“Gluten-free” for Food Labeling Defined by FDA

A new regulation published by the FDA earlier this month defines the term “gluten-free” for voluntary food labeling. The regulation provides a uniform standard definition to help patients who have celiac disease, up to 3 million Americans.

“Adherence to a gluten-free diet is the key to treating celiac disease,” said FDA Commissioner Margaret A. Hamburg, MD. “The 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. To use the term “gluten-free” on its label, a food must meet all 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.

Many foods currently labeled as “gluten-free” may be able to meet the new federal definition already, the FDA stated. 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, the FDA’s deputy commissioner for foods and veterinary medicine.

The term “gluten” refers to proteins that occur naturally in wheat, rye, barley, and cross-bred hybrids of these grains, the FDA noted. In patients who have celiac disease, foods that contain gluten trigger production of antibodies that attack and damage the lining of the small intestine. Such damage limits their ability to absorb nutrients and places them at risk for other health problems, such as nutritional deficiencies, osteoporosis, growth retardation, infertility, miscarriages, short stature, and intestinal cancers.

The FDA was directed to set guidelines for the use of the term “gluten-free” by the Food Allergen Labeling and Consumer Protection Act.

The regulation was published in the Federal Register. Following are excerpts.

The final rule defines the term “gluten-free” to mean that the food bearing the claim does not contain an ingredient that is a gluten-containing grain (e.g., spelt wheat); an ingredient that is derived from a gluten-containing grain and that has not been processed to remove gluten (e.g., wheat flour); or an ingredient that is derived from a gluten-containing grain and 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 (i.e., 20 milligrams (mg) or more gluten per kilogram (kg) of food); or inherently does not contain gluten; and that any unavoidable presence of gluten in the food is below 20 ppm gluten (i.e., below 20 mg gluten per kg of food). A food that bears the claim “no gluten,” “free of gluten,” or “without gluten” in its labeling and fails to meet the requirements for a “gluten-free” claim will be deemed to be misbranded. A food whose labeling includes the term “wheat” in the ingredient list or in a separate “Contains wheat” statement as required by a section of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) and also bears the claim “gluten-free” will be deemed to be misbranded unless its labeling also bears additional language clarifying that the wheat has been processed to allow the food to meet FDA requirements for a “gluten-free” claim.