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U.S. Department of Health and Human Services

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Summary: Food Labeling; Gluten-Free Labeling of Foods Regulatory Impact Analysis

The Food and Drug Administration is issuing a final rule to define the term "gluten-free" for voluntary use in the labeling of foods.  The final rule defines the term "gluten-free" to mean that the food bearing the claim does not contain an ingredient that is a gluten-containing grain (e.g., spelt wheat); an ingredient that is derived from a gluten-containing grain and that has not been processed to remove gluten (e.g., wheat flour); or an ingredient that is derived from a gluten-containing 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 more gluten in the food (i.e., 20 milligrams (mg) or more gluten per kilogram (kg) of food); or inherently does not contain gluten, and; that any unavoidable presence of gluten in the food is below 20 ppm gluten (i.e., below 20 mg gluten per kg of food). 

A food that bears the claim "no gluten," "free of gluten," or "without gluten" in its labeling and fails to meet the requirements for a "gluten-free" claim will be deemed to be misbranded.  In addition, a food whose labeling includes the term "wheat" in the ingredient list or in a separate "Contains wheat" statement as required by a section of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) and also bears the claim "gluten-free" will be deemed to be misbranded unless its labeling also bears additional language clarifying that the wheat has been processed to allow the food to meet FDA requirements for a "gluten-free" claim.  Establishing a definition of the term “gluten-free” and uniform conditions for its use in food labeling will help ensure that individuals with celiac disease are not misled and are provided with truthful and accurate information with respect to foods so labeled.  We are issuing the final rule under the Food Allergen Labeling and Consumer Protection Act of 2004 (FALCPA).

Regulatory Impact Analysis

 Food Labeling; Gluten-Free Labeling of Foods (PDF - 278KB)