3 years after deadline, FDA still hasn’t defined ‘gluten-free’
By Lyndsey Layton,
For seven years, the Food and Drug Administration has been trying to answer this question: What does it mean to be “gluten-free”?
That is roughly the time it took to build a tunnel beneath the English Channel to connect Britain and France.
In the meantime, foodmakers have been deciding for themselves whether they can jump into a lucrative new niche and market their products as free from gluten, a protein found in wheat, rye and barley. As a result, some products labeled gluten-free contain no gluten, others might have a trace and still more could contain a sizable amount.
That murkiness is creating a real problem for an increasing number of Americans whose health depends on avoiding even tiny amounts of gluten, which is commonly found in bread, pasta and other staples and even in some unexpected products, such as soy sauce and blue cheese.
Celiac disease, an autoimmune disorder in which gluten damages the lining of the small intestine, afflicts about 3 million people in the United States. Exposure to gluten can trigger problems ranging from gastrointestinal distress and infertility to an increased risk of certain cancers.
And new research suggests that an additional 17 million Americans are “gluten-sensitive,” which means that they, too, are sickened by the protein and can experience abdominal pain, fatigue, headaches, “foggy mind” or tingling extremities.
The treatment is straightforward: a lifelong commitment to a gluten-free diet.
‘Should be a no-brainer’
Under a 2004 law, Congress gave the FDA until 2008 to establish a uniform definition for companies that want to label their products as gluten-free. But that deadline has come and gone.
“The FDA has spent years calling upon experts to have open-forum debates, town hall meetings — we’ve been having reiteration and reiteration,” said Alessio Fasano, medical director of the Center for Celiac Research at the University of Maryland School of Medicine. “They’ve been reiterating and listening to Grandma, Grandpa, people on the street corners. . . . I really don’t understand why it’s lingering up in the air when it really should be a no-brainer.”
In the meantime, Fasano said, the prevalence of celiac disease in this country is soaring partly because changes in agricultural practices have increased gluten levels in crops. “We are in the midst of an epidemic,” he said.
And that has caused an explosion in gluten-free foods. The market is projected to reach $2.6 billion next year, up from $100 million in 2003. Gluten-free cereal, snacks and other foods carry a premium price, creating an alluring growth market for food companies.
Some drugmakers are also producing gluten-free coatings, fillings and capsules for medication. Gluten-free blogs and specialty bakeries are sprouting like wheat. And the gluten-free diet has acquired a faddish lustre that is undoubtedly helping drive sales; stars including Gwyneth Paltrow and Oprah Winfrey have dabbled in life without gluten and boasted how their “detox” diets helped them feel better and more energized.
But what exactly does gluten-free mean?
Three years after the congressional deadline, the FDA is still working on that question, a spokeswoman said.
The agency has said the issue is complicated, requiring analyses of various technical issues, including how well manufacturers and regulators can reliably test for the presence of gluten and whether oats are a source of gluten. The agency held a public meeting in 2005, inviting input from millers, foodmakers, medical experts and others, and published a proposed rule in 2007.
And then it continued to study the matter.
Meanwhile, Canada, Brazil, Australia and an international body — the Codex Alimentarius Commission — have all set labeling standards for gluten-free items. In most cases, that standard is 20 parts per million: A food can be labeled gluten-free if it contains less than 0.0007 of an ounce of gluten for every 2.2 pounds of food. That level was chosen largely because it’s the minimum amount of gluten that can be reliably detected.
With no uniform standard in the United States, some foodmakers scrupulously monitor products labeled gluten-free to ensure that they have not come into contact with wheat or other gluten sources. They test their ingredients, segregate equipment so there is no chance for contamination and test the finished product.
Others are less stringent. They might fail to test their products or might allow small amounts of gluten but still label their foods as gluten-free.
In some cases, manufacturers affix the labels to items that don’t naturally contain gluten, such as milk and bottled water.
“Everyone is trying to get on the bandwagon and get a piece of this market, and consumers are being misled,” said Andrea Levario, executive director of the American Celiac Disease Alliance. “People see a ‘gluten-free’ sticker on bottled water and they think, ‘Does that mean I should be concerned about other bottled waters?’ It’s very confusing.”
In the absence of a federal standard, two organizations have formed to certify foods as gluten-free for a fee from the manufacturer.
But for many consumers, it’s buyer beware.
In North Carolina two weeks ago, a man was sentenced to 11 years in prison after he was found guilty of buying regular breads and rolls and repackaging them as gluten-free under the name Great Specialty Products. Dozens of people complained of illness after eating the baked goods, including a woman who gave birth to a 31 / 2 pound baby prematurely, a complication that can result from celiac disease.
“We thought it was fantastic because it tasted just like real bread,” said Rebecca Fernandez of Raleigh, who gave it to her son, Malachy, who has celiac disease.
Within days, an angry rash covered the then-2-year-old’s body. “We thought maybe it was chickenpox,” Fernandez said. He ate the bread for two weeks, as the rash intensified and turned bloody, until Fernandez realized the problem and stopped giving him the bread. Malachy suffered from diarrhea for four more weeks.
“I called the police because this guy had basically poisoned my son,” Fernandez said. “They said it wasn’t really their thing.”
Her call to the FDA’s Charlotte office in December 2009 was not returned, she said.
She finally contacted the North Carolina Department of Agriculture, which regulates bakeries in the state, and an investigation led to the conviction of Great Specialty Products owner Paul Seelig, 48, on 23 counts of obtaining property by false pretense.
FDA spokeswoman Pat El-Hinnaway said the agency “has no history” with Great Specialty Products or Seelig and has not investigated the company.
To pressure the FDA to speed up its work, activists are bringing a 13-foot-tall gluten-free cake to Capitol Hill on May 4. “Doesn’t it seem strange that Congress would have issued a mandate and years go by and it hasn’t been done?” said Jules Shepard, an organizer and author of gluten-free cookbooks who sells gluten-free flour and cake mixes. “It seems like the FDA is breaking the law, and it’s time to do something about it.”
El-Hinnaway, the FDA spokeswoman, said in an e-mail that “efforts are now underway” to publish another document in the Federal Register and reopen the matter to another round of public comments. The FDA will then “consider the comments,” the findings of a safety assessment and “other factors” to develop a final rule.