Washington — The FDA today implemented its final rule defining the characteristics of packaged foods that can be labeled “gluten free.” In addition, the standard applies to all foods described as “without gluten,” “free of gluten” and “no gluten” on labels.
The rule stipulates that to satisfy the definition of gluten-free to the degree that an on-pack claim can be substantiated, a product can have no gluten-containing grain, such as wheat, barley, rye or hybrids of these grains; must not have ingredients derived from these grains that has not been processed to remove gluten; and if it does contain ingredients obtained from processed gluten-containing grain, the amount cannot exceed 20 parts per million, the lowest level in foods consistently detectable using valid scientific analytical tools.
In addition, foods that inherently contain no gluten such as bottled water, produce and eggs can be labeled “gluten-free.”
Effective today, manufacturers must be in compliance with the rule, which was published in the Federal Register on August 5, 2013. Food labels bearing the words “without gluten,” “free of gluten” and “no gluten” that do not adhere to the requirements of the rule will be considered misbranded under the Federal Food, Drug and Cosmetic Act and will be subject to regulatory action by the FDA.
“This standard ‘gluten-free’ definition will eliminate uncertainty about how food producers label their products and will assure people with celiac disease that foods bearing this label meet a clear standard established and enforced by the FDA,” Felicia Billingslea, JD, deputy FDA commissioner for foods and veterinary medicine, says.
Celiac disease affects less than 10 percent of the U.S. population — about three million people — and occurs when the body’s immune system reacts to the proteins that comprise gluten by attacking the lining of the small intestine, preventing absorption of nutrients. Anemia, osteoporosis, autoimmune thyroid disease, diabetes, intestinal cancers and delayed growth are associated with long-term celiac disease.
The agency warns that some items produced prior to August 5 and labeled “gluten free” might still be on shelves.
Under the rule, companies listing a product as “gluten free” won’t have to provide evidence of testing for starting ingredients or finished food to verify compliance. They are responsible for ensuring the products satisfy FDA standards if they do make the claim.