"Proposed FDA Standard for Gluten-Free Foods (20 ppm) May Not Adequately Protect the Food Supply for Celiacs
By: Peter Olins, PhD and Gillian Olins, PhD on August 18, 2011"
8. Examples of studies attempting to determine a safe dietary intake of gluten for celiacs
As explained earlier, there are remarkably few clinical studies which actually address the question of the specific dose of gluten that is safe for a celiac. ... Thirteen celiac patients were tested with 50 mg gluten per day and showed a statistically significant level of mucosal damage compared to placebo. At the lower dose of 10 mg per day (which would correspond to 400 g [~14oz] food containing 25 ppm gluten), no statistically significant effects were observed. However, the authors noted:
The gluten microchallenge disclosed large interpatient variability in the sensitivity to gluten traces. Some CD patients showed a clear-cut worsening of the small-intestinal architecture after ingesting only 10 mg gluten/d[ay]…
and cautioned that:
Because of the limited number of patients, we were not able to reach firm conclusions about the potential toxicity of 10 mg gluten/d[ay], which remained a “gray” area.
Another paper by Chartrand et. al. (Ref. 13) showed that 11 out of 17 celiac patients developed symptoms while consuming processed wheat starch containing 7.5 ppm gluten. They concluded:
The innocuousness of long-term ingestion of “gluten-free” products containing wheat starch is still unproven…
Ref. 13: Wheat starch intolerance in patients with celiac disease. J Am Diet Assoc 1997; 97:612-618. Chartrand, LJ et al.
9. Proposed FDA regulation disregards the available safety data
The proposed FDA regulation focuses on the current limit of detection of “gluten” (approximately 20 ppm using current assays). The FDA argues that the Hazard Assessment values that it developed are too uncertain to be taken into consideration (Ref. 1). In our opinion, this would be analogous to taking a known toxic chemical, and setting a high threshold for food contamination just because the available assay cannot detect lower levels of the toxin. Would the general public want to consume such a food with a label of “toxin-free”? We think not.
10. Risk of setting a “gluten-safe” threshold too high
•What is an acceptable level of risk? We all face countless risks every day, and modify our behavior accordingly. Obviously, there is no way of guaranteeing that a food is safe for everyone.
•For some unseen risks, such as toxins in the food supply, we rely on our government to provide guidance. If the FDA says that a food is “free” of a potential toxin, it sends a strong message to the consumer that the product is “safe”. Unfortunately, such a definitive position is not supported by the FDA’s own report.
•The damage caused by gluten is at the microscopic level and often does not manifest as obvious symptoms, so we also need to be concerned about protecting celiacs from undetected damage. A margin of safety is therefore required to protect the public.
•A margin of safety is also required, given the lack of validation that the current gluten assay is a predictor of biological activity.
•We believe that a designation of “gluten-free” at 20 ppm will lull some people into a false sense of security, potentially resulting in an increased health risk.
•In our opinion, a designation of Low-Gluten would be much more meaningful: it implies that there is a certain level of a toxin present, and that there is a potential risk to those most sensitive to the toxin.
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One person's food is another person's poison.
Celiac Disease: An autoimmune reaction from eating gluten grains: wheat, rye, barley and contaminated oats=nutrient deficiency=cancer. Have 1 of 300 symptoms? bit.ly/cdsymptoms
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