More than four years after the Food and Drug Administration issued a proposed rule 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 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. No final rule has been promulgated or issued since the FDA issued its proposed rule in January 2007. In the letter, Wyden and Leahy raise 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 senators wrote:
"The regulatory uncertainty surrounding FDA's inaction has led to a proliferation of 'gluten free' standards and labels provided by 3rd party groups. 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."
Read the complete letter here.