{"abstract":"The Food and Drug Administration (FDA) is proposing to establish the procedure by which a manufacturer or distributor of dietary supplements, or of a new dietary ingredient, is to submit, under the Federal Food, Drug, and Cosmetic Act (the act), the information on which it has concluded that a dietary supplement containing a new dietary ingredient will reasonably be expected to be safe. FDA is setting out those steps that it has tentatively concluded are necessary to ensure that notification is accomplished efficiently but with the least burden possible on the industry. FDA is issuing this proposal in response to the Dietary Supplement Health and Education Act of 1994 (the DSHEA).","action":"Proposed rule.","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"}],"body_html_url":"https://www.federalregister.gov/documents/full_text/html/1996/09/27/96-24752.html","cfr_references":[{"chapter":null,"citation_url":null,"part":190,"title":21}],"citation":"61 FR 50774","comment_url":null,"comments_close_on":"1996-12-26","correction_of":null,"corrections":[],"dates":"Written comments by December 26, 1996.","disposition_notes":null,"docket_ids":["Docket No. 96N-0232"],"dockets":[],"document_number":"96-24752","effective_on":null,"end_page":50778,"executive_order_notes":null,"executive_order_number":null,"explanation":null,"full_text_xml_url":null,"html_url":"https://www.federalregister.gov/documents/1996/09/27/96-24752/premarket-notification-for-a-new-dietary-ingredient","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/96-24752?publication_date=1996-09-27","mods_url":"https://www.govinfo.gov/metadata/granule/FR-1996-09-27/96-24752/mods.xml","not_received_for_publication":null,"page_length":5,"page_views":{"count":25,"last_updated":"2026-04-04 10:15:04 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-1996-09-27/pdf/96-24752.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":null,"publication_date":"1996-09-27","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/1996/09/27/96-24752.txt","regulation_id_number_info":{},"regulation_id_numbers":[],"regulations_dot_gov_info":{"checked_regulationsdotgov_at":"2011-09-21T09:29:52Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":50774,"subtype":null,"title":"Premarket Notification for a New Dietary Ingredient","toc_doc":null,"toc_subject":null,"topics":[],"type":"Proposed Rule","volume":61}