FDA Defines ‘Gluten-free’ for Food Labels

The U.S. Food and Drug Administration (FDA) has published a new regulation defining the term “gluten-free” for voluntary food labeling, with the goal of providing a uniform standard definition to help the up to 3 million Americans with celiac disease, an autoimmune digestive condition that can be effectively controlled only by following 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,” noted FDA commissioner Margaret A. Hamburg. “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.”

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

Food manufacturers will have a year after the rule's publication 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, the FDA’s deputy commissioner for foods and veterinary medicine.

The agency was directed to issue the new regulation by the Food Allergen Labeling and Consumer Protection Act (FALCPA). The rule was published in the Federal Register.