Tag Archives: Food and Drug administration

Oregon’s Ron Wyden Seeks Gluten-Free Labeling from FDA

Via Food Safety News

Though given a mandate to figure the regulation out more than four years ago, the FDA has still not given guidelines for what constitutes ‘Gluten-Free’ for food packaging, leaving manufacturers in charge of package labeling.

In a letter late last month, U.S. Senators Ron Leahy (D-VT) and Ron Wyden (D-OR) have demanded that the FDA establish universal requirements for Gluten-Free labeling.

“The regulatory uncertainty surrounding FDA’s inaction has led to a proliferation of “gluten free” standards and labels provided by 3rd party groups,”
says the letter.
“This creates confusion for consumers, and hesitancy amongst producers on what their requirements will be.”
Gluten is a protein most commonly found in wheat, barley and rye. In people with celiac disease, it creates an immune reaction in the small intestine, which damages the organ and renders it unable to absorb important nutrients, leading to malnourishment and sometimes causing damage to the brain, nervous system, bones and vital organs.  There is no treatment for the disease, but cutting gluten out of one’s diet can eliminate the symptoms.
“For sufferers of Celiac disease – a painful disorder stemming from the inability to properly digest the gluten found in breads – having accurate and standard labeling for these products is essential,” said Wyden’s office in a news release.
According to the University of Chicago Celiac Disease Center, Celiac disease affects 1 in 133 people, or 1 percent of the health population, meaning that almost 3 million Americans suffer from celiac disease. However, 97 percent go undiagnosed.
Due to an increased awareness of the disease in the medical community, its diagnosis rate has risen steadily in the past few years.
The Senators also requested that Margaret Hamburg, FDA commissioner, explain the agency’s delay in setting a limit for gluten in gluten-free foods.
“We ask that you provide us with an update on when FDA will promulgate a final rule, why FDA has taken so long to issue this rule, and if there are any legal or regulatory hurdles that have prevented the timely implementation of this legislation” the authors write.
Thanks, Senator Wyden! It looks like the Senators’ actions were impactful, and the FDA’s website now has a call for comments on gluten-free labeling.  Get in touch and share your thoughts on official labeling!
We are eager to hear what the official regulations will be, and am glad that there is finally some action on this front.

The FDA & Gluten Free Labeling


Coming Soon. That’s the vague answer coming from the Food and Drug Administration, in regard to Gluten Free labeling requirements.

Via Celiac.com By Jennifer Iscol

On May 4th, members of the national celiac and gluten intolerance community met in Washington, D.C., to urge the Food and Drug Administration to finalize gluten-free labeling rules. The event was very successful and I wanted to share a bit more about it.

The May 4th event was led by a broad-based coalition, including nonprofit organizations, celiac disease centers and gluten-free food manufacturers. Jules Shepard, a gluten-free cookbook author and baker, and John Forberger, a gluten-free athlete and blogger, met through Twitter, came up with the idea for the event and created the website www.1in133.org.

Andrea Levario, Executive Director of the American Celiac Disease Alliance (ACDA), crafted the successful political strategy in conjunction with ACDA President Beth Hillson, who is also food editor of Living Without magazine. ACDA has been a key proponent of gluten- free food labeling since 2003. For this event, I represented the Celiac Disease Foundation, a founding member of ACDA and North Bay Celiacs’ national affiliate, as their national liaison. Here’s part of our group, walking the halls of Congress:

Members of the coalition spent the day visiting members of Congress, who were very receptive. Betty McCollum of Minnesota and Nita Lowey of New York, are particularly committed to tracking FDA’s progress and seeing this through. They both attended the evening reception at the Embassy Suites Washington D.C.

Just a few of the many others present that evening and supporting the event: Dr. Alessio Fasano of the University of Maryland Center for Celiac Research; the University of Chicago Celiac Disease Center; King Arthur Flour Company; Nu-World Amaranth; Glutino/Gluten-Free Pantry; Gluten Intolerance Group; National Foundation for Celiac Awareness; Lee Tobin of Whole Foods Gluten-Free Bakehouse; and support groups from around the region.

Something that week also triggered a response by the FDA. Was it the Washington Post article critical of the FDA’s delay, 5,000 letters to the FDA by members of the public, or perhaps the 11 foot gluten-free cake at the evening reception? Mike Taylor, the FDA’s deputy commissioner for foods, attended the reception and seemed impressed that the coalition is so broad-based and includes the gluten-free food industry.

Here’s a picture from the reception: From the left, FDA Deputy Commissioner Mike Taylor, Living Without magazine editor Alicia Woodward, Representative Betty McCollum (D-MN), American Celiac Disease Alliance executive director Andrea Levario.

“I want people to understand that the FDA gets it. We’re on this. We’ll get this moving,”

Deputy Commissioner Taylor spoke before the assembled crowd in the hotel lobby and promised to get the job done. “I want people to understand that the FDA gets it. We’re on this. We’ll get this moving,” he announced. He said the long-awaited Safety Assessment to determine a safe level for gluten in food would be out within a few weeks, open for a public comment period, and then the final rule would follow.

Let’s see, that was exactly three weeks ago today…FDA, we are watching and waiting.

Stay tuned for more details.