Activists Protest Delayed Gluten-Free Label Standard

May 4, 2011— -- The Food and Drug Administration has dragged its feet in setting a standard for gluten-free foods, say activists who today are assembling a one-ton, 15-foot-high gluten-free cake symbolizing how much their lives depend upon strictly avoiding a protein found in most bakery goods, pasta, beer and even some cold cuts and salad dressings.

Organizers of the Gluten-Free Food Labeling Summit in Washington, D.C., want the baked behemoth, assembled by volunteers from 180 half-sheet cakes made with special gluten-free flour in Whole Foods' Gluten-Free Bakehouse, to send a message to Congress and the FDA about the importance of "clear, accurate, reliable labeling" of packaged foods for Americans who must avoid gluten for medical reasons.

They want the FDA to adopt a gluten-free labeling standard that was due in August 2008, under the Food Allergen Labeling and Consumer Protection Act (FALCPA) of 2004. Also overdue: an assessment of the proposed gluten standard of 20 parts per million.

Andrea Levario, executive director of the American Celiac Disease Alliance, a volunteer organization that's among the summit's sponsors, said community members had sent thousands of letters to FDA Commissioner Peggy Hamburg, and her organization also had written twice. "We have not had a response to our letters."

But Mike Taylor, the FDA deputy commissioner for foods, said Wednesday morning that he was headed to the summit to let participants know "we really understand that there's a big population out there and this is really a serious problem for them, and labeling can help and we want to do our part."

"I want people to understand that the FDA gets it," Taylor told ABC News. "We're on this. We'll get this moving."

He said the safety evaluation had been completed, peer-reviewed "and very shortly – I hope within a matter of weeks, we'll be putting this out for public comment."

Taylor said the proposed 20 ppm threshold represented the limit of what scientifically validated detection methods could identify, though the FDA had been taking time to examine whether it should be "making more effort to validate methods that are more sensitive."

"For many people , there's a diversity of sensitivities. What's protective for one person might not be protective for another," he said.

"It's not fair that we don't know what's in those foods," said Jules Shepard of Catonsville, Md., a gluten-free cookbook author and summit founder. Shepard developed and began marketing her own gluten-free flour after being diagnosed at 29 with celiac disease, a potentially life-threatening genetic illness that makes gluten toxic to her system.

The core constituency for gluten-free eating long has been celiac patients like Shepard, whose immune systems recognize gluten as an invader and unleash attacks on the small intestine, producing diarrhea, abdominal pain, along with fatigue, headaches and joint inflammation. Over time, celiac disease can lead to malnourishment, osteoporosis, neurological conditions, and in rarer cases, infertility or cancer.

An estimated 3 million Americans, or 1 in 133, have celiac disease (the source of the website name for Shepard's campaign, 1in133.org). However, most of them aren't aware of it, in part because it can strike at any time. Only 200,000 to 220,000 Americans have been diagnosed, said Dr. Alessio Fasano, director of the Center for Celiac Research at the University of Maryland in Baltimore, also a summit sponsor.

Another 300,000 to 600,000 Americans avoid gluten because of wheat allergy, Fasano estimated. A third group within the growing gluten-free constituency comprises the 18 million to 20 million Americans who Fasano estimated suffer from gluten sensitivity, with pain, fatigue, headaches and brain fog much like that of celiac patients. However, his research has found that although they don't make the same antibodies that define celiac disease, they have an inflammatory reaction to gluten.

An emerging group of people with gluten sensitivity have such psychiatric and neurological disorders as schizophrenia, ADHD, depression, and bipolar syndrome, and "a higher rate" of some antibodies, said Dr. Peter H.R. Green, director of the Columbia University Celiac Disease Center in New York, another summit sponsor.

"Schizophrenia used to be called bread madness," he said in an interview.

For these patients, he said, gluten-free eating can make the difference between good and ill health: A single smidgen of gluten can set them back.