{"abstract":"The Food and Drug Administration (FDA) is reopening the comment period for the proposed rule on the \"gluten-free\" labeling of foods, published in the Federal Register of January 23, 2007 (72 FR 2795). In that document, FDA proposed to define the term \"gluten- free,\" for voluntary use in the labeling of foods, to mean that the food does not contain an ingredient that is any species of wheat, rye, barley, or a crossbred hybrid of these grains (collectively referred to as \"prohibited grains\"); an ingredient that is derived from a prohibited grain and that has not been processed to remove gluten (e.g., wheat flour); an ingredient that is derived from a prohibited 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; or 20 ppm or more gluten. FDA also announced in the proposed rule that we intended to conduct a safety assessment for gluten exposure and seek comments on the safety assessment and its potential use in defining the term \"gluten-free\" in the final rule. A report by FDA discussing a health hazard assessment we conducted, which included a safety assessment for gluten exposure in individuals with celiac disease, has been peer reviewed by an external group of scientific experts, and we revised the assessment, as appropriate, based upon expert comments. FDA is reopening the comment period for the proposed rule on the \"gluten- free\" labeling of foods to, in part, announce the availability of and solicit comments on the report entitled \"Health Hazard Assessment for Effects of Gluten Exposure in Individuals with Celiac Disease: Determination of Tolerable Daily Intake Levels and Levels of Concern for Gluten\" (\"Gluten Report\"), which discusses the Agency's gluten safety assessment. The Agency also seeks comments on whether and, if so, how, the safety assessment should affect FDA's proposed definition of \"gluten-free\" in the final rule, and on a number of related issues. Finally, FDA seeks comments on the Agency's tentative conclusions that the safety assessment-based approach may lead to a conservative, highly uncertain estimation of risk to individuals with celiac disease associated with very low levels of gluten exposure; and that the final rule should adopt the proposed rule's approach to defining the term \"gluten-free,\" because that approach takes into account the availability of reliable analytical methods and also considers other practical factors related to the needs of individuals with celiac disease and their food consumption.","action":"Proposed rule; reopening of comment period.","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/2011/08/03/2011-19620.html","cfr_references":[{"chapter":null,"citation_url":null,"part":101,"title":21}],"citation":"76 FR 46671","comment_url":null,"comments_close_on":"2011-10-03","correction_of":null,"corrections":[],"dates":"Submit electronic or written comments by October 3, 2011.","disposition_notes":null,"docket_ids":["Docket No. FDA-2005-N-0404","formerly Docket No. 2005N-0279"],"dockets":[],"document_number":"2011-19620","effective_on":null,"end_page":46677,"executive_order_notes":null,"executive_order_number":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2011/08/03/2011-19620.xml","html_url":"https://www.federalregister.gov/documents/2011/08/03/2011-19620/food-labeling-gluten-free-labeling-of-foods-reopening-of-the-comment-period","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2011-19620?publication_date=2011-08-03","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2011-08-03/2011-19620/mods.xml","not_received_for_publication":null,"page_length":7,"page_views":{"count":1642,"last_updated":"2026-08-25 06:15:03 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2011-08-03/pdf/2011-19620.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":null,"publication_date":"2011-08-03","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2011/08/03/2011-19620.txt","regulation_id_number_info":{"0910-ZA26":null},"regulation_id_numbers":["0910-ZA26"],"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":"2011-08-23T08:06:07Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":46671,"subtype":null,"title":"Food Labeling; Gluten-Free Labeling of Foods; Reopening of the Comment Period","toc_doc":"Gluten-Free Labeling of Foods; Reopening of Comment Period","toc_subject":"Food Labeling:","topics":[],"type":"Proposed Rule","volume":76}