Food Allergens/Gluten-Free Guidance Documents & Regulatory Information
On November 29, 2022, the FDA issued two guidance documents about food allergen labeling requirements to help the food industry meet the requirements to list any major food allergen on the labels of FDA-regulated foods. One of the guidance documents is a draft guidance titled Questions and Answers Regarding Food Allergens, Including the Food Allergen Labeling Requirements of the Federal Food, Drug, and Cosmetic Act (Edition 5); Guidance for Industry. This draft guidance updates the previous edition (4th Edition) with new and revised questions and answers related to the labeling of food allergens, including requirements in the Food Allergy Safety, Treatment, Education, and Research Act of 2021 (FASTER Act) and the Food Allergen Labeling and Consumer Protection Act of 2004 (FALCPA). The agency also issued a final guidance with the same title to preserve the questions and answers from the previous edition (4th Edition) that were not changed, except for editorial changes such as renumbering the questions and reorganizing the information in the guidance. Comments about the draft guidance should be submitted within 60 days of publication of the notice in the Federal Register announcing the availability of the draft guidance to ensure we consider your comment before we begin work on the final guidance. Submit comments electronically on www.regulations.gov, using Docket ID: FDA-2022-D-0099.
Food allergies are a significant public health concern with allergic reactions varying in severity from gastrointestinal disturbances and skin irritations, to anaphylaxis, anaphylactic shock and death. Consumers with allergies must avoid food with allergenic materials to prevent serious health consequences since there is no cure.
The following is guidance and regulatory information. For general information, including consumer education and other fact sheets, visit the Food Allergies main page.
Guidance documents contain nonbinding recommendations.
- Program Specific Topics
- Draft Guidance for FDA Staff and Stakeholders: Evaluating the Public Health Importance of Food Allergens Other Than the Major Food Allergens Listed in the Federal Food, Drug, and Cosmetic Act (April 2022)
- Approaches to Establish Thresholds for Major Food Allergens and for Gluten in Food (March 2006)
- Compliance Policy Guide: Statement of Policy for Labeling and Preventing Cross-contact of Common Food Allergens (November 2005)
Program Specific Topics
- Guidance for Industry: Recommendations for the Early Food Safety Evaluation of New Non-Pesticidal Proteins Produced by New Plant Varieties Intended for Food Use (June 2006)
- Statement of Policy - Foods Derived from New Plant Varieties (May 1992)
- Biotechnology Guidance Documents & Regulatory Information
The FDA Food Safety Modernization Act (FSMA), the most sweeping reform of our food safety laws in more than 70 years, was signed into law by President Obama on January 4, 2011. It aims to ensure the U.S. food supply is safe by shifting the focus from responding to contamination to preventing it.
- Draft Guidance for Industry: Hazard Analysis and Risk-Based Preventive Controls for Human Food (August 2017)
- Chapter 11: Food Allergen Control Program (Date TBD)
- FDA Guidances Explain Certain Exemptions from FSMA (August 2017)
- Gluten-Free Labeling of Foods Main Page
- Final Rule for Gluten-Free Labeling of Fermented or Hydrolyzed Foods (August 2020)
- Guidance for Industry: Gluten-Free Labeling of Foods; Small Entity Compliance Guide (June 2014)
- Final Rule for Gluten-Free Labeling of Foods (August 2013)
- Guidance for Industry: Juice HACCP and the FDA Food Safety Modernization Act (August 2017)
- Guidance for Industry: Juice HACCP Hazards and Controls Guidance (1st Edition) (March 2004)
- Guidance for Industry: Questions and Answers on Juice HACCP Regulation -2003 (September 2003)
- Guidance for Industry: Questions and Answers on Juice HACCP Regulation-2001 (September 2001)
To help U.S. consumers avoid the health risks posed by food allergens, the FDA enforces the Food Allergen Labeling and Consumer Protection Act of 2004 (the Act). The Act applies to the labeling of foods regulated by the FDA which includes all foods except poultry, catfish, most meats, certain egg products, and most alcoholic beverages which are regulated by other Federal agencies. The Act requires that food labels must clearly identify the food source names of any ingredients that are one of the major food allergens or contain any protein derived from a major food allergen.
- Guidance for Industry: Questions and Answers Regarding Food Allergen Labeling (Edition 5) (November 2022)
- Draft Guidance for Industry: Voluntary Disclosure of Sesame as an Allergen (November 2020)
- Food Allergen Labeling and Consumer Protection Act of 2004 (Title II of Public Law 108-282)
- Guidance for Industry: Food Allergen Labeling Exemption Petitions and Notifications (June 2015)
- Inventory of Notifications Received under 21 U.S.C. 343(w)(7) for Exemptions from Food Allergen Labeling (July 2006, Updated April 2013)
- Inventory of Petitions Received under 21 U.S.C. 343(w)(6) for Exemptions from Food Allergen Labeling (June 2006, Updated April 2013)
- Guidance for Industry: A Food Labeling Guide (January 2013)
- Report to the Committee on Health, Education, Labor, and Pensions in United States Senate, and the Committee on Energy and Commerce in United States House of Representatives July 2006 (PDF - 1.8 MB)
Retail Food Industry Assistance
The FDA publishes the Food Code, a model that assists food control jurisdictions at all levels of government by providing them with a scientifically sound technical and legal basis for regulating the retail and food service segment of the industry (restaurants and grocery stores and institutions such as nursing homes). Local, state, tribal, and federal regulators use the FDA Food Code as a model to develop or update their own food safety rules and to be consistent with national food regulatory policy.
- Guidance for Industry: Seafood HACCP and the FDA Food Safety Modernization Act (August 2017)
- Fish and Fishery Products Hazards and Controls Guidance (April 2011)
- Dear Colleague Letter on Allergen Guides (May 2001)
- Questions and Answers on Allergen Guides (May 2001)
- Letter to Food Labeling and Standards Concerning Food Allergen Labeling Guidelines (May 2001)
- "Dear Colleague” Letter About the “Food Allergen Partnership (March 2001)
- Food Allergen Partnership (January 2001)
- Label Declaration of Allergenic Substances in Foods; Notice to Manufacturers (June 1996)