{"abstract":"The Food and Drug Administration (FDA) is issuing a notice of proposed rulemaking that would establish that over-the-counter (OTC) skin bleaching drug products are not generally recognized as safe and effective (GRASE) and are misbranded. FDA is also withdrawing the previous proposed rule on skin bleaching drug products for OTC human use, which was issued in the form of a tentative final monograph (TFM). FDA is issuing this proposed rule after considering new data and information on the safety of hydroquinone, the only active ingredient that had been proposed for inclusion in a monograph for these products. This proposal is part of FDA's ongoing review of OTC drug products. Further, upon issuance of a final rule, FDA intends to consider all skin bleaching drug products, whether currently marketed on a prescription or OTC basis, to be new drugs requiring an approved new drug application (NDA) for continued marketing.","action":"Proposed rule; withdrawal of previous 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"},{"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/2006/08/29/E6-14263.html","cfr_references":[{"chapter":null,"citation_url":null,"part":310,"title":21}],"citation":"71 FR 51146","comment_url":null,"comments_close_on":"2006-12-27","correction_of":null,"corrections":[],"dates":"Submit written or electronic comments by December 27, 2006; submit written or electronic comments on FDA's economic impact determination by December 27, 2006. The September 3, 1982, proposed rule (47 FR 39108) is withdrawn as of August 29, 2006. See section IX for the proposed effective date of any final rule that may publish based on this proposal.","disposition_notes":null,"docket_ids":["Docket No. 1978N-0065 (formerly Docket No. 78N-0065)"],"dockets":[],"document_number":"E6-14263","effective_on":null,"end_page":51155,"executive_order_notes":null,"executive_order_number":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2006/08/29/E6-14263.xml","html_url":"https://www.federalregister.gov/documents/2006/08/29/E6-14263/skin-bleaching-drug-products-for-over-the-counter-human-use-proposed-rule","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/E6-14263?publication_date=2006-08-29","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2006-08-29/E6-14263/mods.xml","not_received_for_publication":null,"page_length":10,"page_views":{"count":4057,"last_updated":"2026-07-25 20:15:03 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2006-08-29/pdf/E6-14263.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":null,"publication_date":"2006-08-29","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2006/08/29/E6-14263.txt","regulation_id_number_info":{"0910-AF53":{"issue":"201104","html_url":"https://www.federalregister.gov/regulations/0910-AF53/over-the-counter-otc-drug-review-skin-bleaching-products","title":"Over-the-Counter (OTC) Drug Review--Skin Bleaching Products","xml_url":"http://www.reginfo.gov/public/do/eAgendaViewRule?pubId=201104&RIN=0910-AF53&operation=OPERATION_EXPORT_XML","priority_category":"Routine and Frequent"}},"regulation_id_numbers":["0910-AF53"],"regulations_dot_gov_info":{"supporting_documents":[{"title":"Reference 8 Nordlund, The Safety of Hydroquinone re FDA-1978-N-0023-0160","document_id":"FDA-1978-N-0023-0165"},{"title":"Reference 7 International Agency for Research on Cancer (IARC) - Summaries and Evaluation, HYDROQUINOLONE, (Group 3) re FDA-1978-N-0023-0160","document_id":"FDA-1978-N-0023-0164"},{"title":"Reference 6 The Covalent Bond re FDA-1978-N-0023-0160","document_id":"FDA-1978-N-0023-0163"},{"title":"Reference 5 -Glucuronide (Wikipedia) re FDA-1978-N-0023-0160","document_id":"FDA-1978-N-0023-0162"},{"title":"Reference 1 Minutes of Open Public Meeting Carcinogenicity Assessment Committe December 4  1996 re FDA-1978-N-0023-0160","document_id":"FDA-1978-N-0023-0161"},{"title":"Tab Reference 1: Kari, F. W., \"NTP Technical Report of the Toxicology and Carcinogenesis Studies of Hydroquinone in F344/N Rats and B6C3F1 Mice (Gavage Studies),\" NTP TR366, NTP Publication No. 89-2821, 1989. (Page 101-200) re: Internal Memorandum from Susan S. Johnson, Acting Director Division of Nonprescription Regulation Development Office of Nonprescription Products to Division of Dockets","document_id":"FDA-1978-N-0023-0060"},{"title":"Internal Memorandum from Susan S. Johnson, Acting Director Division of Nonprescription Regulation Development Office of Nonprescription Products to Division of Dockets Management (HFA-350) August 17 2006","document_id":"FDA-1978-N-0023-0059"},{"title":"Tab Reference 6: Bio/dynamics Inc., \"A Developmental Toxicity Study in Rabbits With Hydroquinone,\" Project No. 87-3Z20, 1989, in OTC Vol. 16ATFM2. re: Internal Memorandum from Susan S. Johnson, Acting Director Division of Nonprescription Regulation Development Office of Nonprescription Products to Division of Dockets Management (HFA-350) August 17 2006","document_id":"FDA-1978-N-0023-0058"},{"title":"Tab Reference 1: Kari, F. W., \"NTP Technical Report of the Toxicology and Carcinogenesis Studies of Hydroquinone in F344/N Rats and B6C3F1 Mice (Gavage Studies),\" NTP TR366, NTP Publication No. 89-2821, 1989. (Page 1-100) re: Internal Memorandum from Susan S. Johnson, Acting Director Division of Nonprescription Regulation Development Office of Nonprescription Products to Division of Dockets","document_id":"FDA-1978-N-0023-0057"},{"title":"Tab Reference 1: Kari, F. W., \"NTP Technical Report of the Toxicology and Carcinogenesis Studies of Hydroquinone in F344/N Rats and B6C3F1 Mice (Gavage Studies),\" NTP TR366, NTP Publication No. 89-2821, 1989. (Page 201-253) re: Internal Memorandum from Susan S. Johnson, Acting Director Division of Nonprescription Regulation Development Office of Nonprescription Products to Division of Dockets","document_id":"FDA-1978-N-0023-0056"}],"regulatory_plan":{"html_url":"https://www.federalregister.gov/regulations/0910-AF53/over-the-counter-otc-drug-review-skin-bleaching-products","title":"Over-the-Counter (OTC) Drug Review--Skin Bleaching Products"},"comments_url":"https://www.regulations.gov/docketBrowser?rpp=50&so=DESC&sb=postedDate&po=0&dct=PS&D=FDA-1978-N-0023","supporting_documents_count":12,"docket_id":"FDA-1978-N-0023","regulation_id_number":"0910-AF53","title":"Skin Bleaching Drug Products- OPEN","checked_regulationsdotgov_at":"2019-09-29T03:30:08Z"},"regulations_dot_gov_url":null,"significant":false,"signing_date":null,"start_page":51146,"subtype":null,"title":"Skin Bleaching Drug Products For Over-the-Counter Human Use; Proposed Rule","toc_doc":"Skin bleaching drug products; over-the-counter use","toc_subject":"Human drugs:","topics":["Administrative practice and procedure","Drugs","Labeling","Medical devices","Reporting and recordkeeping requirements"],"type":"Proposed Rule","volume":71}