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FDA sets 'gluten-free' labeling standards

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By Sarah LeTrent

(CNN) -- The U.S. Food and Drug Administration set a final standard on Friday to clearly define what the term "gluten-free" means on food labels.

The new regulation is targeted to help the estimated 3 million Americans who have celiac disease, a chronic inflammatory auto-immune disorder that can affect the lining of the small intestine when gluten is consumed. Gluten is a protein composite found in wheat, rye, barley and crossbreeds of these grassy grains.

"Adherence to a gluten-free diet is the key to treating celiac disease, which can be very disruptive to everyday life," said FDA Commissioner Margaret A. Hamburg, in the release. "The FDA's new 'gluten-free' definition will help people with this condition make food choices with confidence and allow them to better manage their health."

The FDA outlined products that comply with the new "gluten-free" labeling rule as:

-- Foods that inherently do not contain gluten (i.e. raw carrots or grapefruit juice) may use the "gluten-free" claim.

-- Foods with any whole, gluten-containing grains (i.e. spelt wheat) as ingredients may not use the claim.

-- Foods with ingredients that are gluten-containing grains that are refined but still contain gluten (i.e. wheat flour) may not use the claim.

-- Foods with ingredients that are gluten-containing grains that have been refined in such a way to remove the gluten may use the claim, so long as the food contains less than 20 parts per million of gluten (i.e. wheat starch).

-- Foods may not use the claim if they contain 20 parts per million of gluten or more as a result of cross-contact with gluten containing grains.

Manufacturers will have until August 5, 2014, to update their labels in compliance with the new requirements. Foods labeled as "without gluten," "free of gluten" or "no gluten" will also be held to the same standard.

"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 FDA's deputy commissioner for foods and veterinary medicine, in the release.

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