It’s time for the government to establish universal requirements for gluten-free labeling, say U.S. Senators Ron Leahy (D-VT) and Ron Wyden (D-OR).

In a letter to the Food and Drug Administration (FDA) in July, the Senators expressed concern that the agency has not yet set a threshold for gluten in “gluten-free” foods, despite receiving a mandate from Congress to do so 4 years ago. 

In 2004, Congress passed the Food Allergen Labeling and Consumer Protection Act, part of which mandated that FDA issue proposed rules on gluten-free labeling within two years. In 2007, FDA published its proposed rule, but has neither proposed nor passed a final rule since that time. 

This lack of standardized limits for gluten has left room for interpretation of the definition of “gluten free.”

“The regulatory uncertainty surrounding FDA’s inaction has led to a proliferation of “gluten free” standards and labels provided by 3rd party groups,” says the letter. “This creates confusion for consumers, and hesitancy amongst producers on what their requirements will be.”  

Gluten is a protein most commonly found in wheat, barley and rye. In people with celiac disease, it creates an immune reaction in the small intestine, which damages the organ and renders it unable to absorb important nutrients, leading to malnourishment and sometimes causing damage to the brain, nervous system, bones and vital organs. 

There is no treatment for the disease, but cutting gluten out of one’s diet can eliminate the symptoms.

“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,” said Wyden’s office in a news release

According to the University of Chicago Celiac Disease Center, Celiac disease affects 1 in 133 people, or 1 percent of the health population, meaning that almost 3 million Americans suffer from celiac disease. However, 97 percent go undiagnosed.

Due to an increased awareness of the disease in the medical community, its diagnosis rate has risen steadily in the past few years. 

The Senators also requested that Margaret Hamburg, FDA commissioner, explain the agency’s delay in setting a limit for gluten in gluten-free foods. 

“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” the authors write.