{"abstract":"The Food and Drug Administration (FDA, the Agency, or we) is proposing to revoke its regulation authorizing the use of health claims on the relationship between soy protein and coronary heart disease on the label or in the labeling of foods. We are taking this action based on our review of the totality of publicly available scientific evidence currently available and our tentative conclusion that such evidence does not support our previous determination that there is significant scientific agreement (SSA) among qualified experts for a health claim regarding the relationship between soy protein and reduced risk of coronary heart disease.","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"},{"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/2017/10/31/2017-23629.html","cfr_references":[{"chapter":null,"citation_url":null,"part":101,"title":21}],"citation":"82 FR 50324","comment_url":null,"comments_close_on":"2018-01-16","correction_of":null,"corrections":[],"dates":"Submit either electronic or written comments on the proposed rule by January 16, 2018.","disposition_notes":null,"docket_ids":["Docket No. FDA-2017-N-0763"],"dockets":[{"supporting_documents":[{"title":"Reference_222 Yang_2005_Longitudinal study of soy food intake and blood pressure among middle-aged and elderly Chinese","document_id":"FDA-2017-N-0763-0229"},{"title":"Reference_228 The ATBC cancer prevention study group._1994_The effect of vitamin E and beta carotene on the incidence","document_id":"FDA-2017-N-0763-0223"},{"title":"Reference_174 Mangano-2013-Soy proteins and isoflavones reduce interleukin-6 but not serum lipids in older women","document_id":"FDA-2017-N-0763-0177"},{"title":"Reference_151 Jenkins_2003_Effects of a dietary portfolio of cholesterol-lowering foods vs lovastatin on serum lipids","document_id":"FDA-2017-N-0763-0160"},{"title":"Reference_155 Jones_2005_Effects of a diet high in plant sterols, vegetable proteins, and viscous fibers","document_id":"FDA-2017-N-0763-0156"},{"title":"Reference_158_NHLBI_2003_Seventh Report of the Joint National Committee on Prevention","document_id":"FDA-2017-N-0763-0153"},{"title":"Reference_141 Li_2005_Long-term efficacy of soy-based meal replacements vs and individualized diet plan in obese type","document_id":"FDA-2017-N-0763-0150"},{"title":"Reference_142 Chiechi_2002_The effects of a soy rich diet on serum lipids-the menfis randomized trial","document_id":"FDA-2017-N-0763-0149"},{"title":"Reference_146 Zittermann-2004_Short-term effects of high soy. supplementation on sex hormones, bone markers","document_id":"FDA-2017-N-0763-0145"},{"title":"Reference_139 D'Amico_1991_Effect of dietary proteins and lipids in patients with membranous nephropathy","document_id":"FDA-2017-N-0763-0132"}],"agency_name":"FDA","documents":[{"comment_count":1065,"comment_start_date":"2017-10-31","updated_at":"2023-02-28T21:36:11.100-05:00","comment_url":"https://www.regulations.gov/commenton/FDA-2017-N-0763-0001","allow_late_comments":null,"id":"FDA-2017-N-0763-0001","comment_end_date":"2018-01-17","regulations_dot_gov_open_for_comment":false}],"supporting_documents_count":231,"id":"FDA-2017-N-0763","title":"Food Labeling: Health Claims; Soy Protein and Coronary Heart Disease"}],"document_number":"2017-23629","effective_on":null,"end_page":50346,"executive_order_notes":null,"executive_order_number":null,"explanation":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2017/10/31/2017-23629.xml","html_url":"https://www.federalregister.gov/documents/2017/10/31/2017-23629/food-labeling-health-claims-soy-protein-and-coronary-heart-disease","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2017-23629?publication_date=2017-10-31","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2017-10-31/2017-23629/mods.xml","not_received_for_publication":null,"page_length":23,"page_views":{"count":7192,"last_updated":"2026-05-13 10:15:06 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2017-10-31/pdf/2017-23629.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2017-23629.pdf?1509371600","publication_date":"2017-10-31","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2017/10/31/2017-23629.txt","regulation_id_number_info":{"0910-AH43":{"issue":"202404","html_url":"https://www.federalregister.gov/regulations/0910-AH43/food-labeling-health-claims-soy-protein-and-coronary-heart-disease","title":"Food Labeling: Health Claims; Soy Protein and Coronary Heart Disease","xml_url":"http://www.reginfo.gov/public/do/eAgendaViewRule?pubId=202404&RIN=0910-AH43&operation=OPERATION_EXPORT_XML","priority_category":"Other Significant"}},"regulation_id_numbers":["0910-AH43"],"regulations_dot_gov_info":{"supporting_documents":[{"title":"Reference_222 Yang_2005_Longitudinal study of soy food intake and blood pressure among middle-aged and elderly Chinese","document_id":"FDA-2017-N-0763-0229"},{"title":"Reference_228 The ATBC cancer prevention study group._1994_The effect of vitamin E and beta carotene on the incidence","document_id":"FDA-2017-N-0763-0223"},{"title":"Reference_174 Mangano-2013-Soy proteins and isoflavones reduce interleukin-6 but not serum lipids in older women","document_id":"FDA-2017-N-0763-0177"},{"title":"Reference_151 Jenkins_2003_Effects of a dietary portfolio of cholesterol-lowering foods vs lovastatin on serum lipids","document_id":"FDA-2017-N-0763-0160"},{"title":"Reference_155 Jones_2005_Effects of a diet high in plant sterols, vegetable proteins, and viscous fibers","document_id":"FDA-2017-N-0763-0156"},{"title":"Reference_158_NHLBI_2003_Seventh Report of the Joint National Committee on Prevention","document_id":"FDA-2017-N-0763-0153"},{"title":"Reference_141 Li_2005_Long-term efficacy of soy-based meal replacements vs and individualized diet plan in obese type","document_id":"FDA-2017-N-0763-0150"},{"title":"Reference_142 Chiechi_2002_The effects of a soy rich diet on serum lipids-the menfis randomized trial","document_id":"FDA-2017-N-0763-0149"},{"title":"Reference_146 Zittermann-2004_Short-term effects of high soy. supplementation on sex hormones, bone markers","document_id":"FDA-2017-N-0763-0145"},{"title":"Reference_139 D'Amico_1991_Effect of dietary proteins and lipids in patients with membranous nephropathy","document_id":"FDA-2017-N-0763-0132"}],"comments_count":1065,"agency_id":"FDA","comments_url":"https://www.regulations.gov/docketBrowser?rpp=50&so=DESC&sb=postedDate&po=0&dct=PS&D=FDA-2017-N-0763","supporting_documents_count":231,"docket_id":"FDA-2017-N-0763","document_id":"FDA-2017-N-0763-0001","regulation_id_number":null,"title":"Food Labeling: Health Claims; Soy Protein and Coronary Heart Disease","checked_regulationsdotgov_at":"2023-03-01T02:36:09Z"},"regulations_dot_gov_url":null,"significant":true,"signing_date":null,"start_page":50324,"subtype":null,"title":"Food Labeling: Health Claims; Soy Protein and Coronary Heart Disease","toc_doc":"Health Claims; Soy Protein and Coronary Heart Disease","toc_subject":"Food Labeling:","topics":["Food labeling","Nutrition","Reporting and recordkeeping requirements"],"type":"Proposed Rule","volume":82}