Food Allergens/Gluten-Free Guidance Documents & Regulatory Information
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 Allergens main page.
Guidance documents contain nonbinding recommendations.
- Recent Updates
- General
- Program Specific Topics
Recent Updates
- FDA Acknowledges Qualified Health Claim Linking Early Peanut Introduction and Reduced Risk of Developing Peanut Allergy (September 2017)
- Statement from FDA Commissioner Scott Gottlieb, M.D., on a New Qualified Health Claim: Advising that early introduction of peanuts to certain high-risk infants may reduce risk of peanut allergy (September 2017)
- FDA Response to Petition for a Qualified Health Claim for Ground Peanuts and Reduced Risk of Developing Peanut Allergy (September 2017)
- FDA Guidances Explain Certain Exemptions from FSMA (August 2017)
General
- Allergy Inspection Guide (April 2001)
- Compliance Policy Guide: Statement of Policy for Labeling and Preventing Cross-contact of Common Food Allergens
- Approaches to Establish Thresholds for Major Food Allergens and for Gluten in Food (March 2006)
Program Specific Topics
Biotechnology
- 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
FSMA
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- Draft Guidance for Industry: Hazard Analysis and Risk-Based Preventive Controls for Human Food (August 2017)
- FDA Guidances Explain Certain Exemptions from FSMA (August 2017)
Gluten-Free
- 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)
Juice HACCP
- Guidance for Industry: Juice HACCP Hazards and Controls Guidance (1st Edition) (March 2004)
- Section IV.C.1.22 – Undeclared Food Allergens in Juice Due to Cross-Contact from Shared Processing Equipment
- Section IV.C.1.23 – Allergens and Food Intolerances Substances Added to Juice as Ingredients
- Section IV.C.3.3 – Hazards Related to Facility Sanitation
- Section IV.C.3.4 – Controls for Allergens Arising from Food Contact Surfaces
- Section V.D.2.0 – Control Measures for Food Allergens That Can Contaminate Juice from Improperly Cleaned Shared Processing Equipment
- Section VII.C. Example CCP and SSOP for Prevention of occurrence of undeclared milk residues in juice
- Guidance for Industry: Juice HACCP and the FDA Food Safety Modernization Act (August 2017)
- Section II, Subpart B – Current Good Manufacturing Practice – Question 7
- Guidance for Industry: The Juice HACCP Regulation - Questions & Answers (August 2001)
Labeling
To help Americans avoid the health risks posed by food allergens, FDA enforces the Food Allergen Labeling and Consumer Protection Act of 2004 (the Act). The Act applies to the labeling of foods regulated by FDA which includes all foods except poultry, 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.
- 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: A Food Labeling Guide (January 2013)
- 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: Questions and Answers Regarding Food Allergens, including the Food Allergen Labeling and Consumer Protection Act of 2004 (Edition 4) (October 2006)
- Food Allergen Labeling and Consumer Protection Act of 2004 Questions and Answers (July 2006)
- 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
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.
Seafood HACCP
- Fish and Fishery Products Hazards and Controls Guidance (April 2011)
- Guidance for Industry: Seafood HACCP and the FDA Food Safety Modernization Act (August 2017)
Historical Information
- 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)
- Food Allergen Partnership (January 2001)
- "Dear Colleague” Letter About the “Food Allergen Partnership (March 2001)
- Label Declaration of Allergenic Substances in Foods; Notice to Manufacturers (June 1996)