Food labeled gluten-free must contain less than 20 parts per million of gluten, a protein found in wheat, rye and barley. Product manufacturers such as General Mills, which has a line of gluten-free Betty Crocker products, will have one year to meet the standard, according to Bloomberg.
About 3 million Americans have celiac disease, a condition that causes an immune reaction that can lead to serious health problems when they eat gluten. Millions more have gluten sensitivity, and countless others suffer from gluten paranoia.
"Adherence to a gluten-free diet is the key to treating celiac disease, which can be very disruptive to everyday life," FDA Commissioner Margaret Hamburg said in a statement. "The FDA's new 'gluten-free' definition will help people with this condition make food choices with confidence and allow them to better manage their health."
The FDA first proposed the standard in 2007 in response to a 2004 law on food-allergen labeling that required a definition of gluten-free.
Until now, gluten-free has had no clear definition. Companies basically were on the honor system, and could say something was gluten-free even if, for example, it was made in a factory where gluten was used. An estimated 5 percent of foods currently labeled "gluten-free" contain 20 ppm or more of gluten, according to the FDA.
The new rule is voluntary, so the cost to the food industry shouldn't be significant unless they want a big bite of the gluten-free market.
Andrea Levario, executive director of the American Celiac Disease Alliance, notes that there is no cure for celiac disease and the only way to manage the disease is dietary -- not eating gluten. Without a legal definition of "gluten-free," consumers could never really be sure if their body would tolerate a food with that label, she said.
"This is a tool that has been desperately needed," Levario said. "It keeps food safe for this population, gives them the tools they need to manage their health, and obviously has long-term benefits for them."
"It's not the FDA's job to tell people what they should and shouldn't eat, but it is our responsibility to make sure that people can trust what the labels say on the foods they do choose to eat," says the FDA's Virginia Cox, herself a celiac.