WASHINGTON — A label that reads “gluten free” will now mean the same thing for all food.
The Food and Drug Administration (FDA) has set a new standard for labels that will make shopping easier for consumers on gluten-restricted diets. Until now, the term “gluten free” had not been regulated, and manufacturers made their own decisions about its meaning.
Gluten is a composite of starch and proteins found in certain grassy grains such as wheat, barley and rye. When eaten by people with celiac disease, gluten can trigger the production of antibodies that damage the lining of the small intestine.
Under an FDA rule announced Friday, products labeled “gluten free” still won’t have to be technically free of wheat, rye and barley and their derivatives. But they will have to contain less than 20 parts per million of gluten.
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That amount is generally recognized by the medical community to be low enough so that most people who have celiac disease won’t get sick if they eat it.
Other countries already have similar standards.
Celiac disease, an autoimmune disease, affects up to 3 million Americans. It causes abdominal pain, bloating and diarrhea, and people who have it can experience weight loss, fatigue, rashes and other long-term medical problems. Celiac is a diagnosed illness that is more severe than gluten sensitivity, which some people self-diagnose.
Only a very small number of people wouldn’t be able to ingest the amount of gluten allowed under the new rule, FDA officials said. “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. “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 same new FDA rule also applies to such labels as “no gluten,” “free of gluten,” and “without gluten.” Manufacturers will have a year to comply, though the FDA urged companies to meet the definition sooner.
The agency has tools to keep companies in compliance. It can seize products whose gluten level is above the limit, or require companies to recall products.
Many companies that market gluten-free foods already meet the standard. But Andrea Levario of the American Celiac Disease Alliance said the federal guidelines will cut down on painstaking shopping for those who have celiac disease.
Levario said wheat must be labeled on food packages but barley and rye are often hidden ingredients in food. The standard will also ensure that companies can’t label products “gluten-free” if they are cross-contaminated from other products made in the same manufacturing facility.
Michael Taylor, FDA deputy commissioner for foods, said the rule originally proposed during the George W. Bush administration was delayed because the agency was evaluating what standard was correct.
Congress originally directed the FDA to set the standards in 2004 as part of a larger law that required food packaging to list major allergens.
In the years since Congress considered the standards, gluten-free foods have become big business. According to Packaged Facts, a consumer market-research company, sales of gluten-free products stood at $4.2 billion in 2012, nearly triple what they were in 2008.
In a poll of consumers in August 2012, Packaged Facts found that the top two reasons people gave for buying gluten-free food was that they believed it was healthier and that it would help them manage their weight. Experts say there is no evidence that such foods help with weight loss.
One of the largest manufacturers of gluten-free foods, Boulder Brands, said it has been seeing double-digit growth in sales and is planning to expand. The company’s brands, Glutino and Udi’s, already meet the new standards.
“We expect the new regulations to impact sales in a positive way as consumers can feel more confident in their gluten-free choices,” said T.J. McIntyre, executive vice president of the company.
Material from The New York Times is included in this report.