When the definition is final and is published in the United States Congressional Federal Register, the CSA national office will alert, by email, those CSA members with a current email address in the CSA database. We encourage members to 1) call the office and provide a valid, current email address so that you may receive the alert, and 2) periodically check the CSA website, or the FDA website, www.FDA.gov, for the announcement and details.

• In summary - as of April 23, 2007

  The proposed FDA definition specifies that a food labeled “gluten-free” does not contain any of the following:

          

  • An ingredient that is any species of the grains wheat, rye, barley, or a crossbred hybrid of these grains (collectively referred to as “prohibited grains”)
  • An ingredient that is derived from a prohibited grain and that has NOT been processed to remove gluten (e.g. wheat flour)
  • An ingredient that is derived from a prohibited grain and that has been processed to remove gluten (e.g. wheat starch) if the use of that ingredient results in the presence of 20 parts per million (ppm or mg/kg) or more gluten in the food
  • 20 ppm or more gluten

   

  A food that bears the claim “gluten-free” in its labeling and does not meet these conditions would be deemed misbranded. Foods that are inherently or naturally free of gluten would also be deemed misbranded if the claim does not refer to all foods of that same type (e.g., “milk, a gluten-free food” or “all milk is gluten-free”)

   

  A food made from oats and labeled “gluten-free” must contain less than 20 ppm gluten.

   

  According to the FDA, establishing a definition of the term “gluten-free” and uniform conditions for its use in the labeling of foods is needed to ensure that individuals with celiac disease are not misled and are provided with truthful and accurate information with respect to foods so labeled. The proposed definition is in response to the Food Allergen Labeling and Consumer Protection Act of 2004 (FALCPA)

• Full Text of FDA Proposed Definition Published January 23, 2007

•  FDA "Questions and Answers" on the Gluten-Free Labeling Proposed Rule

• Allergen Advisory Labeling

• Public Hearing on Food Advisory Labeling - 2008

The U.S. Food and Drug Administration (FDA) held a public hearing on allergen advisory labeling on September 16, 2008, at the FDA Center for Food Safety and Applied Nutrition's Harvey W. Wiley Building in College Park, Maryland. The hearing included presentations by agency officials, invited speakers and members of the public. Formal notice of the Hearing was published in the Federal Register on August 8, 2008.

Federal Register Notice and background information

   

FDA is developing a long-term strategy to assist manufacturers in using allergen advisory labeling that is truthful and not misleading, conveys a clear and uniform message, and adequately informs food allergic consumers and their caregivers. To that end, FDA is soliciting comments and information to assist the agency in determining how manufacturers currently use advisory labeling, how consumers interpret different advisory labeling statements, and what wording is likely to be most effective in communicating to consumers the likelihood that an allergen may be present in a food. The agency is also interested in receiving comments about whether consumers find advisory labeling helpful for making food purchasing decisions. This public hearing is the first step in closing existing knowledge gaps in developing our long-term strategy.

   

• Presentations and Public Comments already submitted

      

• Add your own comments   

• The Food Allergen Labeling and Consumer Protection Act of 2004

The Food Allergen Labeling and Consumer Protection Act of 2004 (FALCPA) became law on August 2, 2004. Beginning January 1, 2006, FALCPA requires food manufacturers to identify in plain English any ingredient from any of the eight major food allergens: milk, eggs, fish, crustacean shellfish, tree nuts, peanuts, wheat, or soybeans. Such identification must be within ingredient labeling or in a "contains" statement after ingredient labeling. 

• Full text of The Food Allergen Labeling and Consumer Protection Act of 2004

• 2006 Report on Section 204 of The Food Allergen Labeling and Consumer Production act of 2004.

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

Full Report

• Summary Outline

• The Occurrence of Cross-Contact and Use of CGMP
• Use of Advisory Labeling by Food Producers
• Consumer Perferences for Food Allergen Labeling
• FDA's Allergen-focused Inspections
• Allergen Recalls
• Current Efforts to Control Cross-contact  

• FDA Information for Consumers:

Food Allergen Labeling And Consumer Protection Act of 2004

Questions and Answers

• More FDA information about Food Allergies

 

• FDA Guidance for Industry:

Questions and Answers Regarding Food Allergens, including the Food Allergen Labeling and Consumer Protection Act of 2004 (Edition 4)

Final Guidance

CSA efforts for Food Allergen Labeling since 1990

• Lifeline 2005 No. III article "Public Hearing resulting from passage of the Food Allergen Labeling and Consumer Protection Act of 2004" by CSA Executive Director, Mary A. Schluckebier.

• Lifeline Summer 2004 article "The Food Allergen Labeling and Consumer Protection Act" A summary of the bill's provisions by CSA Executive Director, Mary A. Schluckebier M.S.