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FDA Trying to Define and Refine "Gluten Free"


On August 2, 2011, the FDA reopened the public comment period on its proposed gluten-free labeling rule.  After the 60 day comment period, the FDA will issue a final rule that defines “gluten-free” for labeling food products.  The original rule was published on January 23, 2007.

By establishing a standard for “gluten-free,” the FDA will help consumers who are sensitive to gluten to know what is in the foods that they are purchasing.

Gluten helps dough rise, keeps bread from falling apart, makes bread chewy, and adds flavor and texture.  The term gluten is used to refer to proteins that occur naturally in wheat, rye, barley.

According to Dr. Stefano Luccioli, a FDA allergist and immunologist, most consumers don’t have a problem with gluten; but when you are sensitive to gluten, it can be a big problem for you.  People with celiac disease may have health-threatening reactions to gluten and need to be put on notice as to whether a food contains gluten and must avoid those foods.

According to the National Institutes of Health, celiac disease affects over 3.1 million people in the United States alone.  The disease occurs when the body’s defense system attacks the lining of the small intestine in reaction to gluten exposure.  The result is a condition that damages the lining of the small intestine and prevents it from absorbing parts of food that are important for staying healthy; leading to growth and nutrient deficiencies which can lead to anemia, osteoporosis and, in extreme cases, death.

The FDA has been working to define “gluten-free” to eliminate uncertainty about how food producers may label their products and to assure consumers who must avoid gluten that foods labeled “gluten-free” meet a clear standard established and enforced by FDA.

When the FDA published the rule in 2007, it allowed 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
  • 20 ppm or more gluten

The FDA continues to believe that these criteria for “gluten-free” are the correct criteria.  After the FDA considers the comments received during this comment period, the agency will issue a final rule that defines “gluten-free.”

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