Definitions. (1) The term “gluten-containing grain” means any one of the following grains or their crossbred hybrids (e.g., triticale, which is a cross between wheat and rye):

Wheat, including any species belonging to the genus Triticum;

Rye, including any species belonging to the genus Secale; or

Barley, including any species belonging to the genus Hordeum.

The term “gluten” means the proteins that naturally occur in a gluten-containing grain and that may cause adverse health effects in persons with celiac disease (e.g., prolamins and glutelins).

The labeling claim “gluten-free” means:

That the food bearing the claim in its labeling:

Does not contain any one of the following:

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

Any unavoidable presence of gluten in the food bearing the claim in its labeling is below 20 ppm gluten (i.e., below 20 mg gluten per kg of food).

Requirements. (1) A food that bears the claim “gluten-free” in its labeling and fails to meet the requirements of paragraph (a)(3) of this section will be deemed misbranded.

A food that bears the claim “no gluten,” “free of gluten,” or “without gluten” in its labeling and fails to meet the requirements of paragraph (a)(3) of this section will be deemed misbranded.

A food that bears the term “wheat” in the ingredient list or in a separate “Contains wheat” statement in its labeling, as required by 21 U.S.C. 343(w)(1)(A), and also bears the claim “gluten-free” or a claim identified in paragraph (b)(2) of this section will be deemed misbranded unless the word “wheat” in the ingredient list or in the “Contains wheat” statement is followed immediately by an asterisk (or other symbol) that refers to another asterisk (or other symbol) in close proximity to the ingredient statement that immediately precedes the following: “The wheat has been processed to allow this food to meet the Food and Drug Administration (FDA) requirements for gluten-free foods.”

Compliance. When compliance with paragraph (b) of this section is based on an analysis of the food, FDA will use a scientifically valid method that can reliably detect the presence of 20 ppm gluten in a variety of food matrices, including both raw and cooked or baked products.

Preemption. A State or political subdivision of a State may not establish or continue into effect any law, rule, regulation, or other requirement that is different from the requirements in this section for the definition and use of the claim “gluten-free,” as well as the claims “no gluten,” “free of gluten,” or “without gluten.”