F.D.A. issues proposed rule on 'gluten-free' claims

by Jay Sjerven
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Industry encouraged to submit comments to the F.D.A. by April 23

WASHINGTON — The Food and Drug Administration in the Jan. 23 Federal Register issued a proposed rule defining the term "gluten free" for use in labeling of foods. The proposed rule set out criteria that would have to be satisfied in order for a food manufacturer to claim its product was gluten free, and delineated how the manufacturer might indicate that claim on product packaging.

The F.D.A. was directed to propose a definition for "gluten free" by the Food Allergen Labeling and Consumer Protection Act of 2004. The act required the F.D.A. to issue a proposed definition of "gluten free" within two years and a final rule on "gluten free" claims by August 2008.

The aim of the rule was to enable consumers suffering from celiac disease to identify foods free of gluten. Celiac disease is a chronic inflammatory disorder of the small intestine in genetically susceptible individuals that is triggered by ingesting gluten or similar proteins that occur naturally in certain cereal grains. It affects as many as 3 million Americans.

The proposed rule indicated a food may be considered gluten free if it does not contain any of the following: an ingredient that is any species of wheat, rye, barley or a crossbred hybrid of these grains (denoted collectively as "prohibited 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. Also, any food, even if not containing ingredients derived from prohibited grains, that for any reason contains 20 p.p.m. or more gluten would not be allowed to make the claim "gluten free."

The F.D.A. said the 20 p.p.m. level was proposed based on available analytical methods and technologies, which can reliably and consistently detect gluten in wheat, rye and barley at levels that are low but as yet not lower.

The F.D.A. further said it is planning to conduct an assessment for gluten, under which scientific data and methods would be used to estimate a "safe" level of gluten exposure. The agency will publish a notice in the Federal Register seeking comment on the draft safety assessment and its potential use in the final "gluten free" claims rule.

The proposed rule also contained provisions relating to use of "gluten free" claims on foods inherently free of the protein and on oats.

The F.D.A. proposed to deem misbranded a food bearing a gluten-free claim in its labeling if the food is inherently free of gluten and if the claim does not refer to all foods of the same type. For instance, milk is inherently free of gluten. For a manufacturer to use a gluten-free claim on its milk, its labeling must include modifying language indicating all milk, not just its branded milk, is gluten free.

The issue was more complex in the case of oats. The F.D.A. noted there is no agreement among experts about the extent to which oats might present a hazard to individuals with celiac disease. Oats are not a source of gluten. And oats were not designated a prohibited grain.

But there was considerable evidence that oats are at risk from commingling with wheat, rye or barley in the field or in transportation, storage and processing, and that gluten from the prohibited grains might be found in finished oats products.

For that reason, it would be misleading to indicate on labels that all oats products are inherently gluten free. Still, particular oats products may qualify for a gluten-free claim under the proposed rule if gluten content is below 20 p.p.m.

Robert Earl, senior director, nutrition policy, GMA/FPA, Washington, said the food industry supported the F.D.A. effort to establish a uniform standard for the voluntary use of a gluten-free claim. Mr. Earl said such uniformity certainly was in the interest of those suffering from celiac disease.

Mr. Earl said the 20 p.p.m. level for gluten above which a food could not claim to be gluten free was in accord with similar international standards for gluten-free labeling and provided an acceptable margin of safety for those with celiac disease. At the same time, he noted scientific knowledge of the relationship between gluten and celiac disease was evolving. Research may find a higher level of gluten in food produces no adverse reaction among those suffering from celiac disease. He said he was hopeful the F.D.A. would be open to reexamining the 20 p.p.m. level in the proposed rule as scientific knowledge advances.

The F.D.A. will accept public comment on the proposed rule until April 23.

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