FDA One Step Closer to Defining Gluten Free

 Thanks to an act last year by the U.S. Senate, September 13 is designated as National Celiac Disease Awareness Day. The date honors the birthday of Dr. Samuel Gee, the first researcher to establish the connection between celiac disease and a gluten-free diet. The great doctor said, “If the patient can be cured at all, it must be by means of diet.”

In the early 1900s, the discovery by Dr. Gee likely had little impact on a local market or trading post, but today’s shoppers see the term “gluten-free” plastered all over products in their grocery stores. But, even in modern times does anyone actually know exactly what the gluten-free label means?

To date, food manufacturers have relied on an FDA proposed regulation for the definition of gluten free. However, with a recent announcement from the Food & Drug Administration, the United States is one step closer to having a clear understanding of what it means when you see a product labeled as gluten-free.

The most recent move by the FDA includes a published Federal Register Notice that reopens the gluten-free food labeling discussion to the general public. In 2007, the Administration released a proposal defining gluten-free food as containing less than 20 parts per million (ppm) of gluten, and has since conducted numerous scientific studies to guage whether this is an appropriate definition.

Dr. Alessio Fasano—Director of the University of Maryland’s Center for Celiac Research and an internationally renowned expert on celiac disease—has authored research demonstrating a 20ppm threshold would be safe. “This is a standard that has been in use in Europe for almost two decades, and the science supports the U.S. adopting it as well,” Fasano said.

Additionally, the 20ppm standard for labeling products as gluten-free was adopted as the Codex Alimentarius standard in July 2008, and has subsequently been adopted via regulation by the 27 countries of the European Union. The FDA notes that support for the 20ppm figure also comes in part from currently available methods of gluten detection, including a method used by the Japanese Ministry of Health, Labor and Welfare.

This 60-day public comment period will allow all members of the celiac disease and gluten-free communities the opportunity to look at the 2007 proposal and then submit suggestions on defining what is universally "gluten-free."

During the announcement of the federal register opening for public comment, Michael Landa, the Acting Director for the Center for Food Safety and Applied Nutrition, stressed the importance of this comment period, stating "we take seriously what people have to say, and take comments into account in making a final decision."

The FDA hopes to finalize the proposal by the third quarter of 2012. To learn more, please visit www.regulations.gov. The Federal Register Notice and docket number is FDA2005-N-0404. You can also visit www.fda.gov for more information.

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Mon, November 14, 2011 @ 6:42 AM

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