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Gluten-Free Labels Defined Under New U.S. FDA Standard

FDA Commissioner Margaret Hamburg
"Adherence to a gluten-free diet is the key to treating celiac disease," says FDA Commissioner Margaret Hamburg, following a 2013-released federal requirement to ensure that food labled gluten-free contains less than 20 parts per million of gluten. Photographer: Alex Wong/Getty Images

Food labeled as gluten-free must now adhere to a uniform standard in the U.S. as the result of a new federal requirement.

The Food and Drug Administration today defined “gluten-free” as food that contains less than 20 parts per million of gluten, a protein found in wheat, rye and barley. Food makers such as Minneapolis-based General Mills Inc., which has rolled out a line of gluten-free Betty Crocker products, will have one year to ensure labels on their cans and boxes meet the standard.

About 3 million Americans have celiac disease, a condition that causes an immune reaction when they eat gluten. Gluten can cause intestinal damage to those with the disorder, which may lead to nutritional and bone deficiencies, infertility and intestinal cancer. As a result, health gains from the rule may total $110 million annually, the FDA said in a statement.

“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 the 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.

European Standard

The U.S. has lagged behind its European counterparts in establishing such labeling, and the 20 parts per million set by the FDA is in-line with what is used and accepted overseas, Carol Shilson, executive director of the University of Chicago’s Celiac Disease Center, said in an interview.

“Until now, gluten-free has had no clear definition so companies have been on the honor system,” Shilson said. “Companies could say a tomato is gluten-free or that something was gluten-free if it was made in a factory where gluten is used. This will help people with celiac disease and those” who choose to eat gluten free.

The FDA says it used an analytical methods-based approach to determine the 20 parts per million limit.

The Food Marketing Institute, which represents grocery wholesalers and retail supermarkets, welcomes the FDA’s definition, Hilary Thesmar, vice president of food safety programs at the Arlington, Virginia-based trade group.

“This will be helpful because it gives us clarity and informs us what gluten-free is for the industry,” Thesmar said, adding that cost to industry shouldn’t be significant because the rule is voluntary. “It does seem to make sense.”

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