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How many of you have seen the letter that Dr. Fasano wrote to the FDA this summer, to help persuade them to adopt the 20 ppm standard for "gluten-free" labeling, rather than a lower number? Here are a few quotes from that letter, and my impressions/snappy comebacks, are shown in blue:
The red emphasis is mine, of course.Testing Toxicity of a Substance
In the typical method of establishing the toxicity of a substance (usually a drug), human clinical trials are preceded by animal studies. Since there are no reliable animal models for celiac disease, this cannot be the case for the assessment of a safe gluten threshold. However, we already have a vast "body of evidence" to support the safety of the gluten-free diet in current commercial gluten-free products. For more than 30 years, millions of people worldwide have been following a gluten-free diet based on a safety level of 20 ppm or more (up to 100 ppm). The vast majority of those consumers have suffered no ill consequences.
The "vast majority"? Apparently, it's OK if hundreds or thousands of us get sick, so long as the "vast majority" can safely eat the stuff. That's mighty comforting, isn't it.
5 ppm is not by any means, a "miniscule amount, by today's testing standards. 20 years ago, I was using ELISA test kits that allowed me to test for aflatoxin in food corn, down to 5 ppb - that's parts per billion, not million. This is because aflatoxin levels are required by law to not exceed a level of 20 ppb. IOW, those regulatory standards, and the tests used to enforce them, are 1,000 times more sensitive than what he is whining about, and the technology that I used was available over 20 years ago. So my question is, "why should we use obsolete technology, and obsolete standards, just to satisfy his agenda, whatever it might be?". For the purposes of testing, 20 ppm is not a small amount - it's a relatively large amount, in comparison with many mycotoxins, that are also regulated in food.When we first began to measure the ppm level of gluten in products, the assay measurement used was only sensitive to a 100 ppm threshold. As assay measurements became more sensitive, the level of "safe" as defined as gluten-free was lowered.
Currently, the assay measurement is sensitive to a threshold of 5 ppm. However, just because we can measure gluten to the level of 5 ppm (an incredibly miniscule amount), does not mean that we should determine safety levels based on the sensitivity of the assay. This is not the best use of our scientific methods.
And the reason, of course, is because neither he, nor any other celiac researchers have gone to the trouble of doing such a study, even though they have had all the time in the world in which to do so, (celiac disease was described over 2,000 years ago).And, as far as I know, there are no evidence-based published studies that demonstrate toxicity with exposure to 20 ppm and safety with 5 ppm exposure.
I should hope so - the point of the whole project is to get unsafe products off the market, not to figure out ways to justify how they can be allowed to remain on the market. We need to get the products off the market that are regularly hugging that 20 ppm level, because when they consistently run in that range, they often exceed the limit, but are rarely "caught" and rejected.Setting a safe gluten-free threshold below 20 ppm could result in a drastic reduction in the amount and availability of gluten-free products in the U.S. market.
Apparently, the good doctor is having math problems, because the last time I checked, 20% of 5 is "1", (not "2"). To get a numerical error of "2", the test margin of error would have to be 40%, which would be ridiculously inaccurate. If that's representative of his math skills, how on earth did he get through high school? That makes it difficult to trust any of his work.Since the assay variability (margin of error of the ELISA) measurement of gluten in safety-based assessments can range from 10 to 20 percent, extremely low thresholds (like 5 ppm) do not give manufacturers enough flexibility to produce good-tasting and safe products. For instance, a batch of brownies tested today could measure 3 ppm. Keeping in mind the 10 to 20 percent margin of error inherent in assay measurement, that same batch tested tomorrow could measure 7 ppm. If the safety threshold was set at 5 ppm, a manufacturer could test the product as safe at 3 ppm, and it could be measured as unsafe at 7 ppm in a different test.
Under these restrictive limits, manufacturers would either discontinue gluten-free products or be forced to create much more expensive and much less palatable products, resulting in a drastic loss of selection and quality.
Would they, now? If they did, at least they would stop turning out unsafe products. That same argument was probably made back when the 200 ppm rule was adopted in Europe.
That argument can be made at any threshold level, and it's just a way to rationalize sloppy product handling. Cross-contamination is ubiquitous, and it needs to be curtailed, not encouraged by way of acceptance.If a very low threshold (such as 5 ppm) is chosen, even minimal cross contamination from various sources in the surrounding environment can come into play. In after-the fact contamination, products can pick up extra contamination from the factory to shipping to market, thus raising the level above the restrictively low threshold.
On the contrary, their products would be in high demand in other countries, because of their safer standards.A final, but very important implication in setting the safety threshold of ppm for gluten is the nature of our gluten-free "global village." If U.S. manufacturers are forced to abide by an unnecessarily restrictive safety threshold, they will not be able to compete successfully in the gluten-free global marketplace.
Conversely, overseas manufacturers with products that have a higher ppm level than the U.S. safety threshold will not be able to sell their products in the U.S.
Our balance of trade can use all the help it can get. 
Say what? If 20 ppm is so safe, (and the rest of the world adheres to it), what's the problem? Why wouldn't U. S. consumers be able to survive for a few weeks on a 20 ppm diet, if he's insisting that we should adopt that standard in this country. Talk about talking out of both sides of one's mouth at the same time. Geez!Consequently, U.S. consumers of gluten-free products will find themselves in a conundrum while traveling overseas: they either bring their own gluten-free items or limit their diet while traveling outside the U.S. These developments would certainly worsen the quality of life for people with celiac disease and gluten sensitivity and deliver the opposite outcome that this law is intended to obtain for these patients.
The entire letter can be read here:
http://www.adventuresofaglutenfreemom.c ... asano-m-d/
I'm not saying that the FDA shouldn't adopt the 20 ppm standard, I'm just saying that Dr. Fasano's logic is so full of holes that it appears somewhat pathetic. It sounds more political than scientific. That letter could have been written by a middle school student. Is that the best that he can do, with all the facilities available at his disposal?
Tex
