Senators Press FDA to Finally Establish Gluten-Free Labeling Standards

August 5, 2011

As part of the Food Allergen Labeling and Consumer Protection Act of 2004, FDA was required to finalize labeling rules within four years.

In late July, U.S. Senators Ron Wyden (D-OR) and Patrick Leahy (D-VT) sent a letter to FDA, chastising the agency for the “extreme delay” and “more than four years of inaction” in establishing labeling standards for gluten-free foods.

As part of the Food Allergen Labeling and Consumer Protection Act of 2004, FDA was required to finalize labeling rules within four years. The agency issued a proposed rule in 2007, but since then, no final rule has been issued.

“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.”