{"abstract":"The Food and Drug Administration (FDA or we) is amending the regulation authorizing a health claim on the relationship between dietary saturated fat and cholesterol and risk of coronary heart disease (CHD) to permit raw fruits and vegetables that fail to comply with the \"low fat\" definition and/or the minimum nutrient content requirement to be eligible to bear the claim. We are taking this action in response to a petition submitted by the American Heart Association (the petitioner). The amendment expands the use of this health claim to certain fruits and vegetables that are currently ineligible for the health claim.","action":"Interim final rule; request for comments.","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/2016/12/19/2016-29997.html","cfr_references":[{"chapter":null,"citation_url":null,"part":101,"title":21}],"citation":"81 FR 91716","comment_url":null,"comments_close_on":"2017-03-06","correction_of":null,"corrections":[],"dates":"This interim final rule is effective December 19, 2016. Interested persons may submit either electronic or written comments by March 6, 2017.","disposition_notes":null,"docket_ids":["Docket No. FDA-2013-P-0047"],"dockets":[{"supporting_documents":[{"title":"Reference 9 FINAL RIA - FRDTS_2014-912 re Food Labeling: Health Claims; Dietary Saturated Fat and Cholesterol and Risk of Coronary Heart Disease","document_id":"FDA-2013-P-0047-0014"},{"title":"Reference 8 IOM DRIs for Dietary Fats, Chapter 8 re Food Labeling: Health Claims; Dietary Saturated Fat and Cholesterol and Risk of Coronary Heart Disease","document_id":"FDA-2013-P-0047-0013"},{"title":"Reference 7 Dietary Guidelines 2005 re Food Labeling: Health Claims; Dietary Saturated Fat and Cholesterol and Risk of Coronary Heart Disease","document_id":"FDA-2013-P-0047-0012"},{"title":"Reference 6 Dietary Guidelines 2000 re Food Labeling: Health Claims; Dietary Saturated Fat and Cholesterol and Risk of Coronary Heart Disease","document_id":"FDA-2013-P-0047-0011"},{"title":"Reference 5 Dietary Guidelines 2015 2020 re Food Labeling: Health Claims; Dietary Saturated Fat and Cholesterol and Risk of Coronary Heart Disease","document_id":"FDA-2013-P-0047-0010"},{"title":"Reference 4 Third Report of the National Cholesterol Education Program re Food Labeling: Health Claims; Dietary Saturated Fat and Cholesterol and Risk of Coronary Heart Disease","document_id":"FDA-2013-P-0047-0009"},{"title":"Reference 3 Dietary Guidelines 2010 re Food Labeling: Health Claims; Dietary Saturated Fat and Cholesterol and Risk of Coronary Heart Disease","document_id":"FDA-2013-P-0047-0008"},{"title":"Reference 2 Appel 1997 A CLINICAL TRIAL OF THE EFFECTS OF DIETARY PATTERNS ON BLOOD PRESSURE re Food Labeling: Health Claims; Dietary Saturated Fat and Cholesterol and Risk of Coronary Heart Disease","document_id":"FDA-2013-P-0047-0007"},{"title":"Reference 1 Liu 2000 Fruit and vegetable intake and risk of cardiovascular disease: the Women’s Health Study1,2 re Food Labeling: Health Claims; Dietary Saturated Fat and Cholesterol and Risk of Coronary Heart Disease","document_id":"FDA-2013-P-0047-0006"},{"title":"FDA/CFSAN to Dockets Management - Memorandum","document_id":"FDA-2013-P-0047-0004"}],"agency_name":"FDA","documents":[{"comment_count":17,"comment_start_date":"2016-12-19","updated_at":"2023-02-28T15:48:59.020-05:00","comment_url":"https://www.regulations.gov/commenton/FDA-2013-P-0047-0005","allow_late_comments":null,"id":"FDA-2013-P-0047-0005","comment_end_date":"2017-03-07","regulations_dot_gov_open_for_comment":false}],"supporting_documents_count":10,"id":"FDA-2013-P-0047","title":"Petition for the Amendment of the Health Claim Regulation 21 C.F.R 101.75 - Dietary Saturated Fat and Cholesterol and Risk of Coronary Heart Disease"}],"document_number":"2016-29997","effective_on":"2016-12-19","end_page":91722,"executive_order_notes":null,"executive_order_number":null,"explanation":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2016/12/19/2016-29997.xml","html_url":"https://www.federalregister.gov/documents/2016/12/19/2016-29997/food-labeling-health-claims-dietary-saturated-fat-and-cholesterol-and-risk-of-coronary-heart-disease","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2016-29997?publication_date=2016-12-19","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2016-12-19/2016-29997/mods.xml","not_received_for_publication":null,"page_length":7,"page_views":{"count":5690,"last_updated":"2026-04-04 16:15:04 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2016-12-19/pdf/2016-29997.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2016-29997.pdf?1481895926","publication_date":"2016-12-19","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2016/12/19/2016-29997.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 9 FINAL RIA - FRDTS_2014-912 re Food Labeling: Health Claims; Dietary Saturated Fat and Cholesterol and Risk of Coronary Heart Disease","document_id":"FDA-2013-P-0047-0014"},{"title":"Reference 8 IOM DRIs for Dietary Fats, Chapter 8 re Food Labeling: Health Claims; Dietary Saturated Fat and Cholesterol and Risk of Coronary Heart Disease","document_id":"FDA-2013-P-0047-0013"},{"title":"Reference 7 Dietary Guidelines 2005 re Food Labeling: Health Claims; Dietary Saturated Fat and Cholesterol and Risk of Coronary Heart Disease","document_id":"FDA-2013-P-0047-0012"},{"title":"Reference 6 Dietary Guidelines 2000 re Food Labeling: Health Claims; Dietary Saturated Fat and Cholesterol and Risk of Coronary Heart Disease","document_id":"FDA-2013-P-0047-0011"},{"title":"Reference 5 Dietary Guidelines 2015 2020 re Food Labeling: Health Claims; Dietary Saturated Fat and Cholesterol and Risk of Coronary Heart Disease","document_id":"FDA-2013-P-0047-0010"},{"title":"Reference 4 Third Report of the National Cholesterol Education Program re Food Labeling: Health Claims; Dietary Saturated Fat and Cholesterol and Risk of Coronary Heart Disease","document_id":"FDA-2013-P-0047-0009"},{"title":"Reference 3 Dietary Guidelines 2010 re Food Labeling: Health Claims; Dietary Saturated Fat and Cholesterol and Risk of Coronary Heart Disease","document_id":"FDA-2013-P-0047-0008"},{"title":"Reference 2 Appel 1997 A CLINICAL TRIAL OF THE EFFECTS OF DIETARY PATTERNS ON BLOOD PRESSURE re Food Labeling: Health Claims; Dietary Saturated Fat and Cholesterol and Risk of Coronary Heart Disease","document_id":"FDA-2013-P-0047-0007"},{"title":"Reference 1 Liu 2000 Fruit and vegetable intake and risk of cardiovascular disease: the Women’s Health Study1,2 re Food Labeling: Health Claims; Dietary Saturated Fat and Cholesterol and Risk of Coronary Heart Disease","document_id":"FDA-2013-P-0047-0006"},{"title":"FDA/CFSAN to Dockets Management - Memorandum","document_id":"FDA-2013-P-0047-0004"}],"comments_count":17,"agency_id":"FDA","comments_url":"https://www.regulations.gov/docketBrowser?rpp=50&so=DESC&sb=postedDate&po=0&dct=PS&D=FDA-2013-P-0047","supporting_documents_count":10,"docket_id":"FDA-2013-P-0047","document_id":"FDA-2013-P-0047-0005","regulation_id_number":null,"title":"Petition for the Amendment of the Health Claim Regulation 21 C.F.R 101.75 - Dietary Saturated Fat and Cholesterol and Risk of Coronary Heart Disease","checked_regulationsdotgov_at":"2023-02-28T20:48:58Z"},"regulations_dot_gov_url":null,"significant":true,"signing_date":null,"start_page":91716,"subtype":null,"title":"Food Labeling: Health Claims; Dietary Saturated Fat and Cholesterol and Risk of Coronary Heart Disease","toc_doc":"Health Claims; Dietary Saturated Fat and Cholesterol and Risk of Coronary Heart Disease","toc_subject":"Food Labeling:","topics":["Food labeling","Nutrition","Reporting and recordkeeping requirements"],"type":"Rule","volume":81}