January 23, 2007

FDA Proposes to Define the Term "Gluten-Free" for Voluntary Use in Food Labeling

The Food and Drug Administration (FDA) has published a proposed rule in the Federal Register, Docket No. 2005N-0279, titled "Food-Labeling: Gluten Free Labeling of Foods" (72 FR 2795). Included in the proposed rule is a definition established by the FDA for the term "gluten-free" for voluntary use in the labeling of foods. A definition for the term "gluten-free" would assist those who have celiac disease (also know as celiac spue or gluten-sensitive enteropathy) and their caregivers to more easily identify packaged foods that are safe for persons with celiac disease to eat. Celiac disease occurs in genetically susceptible individuals and causes damage to their small intestine when they consume gluten found in "prohibited grains." Celiac disease has no cure, but avoiding the consumption of gluten can resolve its symptoms, mitigate and possibly reverse damage, and reduce associated health risks. This proposed rule has been prepared in response to the Food Allergen Labeling and Consumer Protection Act of 2004, Title II of Public Law 108-282, enacted on August 2, 2004, which directs the Secretary of the Department of Health and Human Services to propose, and later make final, a rule that defines and permits the use of the food labeling term "gluten-free."

FDA is proposing to define the food labeling term "gluten-free" to mean that a food bearing this claim does not contain any of the following:

• an ingredient that is a "prohibited grain," which refers to any species of wheat (e.g., durum wheat, spelt wheat, or kamut), rye, barley or their crossbred hybrids;
• an ingredient (e.g., wheat flour) that is derived from a "prohibited grain" and that has not been processed to remove gluten;
• an ingredient (e.g., wheat starch) that is derived from a "prohibited grain" that has been processed to remove gluten, if the use of that ingredient results in the presence of 20 micrograms or more gluten per gram of food,
• or 20 micrograms or more gluten per gram of food.

A food that bears the claim "gluten-free" or a similar claim (e.g. "free of gluten," "without gluten," "no gluten") in its labeling and fails to meet the conditions specified in the proposed definition of "gluten-free" would be deemed misbranded.

Currently, there is no Federal regulation that defines the term "gluten-free" used in the labeling of foods. Based upon comments FDA received during its public meeting on "gluten-free" food labeling held in August 2005 and other information available to the Agency, there is no universal understanding among U.S. food manufacturers or consumers about the meaning of a food labeled as "gluten-free." FDA believes that establishing a definition for the term "gluten-free" and uniform conditions for its use in the labeling of foods will ensure that persons with celiac disease are not misled and are provided with truthful and accurate information.

The proposed rule has a 90-day public comment period. Interested persons can submit comments electronically or in writing as per instructions provided in Docket No. 2005N-0279.

A document titled "Questions and Answers on the Gluten-Free Labeling Proposed Rule" has been prepared by FDA and is available online.