“Establishing a definition of the term ‘gluten-free’ and uniform conditions for its use in food labeling will help ensure that individuals with celiac disease are not misled and are provided with truthful and accurate information with respect to foods so labeled,” the agency said in its 95-page regulation.
Celiac disease is an autoimmune digestive disorder that causes gluten to trigger a reaction in the small intestine. The disease affects about one in 133 Americans, though as many as 83 percent could be undiagnosed, according to the foundation.
There is no cure for the disease, but maintaining a gluten-free diet can prevent the symptoms.
The new rule will help allow people with the condition to accurately monitor what they eat.
“Before, without a regulation, there wasn’t a standard,” Bast said. “So it’s important that our community knows that gluten-free will mean that it’s free from gluten and it will be less than 20 parts per million.”
According to the FDA, compliance with the rule will yield health benefits for people with celiac disease adding up to about $110 million per year, while it will cost businesses an estimated $7 million annually to test and label their foods.
The new rule has been under consideration at the FDA since 2005.
In April, representatives from an Oregon-based beer company met with White House officials to express concern that the final rule would prevent foods that extract gluten after being processed from carrying the “gluten-free” label.
The final rule seems to address their concern, however.
It indicates that the label can be applied to products made from ingredients that do not contain gluten “or an ingredient that is derived from a gluten-containing grain and that has been processed to remove gluten.”