Restaurants and food manufacturers who market food or beverage items as “gluten free,” must meet all requirements of a new, regulatory definition of that term, the U.S. Food and Drug Administration said in a final rule issued Aug. 3.
According to the FDA’s final rule, which was published in the Federal Register Aug. 5, restaurants serving food or beverages termed "gluten-free," "free of gluten," "without gluten" or "no gluten," are making a food-labeling claim that should be consistent with the new regulatory definition for gluten-free.
The new federal definition, effective Sept. 4 with a compliance date of Aug. 5, 2014, would standardize the meaning of “gluten-free” claims across the food industry, the FDA said. In order to use the term "gluten-free" on labels, the food items must meet all of the requirements of the definition, including that they must contain less than 20 parts per million of gluten.
The FDA has broad discretion over food labels, and since 1993 has held restaurants to certain standards if they make nutrient-content or health claims about menu items, such as “fat free” or “low cholesterol.” The agency has now added “gluten-free” to the list of FDA-regulated claims. In guidance accompanying the new “gluten-free” definition suggested that “any use of an FDA-defined food labeling claim … on restaurant menus should be consistent with the respective definitions.”
This new, standardized definition is expected 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. The term "gluten" refers to proteins that occur naturally in wheat, rye, barley and cross-bred hybrids of those grains. Foods that contain gluten trigger production of antibodies that attack and damage the lining of the small intestine. That damage limits the ability of celiac disease patients to absorb nutrients and puts them at risk of other health problems, including nutritional deficiencies, osteoporosis, growth retardation, infertility, miscarriages, short stature and intestinal cancers.
“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 agency’s deputy commissioner for foods and veterinary medicine.
Joy Dubost, the National Restaurant Association’s director of nutrition, advised operators offering gluten-free items on their menus to make sure their labels are consistent with the FDA’s regulatory definition.
“Restaurants will be well-served to ensure they comply with FDA-defined claims,” she said.
According to the final rule, the FDA indicated that:
• Foods that inherently do not contain gluten, such as raw carrots or grapefruit juice, may use the ‘‘gluten-free’’ claim.
• Foods with any whole, gluten-containing grains, like spelt wheat, as ingredients may not use the claim;
• Foods with ingredients that are gluten-containing grains that are refined, but still contain gluten, such as wheat flour, may not use the claim, but
• Foods with ingredients that are gluten-containing grains that have been refined in such a way to remove the gluten, like wheat starch, may use the claim, as long as the food contains less than 20 parts per million of gluten, or has less than 20 milligrams of gluten per kilogram.
Working closely with suppliers is an important first step in developing menu options that qualify for gluten-free claims, Dubost said. “If you’re making gluten-free claims about any menu items, ask your suppliers to ensure they are providing grains or food components that comply with the new rule.”