Friday, August 2, 2013

FDA Sets New Food Safety Regulations for Gluten-Free Foods

Center for Celiac Research at MGHfC Led Efforts for New Definition

In a long-awaited step toward accurate gluten-free food labeling, the 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. “We welcome the new FDA regulations, which will bring us in line with gluten-free labeling regulations for millions of people around the world.”

Twenty parts per million, or 20 parts of gluten per one million parts of food sample, is an accepted standard in many parts of the world for products that are labeled gluten-free, says Dr. 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 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, physician-in-chief at MassGeneral Hospital for Children.

The new gluten-free labeling regulations are 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 the eight food allergens, is a major source of gluten. In the autoimmune disorder of celiac disease, individuals sustain damage to their small intestines through the consumption of gluten, 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. “Accurate gluten-free labeling will help our patients stay safe in a world where gluten is included in many, many food products,” says Dr. 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,” adds Dr. Fasano.

Founded in 1996, the Center for Celiac Research treats patients of all ages with celiac disease, wheat allergy and gluten sensitivity and is committed to improving the quality of life for people with these conditions. For more information visit and

Founded in 1811, the Massachusetts General Hospital ( is the oldest and largest teaching hospital of Harvard Medical School. The 950-bed medical center each year admits approximately 48,500 inpatients, handles more than 1.5 million visits to its extensive outpatient programs at the main campus and four health centers, and records more than 95,500 emergency visits. The surgical staff perform more than 41,000 operations annually, and the MGH Vincent Obstetrics Service delivers almost 3,700 babies a year. The largest nongovernment employer in the city of Boston, the MGH has more than 24,500 employees, including more than 4,100 registered nurses.  MGH conducts the largest hospital-based research program in the United States, with an annual research budget of more than $775 million.  MGH and Brigham and Women's Hospital are founding members of Partners HealthCare HealthCare System, a Boston-based integrated health care delivery system.

Susie Flaherty,, 617-643-2225

Kory Zhao,, 617-726-0274

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