{"abstract":"The Food and Drug Administration (FDA) is announcing that we have concluded that certain statements set forth in the FDA-approved labels of over-the-counter nicotine replacement therapy products, related to concomitant use with other nicotine-containing products and duration of use, can be modified. In light of currently available evidence, these statements are no longer believed to be necessary in their current form to ensure the safe and effective use of over-the- counter nicotine replacement therapy products for their approved intended use as aids to smoking cessation. We encourage the submission of supplemental new drug applications (labeling supplements) to modify these statements as described in this notice.","action":"Notice.","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/2013/04/02/2013-07528.html","cfr_references":[],"citation":"78 FR 19718","comment_url":null,"comments_close_on":null,"correction_of":null,"corrections":[],"dates":null,"disposition_notes":null,"docket_ids":["Docket No. FDA-2013-N-0341"],"dockets":[],"document_number":"2013-07528","effective_on":null,"end_page":19721,"executive_order_notes":null,"executive_order_number":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2013/04/02/2013-07528.xml","html_url":"https://www.federalregister.gov/documents/2013/04/02/2013-07528/modifications-to-labeling-of-nicotine-replacement-therapy-products-for-over-the-counter-human-use","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2013-07528?publication_date=2013-04-02","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2013-04-02/2013-07528/mods.xml","not_received_for_publication":null,"page_length":4,"page_views":{"count":7515,"last_updated":"2026-07-26 20:15:03 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2013-04-02/pdf/2013-07528.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2013-07528.pdf?1364820854","publication_date":"2013-04-02","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2013/04/02/2013-07528.txt","regulation_id_number_info":{},"regulation_id_numbers":[],"regulations_dot_gov_info":{"supporting_documents":[],"comments_url":"https://www.regulations.gov/docketBrowser?rpp=50&so=DESC&sb=postedDate&po=0&dct=PS&D=FDA-2013-N-0341","supporting_documents_count":0,"docket_id":"FDA-2013-N-0341","regulation_id_number":null,"title":"Modifications to Labeling of Nicotine Replacement Therapy Products for Over-the-Counter Human Use","checked_regulationsdotgov_at":"2013-04-22T06:00:13Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":19718,"subtype":null,"title":"Modifications To Labeling of Nicotine Replacement Therapy Products for Over-the-Counter Human Use","toc_doc":"Nicotine Replacement Therapy Products for Over-the-Counter Human Use","toc_subject":"Modifications to Labeling:","topics":[],"type":"Notice","volume":78}