FDA Announces Long-Awaited Standards for Labeling of Gluten-Free Food

After More Than Four Years of Silence, FDA To Fulfill Its Legal Requirement To Issue Standards on Gluten-Free Labeling

Washington (Wednesday, Aug. 3) – After more than four years of inaction, the Food and Drug Administration has announced that a final rule setting standards for the labeling of gluten-free food will move forward.  U.S. Senators Patrick Leahy (D-Vt.) and Ron Wyden (D-Ore.) two weeks ago had written to FDA Commissioner Margaret Hamburg, asking that the agency end more than four years of silence and fulfill FDA’s statutory requirement to establish standards for the growing gluten-free food industry.

“I am delighted to finally see some movement by the FDA on an issue of concern and safety for millions of Americans,” Leahy said. “This brings us one step closer to finalizing standards for gluten-free labeling on foods.  I hope that Vermont food companies, and Vermont consumers who live with celiac disease or are gluten-intolerant, now will get involved and offer their comments and suggestions about gluten-free labeling.  The lack of FDA guidance has led many firms to feel that they are doing a good enough job of formulating and testing the products they label as being gluten free.  Unfortunately, real-world experience with this uncertainty and imprecision have made clear that uniform, credible standards are needed so consumers can know how safe specific products really are for them.”

“As medical science’s understanding of celiac disease and the public’s interest in healthful alternatives for bread products increases, the demand for gluten-free foods has grown in lock step,” Wyden said.  “However, the FDA had failed to provide the standards producers of these foods need to accurately describe their products as ‘gluten-free.’  Without these legally recognized standards, consumers had a hard time ensuring that the products they were purchasing were labeled truthfully and producers had to contend with some in their industry holding themselves to lower standards than others. Today’s announcement gets the ball rolling on the process toward labeling standards and I will work with the FDA to ensure these rules are put in place as quickly as possible.”

The FDA announced Wednesday that after conducting a peer reviewed study from independent experts, the agency has promulgated industry-wide standards to measure the amount of gluten that is safe to include in “gluten-free” foods and is prepared to issue a final rule.  The rule will be given a 60-day comment period and the final implementation is expected shortly thereafter.  The FDA was tasked under the Food Allergen Labeling and Consumer Protection Act of 2004 with proposing rules within two years of enactment of the legislation,  with the final rules to be issued two years after that. In 2007, the FDA issued its proposed rule but no final rule had been promulgated since then.

Click here to read more about the FDA’s proposed rule.

Senators Wyden and Leahy sent their letter on July 21, 2011, seeking answers for the delay and urging the FDA to quickly move forward on the process. Click here to read the letter.

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