Washington, D.C. – After more than four years of inaction by the Food and Drug Administration on their statutory requirement to finalize standards for gluten-free labeling on foods, U.S. Senators Ron Wyden (D-Ore.) and Patrick Leahy (D-Vt.) have sent a letter to FDA Commissioner Dr. Margaret A. Hamburg seeking answers for the extreme delay and an update on when the FDA will propose a final rule.
Included as part of the Food Allergen Labeling and Consumer Protection Act of 2004, the FDA was tasked with proposing rules for gluten labeling within two years of enactment and finalizing rules within four. In January of 2007, the FDA issued its proposed rule but no final rule has been promulgated or issued since then. In the letter, Wyden and Leahy raised concern that the lack of federal standards for what could be counted as “gluten-free” has caused confusion for consumers and agricultural producers leaving outside groups free to create their own standards.
“The regulatory uncertainty surrounding FDA’s inaction has led to a proliferation of ‘gluten free’ standards and labels provided by 3rd party groups,” the senators wrote. “This creates confusion for consumers, and hesitancy amongst producers on what their requirements will be. We ask that you provide us with an update on when FDA will promulgate a final rule, why FDA has taken so long to issue this rule, and if there are any legal or regulatory hurdles that have prevented the timely implementation of this legislation.”
For many, gluten-free products are a dietary alternative to bread-based products but for sufferers of Celiac disease – a painful disorder stemming from the inability to properly digest the gluten found in breads – having accurate and standard labeling for these products is essential.
