"2026-05-12","updated_at":"2026-05-12T09:59:04.624-04:00","comment_url":"https://www.regulations.gov/commenton/FDA-2026-D-5083-0001","allow_late_comments":false,"id":"FDA-2026-D-5083-0001","comment_end_date":null,"regulations_dot_gov_open_for_comment":false}],"supporting_documents_count":1,"id":"FDA-2026-D-5083","title":"Enforcement Policies for Certain Electronic Nicotine Delivery Systems (ENDS) Marketed Without Premarket Authorization; Guidance for Industry; Availability"}],"document_number":"2026-09368","effective_on":null,"end_page":25894,"executive_order_notes":null,"executive_order_number":null,"explanation":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2026/05/12/2026-09368.xml","html_url":"https://www.federalregister.gov/documents/2026/05/12/2026-09368/enforcement-priorities-for-certain-new-tobacco-products-marketed-without-premarket-authorization","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2026-09368?publication_date=2026-05-12","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2026-05-12/2026-09368/mods.xml","not_received_for_publication":null,"page_length":3,"page_views":{"count":1507,"last_updated":"2026-05-19 06:15:04 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2026-05-12/pdf/2026-09368.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2026-09368.pdf?1778244323","publication_date":"2026-05-12","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2026/05/12/2026-09368.txt","regulation_id_number_info":{},"regulation_id_numbers":[],"regulations_dot_gov_info":{"supporting_documents":[],"comments_count":0,"agency_id":"FDA","comments_url":"https://www.regulations.gov/docketBrowser?rpp=50&so=DESC&sb=postedDate&po=0&dct=PS&D=FDA-2026-D-5083","supporting_documents_count":0,"docket_id":"FDA-2026-D-5083","document_id":"FDA-2026-D-5083-0001","regulation_id_number":null,"title":"Enforcement Policies for Certain Electronic Nicotine Delivery Systems (ENDS) Marketed Without Premarket Authorization; Guidance for Industry; Availability","checked_regulationsdotgov_at":"2026-05-13T11:55:04Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":25892,"subtype":null,"title":"Enforcement Priorities for Certain New Tobacco Products Marketed Without Premarket Authorization; Guidance for Industry; Availability","toc_doc":"Enforcement Priorities for Certain New Tobacco Products Marketed without Premarket Authorization","toc_subject":"Guidance","topics":[],"type":"Notice","volume":91}