Gluten-Free Food Label

Gluten-Free Food Label

On August 5, 2013, FDA issued a final rule defining the term “gluten-free” for voluntary use in the labeling of foods. The compliance date for the final rule was August 5, 2014. Food products bearing a gluten-free claim labeled on or after that date must meet the rule's requirements. In addition, on June 25, 2014, FDA issued a guide for small food businesses to help them comply with the final rule's requirements. FDA will continue to educate and monitor industry on the gluten-free claim.

 Who does the rule benefit? These actions benefit people with celiac disease, an inherited chronic inflammatory auto-immune disorder that is estimated to affect up to 3 million Americans. For people who have celiac disease, consumption of gluten results in the destruction of the lining of the small intestine and the risk of other serious health conditions. The definition also benefits the food industry by establishing a level playing field among manufacturers of products labeled “gluten-free.”

In general, foods may be labeled “gluten-free” if they meet the definition and otherwise comply with the final rule’s requirements. More specifically, the final rule defines "gluten-free" as meaning that the food either is inherently gluten free; or does not contain an ingredient that is: 1) a gluten-containing grain (e.g., spelt wheat); 2) derived from a gluten-containing grain that has not been processed to remove gluten (e.g., wheat flour); or 3) derived from a gluten-containing grain 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. Also, any unavoidable presence of gluten in the food must be less than 20 ppm.

The final rule applies to all FDA-regulated packaged foods, including dietary supplements. The rule excludes those foods whose labeling is regulated by the U.S. Department of Agriculture (USDA) and the Alcohol and Tobacco Tax and Trade Bureau (TTB). Generally, USDA regulates the labeling of meats, poultry, and certain egg products (FDA regulates the labeling of shell eggs). TTB regulates the labeling of most alcoholic beverages, including all distilled spirits, wines that contain 7 percent or more alcohol by volume, and malted beverages that are made with both malted barley and hops.  FDA says that restaurants making a gluten-free claim on their menus should be consistent with FDA’s definition

All foods imported into the United States must meet the same federal requirements as foods domestically produced. Therefore, if the label of an imported food subject to FDA regulations makes a gluten-free claim, that food must comply with the gluten-free labeling requirements.