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Information about Food Allergens

Each year, millions of Americans have allergic reactions to food. Although most food allergies cause relatively mild and minor symptoms, some food allergies can cause severe reactions, and may even be life-threatening.

There is no cure for food allergies. Strict avoidance of food allergens — and early recognition and management of allergic reactions to food — are important measures to prevent serious health consequences.

Information from FDA
- Consumer Information
- Industry/Regulator Information
  (including Food Allergen Labeling & Consumer Protection Act of 2004; Allergen Guides; Training)
- Background Information
Information from Other Federal Government Agencies

Information from FDA

Consumer Information

FDA Announces Public Hearing on Food Advisory Labeling August 8, 2008
- Federal Register Notice: Food Labeling; Current Trends in the Use of Allergen Advisory Labeling: Its Use, Effectiveness, and Consumer Perception; September 16, 2008 August 8, 2008
- Registration Information and Deadlines
Food Allergies: What You Need to Know February 2007 (also available in Spanish)
Food Labels Identify Allergens More Clearly March-April 2006
Food Allergen Labeling And Consumer Protection Act of 2004 Questions and Answers December 12, 2005; Updated July 18, 2006
Food Allergies: When Food Becomes the Enemy April 2004
Food Allergies: Rare but Risky May 1994; Updated December 2004
Search the FDA Web site for Allergy Alert.

Industry/Regulator Information

Food Allergen Labeling and Consumer Protection Act of 2004 (Title II of Public Law 108-282) August 2, 2004 (also available in PDF)
- Report to The Committee on Health, Education, Labor, and Pensions United States Senate And The Committee on Energy and Commerce United States House of Representatives, July 2006 (available in PDF, 1.8 Mb)
- Inventory of Petitions Received under 21 U.S.C. 343(w)(6) for Exemptions from Food Allergen Labeling June 13, 2006
- Inventory of Notifications Received under 21 U.S.C. 343(w)(7) for Exemptions from Food Allergen Labeling July 18, 2006
- Approaches to Establish Thresholds for Major Food Allergens and for Gluten in Food March 2006
  - FDA's Responses to Public Comments on the Draft Report "Approaches to Establish Thresholds for Major Food Allergens and for Gluten in Food" March 2006
  - Draft Report: Approaches to Establish Thresholds for Major Food Allergens and for Gluten in Food June 15, 2005
- FDA to Require Food Manufacturers to List Food Allergens December 20, 2005
- Guidance
  - Guidance for Industry: Questions and Answers Regarding Food Allergens, including the Food Allergen Labeling and Consumer Protection Act of 2004 (Edition 4) October 2006
  - Guidance for Industry: Guidance on the Labeling of Certain Uses of Lecithin Derived from Soy Under Section 403(w) of the Federal Food, Drug, and Cosmetic Act April 2006
- Federal Register Notice of Public Meeting, Request for Comments: Gluten-Free Labeling of Foods July 19, 2005
  - Transcript of Public Meeting on Gluten-Free Labeling, August 19, 2005
  - Errata Sheet for Transcript
- See also Information for Consumers: Food Allergen Labeling And Consumer Protection Act of 2004 Questions and Answers December 12, 2005; Updated July 18, 2006
Allergen Guides
- Dear Colleague Letter on Allergen Guides May 3, 2001
- Questions and Answers on Allergen Guides May 3, 2001
- Compliance Policy Guide: "Statement of Policy for Labeling and Preventing Cross-contact of Common Food Allergens" April 19, 2001
- Inspection Guide: "Guide to Inspections of Firms Producing Products Susceptible to Contamination with Allergenic Ingredients" August 2001
Food Allergen Inspection Training for Regulators October 5, 2001
- Conducting Food Allergen Inspections (training videos)
Training Video: Requirements for Labeling on Food & Dietary Supplements, Nutrition Labeling, & Allergen Labeling August 2007

Background Information

FDA Commends Passage by the House of Representatives of S. 741, a Bill Providing Improved Consumer Protection and Incentives for Animal Drug Development FDA Press Release, July 20, 2004
FDA Collaborates with AOAC to Gain Approval of Peanut Test Kits for Food Products October 30, 2003
FDA Food Labeling and Allergen Declaration; Public Workshop - August 14-15, 2002 in Dallas, Texas
- Announcement
- Federal Register Notice of Public Workshop March 29, 2002 (also available in PDF)
FDA Public Meeting on August 13, 2001: The Challenge of Labeling Food Allergens July 24, 2001
Letter on Food Allergen Labeling Guidelines May 30, 2001
Food Allergen Partnership January 2001
- Letter About the Food Allergen Partnership March 2001
Food Allergen Awareness: An FDA Priority February-March 2001 (also available in PDF)
The FDA, Food Allergens and You Audio Slide Presentation November 2000
Label Declaration of Allergenic Substances in Foods; Notice to Manufacturers June 1996

Information from Other Federal Government Agencies

Department of Agriculture
- Food Allergy Educational Materials WIC Works Resource System
- Food Allergies and Intolerances (Nutrition.gov)
Department of Health and Human Services Healthfinder
- Food Allergies
National Institutes of Health
- Food Allergy
National Institute of Allergy and Infectious Diseases
- Food Allergy An Overview (available in PDF, 395 Kb)
National Library of Medicine
- Food Allergy (Medical Encyclopedia)
- Food Allergy (MEDLINEplus)

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