The U.S. Food and Drug Administration (FDA) officially set a final standardization for labeling foods as “gluten-free.” Previously, there had been no guidelines concerning what amounts of gluten in a product qualified it as “gluten-free” and thus safe for the 25 million Americans who suffer from celiac disease or gluten-intolerance.

The new regulation, issued on August 2, 2013 under the Food Allergen Labeling and Consumer Protection Act (FALCPA), calls for any food that claims to be “gluten-free,” “without gluten,” or any variation of the term to contain less than 20 parts per million (ppm) or 20 mg/kg of gluten. Some companies, such as Boulder Brands (owner of Glutino and Udi’s gluten-free brands), whose products contain less than 10 ppm gluten, say they are already well within regulation guidelines. Other companies, however, will have a year to either remove the “gluten-free” claim from their products’ labels or change the ingredients of their products so they fit the new FDA regulations.

FDA Commissioner Margaret A. Hamburg, M.D., understands how important the standardization of “gluten-free” products will be to those suffering from celiac disease, saying it will “help people with this condition make food choices with confidence and allow them to better manage their health.”
Celiac disease is a chronic, hereditary digestive disorder triggered by the ingestion of gluten, storage proteins found in wheat, barley and rye. For people with the disease, gluten damages the body’s ability to absorb nutrients, which can lead to other conditions ranging from vitamin deficiencies to life-threatening diseases such as intestinal cancer. There is no cure for celiac disease, only management through a strict gluten-free diet.

Andrea Levario, executive director of the American Celiac Disease Alliance (ACDA), is thrilled with the FDA’s decision to regulate “gluten-free” labeling: “This is a tool that has been desperately needed,” Levario stated. “It gives [people with celiac disease] the tools they need to manage their health.”

The new FDA regulation will affect millions of Americans, both consumers and businesses; sales of gluten-free products in the U.S. rose to $4.2 billion last year and are expected to hit $6 billion by 2017.


Pubished in WholeFoods Magazine September 2013 (online 8/5/13)