{"abstract":"The Food and Drug Administration (FDA) is announcing the availability of a guidance entitled \"Guidance for Industry: Substantiation for Dietary Supplement Claims Made Under Section 403(r)(6) of the Federal Food, Drug, and Cosmetic Act.\" The guidance describes the amount, type, and quality of evidence that FDA recommends a manufacturer have to substantiate a claim under this section of the Federal Food, Drug, and Cosmetic Act (the act).","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/2009/01/05/E8-31249.html","cfr_references":[],"citation":"74 FR 304","comment_url":null,"comments_close_on":null,"correction_of":null,"corrections":[],"dates":"Submit written or electronic comments on agency guidances at any time.","disposition_notes":null,"docket_ids":["Docket No. FDA-2004-D-0303"],"dockets":[],"document_number":"E8-31249","effective_on":null,"end_page":305,"executive_order_notes":null,"executive_order_number":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2009/01/05/E8-31249.xml","html_url":"https://www.federalregister.gov/documents/2009/01/05/E8-31249/guidance-for-industry-substantiation-for-dietary-supplement-claims-made-under-section-403r6-of-the","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/E8-31249?publication_date=2009-01-05","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2009-01-05/E8-31249/mods.xml","not_received_for_publication":null,"page_length":2,"page_views":{"count":2253,"last_updated":"2026-06-16 20:15:03 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2009-01-05/pdf/E8-31249.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":null,"publication_date":"2009-01-05","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2009/01/05/E8-31249.txt","regulation_id_number_info":{},"regulation_id_numbers":[],"regulations_dot_gov_info":{"checked_regulationsdotgov_at":"2011-11-15T09:30:22Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":304,"subtype":null,"title":"\"Guidance for Industry: Substantiation for Dietary Supplement Claims Made Under Section 403(r)(6) of the Federal Food, Drug, and Cosmetic Act;\" Availability","toc_doc":"Substantiation for Dietary Supplement Claims Made Under Section 403(r)(6) of the Federal Food, Drug, and Cosmetic Act; Availability","toc_subject":"Guidance for Industry:","topics":[],"type":"Notice","volume":74}