{"abstract":"The Food and Drug Administration (FDA or we) is announcing the availability of a final guidance for FDA staff and interested parties entitled \"Evaluating the Public Health Importance of Food Allergens Other Than the Major Food Allergens Listed in the Federal Food, Drug, and Cosmetic Act.\" This guidance document provides our current thinking on the approach we generally intend to take when we evaluate the public health importance of a food allergen other than one of the major food allergens (i.e., milk, eggs, fish, Crustacean shellfish, tree nuts, wheat, peanuts, soybean, and sesame) listed in the Federal Food, Drug, and Cosmetic Act (FD&C Act).","action":"Notice of availability.","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/2025/01/07/2024-31529.html","cfr_references":[],"citation":"90 FR 1163","comment_url":null,"comments_close_on":null,"correction_of":null,"corrections":[],"dates":"The announcement of the guidance is published in the Federal Register on January 7, 2025.","disposition_notes":null,"docket_ids":["Docket No. FDA-2021-N-0553"],"dockets":[{"supporting_documents":[{"title":"FG-Ref 40 - Taylor-2014-Establishment Reference Doses COPYRIGHT","document_id":"FDA-2021-N-0553-2004"},{"title":"FG-Ref 39-Allen-2014-Allergen reference doses for precautionary labeling COPYRIGHT","document_id":"FDA-2021-N-0553-2003"},{"title":"FG-Ref 37-Zhu 2015 COPYRIGHT","document_id":"FDA-2021-N-0553-2001"},{"title":"FG-Ref 36-GRADE Working Group welcome COPYRIGHT","document_id":"FDA-2021-N-0553-2000"},{"title":"FG-Ref 29-Chung 2012 COPYRIGHT","document_id":"FDA-2021-N-0553-1993"},{"title":"FG-Ref 24-FDA Sesame-Allergen-Draft-Guidance-November-2020","document_id":"FDA-2021-N-0553-1988"},{"title":"FG-Ref 21-FDA-Citizen Petition LabelGarlic","document_id":"FDA-2021-N-0553-1985"},{"title":"FG-Ref 19-FDA CPG-Sec.-555.250","document_id":"FDA-2021-N-0553-1983"},{"title":"FG-Ref 15-FDA-Guidance-Jan2025-AllergenLabelingQA-12292024","document_id":"FDA-2021-N-0553-1979"},{"title":"FG-Ref 2-NASEM Report COPYRIGHT","document_id":"FDA-2021-N-0553-1966"}],"agency_name":"FDA","documents":[{"comment_count":0,"comment_start_date":null,"updated_at":"2025-01-07T15:56:29.844-05:00","comment_url":"https://www.regulations.gov/commenton/FDA-2021-N-0553-1962","allow_late_comments":false,"id":"FDA-2021-N-0553-1962","comment_end_date":null,"regulations_dot_gov_open_for_comment":false}],"supporting_documents_count":96,"id":"FDA-2021-N-0553","title":"Evaluating the Public Health Importance of Food Allergens Other Than the Major Food Allergens Defined in the Federal Food, Drug, and Cosmetic Act; Draft Guidance for Industry; Availability"}],"document_number":"2024-31529","effective_on":null,"end_page":1164,"executive_order_notes":null,"executive_order_number":null,"explanation":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2025/01/07/2024-31529.xml","html_url":"https://www.federalregister.gov/documents/2025/01/07/2024-31529/evaluating-the-public-health-importance-of-food-allergens-other-than-the-major-food-allergens-listed","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2024-31529?publication_date=2025-01-07","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2025-01-07/2024-31529/mods.xml","not_received_for_publication":null,"page_length":2,"page_views":{"count":474,"last_updated":"2026-04-04 14:15:05 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2025-01-07/pdf/2024-31529.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2024-31529.pdf?1736171120","publication_date":"2025-01-07","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2025/01/07/2024-31529.txt","regulation_id_number_info":{},"regulation_id_numbers":[],"regulations_dot_gov_info":{"supporting_documents":[{"title":"FG-Ref 40 - Taylor-2014-Establishment Reference Doses COPYRIGHT","document_id":"FDA-2021-N-0553-2004"},{"title":"FG-Ref 39-Allen-2014-Allergen reference doses for precautionary labeling COPYRIGHT","document_id":"FDA-2021-N-0553-2003"},{"title":"FG-Ref 37-Zhu 2015 COPYRIGHT","document_id":"FDA-2021-N-0553-2001"},{"title":"FG-Ref 36-GRADE Working Group welcome COPYRIGHT","document_id":"FDA-2021-N-0553-2000"},{"title":"FG-Ref 29-Chung 2012 COPYRIGHT","document_id":"FDA-2021-N-0553-1993"},{"title":"FG-Ref 24-FDA Sesame-Allergen-Draft-Guidance-November-2020","document_id":"FDA-2021-N-0553-1988"},{"title":"FG-Ref 21-FDA-Citizen Petition LabelGarlic","document_id":"FDA-2021-N-0553-1985"},{"title":"FG-Ref 19-FDA CPG-Sec.-555.250","document_id":"FDA-2021-N-0553-1983"},{"title":"FG-Ref 15-FDA-Guidance-Jan2025-AllergenLabelingQA-12292024","document_id":"FDA-2021-N-0553-1979"},{"title":"FG-Ref 2-NASEM Report COPYRIGHT","document_id":"FDA-2021-N-0553-1966"}],"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-2021-N-0553","supporting_documents_count":96,"docket_id":"FDA-2021-N-0553","document_id":"FDA-2021-N-0553-1962","regulation_id_number":null,"title":"Evaluating the Public Health Importance of Food Allergens Other Than the Major Food Allergens Defined in the Federal Food, Drug, and Cosmetic Act; 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