{"abstract":"The Food and Drug Administration (FDA or we) is issuing a final rule to establish requirements concerning \"gluten-free\" labeling for foods that are fermented or hydrolyzed or that contain fermented or hydrolyzed ingredients. These requirements f are needed to help ensure that individuals with celiac disease are not misled and receive truthful and accurate information with respect to fermented or hydrolyzed foods labeled as \"gluten- free.\" Currently, FDA knows of no scientifically valid analytical method effective in detecting and quantifying with precision the gluten protein content in fermented or hydrolyzed foods in terms of equivalent amounts of intact gluten proteins. Thus, we plan to evaluate compliance of such fermented or hydrolyzed foods that bear a \"gluten-free\" claim based on records that are made and kept by the manufacturer of the food bearing the \"gluten-free\" claim and made available to us for inspection and copying. The records need to provide adequate assurance that the food or ingredients used in the food are \"gluten-free\" before fermentation or hydrolysis. Once we identify that a scientifically valid method has been developed that can accurately detect and quantify gluten in fermented or hydrolyzed foods or ingredients, it would no longer be necessary for the manufacturer of foods bearing the \"gluten-free\" claim to make and keep these records. In addition, because currently there is no scientifically valid analytical method effective in detecting and quantifying the gluten protein content in fermented or hydrolyzed foods the final rule requires the manufacturer of these kinds of foods bearing the \"gluten- free\" claim to document that it has adequately evaluated the potential for gluten cross-contact and, if identified, that the manufacturer has implemented measures to prevent the introduction of gluten into the food during the manufacturing process. Likewise, the final rule requires manufacturers of foods that contain fermented or hydrolyzed ingredients and bear the \"gluten-free\" claim to make and keep records that demonstrate with adequate assurance that the fermented or hydrolyzed ingredients are \"gluten-free\" in compliance with the 2013 gluten-free food labeling final rule. Finally, this final rule states that we will evaluate compliance of distilled foods by verifying the absence of protein using scientifically valid analytical methods that can reliably detect the presence of protein or protein fragments in the distilled food.","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/2020/08/13/2020-17088.html","cfr_references":[{"chapter":null,"citation_url":null,"part":"101","title":21}],"citation":"85 FR 49240","comment_url":null,"comments_close_on":null,"correction_of":null,"corrections":[],"dates":"Effective date: This rule is effective October 13, 2020.","disposition_notes":null,"docket_ids":["Docket No. FDA-2014-N-1021"],"dockets":[],"document_number":"2020-17088","effective_on":"2020-10-13","end_page":49261,"executive_order_notes":null,"executive_order_number":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2020/08/13/2020-17088.xml","html_url":"https://www.federalregister.gov/documents/2020/08/13/2020-17088/food-labeling-gluten-free-labeling-of-fermented-or-hydrolyzed-foods","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2020-17088?publication_date=2020-08-13","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2020-08-13/2020-17088/mods.xml","not_received_for_publication":null,"page_length":22,"page_views":{"count":38270,"last_updated":"2026-06-28 00:15:03 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2020-08-13/pdf/2020-17088.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2020-17088.pdf?1597236315","publication_date":"2020-08-13","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2020/08/13/2020-17088.txt","regulation_id_number_info":{"0910-AH00":{"issue":"202004","html_url":"https://www.federalregister.gov/regulations/0910-AH00/food-labeling-gluten-free-labeling-of-fermented-or-hydrolyzed-foods","title":"Food Labeling; Gluten-Free Labeling of Fermented or Hydrolyzed Foods","xml_url":"http://www.reginfo.gov/public/do/eAgendaViewRule?pubId=202004&RIN=0910-AH00&operation=OPERATION_EXPORT_XML","priority_category":"Other Significant"}},"regulation_id_numbers":["0910-AH00"],"regulations_dot_gov_info":{"supporting_documents":[{"title":"FDA tab C - Gluten F-H - RIA (7-16-20 OMB final) re FDA - Gluten F-H Memo to DMS","document_id":"FDA-2014-N-1021-0577"},{"title":"FDA tab B - Gluten F-H - RIA (OMB redline compare 2-7-20 to 7-16-20) re FDA - Gluten F-H Memo to DMS","document_id":"FDA-2014-N-1021-0575"},{"title":"FDA tab B - Gluten F-H - Final Rule (OMB redline compare 2-7-20 to 7-16-20) re FDA - Gluten F-H Memo to DMS","document_id":"FDA-2014-N-1021-0574"},{"title":"FDA tab A - Gluten F-H - RIA (2-7-20 to OMB) re FDA - Gluten F-H Memo to DMS","document_id":"FDA-2014-N-1021-0573"},{"title":"Reference 16 2010 NATIONWIDE SURVEY OF FOOD INDUSTRY SAFETY PRACTICES re: Food Labeling; Gluten-Free Labeling of Fermented or Hydrolyzed Foods","document_id":"FDA-2014-N-1021-0568"},{"title":"Reference 12 Improving wheat to remove coeliac epitopes but retain functionality re: Food Labeling; Gluten-Free Labeling of Fermented or Hydrolyzed Foods","document_id":"FDA-2014-N-1021-0566"},{"title":"Reference 10 Using mass spectrometry to detect hydrolysed gluten in beer that isresponsible for false negatives by ELISA re: Food Labeling; Gluten-Free Labeling of Fermented or Hydrolyzed Foods","document_id":"FDA-2014-N-1021-0564"},{"title":"Reference 9 Effects of a Proline Endopeptidase on the Detection and\nQuantitation of Gluten by Antibody-Based Methods during the\nFermentation of a Model Sorghum Beer re: Food Labeling; Gluten-Free Labeling of Fermented or Hydrolyzed Foods","document_id":"FDA-2014-N-1021-0563"},{"title":"Reference 8 AN-PEP, Proline-Specific Endopeptidase, Degrades All Known\nImmunostimulatory Gluten Peptides in Beer Made from Barley\nMalt re: Food Labeling; Gluten-Free Labeling of Fermented or Hydrolyzed Foods","document_id":"FDA-2014-N-1021-0562"},{"title":"Attachment A-6 Janssen G, et al (2015) Ineffective Degradation of Immunogenic Gluten Epitopes by Currently Available Digestive Enzyme Supplements. PLoS One, Jun 1;10(6):e0128065. doi: 10.1371 journal.pone.0128065 re: Comment from Craft Brew Alliance","document_id":"FDA-2014-N-1021-0557"}],"comments_count":0,"agency_id":"FDA","comments_url":"https://www.regulations.gov/docketBrowser?rpp=50&so=DESC&sb=postedDate&po=0&dct=PS&D=FDA-2014-N-1021","supporting_documents_count":36,"docket_id":"FDA-2014-N-1021","document_id":"FDA-2014-N-1021-0560","regulation_id_number":null,"title":"Food Labeling; Gluten-Free Labeling of Fermented or Hydrolyzed Foods","checked_regulationsdotgov_at":"2020-08-16T03:00:06Z"},"regulations_dot_gov_url":null,"significant":true,"signing_date":null,"start_page":49240,"subtype":null,"title":"Food Labeling; Gluten-Free Labeling of Fermented or Hydrolyzed Foods","toc_doc":"Gluten-Free Labeling of Fermented or Hydrolyzed Foods","toc_subject":"Food Labeling:\n","topics":["Food labeling","Nutrition","Reporting and recordkeeping requirements"],"type":"Rule","volume":85}