FDA has issued a final rule that defines what characteristics a food has to have to bear a label that proclaims it “gluten-free,” including a gluten limit of less than 20 parts per million in foods that carry this label. This rule has been eagerly awaited by advocates for people with celiac disease.
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How Does FDA Define ‘Gluten-Free’?
In addition to limiting the unavoidable presence of gluten to less than 20 ppm, FDA will allow manufacturers to label a food “gluten-free” if the food does not contain any of the following:
an ingredient that is any type of wheat, rye, barley, or crossbreeds of these grains
an ingredient derived from these grains and that has not been processed to remove gluten
an ingredient derived from these grains and that has been processed to remove gluten, if it results in the food containing 20 or more parts per million (ppm) gluten
Foods such as bottled spring water, fruits and vegetables, and eggs can also be labeled “gluten-free” if they inherently don’t have any gluten.
The regulation will be published Aug. 5, 2013 in the Federal Register, and manufacturers have one year from the publication date to bring their labels into compliance. Taylor says he believes many foods labeled “gluten free” may be able to meet the new federal definition already. However, he adds, “We encourage the food industry to come into compliance with the rule as soon as possible.”
Under the new rule, a food label that bears the claim “gluten-free,” as well as the claims “free of gluten,” “without gluten,” and “no gluten,” but fails to meet the requirements of the rule would be considered misbranded and subject to regulatory action by FDA.
Those who need to know with certainty that a food is gluten-free are heralding the arrival of this definition. “This is a huge victory for people with celiac disease,” says Levario. “In fact, that’s the understatement of the year.”
Says Taylor, “FDA’s ‘gluten-free’ definition will help people make food choices with confidence.”