WASHINGTON – The deadline is up, and the US Food and Drug Administration is prepared to enforce provisions in the agency's final rule regarding gluten-free claims.

Manufacturers had one year to bring their labels into compliance. But as of Aug. 5, any food product bearing a gluten-free label claim must comply with the federal rule. Criteria for using the gluten-free claim includes a gluten limit of less than 20 ppm (parts per million) in foods that carry the label claim, according to FDA. The agency said this is the lowest level that can be consistently detected in foods using valid scientific analytical tools.

Additionally, most people with celiac disease can tolerate foods containing very small amounts of gluten. FDA noted the 20 ppm level is consistent with standards set by other countries and international bodies.

"This standard 'gluten-free' definition will eliminate uncertainty about how food producers label their products and will assure people with celiac disease that foods labeled 'gluten-free' meet a clear standard established and enforced by FDA," Felicia Billingslea, JD, deputy FDA commissioner for foods and veterinary medicine, said in an FDA consumer update.

FDA noted that as many as 3 million individuals in the United States have celiac disease, a condition that occurs when the body's immune system react to gluten by attacking the lining of the small intestine.

FDA's rule states gluten-free is not:

• an ingredient that is any type of wheat, rye, barley or crossbreeds of these grains
• an ingredient derived from these grains and that has not been processed to remove gluten
• an ingredient derived from these grains and that has been processed to remove gluten, if it results in the food containing 20 or more parts per million (ppm) gluten

Foods that are inherently gluten-free, such as bottled water, produce and eggs, can be labeled gluten-free. FDA's Billingslea said restaurants or other foodservice establishments should be consistent with FDA's definition when using gluten-free claims on menus.

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