‘Gluten-free’ definition standardized

Aug. 7, 2013

The U.S. Food and Drug Administration (FDA) has standardized the definition of “gluten-free” in a move designed to help millions of Americans affected by celiac disease (CD).

The U.S. Food and Drug Administration (FDA) has standardized the definition of "gluten-free" in a move designed to help millions of Americans affected by celiac disease (CD). With a clear definition available, food manufacturers will have a reliable guide for labeling, while consumers with special dietary needs can be certain that they are not buying products which could damage their health.

If a food company wants to label a product as "gluten-free" it can only do so if the food complies with all definition requirements, including a gluten presence of less than 20 parts per million. The same rules apply to foods with labels that say "no gluten," "free of gluten" and "without gluten."

The issuance of the new regulation was mandated by the Food Allergen Labeling and Consumer Protection Act (FALCPA). The FDA was tasked with providing guidelines on "gluten-free" labeling so that people with CD can effectively manage their condition. As FDA Commissioner Margaret Hamburg noted, a gluten-free diet is key to dealing with CD, which affects about three million Americans. The introduction of a uniform definition will give these people confidence in making their food choices and will help them lead healthier lives, Hamburg said.

"Gluten" is a term covering proteins found in wheat, rye and barley, as well as hybrids derived through cross-breeding of these grains. CD is an autoimmune digestive condition that requires a gluten-free diet for effective management. If people with this condition consume foods with gluten, the result is the production of antibodies damaging the lining of the small intestine. This prevents proper absorption of nutrients and can lead to other serious health problems, among then nutritional deficiencies, osteoporosis and intestinal cancers.

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The FDA noted that many foods which currently sport the "gluten-free" label may already be capable of meeting the new definition requirements. Food producers have a year to become compliant with the new rule, starting from the date of its publication (Aug. 2, 2013). Michael Taylor, deputy commissioner for foods and veterinary medicine at the FDA, urged the food industry to make their labels compliant with the regulation as soon as possible for the sake of all people relying on a gluten-free diet for their health.

The new rule was described as a "very big deal" by Virginia Cox, associate commissioner at the FDA office of external affairs. As a person affected by CD, Cox is in a strong position to appreciate the significance of this move. In her post on the FDA blog, Cox said that food manufacturers had made impressive progress in delivering a vast choice of products for people with gluten intolerance. Since there is no cure for the disease, one in 133 Americans has to rely on a gluten-free diet to keep in good health. Now that all food manufacturers have a clear, standard definition to guide them, people will be safe in the knowledge that the products they are buying are really "gluten-free." Awareness of CD and its management are still work in progress but the availability of a uniform "gluten-free" definition for food labeling purposes will significantly facilitate efforts to improve the situation, both for CD patients and healthcare professionals, Cox added.