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    Act Now! Send Feedback to the Food and Drug Administration Regarding the Gluten-Free Labeling of Foods (Docket No. 2005N-0279)


    Scott Adams


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    Celiac.com 09/01/2005 - The Food and Drug Administration (FDA) will hold a public meeting to obtain expert comment and consultation from the public to help them define and permit the voluntary use on food labeling of the term ``gluten-free. The meeting will focus on food manufacturing, analytical methods, and consumer issues related to reduced levels of gluten in food. Celiac.com needs your help to speak out to make sure that this regulation will be written in such a way as to provide the greatest benefit to the gluten-free community, and to make sure that the new regulation will not create an undue burden on any exiting and future gluten-free food manufacturers.

    To have an influence on this process please Click Here and send your comments no later than September 19, 2005. If you feel the same way as us feel free to cut and paste the following letter into the comments area of this form:

    Dear FDA:

    We encourage you to adopt a regulation on the use of gluten-free on product labels that is in line with that which has been used in Europe and other countries (including the USA via the Codex Alimentarius) for many years--20 PPM for products that contain naturally gluten-free ingredients, and 200 PPM for products that have been rendered gluten-free such as those that may contain Codex Alimentarius quality wheat starch. The formal adoption of these existing regulations will allow for the continued importation of excellent, safe European products that are labeled gluten-free.

    It is very important that you do not adopt a zero tolerance regulation in this matter because doing so will cause many gluten-free food companies to discontinue their use of the term gluten-free on their labels out of fear of litigation--which is counterproductive for all people with this disease (most, if not all, gluten-free food companies do not grow, transport or mill the gluten-free grains that they use as ingredients--a fact that will make them vulnerable to litigation if a zero tolerance level is adopted). Last, the inclusion of trace levels of gluten in the diets of those with celiac disease have been shown to be safe in many scientific studies, for more details please see:
    http://www.celiac.com

    Thank you,
    Your Name

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  • Related Articles

    Scott Adams
    (Celiac.com 03/17/2000) Under the new FDA rules (effective in 2000), consumers will get more information about the sources of protein hydrolysates in their food. Hydrolyzed proteins are added to foods to serve various functions, including thickeners, flavorings and flavor enhancers, and they pose a major problem for people on special diets. From now on food makers will have to declare the source of added hydrolyzed proteins. The new laws state that the source of all protein hydrolysates--regardless of use--will now have to be identified. Further, caseinate will have to be identified as a milk derivative in the ingredient statement when its used in foods that claim to be non-dairy. According to the FDA these new requirements will help people who have special diet restrictions.

    Scott Adams
    Celiac.com 03/07/2007 - The Food and Drug Administration (FDA) recently proposed the following rule regarding the labeling of foods as "Gluten-Free (gluten-free). The rule appears in the Federal Register, Docket No. 2005N-0279, titled Food-Labeling: Gluten Free Labeling of Foods," and includes a definition of the term "gluten-free." There is no current Federal regulation to define the term "gluten-free" for labeling food. By clearly defining the term the FDA seeks to help those with celiac disease, along with their caregivers, to better identify packaged foods that are safe for consumption.
    The FDA proposes to set the standard acceptable gluten level for products labeled "gluten-free" at no greater than 20 parts of gluten per million. More specifically, the FDA proposes that the term "gluten-free" on food labels will apply to food that is free of any or all of the following:
    "Prohibited grains," meaning any species of wheat (e.g., durum wheat, spelt wheat, or kamut), rye, barley or their hybrids; Ingredients derived from "prohibited grains," (e.g., wheat flour), that have not been treated to remove gluten. Ingredients derived from "prohibited grains," (e.g., wheat flour), that HAVE been treated to remove gluten, but which results in 20 ppm (parts per million) or more of gluten per gram of food. 20 ppm or more of gluten per gram of food. Foods that are labeled "gluten-free," or claim to be "free of gluten," without gluten, or to contain no gluten," and which fail to meet the terms of the proposed definition of "gluten-free" would be designated as "misbranded."
    One aspect of the FDA rules that seems to have caused some confusion concerns the status of oats. One recent posting making the rounds among celiac support groups claims that page 2798 of the Federal Register states: that None of the four U.S. celiac associations that responded to the survey considered oats to be an acceptable food for individuals with celiac disease. This quotation is from an April 2000 article by Tricia Thompson, titled: Questionable food and the gluten-free diet: Survey of Current Recommendations. However, page 2798 of the Federal Register actually states the CURRENT positions held by the organizations:

    According to more recent position statements of 3 of the 4 major celiac associations in the United States that responded to the earlier survey conducted by Thompson (Ref. 57), one of these associations continues to take the position that oats are not an acceptable food for individuals with celiac disease; but, the other two of these associations are not opposed to the inclusion of oats in the diets of individuals with celiac disease, provided that the oats do not contain gluten from other grains and that the daily amount of oats consumed is limited to 1 cup cooked (Ref. 56)."
    The FDA held an initial public comment meeting for "gluten-free" food labeling in August 2005. Comments received during this meeting, coupled with other information compiled by the FDA, indicate that there is no consensus among either consumers or U.S. food manufacturers as to the nature of foods labeled "gluten-free." The FDA feels strongly that the establishment of clear definitions of "gluten-free," and of uniform guidelines for applying the term in labeling foods, will enable persons with celiac to obtain accurate and truthful information about the foods they purchase, and help to make sure they avoid the adverse health affects that can come consuming food that is mislabeled.
    For more information the FDA has prepared a document titled:
    Questions and Answers on the Gluten-Free Labeling Proposed Rule" The document is available for review through the following web-link:
    http://www.cfsan.fda.gov/~dms/glutqa.html.
    Act Now!
    There is a 90-day public comment period for the proposed rule. Submit your comments by April 23, 2007 by clicking here, or comments can also be submit it in writing to the Division of Dockets Management, Food and Drug Administration, 5630 Fishers Lane, Room 1061, (HFA-305) Rockville, MD 20852.
    Celiac.com supports the FDA proposals, and encourages those with celiac disease and their supporters, to review the FDA document and to share your comments in support of these standards.

    Michael Weber
    Celiac.com 02/06/2009 - Have you, as a Celiac, ever suspected that the medicine you were taking was making you sick? It could be because that pill or capsule was made with gluten. That’s because the U.S. Food and Drug Administration (FDA) allows pharmaceutical companies to use wheat gluten, a large protein that celiacs can’t eat, to be used as a mixing agent in drugs. Drug companies use chemical agents called excipients as inert additives to mix and bind the actual active ingredient of a drug so that you can take it in the form of a conveniently sized pill. Currently gluten is on the list of permitted excipients that you might be taking without even knowing it. That’s why I have petitioned the FDA to get gluten out of medicine.
    In a constitutionally protected act, I have submitted a Citizen’s Petition to the FDA requesting that they take gluten off of their list of permitted excipients. As I write, the National Foundation for Celiac Awareness has asked the FDA only to label medicines that contain gluten, but this approach will continue to allow gluten to be used at the decision of the manufacturer.  
    The FDA has a decision to make. I believe that they should follow existing law and recognize that gluten is toxic to a significant segment of the population. If the FDA got gluten out of medicine it would mean that you could confidently take aspirin, any generic, or any othe drug whether prescribed or over the counter, and not have to worry about gluten—and that would be true for all drugs. It would not, however, mean that the supplements you were taking would be gluten-free, because supplements aren’t regulated like drugs, but are regulared like food.
    As you probably know, foods will soon be labeled according to a federal gluten-free standard. But only some food makers will decide to make the products that will be labeled gluten-free. And the same thing might happen to drugs, if the FDA decides it is sufficient only to extend the labeling standard to drugs. As a Celiac, you won’t be able to take a drug unless it says gluten-free, because if doesn’t say gluten-free, who knows what’s inside? Is that Tylenol OK for you? Or how about that generic heart medication you get in the mail? The reality is that some day soon, the FDA might allow pharmaceutical companies to make business decisions on whether or not you can take a necessary medication. Taking medicine isn’t a matter of personal choice like foods. Rather, a doctor might not be able to give you a prescription because it might contain gluten. Maybe there won't be an equivalent drug that is also gluten-free.
    Time to Take Action!
    There is, however, something you can do. I petitioned the FDA to get gluten gone for good. I asked my congresswoman to write a letter to the FDA highlighting her concern about my petition. And any citizen can comment to the FDA about my petition, for or against. You can ask your congressman to pay attention to the decision, which the FDA is about to make.
    Now that I’ve wound you all up, here is how to contact the FDA. Go on the internet and surf to www.regulations.gov and enter the Docket number of my petition, 2008-P-0333, which you might enjoy reading. My petition is called Michael Weber of New York State. Highlight the line for comments of submissions, and then tell them what you think and who you are. Tell the FDA why you think there shouldn’t be any gluten in your medicine—please do it now!


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    Jefferson Adams
    Celiac.com 06/19/2018 - Could baking soda help reduce the inflammation and damage caused by autoimmune diseases like rheumatoid arthritis, and celiac disease? Scientists at the Medical College of Georgia at Augusta University say that a daily dose of baking soda may in fact help reduce inflammation and damage caused by autoimmune diseases like rheumatoid arthritis, and celiac disease.
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    Read more at: Sciencedaily.com

    Jefferson Adams
    Celiac.com 06/18/2018 - Celiac disease has been mainly associated with Caucasian populations in Northern Europe, and their descendants in other countries, but new scientific evidence is beginning to challenge that view. Still, the exact global prevalence of celiac disease remains unknown.  To get better data on that issue, a team of researchers recently conducted a comprehensive review and meta-analysis to get a reasonably accurate estimate the global prevalence of celiac disease. 
    The research team included P Singh, A Arora, TA Strand, DA Leffler, C Catassi, PH Green, CP Kelly, V Ahuja, and GK Makharia. They are variously affiliated with the Division of Gastroenterology and Hepatology, Beth Israel Deaconess Medical Center, Boston, Massachusetts; Lady Hardinge Medical College, New Delhi, India; Innlandet Hospital Trust, Lillehammer, Norway; Centre for International Health, University of Bergen, Bergen, Norway; Division of Gastroenterology and Hepatology, Beth Israel Deaconess Medical Center, Boston, Massachusetts; Gastroenterology Research and Development, Takeda Pharmaceuticals Inc, Cambridge, MA; Department of Pediatrics, Università Politecnica delle Marche, Ancona, Italy; Department of Medicine, Columbia University Medical Center, New York, New York; USA Celiac Disease Center, Columbia University Medical Center, New York, New York; and the Department of Gastroenterology and Human Nutrition, All India Institute of Medical Sciences, New Delhi, India.
    For their review, the team searched Medline, PubMed, and EMBASE for the keywords ‘celiac disease,’ ‘celiac,’ ‘tissue transglutaminase antibody,’ ‘anti-endomysium antibody,’ ‘endomysial antibody,’ and ‘prevalence’ for studies published from January 1991 through March 2016. 
    The team cross-referenced each article with the words ‘Asia,’ ‘Europe,’ ‘Africa,’ ‘South America,’ ‘North America,’ and ‘Australia.’ They defined celiac diagnosis based on European Society of Pediatric Gastroenterology, Hepatology, and Nutrition guidelines. The team used 96 articles of 3,843 articles in their final analysis.
    Overall global prevalence of celiac disease was 1.4% in 275,818 individuals, based on positive blood tests for anti-tissue transglutaminase and/or anti-endomysial antibodies. The pooled global prevalence of biopsy-confirmed celiac disease was 0.7% in 138,792 individuals. That means that numerous people with celiac disease potentially remain undiagnosed.
    Rates of celiac disease were 0.4% in South America, 0.5% in Africa and North America, 0.6% in Asia, and 0.8% in Europe and Oceania; the prevalence was 0.6% in female vs 0.4% males. Celiac disease was significantly more common in children than adults.
    This systematic review and meta-analysis showed celiac disease to be reported worldwide. Blood test data shows celiac disease rate of 1.4%, while biopsy data shows 0.7%. The prevalence of celiac disease varies with sex, age, and location. 
    This review demonstrates a need for more comprehensive population-based studies of celiac disease in numerous countries.  The 1.4% rate indicates that there are 91.2 million people worldwide with celiac disease, and 3.9 million are in the U.S.A.
    Source:
    Clin Gastroenterol Hepatol. 2018 Jun;16(6):823-836.e2. doi: 10.1016/j.cgh.2017.06.037.

    Jefferson Adams
    Celiac.com 06/16/2018 - Summer is the time for chips and salsa. This fresh salsa recipe relies on cabbage, yes, cabbage, as a secret ingredient. The cabbage brings a delicious flavor and helps the salsa hold together nicely for scooping with your favorite chips. The result is a fresh, tasty salsa that goes great with guacamole.
    Ingredients:
    3 cups ripe fresh tomatoes, diced 1 cup shredded green cabbage ½ cup diced yellow onion ¼ cup chopped fresh cilantro 1 jalapeno, seeded 1 Serrano pepper, seeded 2 tablespoons lemon juice 2 tablespoons red wine vinegar 2 garlic cloves, minced salt to taste black pepper, to taste Directions:
    Purée all ingredients together in a blender.
    Cover and refrigerate for at least 1 hour. 
    Adjust seasoning with salt and pepper, as desired. 
    Serve is a bowl with tortilla chips and guacamole.

    Dr. Ron Hoggan, Ed.D.
    Celiac.com 06/15/2018 - There seems to be widespread agreement in the published medical research reports that stuttering is driven by abnormalities in the brain. Sometimes these are the result of brain injuries resulting from a stroke. Other types of brain injuries can also result in stuttering. Patients with Parkinson’s disease who were treated with stimulation of the subthalamic nucleus, an area of the brain that regulates some motor functions, experienced a return or worsening of stuttering that improved when the stimulation was turned off (1). Similarly, stroke has also been reported in association with acquired stuttering (2). While there are some reports of psychological mechanisms underlying stuttering, a majority of reports seem to favor altered brain morphology and/or function as the root of stuttering (3). Reports of structural differences between the brain hemispheres that are absent in those who do not stutter are also common (4). About 5% of children stutter, beginning sometime around age 3, during the phase of speech acquisition. However, about 75% of these cases resolve without intervention, before reaching their teens (5). Some cases of aphasia, a loss of speech production or understanding, have been reported in association with damage or changes to one or more of the language centers of the brain (6). Stuttering may sometimes arise from changes or damage to these same language centers (7). Thus, many stutterers have abnormalities in the same regions of the brain similar to those seen in aphasia.
    So how, you may ask, is all this related to gluten? As a starting point, one report from the medical literature identifies a patient who developed aphasia after admission for severe diarrhea. By the time celiac disease was diagnosed, he had completely lost his faculty of speech. However, his speech and normal bowel function gradually returned after beginning a gluten free diet (8). This finding was so controversial at the time of publication (1988) that the authors chose to remain anonymous. Nonetheless, it is a valuable clue that suggests gluten as a factor in compromised speech production. At about the same time (late 1980’s) reports of connections between untreated celiac disease and seizures/epilepsy were emerging in the medical literature (9).
    With the advent of the Internet a whole new field of anecdotal information was emerging, connecting a variety of neurological symptoms to celiac disease. While many medical practitioners and researchers were casting aspersions on these assertions, a select few chose to explore such claims using scientific research designs and methods. While connections between stuttering and gluten consumption seem to have been overlooked by the medical research community, there is a rich literature on the Internet that cries out for more structured investigation of this connection. Conversely, perhaps a publication bias of the peer review process excludes work that explores this connection.
    Whatever the reason that stuttering has not been reported in the medical literature in association with gluten ingestion, a number of personal disclosures and comments suggesting a connection between gluten and stuttering can be found on the Internet. Abid Hussain, in an article about food allergy and stuttering said: “The most common food allergy prevalent in stutterers is that of gluten which has been found to aggravate the stutter” (10). Similarly, Craig Forsythe posted an article that includes five cases of self-reporting individuals who believe that their stuttering is or was connected to gluten, one of whom also experiences stuttering from foods containing yeast (11). The same site contains one report of a stutterer who has had no relief despite following a gluten free diet for 20 years (11). Another stutterer, Jay88, reports the complete disappearance of her/his stammer on a gluten free diet (12). Doubtless there are many more such anecdotes to be found on the Internet* but we have to question them, exercising more skepticism than we might when reading similar claims in a peer reviewed scientific or medical journal.
    There are many reports in such journals connecting brain and neurological ailments with gluten, so it is not much of a stretch, on that basis alone, to suspect that stuttering may be a symptom of the gluten syndrome. Rodney Ford has even characterized celiac disease as an ailment that may begin through gluten-induced neurological damage (13) and Marios Hadjivassiliou and his group of neurologists and neurological investigators have devoted considerable time and effort to research that reveals gluten as an important factor in a majority of neurological diseases of unknown origin (14) which, as I have pointed out previously, includes most neurological ailments.
    My own experience with stuttering is limited. I stuttered as a child when I became nervous, upset, or self-conscious. Although I have been gluten free for many years, I haven’t noticed any impact on my inclination to stutter when upset. I don’t know if they are related, but I have also had challenges with speaking when distressed and I have noticed a substantial improvement in this area since removing gluten from my diet. Nonetheless, I have long wondered if there is a connection between gluten consumption and stuttering. Having done the research for this article, I would now encourage stutterers to try a gluten free diet for six months to see if it will reduce or eliminate their stutter. Meanwhile, I hope that some investigator out there will research this matter, publish her findings, and start the ball rolling toward getting some definitive answers to this question.
    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.

    Jefferson Adams
    Celiac.com 06/14/2018 - Refractory celiac disease type II (RCDII) is a rare complication of celiac disease that has high death rates. To diagnose RCDII, doctors identify a clonal population of phenotypically aberrant intraepithelial lymphocytes (IELs). 
    However, researchers really don’t have much data regarding the frequency and significance of clonal T cell receptor (TCR) gene rearrangements (TCR-GRs) in small bowel (SB) biopsies of patients without RCDII. Such data could provide useful comparison information for patients with RCDII, among other things.
    To that end, a research team recently set out to try to get some information about the frequency and importance of clonal T cell receptor (TCR) gene rearrangements (TCR-GRs) in small bowel (SB) biopsies of patients without RCDII. The research team included Shafinaz Hussein, Tatyana Gindin, Stephen M Lagana, Carolina Arguelles-Grande, Suneeta Krishnareddy, Bachir Alobeid, Suzanne K Lewis, Mahesh M Mansukhani, Peter H R Green, and Govind Bhagat.
    They are variously affiliated with the Department of Pathology and Cell Biology, and the Department of Medicine at the Celiac Disease Center, New York Presbyterian Hospital/Columbia University Medical Center, New York, USA. Their team analyzed results of TCR-GR analyses performed on SB biopsies at our institution over a 3-year period, which were obtained from eight active celiac disease, 172 celiac disease on gluten-free diet, 33 RCDI, and three RCDII patients and 14 patients without celiac disease. 
    Clonal TCR-GRs are not infrequent in cases lacking features of RCDII, while PCPs are frequent in all disease phases. TCR-GR results should be assessed in conjunction with immunophenotypic, histological and clinical findings for appropriate diagnosis and classification of RCD.
    The team divided the TCR-GR patterns into clonal, polyclonal and prominent clonal peaks (PCPs), and correlated these patterns with clinical and pathological features. In all, they detected clonal TCR-GR products in biopsies from 67% of patients with RCDII, 17% of patients with RCDI and 6% of patients with gluten-free diet. They found PCPs in all disease phases, but saw no significant difference in the TCR-GR patterns between the non-RCDII disease categories (p=0.39). 
    They also noted a higher frequency of surface CD3(−) IELs in cases with clonal TCR-GR, but the PCP pattern showed no associations with any clinical or pathological feature. 
    Repeat biopsy showed that the clonal or PCP pattern persisted for up to 2 years with no evidence of RCDII. The study indicates that better understanding of clonal T cell receptor gene rearrangements may help researchers improve refractory celiac diagnosis. 
    Source:
    Journal of Clinical Pathologyhttp://dx.doi.org/10.1136/jclinpath-2018-205023