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FDA issues rules for gluten-free food labeling


SILVER SPRING, Md. — Gluten-free foods have been all the rage lately as more retailers move to address patients with gluten intolerance and celiac disease.

In response, the Food and Drug Administration moved Friday to issue rules defining "gluten-free" and the characteristics of food that bear the label. Criteria for gluten-free food include a gluten limit of less than 20 parts per million, which is the lowest level that can be consistently detected in foods using scientific tools, is tolerable to most people with celiac disease and is consistent with rules in other countries.

The regulation will be published on Monday in the Federal Register and also applies to labels such as "free of gluten," "without gluten" and "no gluten."

"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," FDA commissioner for foods and veterinary medicine Michael Taylor said.

Gluten is a kind of protein that occurs naturally in wheat, rye, barley and crossbreeds of them, but up to 3 million people in the United States have celiac disease. In celiac disease, the body reacts to gluten by attacking the lining of the small intestine, preventing the body from absorbing the nutrients it needs and causing problems like delayed growth, anemia and osteoporosis, as well as diabetes, autoimmune thyroid disease and intestinal cancers.

"This is a tool that has been desperately needed," American Celiac Disease Alliance executive director Andrea Levario said, referring to the new rule. "It keeps food safe for this population, gives them the tools they need to manage their health and obviously has long-term benefits for them."

Other criteria for the rule include absence of a gluten-containing grain; absence of ingredients derived from those grains that have not been processed to remove gluten; and absence of ingredients that have been processed to remove gluten, but still contain 20 parts per million or more of the protein.

"This is bigger than products or brands; this is a consumer safety issue," gluten-free food maker Boulder Brands EVP T.J. McIntyre said. "For Americans with celiac disease, eating gluten-free foods is the only treatment, as there are no medications available to them."

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