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Dairy Facts 2016

FDA Issues Final Definition of ‘Gluten-Free’

Aug 07, 2013

The Food and Drug Administration finalized on Monday a definition for the voluntary claim “gluten-free” on foods and beverages. According to the final rule, products that contain less than 20 parts per million of gluten may make a “gluten-free” claim. This claim will apply to products that naturally contain no gluten, including many dairy products, and to products that contain ingredients that have been processed to remove the gluten.

The definition was required by the Food Allergen Labeling and Consumer Protection Act (FALCPA), which also requires labeling for major food allergens. A proposed rule for gluten-free claims was published in January 2007.

One difference between the final rule and the proposed rule is that foods that are inherently gluten-free can make a “gluten-free” claim just like other foods that are specially processed to remove gluten. In the proposed rule, foods that are naturally gluten-free, such as milk, would have been required to show an alternate claim – “a gluten-free food” – to emphasize that all products of the type were naturally free of gluten.

Single Gluten-Free Claim Easier for Consumers

This change came after comments to the proposed rule indicated that even products that are naturally gluten-free could be available in various formulations, such as different flavors, some of which may contain gluten. A single “gluten-free” claim is easier for consumers to understand, allowing less chance for confusion about which foods are naturally gluten free.

Products that would qualify for the “gluten-free” claim but that do contain a wheat ingredient, which is a major source of gluten in foods, would need to make an additional statement: “The wheat has been processed to allow this food to meet the Food and Drug Administration (FDA) requirements for gluten-free foods.”

The requirements for a “gluten-free” claim would also apply to the claims “no gluten,” “free of gluten,” and “without gluten.” The final rule will preempt all state or local regulations regarding these specific gluten claims, but it will not necessarily preempt any additional gluten statements. FDA declined to define levels for “low gluten” or “very low gluten” claims or to set a single symbol to designate gluten-free foods.

The compliance date for the final rule is August 5, 2014. All companies with “gluten-free” claims on their product labels should ensure that the claims are in line with the requirements of the final rule by this date.

Members with questions may contact Cary Frye, IDFA vice president of regulatory and scientific affairs, at or Michelle Matto, IDFA’s nutrition and labeling consultant, at

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