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FDA Passes First-Ever "Gluten-Free" Labeling Guidelines

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The gluten-free foods market is big and getting bigger. It's increased 30 percent in just four years, and every major food company now markets gluten-free foods, usually at a higher cost than their non-gluten-free counterparts. And people gobble them up, spending about $4 billion per year on them.

Still, there's never been any real evidence that foods claiming to be "gluten-free" are actually gluten free, thanks to the fact that the Food and Drug Administration (FDA) has never defined the label. Any marketer could slap the claim on a box and put it on a shelf, and people who need to avoid gluten for medical reasons have just had to hope the marketers were being honest.

Until now. For the first time ever, the FDA has created a definition of what "gluten free" actually means. The agency has said that any food bearing the label must contain no more than 20 parts per million (ppm) gluten, an internationally accepted standard used by the European Union and a level that most physicians agree is tolerable for people who can't tolerate gluten.

The new label will help the estimated 3 million Americans who suffer from celiac disease, an autoimmune disorder that results in diarrhea, fatigue, nerve damage, rashes, or anemia (among other symptoms) after eating wheat and wheat relatives, namely rye, barley, and triticale (a cross between wheat and rye).

In a statement issued by the American Celiac Disease Alliance, Alessio Fasano, MD, director of the Center for Celiac Research at Mass General Hospital, said, "A decade ago, our research determined that the prevalence of celiac disease in the United States was 1 in 133. Even then it was obvious that patients could not safely manage their diet without better labeling requirements." There currently is no medical treatment for celiac disease other than avoiding gluten in the diet.

His research has also revealed that an estimated 18 million people suffer from gluten sensitivity, a condition in which people react negatively to those grains but never test positive for celiac. They, too, will benefit from the new labeling, as will hundreds of thousands of people who suffer from autoimmune disorders linked to gluten sensitivities, Jules Shepard, founder of the advocacy group 1in133.org, told Rodale News in 2011. "You have people with rheumatoid arthritis, lupus, and other inflammatory diseases who are told to go on an anti-inflammatory diet to help manage their symptoms," she said, adding that studies have linked gluten sensitivity to inflammation. And though there's some controversy about the links between gluten sensitivity and autism, many parents find that autistic children do better on gluten-free diets.

Until now, none of these groups could rely on gluten-free foods because there was no legal definition and any food marketer could jump on the gluten-free bandwagon whether their foods were tolerable or not.

But is it strict enough? Possibly not, says Arthur Agatston, MD, clinical professor of medicine at the Florida International University Herbert Wertheim College of Medicine and author of The South Beach Diet Gluten Solution. "While 20 ppm is the generally accepted safe threshold for gluten for most people with celiac disease, it is still more than some people with the disease or with a serious gluten sensitivity can tolerate," he says. People suffering from either condition should consult their doctors, he advises, before assuming that gluten-free foods are safe for them to eat. Not only that, he adds, the FDA is allowing any food that is inherently gluten free to also carry the label, "which does muddy the waters a bit." Eggs, fruits, and vegetables—even bottled water—will classify as "gluten free," though those foods never contained gluten to begin with.

Then there's the issue of cross-contamination. Celiac sufferers and the gluten intolerant have complained in the past that there isn't enough quality control to prevent gluten-free foods from being contaminated, particularly in food-processing facilities making both gluten-free and gluten-containing foods.

According to FDA spokesperson Shelly Burgess, the new regulations will theoretically take care of all that. "Any grain other than the gluten-containing grains…can be labeled gluten free if it meets the definition, including that the presence of any unavoidable gluten due to cross-contact situations is less than 20 ppm," she says. Food companies will have to figure out for themselves how to ensure that gluten-free products stay under that 20-ppm threshold, she adds.

Furthermore, warns Dr. Agatston, don't assume that gluten-free foods are now automatically healthy. "Many gluten-free products are high in fat, sugar and sodium. Reading food labels carefully is therefore essential," he says. And the reality is that just one percent of the population—those suffering from celiac disease—need to be completely gluten-free, he adds. "Those with gluten sensitivity must be what I call 'gluten aware' and determine just how much gluten, if any, they can tolerate."

Wondering if you qualify as gluten-sensitive? Pick up a copy of The South Beach Diet Gluten Solution today!


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