FDA Releases Proposed Rule on Labels for Gluten-Free Foods

The Food and Drug Administration (FDA) last month proposed a rule defining the term "gluten free" that seeks 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 currently is reviewing the proposed rule and plans to work with members of the IDFA Allergens Task Force and the National Cheese Institute (NCI) Regulatory Committee to develop comments, which are due by April 23. Members interested in contributing to these comments should contact Frye at cfrye@idfa.org or 202-220-3543.

To read the proposed rule, click here. Members can click here for a detailed analysis of the proposed rule.

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Posted February 5, 2007