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.
Despite Explosion of Gluten-Free Offerings, Patients Remain Vigilant Label-Checkers
Despite the explosion of gluten-free offerings at supermarkets, big-box stores (half of gluten-free shoppers buy their products at Walmart, a February 2011 Packaged Facts report found ), and health food stores, celiac patients still find themselves endlessly double-checking ingredient lists. Many call companies to learn if they've paid meticulous attention to preventing potential cross-contamination in the field, during transportation, during milling, and properly washed down equipment that handles foods containing gluten before they do any gluten-free runs.
Maria Monteverde-Jackson, 40, of Arlington, Va., recently diagnosed with gluten sensitivity, expressed frustration about gluten-free food packaging.
"The biggest challenge I have found is there is no consistency in the labeling. There is no symbol that all the products use," said Monteverde-Jackson, who went gluten-free about six weeks ago.
Summit co-organizer John Forberger, of Merchantsville, N.J., said companies may seek voluntary certification from the Gluten Intolerance Group's Gluten Free Certification Organization (GFCO) or from the Celiac Sprue Association (CSA) that their products contain less than 10 parts per million of gluten.
Other companies label their products gluten-free based on their own good-faith standard. Still others may state on packages that their products contain "no gluten ingredients." But this hodgepodge approach doesn't provide much security for patients like him or Monteverde-Jackson.
Forberger said his severe gluten intolerance manifests as painful attacks of pancreatitis that occur within 30 minutes of ingesting any gluten. A triathlete who has followed a "paleo diet" of meat, fish, fruits and vegetables for several years, he regrets the day last October that he decided to try a couple of Snyder's of Hanover pretzel sticks in a brown bag bearing the words "gluten-free" in a big blue circle on the package.
"The next thing you know, I had stomach cramping," he said. He ended up hospitalized for three weeks. Although Snyder's obtained GFCO certification for its gluten-free pretzels in April 2010, and produces its pretzels to have no more than 5 ppm of gluten, Forberger said he's been contacted by some others who, like him, became sick after eating the pretzels, and says he wished he hadn't veered from his no-starchy-carbs diet.
While it's possible the pretzels might have contained some trace of gluten, activists active in the blogosphere have said Snyder's sought gluten-free certification in good faith. That can't be said for Paul Seelig, sentenced by a North Carolina judge on April 12 to an 11-year prison term for knowingly misrepresenting Great Specialty Products bakery goods as gluten-free.
Among the dozen sickened was Zach Becker, who had recommended Great Specialty foods on his Gluten Free Raleigh blog for two weeks before developing a blistering, bleeding celiac rash called dermatitis herpetiformis.
In a statement he read before the judge sentenced Seelig, Becker said the lack of an FDA standard for what constitutes a gluten-free product "has left the gluten-free community vulnerable to fraudulent companies like Great Specialty Products."