Gluten Contamination of Grains, Seeds, and Flours in the United States: A Pilot Study
Under the Food Allergen and Consumer Protection Act, the Food and Drug Administration (FDA) must issue a rule for the voluntary labeling of food as gluten-free. In the proposed rule, many single-ingredient foods, such as millet, are considered inherently free of gluten. Inherently gluten-free grains will be considered misbranded if they carry a gluten-free label and do not also state that all foods of the same type are gluten-free (eg, "all millet is gluten free"). Twenty-two inherently gluten-free grains, seeds, and flours not labeled gluten-free were purchased in June 2009 and sent unopened to a company who specializes in gluten analysis. All samples were homogenized and tested in duplicate using the Ridascreen Gliadin sandwich R5 enzyme-linked immunosorbent assay with cocktail extraction. Thirteen of 22 (59%) samples contained less than the limit of quantification of 5 parts per million (ppm) for gluten. Nine of 22 (41%) samples contained more than the limit of quantification, with mean gluten levels ranging from 8.5 to 2,925.0 ppm. Seven of 22 samples (32%) contained mean gluten levels >/=20 ppm and would not be considered gluten-free under the proposed FDA rule for gluten-free labeling. Gluten contamination of inherently gluten-free grains, seeds, and flours not labeled gluten-free is a legitimate concern. The FDA may want to modify their proposed rule for labeling of food as gluten-free, removing the requirement that gluten-free manufacturers of inherently gluten-free grains, seeds, and flours must state on product labels that all foods of that type are gluten-free.
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- "One exception is gluten, in large part due to ''gluten-free'' labeling, with North American levels of gluten contamination in other grains reported by multiple studies. Thompson et al. (2010) reported gluten contamination in 9 of 22 (41%) inherently gluten-free grain samples with levels up to 2925 ppm gluten. "
ABSTRACT: In the United States, packaged food ingredients derived from allergenic sources must be clearly labeled. However, no requirement exists to declare the presence of residues of raw agricultural commodities due to agricultural commodity comingling. Clinical reports of allergic reactions to undeclared soy in wheat-based products do not exist suggesting that a rather low degree of risk is posed by wheat-based products that are comingled with soy. Detectable soybean residues (>2.5 ppm soy flour) were found in 62.8% of commercially available wheat flours at concentrations of 3 - 443 ppm soy flour (1.6 - 236 ppm soy protein). Conservative probabilistic risk assessments predict a risk of allergic reaction among the most sensitive soy-allergic individuals of 2.8 ± 2.0 per 1,000 soy-allergic user eating occasions of foods containing wheat flour. However, the predicted reactions occur at exposure levels below the lowest eliciting dose observed to provoke objective reactions in clinical oral soy challenges. Given this low level of predicted risk and the lack of evidence for allergic reactions among soy-allergic consumers to wheat-based products, the avoidance of wheat-based products by soy-allergic consumers does not appear to be necessary.
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- "The only grains permitted in the GCED are brown and white rice as even inherently gluten-free cereal grains have been found to be significantly cross-contaminated with gluten, presumably via comingling at harvest, transport and/or milling/processing. For example, in a recent study that tested 22 single-ingredient inherently gluten-free grains, seeds and flours, 32% of these products contained >20 ppm gluten; one product contained 2,925 ppm of gluten . Such a degree of cross-contamination illustrates how a significant amount of gluten may be ingested despite no apparent dietary indiscretions. "
ABSTRACT: Background Patients with persistent symptoms and/or villous atrophy despite strict adherence to a gluten-free diet (GFD) have non-responsive celiac disease (NRCD). A subset of these patients has refractory celiac disease (RCD), yet some NRCD patients may simply be reacting to gluten cross-contamination. Here we describe the effects of a 3-6 month diet of whole, unprocessed foods, termed the Gluten Contamination Elimination Diet (GCED), on NRCD. We aim to demonstrate that this diet reclassifies the majority of patients thought to have RCD type 1 (RCD1). Methods We reviewed the records of all GFD-adherent NRCD patients cared for in our celiac center from 2005-2011 who were documented to have started the GCED. Response to the GCED was defined as being asymptomatic after the diet, with normal villous architecture on repeat biopsy, if performed. Results Prior to the GCED, all patients were interviewed by an experienced dietitian and no sources of hidden gluten ingestion were identified. 17 patients completed the GCED; 15 were female (88%). Median age at start of the GCED was 42 years (range 6-73). Fourteen patients (82%) responded to the GCED. Six patients met criteria for RCD prior to the GCED; 5 (83%) were asymptomatic after the GCED and no longer meet RCD criteria. Of the 14 patients who responded to the GCED, 11 (79%) successfully returned to a traditional GFD without resurgence of symptoms. Conclusions The GCED may be an effective therapeutic option for GFD-adherent NRCD patients. Response to this diet identifies a subgroup of patients, previously classified as RCD1, that is not truly refractory to dietary treatment. Preventing an inaccurate diagnosis of RCD1 avoids immunotherapy. Most patients are able to return to a traditional GFD without return of symptoms.
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ABSTRACT: Celiac disease (CD) is an immune-mediated enteropathy triggered by exposure to wheat gluten and similar proteins found in rye and barley that affects genetically susceptible persons. This immune-mediated enteropathy is characterized by villous atrophy, intraepithelial lymphocytosis, and crypt hyperplasia. Once thought a disease that largely presented with malnourished children, the wide spectrum of disease activity is now better recognized and this has resulted in a shift in the presenting symptoms of most patients with CD. New advances in testing, both serologic and endoscopic, have dramatically increased the detection and diagnosis of CD. While the gluten-free diet is still the only treatment for CD, recent investigations have explored alternative approaches, including the use of altered nonimmunogenic wheat variants, enzymatic degradation of gluten, tissue transglutaminase inhibitors, induction of tolerance, and peptides to restore integrity to intestinal tight junctions.
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