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Letter to Commissioner Margaret Hamburg

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Date:
Location: Washington, DC

Congressman Jim Moran today led a group of House Democrats in writing the Food and Drug Administration, urging the agency to fulfill its 2008 mandate to define the term "gluten-free" that appears on many food labels. Moran is joined by Representatives Madeleine Bordallo (D-GU), Gerry Connolly (D-VA), Joe Courtney (D- CT), Dennis Kucinich (D-IA), Betty McCollum (D-MN), and Jared Polis (D- CO).

"A trip to the grocery store should not create anxiety and confusion for the growing number of consumers sensitive to gluten," said Rep. Moran. "Inaction by the FDA damages the health of our families and needlessly fosters worry for the millions of parents whose children cannot be exposed to gluten."

Nearly 3 million adults and children suffer from celiac disease, an autoimmune disorder in which consumption of gluten causes damage to the small intestine and does not allow food to be properly absorbed. New research led by the University of Maryland has shown a growing number of gluten-sensitivities, now affecting roughly 17 million Americans.

"The FDA has access to world-class researchers and was given a reasonable timeline to fix the inconsistent labeling," Moran continued. "They need to take immediate action and determine an appropriate system to protect those individuals affected by food-based sensitivities."

The "Food Allergen Labeling and Consumer Protection Act," signed into law in 2004, gave the FDA a 2008 deadline to designate a federal standard for the term "gluten-free" product. Moran's push for accurate gluten labeling has received the support of the American Celiac Disease Alliance.

The full text of the letter is below:

Margaret Hamburg, M.D.
Commissioner
U.S. Food and Drug Administration
10903 New Hampshire Ave.
Silver Spring, MD 20993

Dear Commissioner Hamburg,

We are writing today to express our concern with the delay in producing a definition for the term "gluten-free" for food manufacturers to use in their labeling processes. With the rate of celiac disease on the rise in the United States, it is time to establish a uniform definition to protect these individuals from inconsistent, and in some cases, fraudulent labeling.

As you know, celiac disease (CD) is an autoimmune condition affecting an estimated 3 million children and adults nationwide. Furthermore, The Washington Post recently reported that new research indicates an additional 17 million Americans are gluten-sensitive. According to the Celiac Disease Foundation, when people with CD ingest foods that contain gluten-- whose proteins are found in all forms of wheat -- it creates a toxic reaction that causes damage to the small intestine and does not allow food to be properly absorbed. Contact with gluten, even small amounts, can cause infertility and an increased risk to certain cancers and health problems. Indeed, even when there are no symptoms present, damage can still occur to the small intestines.

In 2004, Congress passed the Food Allergen Labeling and Consumer Protection Act (P.L. 108-282) which gave the FDA until 2008 to create a definition for what a gluten-free product actually means. We have since seen that deadline come and pass without resolution.

In the meantime, the $2.6 billion gluten-free industry has seen many products labeled gluten-free that vary greatly with regard to the amount of gluten actually present. A number of gluten-free food makers go to great lengths, and thus cost, to ensure their products contain no gluten or come into contact with gluten during manufacturing. Others, however, make full use of the gluten-free label while failing to reach the advertised standard, in some cases putting the health of consumers with CD at risk.

Defining what it means to be gluten-free is not an insurmountable task. Other countries have successfully determined what the label gluten-free should mean for their citizens. While we appreciate the hard work the FDA has put into the task of defining this term for the past seven years, it is time to finish that process and establish a federal standard.
We urge you to act now to develop a final rule creating a definition for gluten-free products. Thank you for your attention to this important matter.

Sincerely,

Representative James Moran
Delegate Madeleine Bordallo
Representative Gerry Connolly
Representative Joe Courtney
Representative Dennis Kucinich
Representative Betty McCollum
Representative Jared Polis


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