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FDA Reopens Comment Period on Gluten-Free Claims

Aug 03, 2011

In a move announced in a stakeholder call yesterday and in a Federal Register notice today, the Food and Drug Administration has reopened its proposed rule on "gluten-free" claims originally published in 2007. FDA is seeking input on a new gluten safety assessment to determine whether the results of the assessment should affect "gluten-free" claims.

The agency also requests comments on the levels of gluten that should be allowed in products carrying a "gluten-free" claim and the analytical test methods used to test for gluten in foods. These comments are due October 3, 2011.

In the proposed rule, FDA defines the term "gluten free" and aims to establish uniform conditions for its use on food labels. FDA issued the proposed rule in response to the Food Allergen Labeling and Consumer Protection Act of 2004 (FALCPA), which directed the Secretary of Health and Human Services to ensure that people with celiac disease receive accurate information about gluten-free products. Celiac disease is a condition that makes some people more sensitive or intolerant to gluten, a natural protein found in wheat and other grains.

"People don't normally think about gluten being an ingredient in dairy products, but cultures for some cheeses, such as blue cheese, are grown on a wheat-based medium," said Cary Frye, vice president of regulatory affairs. "Also, some ice cream products, like an ice cream sandwich, would contain wheat and wheat flour."

The use of "gluten free" as a claim on food labels is voluntary, but the proposed rule would require processors using the claim to adhere to a new set of guidelines. The proposed rule would prohibit the use of "gluten free" on labels for any products containing wheat, rye and barley, as well as for foods containing 20 parts per million or more of gluten.

IDFA submitted comments in 2007, saying "IDFA and its members support the agency's proposal for labeling of gluten-free foods that would establish a 20 ppm threshold based on the accuracy of current analytical detection methods. However, we strongly endorse that new thresholds be determined only on future safety assessments.

"Based on the need for foods that are inherently free of gluten to add additional qualification that these foods are naturally gluten free, IDFA also seeks clarification that this qualification language would be required only for basic foods with no added ingredients such as flavoring. Therefore, foods such a flavored milk or yogurt with other indigents added would still be permitted to bear the unqualified 'gluten-free' claim."

Members with questions may contact Michelle Matto, IDFA nutrition and labeling consultant, at (202) 431-6864 or


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