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FDA Provides Ultimate Definition for Gluten-Free Products

Gluten-Free or Not?

For those with celiac disease or gluten sensitivity, labels saying "gluten-free" are important. But until now, they haven't known of they can believe those labels. In an August 2 announcement, the Food and Drug Administration (FDA) provided a final rule that defines what characteristics a food has to have to bear a label that proclaims it "gluten- free." The rule also holds foods labeled "without gluten," "free of gluten," and "no gluten" to the same standard.

The FDA has set a gluten limit of less than 20 ppm (parts per million) in foods that carry this label. That limit parallels those levels of other countries and establishes a standard definition designed to "eliminate uncertainty about how food producers label their products and will assure people with celiac disease that foods labeled 'gluten-free' meet a clear standard established and enforced by FDA," says Michael R. Taylor, J.D., deputy FDA commissioner for foods and veterinary medicine.

Cheering the news: Andrea Levario, executive director of the American Celiac Disease Alliance, who declared, "This is a tool that has been desperately needed. It keeps food safe for this population, gives them the tools they need to manage their health, and obviously has long-term benefits for them." Agreeing with her are other experts because it provides celiac patients in particular with reassurance about their diets.

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"Without proper food labeling regulation, celiac patients cannot know what the words 'gluten free' mean when they see them on a food label," says Allessio Fasano, M.D., director of the Center for Celiac Research at MassGeneral Hospital for Children, visiting professor of pediatrics at Harvard Medical School and member of the American Celiac Disease Alliance.

What Is Gluten?
The word "gluten" refers to the proteins that occur naturally in wheat, rye, barley, and crossbreeds of these grains. And although those are healthy foods for most of us, they cause problems for the estimated 3 million people in the United States with celiac disease. Their bodies' natural defense system reacts to gluten by attacking the lining of the small intestine. They do not get enough nutrition and that can result in conditions such as anemia (a lower than normal number of red blood cells) and osteoporosis, a disease in which bones become fragile and more likely to break. Other diseases associated with celiac disease are diabetes, thyroid disease and even certain types of cancer.

How Does FDA Define 'Gluten-Free'?
The FDA said that food producers can label an item "gluten-free" if it does not contain:

  • 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

In addition, 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.

"We encourage the food industry to come into compliance with the rule as soon as possible," says Taylor. "FDA's 'gluten-free' definition will help people make food choices with confidence."