The Food and Drug Administration Friday announced plans to regulate the "gluten-free" label, which indicates that gluten proteins –naturally found in wheat, rye, barley and cross-bred hybrids of these grains – are only present in foods at certain levels.
FDA said the term should be reserved for foods that contain less than 20 parts per million of gluten. The rule also requires foods with the claims "no gluten," "free of gluten," and "without gluten" to meet the definition for "gluten-free."
Food already manufactured with the label may meet requirements, though the FDA is allowing companies one year from the time the rule is published to adhere to the new standards.
About 3 million Americans adopt a gluten-free diet to manage celiac disease, a digestive condition that causes foods that contain gluten to trigger production of antibodies that attack and damage the lining of the small intestine.
Lining damage further limits the ability of celiac disease patients to absorb nutrients and puts them at risk of other very serious health problems, including nutritional deficiencies, osteoporosis, growth retardation, infertility, miscarriages, short stature, and intestinal cancers, FDA said.
FDA Commissioner Margaret A. Hamburg said the new 'gluten-free' definition will help people with celiac disease make food choices that allow them to better manage their health. The rule was created under the Food Allergen Labeling and Consumer Protection Act, which directs the FDA to set allergy guidelines, even though gluten is not listed as an allergen.
While the number of Americans that have been diagnosed with celiac disease grows, so does the amount spent on food marketed as "gluten-free." That total reached $4.2 billion in 2012, for a compound annual growth rate of 28% over the 2008-2012 period, according to Packaged Facts, a food research firm.