Guidance, Compliance & Regulatory Information

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
  • 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
  • Gluten-Free
    • 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
        • Notice: Draft Report of the Threshold Working Group: Approaches to Establish Thresholds for Major Food Allergens and for Gluten in Food; Request for Comments and for Scientific Data and Information (June 17, 2005)
    • Proposed Rule: Food Labeling; Gluten-Free Labeling of Foods (January 23, 2007)
      • Questions and Answers on the Gluten-Free Labeling Proposed Rule January 23, 2007
    • 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

• 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 Food Labeling and Allergen Declaration; Public Workshop - August 14-15, 2002 in Dallas, Texas*
  • Federal Register Notice of Public Workshop* March 29, 2002
• Letter on Food Allergen Labeling Guidelines May 30, 2001
• Food Allergen Partnership January 2001
  • Letter About the Food Allergen Partnership March 2001
• Label Declaration of Allergenic Substances in Foods; Notice to Manufacturers June 1996

*Document is temporarily unavailable online.