Posts: 10,003
8/20/11 12:09 A

bit.ly/pX5l9s

"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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8/4/11 12:46 A

I hear ya on the 5ppm.
The way I'm thinking is most of our food safety laws set up by the FDA are about 100 years and haven't changed in that time.
I feel that they should pass the law at 5ppm since thats the lowest possible with current technology but write in there that as newer, more accurate tests come out to lower the number till it reaches 0.

Posts: 10,003
8/4/11 12:29 A

Mom bought me some gf soy sauce ... says GF on the bottle. Had gluten in the ingredients. :P Good thing I read the label despite claims. Something "organic" and healthy looking had mom snowed.

What I don't appreciate, and I know this is controversial because it's difficult, I'd like products to be "5" ppm or the lowest detectable level.

I had been taking on and off for about a year a probiotic tested to 20ppm and labeled gf. Whilst I realize that the product also had barley and oat GRASS not seed, the founder and owner of Garden of Life, Jordan Rubin, assured me that it tested to 20 ppm and was safe (Who says what's safe?). It was nice he tried to comply with the upcoming new law (which I believe is headed to the 20ppm rule), but it's a FAIL according to me.

I realize I didn't have to buy the product, but I did on a lark thinking it was not THAT big a deal esp w/the 20 ppm. What about other people? Strict standards are a good thing, and I hope it's helpful in the long run, but my personal experience leaves me feeling dubious.

Why a fail? I took a couple of Cyrex Labs' new tests and was found to have a leaky gut and cross-reactivity to barley (duh, right? But I was shocked to even know I'd been getting contaminated). So this experience has slowed my gut healing a bit, and that's okay; I'm jgrateful to have figured it out before the bottle was empty and thrown out, or I'd not have had it when I went searching for where the heck I was getting BARLEY(??). *sheesh* FYI: I had no gut pain like my previous only "contamination."

Learn from my mistake

bit.ly/o3Tg5n if you're interested in my Cyrex Labs experience.

More info about Cyrex Labs tests: bit.ly/gdgrUA

I wrote a letter in 2007. I will write the FDA again with my latest experience.

Edited by: DOTSLADY at: 8/4/2011 (00:38)

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8/3/11 12:52 A

Very true, but think if they actually pass the gluten labeling it will make it a lot easier to know products are safe or not. And for the products claiming it now will be held accountable for them to be true.

Posts: 30,619
8/2/11 11:04 P

They never listen but to people that pay them money so don't hold your breath and think that they want to help you stay healthy. If they did they would take allot of the pills off the market that are killing people.

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Posts: 1,924
8/2/11 1:14 P

Today the FDA is reopening labeling gluten! There is a conference call today at 4pm EDT you can listen in on it or the replay till Sept, here's the details - glutenfreeville.com/research/fdacall
Then starting tomorrow you can put your 2 cents in at www.fda.gov/NewsEvents/Newsroom/PressAnnou
ncements/ucm265838.htm

I hope they actually finalize it this time and not sit on it another 5 years past due date!