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Gluten Sensitivity: Why is FDA Dragging Its Feet?

Gluten Sensitivity: Why is FDA Dragging Its Feet?
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glutenNearly 20 million Americans experience dire health problems from eating foods that contain gluten. Congress told FDA to define the term “gluten-free” for food manufacturers by 2008. Why are they still “studying the matter”? A new Action Alert!

Celiac disease is an autoimmune condition in which dietary gluten, causes damage to the small intestine, which keeps nutrients from being properly absorbed. Even small amounts of gluten in foods such as wheat, rye, barley, and other products, can lead to serious health problems, ranging from gastrointestinal distress and infertility to an increased risk of osteoporosis and certain cancers, particularly colon cancer.
As we reported recently, gluten-related conditions greatly increase the risk for diabetes. A recent large study published in the Journal of the American Medical Association found that people with diagnosed, undiagnosed, and “latent” celiac disease or gluten sensitivity had a higher risk of death, mostly from heart disease and cancer.
More than 2.3 million people in the US have celiac disease, or about 1 in 133 people; some estimates place the total as high as 3 million Americans—and growing.
Many more Americans—as many as 30–40% of the US population, according to the research of a leading US laboratory working in the field—have gluten sensitivity (also called Non-Celiac Gluten Intolerance), which means that they, too, are sickened by the protein. It is also sometimes referred to as “silent” celiac disease, as the disease may remain latent for twenty years or more before becoming full-blown celiac disease if gluten consumption is continued.
In these people, gluten continues to cause irritation to the lining of the intestine, often giving rise to poor digestion and malabsorption (as enzyme production is compromised), abdominal pain, irritability, achiness, sluggishness or fatigue, apathy, headaches, skin problems, depression, “foggy mind,” other decrease in brain function, or tingling extremities.
Dr. Mark Hyman reports that a review paper in The New England Journal of Medicine listed 55 “diseases” that can be caused by eating gluten. These include osteoporosis, irritable bowel disease, inflammatory bowel disease, anemia, cancer, fatigue, canker sores, rheumatoid arthritis, lupus, multiple sclerosis, and almost all other autoimmune diseases. Gluten is also linked to many psychiatric and neurological diseases, including anxiety, depression, schizophrenia, dementia, migraines, epilepsy, and neuropathy (nerve damage). It has also been linked to autism.
Two important factors that may create gluten sensitivity are a diet containing too much gluten, and increased permeability of the small intestinal lining, also called leaky gut syndrome—which, as we reported last week, may develop because genetically engineered food genes are transferring to our own genes.
The incidence of celiac disease is rising sharply—and not just due to greater awareness: the rate has increased fourfold in the last 50 years. One possible culprit: agricultural changes to wheat that have boosted and changed the amount and quality of proteins present.
Celiac disease is being diagnosed in people as old as 70 who have eaten gluten safely all their lives—most likely the result of adults losing their immunological tolerance for gluten as they get older.
The treatment to this massive, preventable health problem—a problem aggravated by the fact that gluten is ubiquitous in the Western diet and is abundant in wheat, one of our most-consumed foods—is straightforward: a commitment to a gluten-free diet. Not a low-gluten diet, but a diet that is more-or-less completely free of gluten (i.e., containing gluten at less than 20 parts per million, or ppm).
The high numbers of celiac sufferers, and the rise in people with gluten sensitivity, has food manufacturers looking at a lucrative new niche. The gluten-free market is projected to reach $2.6 billion next year, up from $100 million in 2003, with products carrying a premium price. But there’s a problem: while some products labeled gluten-free contain no gluten, others might have a trace, and still others could contain a sizable amount.
In 2004, 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 came and went three years ago.
The Washington Post reports that the FDA has spent years calling on experts to have open-forum debates and town hall meetings—all of whom have been saying the same things about the dangers of gluten and what “gluten-free” should mean. As Alessio Fasano, medical director of the Center for Celiac Research at the University of Maryland School of Medicine, said recently, “I really don’t understand why it’s lingering up in the air when it really should be a no-brainer.”
The FDA 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 (not usually, but they can be—see Note below).
An FDA spokesperson recently told the Washington Post 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.
In other words, the agency is deliberately dragging its feet.
Even the House Appropriations Committee, which is considering FDA funding, noted the agency’s failure to meet its deadline: “Public Law 108–282 required a final rule…not later than August 2008….The Committee instructs FDA to issue a final rule before December 31, 2011.”
Three years of flouting the law, and all FDA gets is a slap on the wrist.
Canada, Brazil, and Australia 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.
These countries have developed this standard after many years of discussion on the subject at the Codex Alimentarius Commission. Before 2008, the Codex standard for “gluten-free” foods was a whopping 200 ppm. The US government delegation, comprised of FDA staff, agreed to the international guideline level being lowered to 20 ppm. Now they seem to have cold feet. Is it that gluten is so widely distributed in processed foods that US food corporations would struggle to cope with the 20 ppm level?
Meanwhile in North Carolina two weeks ago, a man was sentenced to eleven 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 became ill as a result.
On May 4, concerned citizens brought the world’s largest gluten-free cake—“symbolizing the big deal that clear, accurate, reliable labeling plays in the lives of people dependent on labeling for their health”—to Capitol Hill in protest of FDA’s inaction.
Please write to the FDA immediately and tell them to stop listening to Big Food interests, and define “gluten-free” to mean gluten-free.
Update: On August 3, one day after this article was published, the FDA reopened comment on gluten-free labeling. All messages sent through our Action Alert will be redirected so that you can make your voice heard during this comment period.


Click THIS LINK to go to the Action Alert page. Once there, fill out the form with your name and address, etc., and customize your letter. We have a suggested message for you, but please feel free to add your own comments to the letter.
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Gluten is a naturally occurring group of proteins in cereal grains which makes bread dough elastic and chewy and gives pasta its structure. Besides being found in grains, it is very common in more-or-less all processed foods, including foods many consumers would imagine were gluten-free, from processed meats to ready-made meals, soy sauce, blue cheese, brown rice syrup, and what ingredients labels call “flavor enhancer.” It may also be found in everyday products such as medicines, vitamins, and lip balms.

Oats are naturally gluten-free, but cross-contamination is a major problem. If oats are grown in a field that previously grew other gluten-containing grains, some of those grains will naturally grow in the oat field the next year, and they will contaminate next year’s oats. Cross-contamination can also occur if the farmer uses the same equipment to process all his grains, or the transport company bringing the oats to the processor has stored and transported other grains, or if the processor processes other gluten-containing grains. The same problem occurs with corn chips and corn tortillas—there is a high level of gluten cross-contamination. For these reasons, celiacs and those people eating gluten-free should purchase only certified gluten-free oats and corn products.

Prof. Markku Mäki, head of a gluten research at the Academy of Finland’s Research Program on Nutrition, Food, and Health, has been at the forefront of gluten research worldwide for over three decades. He estimates that around 75% of people with gluten intolerance remain undiagnosed owing to mild or atypical symptoms. However, he argues that continued exposure can lead to full-blown celiac disease later in life, explaining the fact that typically around twice as many of people over age 50 have celiac disease as compared with their younger counterparts. His group has also shown that while gluten intolerance may be inherited by many, it may also be triggered by environmental factors, including exposure to particular viruses. Gluten intolerance is the most common genetic disorder in North America and Europe, although it is found in populations all over the world.
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