In a long-awaited step toward accurate gluten-free food labeling, the U.S. Food and Drug Administration (FDA) has released its definition of “gluten free” to be used by food manufacturers.
FDA sets new labeling regulations for gluten-free foods
In a long-awaited step toward accurate gluten-free food labeling, the U.S. Food and Drug Administration (FDA) has released its definition of “gluten free” to be used by food manufacturers. The rule defines gluten free, in part, as having less than 20 parts per million of gluten.
“This is the final step in what has been a very long journey to improved food safety for individuals with celiac disease and other gluten-related disorders,” says Alessio Fasano, MD, director of the Center for Celiac Research at MassGeneral Hospital for Children (MGHfC). “We welcome the new FDA regulations, which will bring us in line with gluten-free labeling regulations for millions of people around the world.”
The new gluten-free labeling regulations were mandated as part
of the Food Allergen Labeling and Consumer Protection Act of 2004, which requires food manufacturers to list the eight major food allergens.
Wheat, one of those allergens, is a major source of gluten. In the autoimmune disorder of celiac disease, consumption of gluten sets off a reaction that damages the small intestine, leading to malabsorption of nutrients and an array of symptoms. For people with celiac disease and other gluten-related disorders, the gluten-free diet is a medical necessity, says Fasano.
“Accurate gluten-free labeling will help our patients stay safe in a world where gluten is included in many, many food products,” says Fasano. “We’re looking forward to working with the federal government, industry members, celiac support groups and health care colleagues to help translate this definition into improved shopping and living conditions for individuals with celiac disease and other gluten-related disorders.”
Twenty parts per million (ppm) – or 20 parts of gluten per one million parts of a food – is an accepted standard in many parts of the world for products that are labeled gluten-free, says Fasano. “The evidence-based research published by our center, which has been confirmed by studies from colleagues around the world, conclusively supports the 20 ppm level as a suitable safety threshold for gluten-free products.”
Research from the center has shown that 10 milligrams per day of gluten consumption is a safe level for the vast majority of individuals with celiac disease. This is the equivalent of about one-eighth of a teaspoon of flour, says the center’s registered dietitian Pam Cureton, RD, LDN. “To put it in perspective, you would have to eat about 18 slices of gluten-free bread in one day to reach the daily 10 mg level of gluten consumption,” says Cureton.
“Through the advocacy work of the Center for Celiac Research, the American Celiac Disease Alliance and other groups, parents of children with celiac disease and people of all ages with gluten-related disorders will be able to shop more safely for the food they need,” says Ronald Kleinman, MD, MGHfC physician-in-chief.
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