FDA Defines “Gluten-Free” for Food Labels


The legal U.S. limit for gluten in a "gluten-free" product is now 20 parts per million.

By Robby Gardner, Associate Editor


FDA has finally established a definition for “gluten-free” food labels. The decision comes not a moment too soon, as gluten-free advocates have pressured FDA for years to make this decision.

Gluten is a protein found in several grains, including wheat, barley, rye, and even some oats. When people with celiac disease consume gluten, their immune systems inflict damage on villi in their small intestines, resulting in poor absorption of nutrients from food. Celiacs experience a variety of symptoms in response to consuming gluten, and non-celiacs who simply choose a gluten-free lifestyle will often claim their own personal health improvements.

FDA’s “gluten-free” definition requires that a food labeled as such “must contain less than 20 parts per million of gluten.” The definition also applies to similar marketing terms, such as “no gluten,” “free of gluten,” and “without gluten.” While the definition is firm, manufacturers of gluten-free products will not be required to use the label.

The agency is giving manufacturers until August 5, 2014, to comply with the new rule, and manufacturers are encouraged to get an early start. In some cases where manufacturers are using common “gluten-free” labeling schemes, their products may already be within legal bounds.

In providing details to the general public, FDA has gone ahead and answered a few important questions about how the new rule will affect commerce. When asked if the agency will seek out offenders (manufacturers using the label and not meeting gluten limits), FDA said it “may use the full range of its routine post-market monitoring activities to enforce the final rule…” but manufacturers are ultimately responsible for the accuracy of their own claims.

When asked about marketing wheat products as “gluten-free,” FDA noted that any product labeled as containing wheat, but also labeled as “gluten-free,” must include additional language clarifying that the wheat was processed in such a way as to meet the FDA’s new threshold of 20 parts per million of gluten.

Nutritional Outlook thanks Justin Prochnow of law firm Greenberg Traurig LLC for the tip.

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