{"abstract":"The Food and Drug Administration (FDA or we) is announcing the availability of a draft guidance for industry entitled \"Policy Regarding Certain New Dietary Ingredients and Dietary Supplements Subject to the Requirement for Pre-market Notification.\" The draft guidance, when finalized, will advise the dietary supplement industry of our intent to exercise enforcement discretion, for a limited time and in limited circumstances, regarding the requirement to submit a new dietary ingredient (NDI) notification prior to marketing. The purpose of the policy is to encourage manufacturers and distributors of certain NDI-containing dietary supplements to correct any past failures to submit a required NDI notification.","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/2022/05/20/2022-10942.html","cfr_references":[{"chapter":null,"citation_url":null,"part":"190","title":21}],"citation":"87 FR 30843","comment_url":null,"comments_close_on":"2022-07-19","correction_of":null,"corrections":[],"dates":"Submit either electronic or written comments on the draft guidance by July 19, 2022 to ensure that we consider your comment on the draft guidance before we begin work on the final version of the guidance. Submit written comments (including recommendations) on the collection of information under the Paperwork Reduction Act of 1995 by July 19, 2022.","disposition_notes":null,"docket_ids":["Docket No. FDA-2022-D-0281"],"dockets":[{"supporting_documents":[],"agency_name":"FDA","documents":[{"comment_count":11,"comment_start_date":"2022-05-20","updated_at":"2023-02-28T12:14:32.578-05:00","comment_url":"https://www.regulations.gov/commenton/FDA-2022-D-0281-0001","allow_late_comments":null,"id":"FDA-2022-D-0281-0001","comment_end_date":"2022-07-20","regulations_dot_gov_open_for_comment":false}],"supporting_documents_count":0,"id":"FDA-2022-D-0281","title":"Policy Regarding Certain New Dietary Ingredients and Dietary Supplements Subject to the Requirement for Pre-market Notification; Draft Guidance for Industry; Availability; Agency Information Collection Activities; Proposed Collection; Comment Request"}],"document_number":"2022-10942","effective_on":null,"end_page":30845,"executive_order_notes":null,"executive_order_number":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2022/05/20/2022-10942.xml","html_url":"https://www.federalregister.gov/documents/2022/05/20/2022-10942/policy-regarding-certain-new-dietary-ingredients-and-dietary-supplements-subject-to-the-requirement","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2022-10942?publication_date=2022-05-20","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2022-05-20/2022-10942/mods.xml","not_received_for_publication":null,"page_length":3,"page_views":{"count":1150,"last_updated":"2026-07-27 22:15:03 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2022-05-20/pdf/2022-10942.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2022-10942.pdf?1652964341","publication_date":"2022-05-20","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2022/05/20/2022-10942.txt","regulation_id_number_info":{},"regulation_id_numbers":[],"regulations_dot_gov_info":{"supporting_documents":[],"comments_count":11,"agency_id":"FDA","comments_url":"https://www.regulations.gov/docketBrowser?rpp=50&so=DESC&sb=postedDate&po=0&dct=PS&D=FDA-2022-D-0281","supporting_documents_count":0,"docket_id":"FDA-2022-D-0281","document_id":"FDA-2022-D-0281-0001","regulation_id_number":null,"title":"Policy Regarding Certain New Dietary Ingredients and Dietary Supplements Subject to the Requirement for Pre-market Notification; Draft Guidance for Industry; Availability; Agency Information Collection Activities; Proposed Collection; Comment Request","checked_regulationsdotgov_at":"2023-02-28T17:14:31Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":30843,"subtype":null,"title":"Policy Regarding Certain New Dietary Ingredients and Dietary Supplements Subject to the Requirement for Pre-Market Notification; Draft Guidance for Industry; Availability; Agency Information Collection Activities; Proposed Collection; Comment Request","toc_doc":"Draft Guidance for Industry; Agency Information Collection Activities; etc.","toc_subject":"Policy Regarding Certain New Dietary Ingredients and Dietary Supplements Subject to the Requirement for Pre-Market Notification:\n","topics":[],"type":"Proposed Rule","volume":87}