F.D.A. proposes standards for 'gluten-free' foods

by Eric Schroeder
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WASHINGTON — The Food and Drug Administration on Tuesday set forth a proposed rule that would allow companies to define foods made without a protein found in wheat, rye and barley as "gluten-free."

The proposal, detailed in the Jan. 23 issue of the Federal Register, would allow companies to voluntarily flag foods without the cereal protein, which can cause inflammation of the small intestine in the estimated 1.5 million to 3 million Americans with celiac disease.

Gluten may trigger an immune response in celiac sufferers that damages the lining of the small intestine. Eventually, that damage may hamper the ability of the intestine to absorb nutrients.

Celiac disease has no cure but may be managed by avoiding foods that contain gluten.

According to the F.D.A., the term "gluten-free" would be eligible to be used in labeling of foods that do not contain any of the following:

• an ingredient that is any species of the grains wheat, rye, barley, or a crossbred hybrid of these grains;

• an ingredient that is derived from a prohibited grain and that has not been processed to remove gluten (e.g., wheat flour);

• an ingredient that is derived from a prohibited grain and that has been processed to remove gluten (e.g., wheat starch), if the use of that ingredient results in the presence of 20 parts per million or more gluten in the food;

• or 20 p.p.m or more gluten.

The F.D.A. noted that any food that bears the "gluten-free" claim but fails to meet the conditions specified in the proposed definition would be considered "misbranded."

"Establishing a definition of the term ‘gluten-free’ and uniform conditions for its use in the labeling of foods is needed to ensure that individuals with celiac disease are not misled and are provided with truthful and accurate information with respect to foods so labeled," the F.D.A. said.

The F.D.A. is accepting comments on the proposed rule until April 23.

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