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    What is Gluten-Free? FDA Has an Answer


    Scott Adams

    Celiac.com 08/05/2013 - People with celiac disease can now have confidence in the meaning of a "gluten-free" label on foods.


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    The Food and Drug Administration (FDA) has issued a final rule that defines what characteristics a food has to have to bear a label that proclaims it "gluten- free." The rule also holds foods labeled "without gluten," "free of gluten," and "no gluten" to the same standard.

    FDAThis rule has been eagerly awaited by advocates for people with celiac disease, who face potentially life-threatening illnesses if they eat the gluten found in breads, cakes, cereals, pastas and many other foods.

    As one of the criteria for using the claim "gluten-free," FDA is setting a gluten limit of less than 20 ppm (parts per million) in foods that carry this label. This is the lowest level that can be consistently detected in foods using valid scientific analytical tools. Also, most people with celiac disease can tolerate foods with very small amounts of gluten. This level is consistent with those set by other countries and international bodies that set food safety standards.

    "This standard 'gluten-free' definition will eliminate uncertainty about how food producers label their products and will assure people with celiac disease that foods labeled 'gluten-free' meet a clear standard established and enforced by FDA," says Michael R. Taylor, J.D., deputy FDA commissioner for foods and veterinary medicine.

    Andrea Levario, executive director of the American Celiac Disease Alliance, notes that there is no cure for celiac disease and the only way to manage the disease is dietary—not eating gluten. Without a legal definition of "gluten-free," these consumers could never really be sure if their body would tolerate a food with that label, she adds.

    "This is a tool that has been desperately needed," Levario says. "It keeps food safe for this population, gives them the tools they need to manage their health, and obviously has long-term benefits for them."

    "Without proper food labeling regulation, celiac patients cannot know what the words 'gluten free' mean when they see them on a food label," says Allessio Fasano, M.D., director of the Center for Celiac Research at MassGeneral Hospital for Children, visiting professor of pediatrics at Harvard Medical School and member of the American Celiac Disease Alliance.

    What Is Gluten?

    Gluten means the proteins that occur naturally in wheat, rye, barley, and crossbreeds of these grains.

    As many as 3 million people in the United States have celiac disease. It occurs when the body's natural defense system reacts to gluten by attacking the lining of the small intestine. Without a healthy intestinal lining, the body cannot absorb the nutrients it needs. Delayed growth and nutrient deficiencies can result and may lead to conditions such as anemia (a lower than normal number of red blood cells) and osteoporosis, a disease in which bones become fragile and more likely to break. Other serious health problems may include diabetes, autoimmune thyroid disease and intestinal cancers.

    Before the rule there were no federal standards or definitions for the food industry to use in labeling products "gluten-free." An estimated 5 percent of foods currently labeled "gluten-free" contain 20 ppm or more of gluten.

    How Does FDA Define 'Gluten-Free'?

    In addition to limiting the unavoidable presence of gluten to less than 20 ppm, FDA will allow manufacturers to label a food "gluten-free" if the food does not contain any of the following:

    1. An ingredient that is any type of wheat, rye, barley, or crossbreeds of these grains;
    2. An ingredient derived from these grains and that has not been processed to remove gluten;
    3. An ingredient derived from these grains and that has been processed to remove gluten, if it results in the food containing 20 or more parts per million (ppm) gluten.

    Foods such as bottled spring water, fruits and vegetables, and eggs can also be labeled "gluten-free" if they inherently don't have any gluten.

    The regulation will be published Aug. 5, 2013 in the Federal Register, and manufacturers have one year from the publication date to bring their labels into compliance. Taylor says he believes many foods labeled "gluten free" may be able to meet the new federal definition already. However, he adds, "We encourage the food industry to come into compliance with the rule as soon as possible."

    Under the new rule, a food label that bears the claim "gluten-free," as well as the claims "free of gluten," "without gluten," and "no gluten," but fails to meet the requirements of the rule would be considered misbranded and subject to regulatory action by FDA.

    Those who need to know with certainty that a food is gluten-free are heralding the arrival of this definition. "This is a huge victory for people with celiac disease," says Levario. "In fact, that's the understatement of the year."

    Says Taylor, "FDA's 'gluten-free' definition will help people make food choices with confidence."

    This article appears on FDA's Consumer Updates page, which features the latest on all FDA-regulated products.

    Source: August 2, 2013 - http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm363069.htm


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    I for one am a VERY sensitive celiac and cannot even tolerate gluten at the level that the FDA deems safe. In my opinion, repeated frequent exposure at even 20ppm will cause damage, but I don't think enough research has been done to push this point. Gluten-free should mean NO GLUTEN!

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    I for one am a VERY sensitive celiac and cannot even tolerate gluten at the level that the FDA deems safe. In my opinion, repeated frequent exposure at even 20ppm will cause damage, but I don't think enough research has been done to push this point. Gluten-free should mean NO GLUTEN!

    JL, I'm there with you! I can't tell you how many times I've gotten sick from "gluten free" foods. I can detect the slightest amount and not in a pleasant way! I'm worried that some companies will relax their standards and let more gluten pass through since their foods can have 20ppm and still be labeled "gluten-free." Also, this ruling just applies to the ingredients in the product, nothing about cross contamination during the processing/production/packaging.

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    I for one am a VERY sensitive celiac and cannot even tolerate gluten at the level that the FDA deems safe. In my opinion, repeated frequent exposure at even 20ppm will cause damage, but I don't think enough research has been done to push this point. Gluten-free should mean NO GLUTEN!

    I agree, and am also super sensitive, but since no tests exist that are as sensitive as our guts, we will have to continue to be vigilant. However, be careful and conscious of other possible troublemakers. I complained for years that I could not travel without getting sick. It turned out I was allergic to xanthan gum and the reaction was identical to gluten reaction. I never used xanthan gum at home, relying on chick pea flour or flax meal or corn starch instead, but it was in almost every pre-made gluten-free product or mix. Xanthan gum is now showing up in everything from juices to skin care products. I also deeply suspect I have trouble with GMO corn. Particularly late diagnosed gluten sensitives may have developed other sensitivities.

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    Guest StephH

    Posted

    I agree, JL. I am very sensitive as well and have to be really strict on what I eat. Now I will really need to watch the food that says gluten-free! It's a win in one sense but for others like us I feel it's something we will have to worry about. I expect gluten-free to mean no gluten; now that it can contain trace amounts, I fear that these products could end up making me sick. I just hope that the strict companies I rely on will not start changing their procedures to be more lax of cross contamination due to law.

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    How will this gluten-free rating be regulated? Is it left to the individual companies to self-regulate and test for 20ppm? Then we are sunk and the ruling means not much of anything new. I like the idea of an independent regulating group as we have now with the gluten-free symbols. (I only eat things with this symbol and also the non-gmo symbol). The companies have to pay for the independent testing of their products now.

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    Guest Marilyn

    Posted

    I responded when the FDA initially did their survey. People with nut allergies can't eat foods with 20 ppm peanuts in them, so why should celiacs be exposed to foods with 20 ppm gluten in them? Not a good solution.

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    Scott Adams
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    When you are in contact with the food-industry, you might ask them:
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    Sources:
    1. Toft M, Dietrichs E. Aggravated stuttering following subthalamic deep brain stimulation in Parkinson’s disease--two cases. BMC Neurol. 2011 Apr 8;11:44.
    2. Tani T, Sakai Y. Stuttering after right cerebellar infarction: a case study. J Fluency Disord. 2010 Jun;35(2):141-5. Epub 2010 Mar 15.
    3. Lundgren K, Helm-Estabrooks N, Klein R. Stuttering Following Acquired Brain Damage: A Review of the Literature. J Neurolinguistics. 2010 Sep 1;23(5):447-454.
    4. Jäncke L, Hänggi J, Steinmetz H. Morphological brain differences between adult stutterers and non-stutterers. BMC Neurol. 2004 Dec 10;4(1):23.
    5. Kell CA, Neumann K, von Kriegstein K, Posenenske C, von Gudenberg AW, Euler H, Giraud AL. How the brain repairs stuttering. Brain. 2009 Oct;132(Pt 10):2747-60. Epub 2009 Aug 26.
    6. Galantucci S, Tartaglia MC, Wilson SM, Henry ML, Filippi M, Agosta F, Dronkers NF, Henry RG, Ogar JM, Miller BL, Gorno-Tempini ML. White matter damage in primary progressive aphasias: a diffusion tensor tractography study. Brain. 2011 Jun 11.
    7. Lundgren K, Helm-Estabrooks N, Klein R. Stuttering Following Acquired Brain Damage: A Review of the Literature. J Neurolinguistics. 2010 Sep 1;23(5):447-454.
    8. [No authors listed] Case records of the Massachusetts General Hospital. Weekly clinicopathological exercises. Case 43-1988. A 52-year-old man with persistent watery diarrhea and aphasia. N Engl J Med. 1988 Oct 27;319(17):1139-48
    9. Molteni N, Bardella MT, Baldassarri AR, Bianchi PA. Celiac disease associated with epilepsy and intracranial calcifications: report of two patients. Am J Gastroenterol. 1988 Sep;83(9):992-4.
    10. http://ezinearticles.com/?Food-Allergy-and-Stuttering-Link&id=1235725 
    11. http://www.craig.copperleife.com/health/stuttering_allergies.htm 
    12. https://www.celiac.com/forums/topic/73362-any-help-is-appreciated/
    13. Ford RP. The gluten syndrome: a neurological disease. Med Hypotheses. 2009 Sep;73(3):438-40. Epub 2009 Apr 29.
    14. Hadjivassiliou M, Gibson A, Davies-Jones GA, Lobo AJ, Stephenson TJ, Milford-Ward A. Does cryptic gluten sensitivity play a part in neurological illness? Lancet. 1996 Feb 10;347(8998):369-71.

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    Journal of Clinical Pathologyhttp://dx.doi.org/10.1136/jclinpath-2018-205023

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    The research team included Y.‐H. Dong; Y. Jin; TN Tsacogianis; M He; PH Hsieh; and JJ Gagne. They are variously affiliated with the Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School in Boston, MA, USA; the Faculty of Pharmacy, School of Pharmaceutical Science at National Yang‐Ming University in Taipei, Taiwan; and the Department of Hepato‐Gastroenterology, Chi Mei Medical Center in Tainan, Taiwan.
    To get solid data on the issue, the team conducted a cohort study among ARB initiators in 5 US claims databases covering numerous health insurers. They used Cox regression models to estimate hazard ratios (HRs) and 95% confidence intervals (CIs) for enteropathy‐related outcomes, including celiac disease, malabsorption, concomitant diagnoses of diarrhea and weight loss, and non‐infectious enteropathy. In all, they found nearly two million eligible patients. 
    They then assessed those patients and compared the results for olmesartan initiators to initiators of other ARBs after propensity score (PS) matching. They found unadjusted incidence rates of 0.82, 1.41, 1.66 and 29.20 per 1,000 person‐years for celiac disease, malabsorption, concomitant diagnoses of diarrhea and weight loss, and non‐infectious enteropathy respectively. 
    After PS matching comparing olmesartan to other ARBs, hazard ratios were 1.21 (95% CI, 1.05‐1.40), 1.00 (95% CI, 0.88‐1.13), 1.22 (95% CI, 1.10‐1.36) and 1.04 (95% CI, 1.01‐1.07) for each outcome. Patients aged 65 years and older showed greater hazard ratios for celiac disease, as did patients receiving treatment for more than 1 year, and patients receiving higher cumulative olmesartan doses.
    This is the first comprehensive multi‐database study to document a higher rate of enteropathy in olmesartan initiators as compared to initiators of other ARBs, though absolute rates were low for both groups.
    Source:
    Alimentary Pharmacology & Therapeutics

    Jefferson Adams
    Celiac.com 06/12/2018 - A life-long gluten-free diet is the only proven treatment for celiac disease. However, current methods for assessing gluten-free diet compliance are lack the sensitivity to detect occasional dietary transgressions that may cause gut mucosal damage. So, basically, there’s currently no good way to tell if celiac patients are suffering gut damage from low-level gluten contamination.
    A team of researchers recently set out to develop a method to determine gluten intake and monitor gluten-free dietary compliance in patients with celiac disease, and to determine its correlation with mucosal damage. The research team included ML Moreno, Á Cebolla, A Muñoz-Suano, C Carrillo-Carrion, I Comino, Á Pizarro, F León, A Rodríguez-Herrera, and C Sousa. They are variously affiliated with Facultad de Farmacia, Departamento de Microbiología y Parasitología, Universidad de Sevilla, Sevilla, Spain; Biomedal S.L., Sevilla, Spain; Unidad Clínica de Aparato Digestivo, Hospital Universitario Virgen del Rocío, Sevilla, Spain; Celimmune, Bethesda, Maryland, USA; and the Unidad de Gastroenterología y Nutrición, Instituto Hispalense de Pediatría, Sevilla, Spain.
    For their study, the team collected urine samples from 76 healthy subjects and 58 patients with celiac disease subjected to different gluten dietary conditions. To quantify gluten immunogenic peptides in solid-phase extracted urines, the team used a lateral flow test (LFT) with the highly sensitive and specific G12 monoclonal antibody for the most dominant GIPs and an LFT reader. 
    They detected GIPs in concentrated urines from healthy individuals previously subjected to gluten-free diet as early as 4-6 h after single gluten intake, and for 1-2 days afterward. The urine test showed gluten ingestion in about 50% of patients. Biopsy analysis showed that nearly 9 out of 10 celiac patients with no villous atrophy had no detectable GIP in urine, while all patients with quantifiable GIP in urine showed signs of gut damage.
    The ability to use GIP in urine to reveal gluten consumption will likely help lead to new and non-invasive methods for monitoring gluten-free diet compliance. The test is sensitive, specific and simple enough for clinical monitoring of celiac patients, as well as for basic and clinical research applications including drug development.
    Source:
    Gut. 2017 Feb;66(2):250-257.  doi: 10.1136/gutjnl-2015-310148.