Food Allergens Guidance Documents & Regulatory Information

Guidance for Industry

Guidance documents contain nonbinding recommendations.

 

• Establishment of Dockets: Risk Assessment for Establishing Food Allergen Thresholds; Request for Comments December 2012

• Request for Comments: Food Labeling; Current Trends in the Use of Allergen Advisory Labeling: Its Use, Effectiveness, and Consumer Perception; Public Hearing August 8, 2008

• Proposed Rule: Food Labeling; Gluten-Free Labeling of Foods January 2007

  • Questions and Answers on the Gluten-Free Labeling Proposed Rule January 2007

• Guidance for Industry: Questions and Answers Regarding Food Allergens, including the Food Allergen Labeling and Consumer Protection Act of 2004 (Edition 4) October 2006

• 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 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

• WITHDRAWN: Guidance for Industry: Guidance on the Labeling of Certain Uses of Lecithin Derived from Soy Under Section 403(w) of the Federal Food, Drug, and Cosmetic Act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

• Approaches to Establish Thresholds for Major Food Allergens and for Gluten in Food March 2006

• Food Allergen Labeling And Consumer Protection Act of 2004 Questions and Answers 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

• Public Meeting: Gluten-Free Food Labeling August 2005

• Draft Report: Approaches to Establish Thresholds for Major Food Allergens and for Gluten in Food June 2005 (available in PDF, 15MB)

• Food Allergen Labeling and Consumer Protection Act of 2004 (Title II of Public Law 108-282) August 2004

• Inspection Guide: "Guide to Inspections of Firms Producing Products Susceptible to Contamination with Allergenic Ingredients" August 2001

• Dear Colleague Letter on Allergen Guides May 2001

• Questions and Answers on Allergen Guides May 2001

• Letter on Food Allergen Labeling Guidelines May 2001

• Compliance Policy Guide: "Statement of Policy for Labeling and Preventing Cross-contact of Common Food Allergens" April 2001

• Food Allergen Partnership January 2001

  • Letter About the Food Allergen Partnership

• Label Declaration of Allergenic Substances in Foods; Notice to Manufacturers June 1996

 

 

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