{"abstract":"The Food and Drug Administration (FDA or we) is amending the food additive regulations to provide for the safe use of vitamin D<INF>3</INF> as a nutrient supplement in meal replacement beverages that are not intended for special dietary use in reducing or maintaining body weight and for use in foods that are sole sources of nutrition for enteral feedings. We are taking this action in response to a petition filed by Abbott Laboratories (Abbott).","action":"Final 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/2014/08/12/2014-18969.html","cfr_references":[{"chapter":null,"citation_url":null,"part":172,"title":21}],"citation":"79 FR 46993","comment_url":null,"comments_close_on":null,"correction_of":null,"corrections":[],"dates":"This rule is effective August 12, 2014. See section VII \"Objections\" for further information on the filing of objections. Submit either electronic or written objections and requests for a hearing by September 11, 2014. The incorporation by reference of certain publications listed in the regulations is approved by the Director of the Federal Register as of August 12, 2014.","disposition_notes":null,"docket_ids":["Docket No. FDA-2012-F-0138"],"dockets":[],"document_number":"2014-18969","effective_on":"2014-08-12","end_page":46996,"executive_order_notes":null,"executive_order_number":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2014/08/12/2014-18969.xml","html_url":"https://www.federalregister.gov/documents/2014/08/12/2014-18969/food-additives-permitted-for-direct-addition-to-food-for-human-consumption-vitamin-d3","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2014-18969?publication_date=2014-08-12","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2014-08-12/2014-18969/mods.xml","not_received_for_publication":null,"page_length":4,"page_views":{"count":1502,"last_updated":"2026-06-24 00:15:03 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2014-08-12/pdf/2014-18969.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2014-18969.pdf?1407761361","publication_date":"2014-08-12","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2014/08/12/2014-18969.txt","regulation_id_number_info":{},"regulation_id_numbers":[],"regulations_dot_gov_info":{"supporting_documents":[{"title":"Reference 4 - Memorandum from A. Khan, Toxicology Review Group, Division of Petition Review, to J. Kidwell, Regulatory Group I, Division of Petition Review, February 11, 2014 re Food Additives Permitted for Direct Addition to Food for Human Consumption; V","document_id":"FDA-2012-F-0138-0012"},{"title":"Reference 3 - Memorandum from D. Folmer, Chemistry Review Group, Division of Petition Review, to J. Kidwell, Regulatory Group I, Division of Petition Review, February 7, 2013 re Food Additives Permitted for Direct Addition to Food for Human Consumption; V","document_id":"FDA-2012-F-0138-0011"},{"title":"Reference 2 - Memorandum from D. Folmer, Chemistry Review Group, Division of Petition Review, to J. Kidwell, Regulatory Group I, Division of Petition Review, December 11, 2013 re Food Additives Permitted for Direct Addition to Food for Human Consumption; ","document_id":"FDA-2012-F-0138-0010"},{"title":"Reference 1 - Committee to Review Dietary Reference Intakes for Vitamin D and Calcium, Food and Nutrition Board, Institute of Medicine, ‘‘Dietary Reference Intakes for Calcium and Vitamin D,’’ National Academies Press, Washington, DC, 2011. re Food Additi","document_id":"FDA-2012-F-0138-0009"},{"title":"List of References - re Food Additives Permitted for Direct\nAddition to Food for Human\nConsumption; Vitamin D3","document_id":"FDA-2012-F-0138-0008"},{"title":"Reference 4 - Memorandum from A Khan to J Kidwell February 11 2014","document_id":"FDA-2012-F-0138-0006"},{"title":"Reference 3 - Memorandum from D Folmer to J Kidwell February 7 2013","document_id":"FDA-2012-F-0138-0005"},{"title":"Reference 2 - Memorandum from D Folmer to J Kidwell December 11 2013","document_id":"FDA-2012-F-0138-0004"},{"title":"References List from FDA/CFSAN","document_id":"FDA-2012-F-0138-0003"}],"comments_url":"https://www.regulations.gov/docketBrowser?rpp=50&so=DESC&sb=postedDate&po=0&dct=PS&D=FDA-2012-F-0138","supporting_documents_count":9,"docket_id":"FDA-2012-F-0138","regulation_id_number":null,"title":"Abbott Laboratories; Filing of Food Additive Petition","checked_regulationsdotgov_at":"2014-09-12T05:01:58Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":46993,"subtype":null,"title":"Food Additives Permitted for Direct Addition to Food for Human Consumption; Vitamin D3","toc_doc":"Food Additives Permitted for Direct Addition to Food for Human Consumption; Vitamin D3","toc_subject":null,"topics":["Food additives","Incorporation by reference","Reporting and recordkeeping requirements"],"type":"Rule","volume":79}