{"abstract":"The Food and Drug Administration (FDA or we) is issuing a final rule to define the term \"gluten-free\" for voluntary use in the labeling of foods. The final rule defines the term \"gluten-free\" to mean that the food bearing the claim does not contain an ingredient that is a gluten-containing grain (e.g., spelt wheat); an ingredient that is derived from a gluten-containing grain and that has not been processed to remove gluten (e.g., wheat flour); or an ingredient that is derived from a gluten-containing grain and that has been processed to remove gluten (e.g., wheat starch), if the use of that ingredient results in the presence of 20 parts per million (ppm) or more gluten in the food (i.e., 20 milligrams (mg) or more gluten per kilogram (kg) of food); or inherently does not contain gluten; and that any unavoidable presence of gluten in the food is below 20 ppm gluten (i.e., below 20 mg gluten per kg of food). A food that bears the claim \"no gluten,\" \"free of gluten,\" or \"without gluten\" in its labeling and fails to meet the requirements for a \"gluten-free\" claim will be deemed to be misbranded. In addition, a food whose labeling includes the term \"wheat\" in the ingredient list or in a separate \"Contains wheat\" statement as required by a section of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) and also bears the claim \"gluten-free\" will be deemed to be misbranded unless its labeling also bears additional language clarifying that the wheat has been processed to allow the food to meet FDA requirements for a \"gluten-free\" claim. Establishing a definition of the term \"gluten-free\" and uniform conditions for its use in food labeling will help ensure that individuals with celiac disease are not misled and are provided with truthful and accurate information with respect to foods so labeled. We are issuing the final rule under the Food Allergen Labeling and Consumer Protection Act of 2004 (FALCPA).","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/2013/08/05/2013-18813.html","cfr_references":[{"chapter":null,"citation_url":null,"part":101,"title":21}],"citation":"78 FR 47154","comment_url":null,"comments_close_on":null,"correction_of":null,"corrections":[],"dates":"Effective date: The final rule becomes effective on September 4, 2013. Compliance date: The compliance date of this final rule is August 5, 2014. See section II.B.4 (comment 35 and response 35) for an additional explanation of the compliance date and implementation of this final rule.","disposition_notes":null,"docket_ids":["Docket No. FDA-2005-N-0404"],"dockets":[],"document_number":"2013-18813","effective_on":"2013-09-04","end_page":47179,"executive_order_notes":null,"executive_order_number":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2013/08/05/2013-18813.xml","html_url":"https://www.federalregister.gov/documents/2013/08/05/2013-18813/food-labeling-gluten-free-labeling-of-foods","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2013-18813?publication_date=2013-08-05","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2013-08-05/2013-18813/mods.xml","not_received_for_publication":null,"page_length":26,"page_views":{"count":76673,"last_updated":"2026-10-25 12:15:05 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2013-08-05/pdf/2013-18813.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2013-18813.pdf?1375447772","publication_date":"2013-08-05","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2013/08/05/2013-18813.txt","regulation_id_number_info":{"0910-AG84":{"issue":"201304","html_url":"https://www.federalregister.gov/regulations/0910-AG84/food-labeling-gluten-free-labeling-of-foods","title":"Food Labeling; Gluten-Free Labeling of Foods","xml_url":"http://www.reginfo.gov/public/do/eAgendaViewRule?pubId=201304&RIN=0910-AG84&operation=OPERATION_EXPORT_XML","priority_category":"Other Significant"}},"regulation_id_numbers":["0910-AG84"],"regulations_dot_gov_info":{"supporting_documents":[{"title":"Reference 3 - Office of Food Safety, Peer Review Report on “External Peer Review of the FDA/CFSAN Health Hazard Assessment for Gluten in Individuals with Celiac Disease: Determination of Tolerable Daily Intake Levels and Levels of Concern for Gluten,” , D","document_id":"FDA-2005-N-0404-0139"},{"title":"Reference 2 - United States Congress, Public Law 108-282, “Title II—Food Allergen Labeling and Consumer Protection Act of 2004,” (118 STAT. 905 – 118 STAT. 911), August 2, 2004 [NPR 8/3/2011 - Reopening of the Comment Period]","document_id":"FDA-2005-N-0404-0138"},{"title":"Reference 1 - Department of Health and Human Services, Food and Drug Administration, Proposed Rule, “Food Labeling; Gluten-Free Labeling of Foods,” (72 FR 2795 - 72 FR 2817), January 23, 2007 [NPR 8/3/2011 - Reopening of the Comment Period]","document_id":"FDA-2005-N-0404-0137"},{"title":"List of Background Documents Cited in the Federal Register Notice on Food Labeling; Gluten-Free Labeling of Foods; Reopening of the Comment Period","document_id":"FDA-2005-N-0404-0136"},{"title":"Regulations Policy and Management Staff Memorandum to Division of Dockets Management - Executive Order 12866 - [Food Labeling; Gluten-Free Labeling of Foods; Proposed Rule] - Reference  re FDA-2005-N-0404-0077","document_id":"FDA-2005-N-0404-0132"},{"title":"Reference 1 - \"National Institutes of health Consensus Development Conference Statement on Celiac Disease, June 28-30, 2004\" - [Food Labeling; Gluten-Free Labeling of Foods; Proposed Rule] - Background re FDA-2005-N-0404-0077 ","document_id":"FDA-2005-N-0404-0131"},{"title":"Reference List for Federal Register Notice: Food Labeling; Gluten-Free Labeling of Foods; Public Meeting [70FR41356]","document_id":"FDA-2005-N-0404-0130"},{"title":"See FDA-2005-N-0404-0132","document_id":"FDA-2005-N-0404-0121"},{"title":"See FDA-2005-N-0404-0132","document_id":"FDA-2005-N-0404-0118"},{"title":"See FDA-2005-N-0404-0132","document_id":"FDA-2005-N-0404-0117"}],"comments_url":"https://www.regulations.gov/docketBrowser?rpp=50&so=DESC&sb=postedDate&po=0&dct=PS&D=FDA-2005-N-0404","supporting_documents_count":15,"docket_id":"FDA-2005-N-0404","regulation_id_number":"0910-ZA26","title":"Food Labeling; Gluten-Free Labeling of Foods-CLOSED","checked_regulationsdotgov_at":"2013-08-25T06:00:08Z"},"regulations_dot_gov_url":null,"significant":true,"signing_date":null,"start_page":47154,"subtype":null,"title":"Food Labeling; Gluten-Free Labeling of Foods","toc_doc":"Gluten-Free Labeling of Foods","toc_subject":"Food Labeling:","topics":["Food labeling","Nutrition","Reporting and recordkeeping requirements"],"type":"Rule","volume":78}