As awareness of gluten intolerance and sensitivity increases, FDA is looking to define “gluten-free” for labeling food products, including dietary supplements. The agency reopened the public comment period on its proposed gluten-free labeling rule published on January 23, 2007. FDA is also seeking comments on a report regarding the health effects of gluten in people with celiac disease. The report includes a safety assessment on levels of gluten sensitivity in people with the disease.

Technically, gluten represents specific proteins that occur naturally in wheat. However, the term “gluten” is commonly used to refer to certain proteins that occur naturally not only in wheat, but also in rye, barley and crossbreeds of these grains and that can harm people who have celiac disease.

Eating gluten doesn’t bother most consumers, but some people with celiac disease have health-threatening reactions, and they need to know whether a food contains gluten. According to the National Institutes of Health (NIH), celiac disease affects as many as 1% of the U.S. population. Currently the only treatment for this disorder is a life-long gluten-free diet.

Having a federal definition of “gluten-free” is critically important, said Andrea Levario, executive director of the American Celiac Disease Alliance. “If we have one national standard, the individual will know that all products labeled ‘gluten-free’ will have no more than a minimal amount of gluten.”

FDA has been working to define “gluten-free” in an effort 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.

In 2007, FDA proposed to 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.

In the notice reopening the comment period, FDA stated that it continues to believe the proposed definition of “gluten-free” is the correct one. FDA’s notice also describes current analytical methods that can reliably and consistently detect gluten at levels of 20 ppm or more in a variety of foods.