FDA News

FDA rules for gluten-free labeling take effect

The FDA standards established in August 2013 defining requirements for food products labeled “gluten-free” go into effect today, according to an FDA consumer update.

Food product manufacturers were given 1 year to comply with the new label requirements, which apply to any food whose label reads, “gluten-free,” “without gluten,” “free of gluten,” or “no gluten.” A key new requirement for a product to be labeled “gluten free” is a gluten limit of less than 20 ppm, which is the lowest level at which gluten can be consistently and objectively detected in food, and is consistent with international food safety standards.

“This standard ‘gluten-free’ definition eliminates uncertainty about how food producers label their products,” Felicia Billingslea, director of the FDA’s division of food labeling and standards, said in the consumer update. “People with celiac disease can rest assured that foods labeled ‘gluten-free’ meet a clear standard established and enforced by FDA.”

Until now there were no federal standards required of the food industry for the use of “gluten-free” on product labels, and as a result an estimated 5% of foods labeled “gluten-free” contained gluten in amounts that exceeded the new threshold.

The new rules also permit manufacturers to use a “gluten-free” label if the food does not contain wheat, rye, barley or crossbreeds of these grains; ingredients derived from these grains and not processed to remove gluten; or ingredients derived from these grains and processed to remove gluten if the resulting product exceeds the 20 ppm threshold. Any product that fails to meet these requirements “is considered misbranded and subject to regulatory action by the FDA.”

The newly enforced requirements apply to packaged foods, and consumers with concerns should be cautious about foods marketed as gluten-free in restaurants, according to the update.

“With the new FDA gluten-free regulations now being enforced, restaurants will be well-served to ensure they are meeting the FDA-defined claim,” Joy Dubost, PhD, RD, senior director of nutrition of the National Restaurant Association, said in the update. “We will continue to work with restaurant operators and chefs to assist and ensure a favorable dining experience for consumers.”

The FDA standards established in August 2013 defining requirements for food products labeled “gluten-free” go into effect today, according to an FDA consumer update.

Food product manufacturers were given 1 year to comply with the new label requirements, which apply to any food whose label reads, “gluten-free,” “without gluten,” “free of gluten,” or “no gluten.” A key new requirement for a product to be labeled “gluten free” is a gluten limit of less than 20 ppm, which is the lowest level at which gluten can be consistently and objectively detected in food, and is consistent with international food safety standards.

“This standard ‘gluten-free’ definition eliminates uncertainty about how food producers label their products,” Felicia Billingslea, director of the FDA’s division of food labeling and standards, said in the consumer update. “People with celiac disease can rest assured that foods labeled ‘gluten-free’ meet a clear standard established and enforced by FDA.”

Until now there were no federal standards required of the food industry for the use of “gluten-free” on product labels, and as a result an estimated 5% of foods labeled “gluten-free” contained gluten in amounts that exceeded the new threshold.

The new rules also permit manufacturers to use a “gluten-free” label if the food does not contain wheat, rye, barley or crossbreeds of these grains; ingredients derived from these grains and not processed to remove gluten; or ingredients derived from these grains and processed to remove gluten if the resulting product exceeds the 20 ppm threshold. Any product that fails to meet these requirements “is considered misbranded and subject to regulatory action by the FDA.”

The newly enforced requirements apply to packaged foods, and consumers with concerns should be cautious about foods marketed as gluten-free in restaurants, according to the update.

“With the new FDA gluten-free regulations now being enforced, restaurants will be well-served to ensure they are meeting the FDA-defined claim,” Joy Dubost, PhD, RD, senior director of nutrition of the National Restaurant Association, said in the update. “We will continue to work with restaurant operators and chefs to assist and ensure a favorable dining experience for consumers.”