FDA has released formal standards for "gluten-free" foods that health officials say will reduce uncertainty for millions of U.S. residents with celiac disease—nearly a decade after Congress requested them.
When consumed by an individual with the autoimmune disease, gluten can trigger the development of antibodies that deplete the lining of the small intestine, which can lead to a variety of health problems. In 2004, Congress passed the Food Allergen Labeling and Consumer Protection Act, which required FDA to develop a uniform definition for companies wishing to label their products as gluten-free.
The final rule on the standards comes five years after the deadline set by lawmakers. In 2007, FDA released a proposed rule defining gluten-free products but continued examining the issue. In 2011, the agency requested a second round of public comments before submitting its proposal for the final rule to the White House earlier this year.
Under the new rule, any product labeled as gluten-free must contain less than 20 parts per million of gluten, a protein found in wheat, barley, and rye that can cause nutritional deficiencies in patients with celiac disease.
The rule also requires foods labeled "free of gluten," "without gluten" and "no gluten" to meet the standard. Food manufacturers have one year to comply with the rule (Abutaleb, Reuters, 8/2; Tavernise, New York Times, 8/2; Dennis, Washington Post, 8/2).
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