{"abstract":"The Food and Drug Administration (FDA or we) is requesting comments related to the regulatory status of vinpocetine. Specifically, we request comments on our tentative conclusion that vinpocetine is not a dietary ingredient and is excluded from the definition of dietary supplement in the Federal Food, Drug, and Cosmetic Act (FD&C Act). This action is being taken as part of an administrative proceeding to determine the regulatory status of vinpocetine. All comments submitted by the comment deadline (see DATES) will be accepted as part of the official record for this proceeding.","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/2016/09/07/2016-21350.html","cfr_references":[],"citation":"81 FR 61700","comment_url":null,"comments_close_on":"2016-11-07","correction_of":null,"corrections":[],"dates":"Submit either electronic or written comments on the notice by November 7, 2016.","disposition_notes":null,"docket_ids":["Docket No. FDA-2016-N-2523"],"dockets":[{"supporting_documents":[{"title":"Reference 7 - US Patent and Trademark Office - Process of Preparation of Vincamine from Tabersonine re Request for Comment on the Status of Vinpocetine","document_id":"FDA-2016-N-2523-0007"},{"title":"Reference 6 - Y Kuge - A Facile One-Pot Synthesis of Vinpocetine - Synthetic Communications - 1994 re Request for Comment on the Status of Vinpocetine","document_id":"FDA-2016-N-2523-0006"},{"title":"Reference 5 - National Toxicology Program - Chemical Information Review Document for Vinpocetine re Request for Comment on the Status of Vinpocetine","document_id":"FDA-2016-N-2523-0005"},{"title":"Reference 3 - Manconi E - A Double-Blind Clinical Trial of Vinpocetine in the Treatment of Cerebral Insufficiency of Vascular and Degenerative Origin - Current re Request for Comment on the Status of Vinpocetine","document_id":"FDA-2016-N-2523-0004"},{"title":"Reference 2 - Maugh II - Firm Hopes to Market New 'Memory' Drug - The Los Angeles Times - April 1986 re Request for Comment on the Status of Vinpocetine","document_id":"FDA-2016-N-2523-0003"},{"title":"REFERENCE LIST re Request for Comment on the Status of Vinpocetine","document_id":"FDA-2016-N-2523-0002"}],"agency_name":"FDA","documents":[{"comment_count":835,"comment_start_date":"2016-09-07","updated_at":"2023-02-28T16:01:46.417-05:00","comment_url":"https://www.regulations.gov/commenton/FDA-2016-N-2523-0001","allow_late_comments":null,"id":"FDA-2016-N-2523-0001","comment_end_date":"2016-11-08","regulations_dot_gov_open_for_comment":false}],"supporting_documents_count":6,"id":"FDA-2016-N-2523","title":"Request for Comment on the Status of Vinpocetine"}],"document_number":"2016-21350","effective_on":null,"end_page":61703,"executive_order_notes":null,"executive_order_number":null,"explanation":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2016/09/07/2016-21350.xml","html_url":"https://www.federalregister.gov/documents/2016/09/07/2016-21350/request-for-comment-on-the-status-of-vinpocetine","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2016-21350?publication_date=2016-09-07","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2016-09-07/2016-21350/mods.xml","not_received_for_publication":null,"page_length":4,"page_views":{"count":4572,"last_updated":"2026-04-23 00:15:03 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2016-09-07/pdf/2016-21350.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2016-21350.pdf?1473165922","publication_date":"2016-09-07","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2016/09/07/2016-21350.txt","regulation_id_number_info":{},"regulation_id_numbers":[],"regulations_dot_gov_info":{"supporting_documents":[{"title":"Reference 7 - US Patent and Trademark Office - Process of Preparation of Vincamine from Tabersonine re Request for Comment on the Status of Vinpocetine","document_id":"FDA-2016-N-2523-0007"},{"title":"Reference 6 - Y Kuge - A Facile One-Pot Synthesis of Vinpocetine - Synthetic Communications - 1994 re Request for Comment on the Status of Vinpocetine","document_id":"FDA-2016-N-2523-0006"},{"title":"Reference 5 - National Toxicology Program - Chemical Information Review Document for Vinpocetine re Request for Comment on the Status of Vinpocetine","document_id":"FDA-2016-N-2523-0005"},{"title":"Reference 3 - Manconi E - A Double-Blind Clinical Trial of Vinpocetine in the Treatment of Cerebral Insufficiency of Vascular and Degenerative Origin - Current re Request for Comment on the Status of Vinpocetine","document_id":"FDA-2016-N-2523-0004"},{"title":"Reference 2 - Maugh II - Firm Hopes to Market New 'Memory' Drug - The Los Angeles Times - April 1986 re Request for Comment on the Status of Vinpocetine","document_id":"FDA-2016-N-2523-0003"},{"title":"REFERENCE LIST re Request for Comment on the Status of Vinpocetine","document_id":"FDA-2016-N-2523-0002"}],"comments_count":835,"agency_id":"FDA","comments_url":"https://www.regulations.gov/docketBrowser?rpp=50&so=DESC&sb=postedDate&po=0&dct=PS&D=FDA-2016-N-2523","supporting_documents_count":6,"docket_id":"FDA-2016-N-2523","document_id":"FDA-2016-N-2523-0001","regulation_id_number":null,"title":"Request for Comment on the Status of Vinpocetine","checked_regulationsdotgov_at":"2023-02-28T21:01:45Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":61700,"subtype":null,"title":"Request for Comment on the Status of Vinpocetine","toc_doc":"Status of Vinpocetine","toc_subject":null,"topics":[],"type":"Notice","volume":81}