FDA defines 'gluten-free' for food labeling

August 7, 2013

FDA defines 'gluten-free' for food labeling

The U.S. Food and Drug Administration (FDA) recently published a new regulation in the Federal Register defining the term “gluten-free” for voluntary food labeling. This final rule will provide a uniform standard definition to help the up to 3 million Americans who have celiac disease, an autoimmune digestive condition that can be effectively managed only by eating a gluten-free diet.

“Adherence to a gluten-free diet is the key to treating celiac disease, which can be very disruptive to everyday life,” said FDA Commissioner Margaret A. Hamburg, M.D. “The FDA’s new gluten-free definition will help people with this condition make food choices with confidence and allow them to better manage their health.”

This new federal definition standardizes the meaning of gluten-free claims across the food industry. It requires that, in order to use the term gluten-free on its label, a food must meet all of the requirements of the definition, including that the food must contain less than 20 parts per million of gluten. The rule also requires foods with the claims “no gluten,” “free of gluten,” and “without gluten” to meet the definition for “gluten-free.”

The FDA recognizes that many foods currently labeled as “gluten-free” may be able to meet the new federal definition already. Food manufacturers will have a year after the rule is published to bring their labels into compliance with the new requirements.

“We encourage the food industry to come into compliance with the new definition as soon as possible and help us make it as easy as possible for people with celiac disease to identify foods that meet the federal definition of gluten-free, said Michael R. Taylor, FDA deputy commissioner for foods and veterinary medicine.

The FDA was directed to issue the new regulation by the Food Allergen Labeling and Consumer Protection Act (FALCPA), which directed FDA to set guidelines for the use of the term gluten-free to help people with celiac disease maintain a gluten-free diet

Federal Register

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