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November 2014 Issue
Last Updated Friday, November 28 2014
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FDA Seeks Comment on ‘Gluten-Free’ Labeling



Published August 9, 2011
Related Searches: Regulations Proteins Analytical Health
As awareness of gluten intolerance and sensitivity increases, FDA is looking to define “gluten-free” for labeling food products, including dietary supplements.

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. The only treatment for this disorder is a life-long gluten-free diet.

Eating gluten doesn’t bother most consumers, but some people with celiac disease have health-threatening reactions, said Stefano Luccioli, MD, an FDA allergist and immunologist. They need to know whether a food contains gluten.

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

The agency has reopened the public comment period on its proposed gluten-free labeling rule published on Jan. 23, 2007.

FDA makes available, and seeks comments on, a report on 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.

According to the National Institutes of Health, celiac disease affects as many as 1% of the U.S. population.

Having a federal definition of “gluten-free” is critically important, said Dr. Levario. “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.”

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 states 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.

The public comment period on the proposed rule officially opened on Aug. 3, 2011, and will remain open for 60 days. To submit comments electronically, go to www.regulations.gov.


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