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      READ FIRST: Super Sensitive Celiacs Disclaimer   09/23/2015

      This section of the forum is devoted to those who have responses to gluten beyond the experience of the majority of celiacs. It should not be construed as representative of the symptoms you are likely to encounter or precautions you need to take. Only those with extreme reactions need go to the lengths discussed here. Many people with newly diagnosed celiac disease have a condition known as leaky gut syndrome, which can lead to the development of sensitivity to other foods until the gut is healed - which may take as long as one to three years. At that time they are often able to reincorporate into their diet foods to which they have formerly been sensitive. Leaky gut syndrome leads many people to believe they are being exposed to gluten when they are in fact reacting to other foods.
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Fda Comment Period Open For 20 Ppm Standard For Gluten Free
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28 posts in this topic

Please go to: http://www.regulations.gov/#!documentDetail;D=FDA-2005-N-0404-0135

Here is my comment: Feel free to use any part or all of it.

Document ID: FDA-2005-N-0404-0135: Food Labeling: Gluten-Free Labeling of Foods; Reopening of Comment Period

I am commenting on the FDA regulation for defining "gluten free".

20 ppm is too high for many of us with celiac. Gluten Free needs to be

just that: free of gluten, totally free of gluten. What is the point of the

label if it is not gluten free?

I have had to quit eating most "gluten free" foods because of this ruling.

Many companies are already following the 20 ppm guideline which

comes from Codex, an industry organization, not from the citizens of this country.

What research has been done to show that 20 ppm in a "normal"

diet for celiacs keeps one healthy? I don't know of any.

NO to 20 ppm "gluten free" and YES to 100% gluten free.

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Yes! I am currently putting my thoughts together to submit to the FDA. One option is to have a "low gluten" label and a "gluten-free" label. Would a company sell a product and claim it was peanut-free if it has 20ppm of peanut in it? I doubt it.

Low-gluten labeling would give the gluten-free trendies and the less sensitives what they need, and gluten-free labeling for the rest of us that really need that info!

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But, padma, how would one test for zero gluten when it's not possible to test that low? Zero is simply not possible to enforce nor is it practical.

richard

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In Australia as of Feb. 2011, anyway, the law was for no detectable gluten. As you can read in the link, that is being changed. They are worried that there will soon be no products available because as testing becomes more sensitive, fewer products can pass the gluten free standard. As you can see from the comments, there are people in Australia too who react to very low levels of gluten.

It seems to be very difficult to serve the needs of all celiacs/gluten intolerants: the most sensitive and the more typical.

http://blog.whatcanieat.com.au/?p=43

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In Australia as of Feb. 2011, anyway, the law was for no detectable gluten. As you can read in the link, that is being changed. They are worried that there will soon be no products available because as testing becomes more sensitive, fewer products can pass the gluten free standard. As you can see from the comments, there are people in Australia too who react to very low levels of gluten.

It seems to be very difficult to serve the needs of all celiacs/gluten intolerants: the most sensitive and the more typical.

http://blog.whatcanieat.com.au/?p=43

I spoke with a receptionist at the Celiac Disease Foundation about this. Their position is that 20 ppm has been "proven" to be ok for most celiacs. I told her I get ill from 20 ppm. She said I was in a small minority. I told her I was aghast that the organization that is suppose to be my representative in the world and be fighting for my rights would support something they know makes some celiacs ill.

I like the idea of 100% gluten free, just like the peanut free. Manufacturers are capable of setting standards of growing, harvesting, shipping and manufacturing to ensure food is gluten free. Some on this forum have figured out how to test to 5 ppm, so why 20 ppm?

Codex is a very powerful organization. All the big corporations from around the world participate annually to set their standards. Some countries have fought against their standards in many areas and won. If you look at the sponsors of the Celiac Disease Foundation (they are on a rotating wheel at the bottom of their home page) you will see all the big corps listed.

I read one of the studies done about levels of tolerance for gluten. The one out of 49 people was so ill from the amount they were giving the subjects that he refused to complete the study, therefore, he is not included in the statistics. He was probably one of us super sensitives. If in every study the people drop out because they are too ill to continue, you can see where that would skew the data. I use to be a statistician, so I know how to read the studies.

If we are capable of making truly gluten free food at home, manufacturers certainly can do the same. We already pay more for products because they say they are gluten free, so cost is not the issue.

If there isn't a 100% Gluten Free standard, we will never get 100% gluten free products. And don't give me the story about it can't be tested for. Science is vast. If it doesn't exit now, it certainly can be created. There are chemical labs that can test chemicals down to 1 ppb...that is BILLION. And they can't test for gluten. Give me a break. Sometimes I think some of the people commenting on this site are from the industry itself.

Obviously, I am passionate about this because I would like to go to the store and buy normal food. It is that simple.

Manufacturers simply need to invest in systems that can deliver real gluten free food. And while I am asking for the moon, I'd like mine organic, too. I use to be able to buy gluten free organic bread 10 years ago.

http://celiaccenter.org/celiac/documents/catassi%20et%20al%20AJCN%202007.pdf

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I forgot to add this info that the CDF sent to me: Celiac Center

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The Fasano group publications.

http://celiaccenter.org/celiac/publications.asp

The one used to establish the safe level of gluten is number 23.

A Prospective Double-Blind Placebo-Controlled Trial to Establish a Safe Theshold for Patients with celiac disease

Someone was excluded due to development of symptoms as you stated.

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I'm sure they could eventually test to near zero, but at what cost? How much would it drive up the price of food?

I predict the level will eventually be set at the point that will help out the vast majority of people with celiac, but it will never be set at the level needed by the small percentage of extremely sensitive folks. I mean, we couldn't even get the industry to list all gluten instead of just wheat.

richard

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I read one of the studies done about levels of tolerance for gluten. The one out of 49 people was so ill from the amount they were giving the subjects that he refused to complete the study, therefore, he is not included in the statistics... If in every study the people drop out because they are too ill to continue, you can see where that would skew the data.

And actually, the data is already going to be skewed before they even START the trials, when you think about it.

Because in this study - and in every one I've ever found that is looking at safe gluten levels - the researchers try to get participants who have healed on their gluten free diet. Except we all know that their gluten free diets aren't ZERO gluten. They are a certain amount of gluten.

So assuming the majority of the population eats a certain number of gluten-free products, that means that any celiacs who can't heal while eating this low level of gluten (20ppm) are automatically excluded from the study.

The only super sensitives the study is going to get are going to be those who are eating whole foods, avoiding processed gluten-free products, etc...

So we have no way of even knowing how many sensitive celiacs there may be, because we almost never get into the studies. :rolleyes:

I honestly wouldn't care sometimes, except these same studies are being used to make decisions about the celiac population as though they ARE completely representative of us. And they aren't, obviously.

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I'm sure they could eventually test to near zero, but at what cost? How much would it drive up the price of food?

I predict the level will eventually be set at the point that will help out the vast majority of people with celiac, but it will never be set at the level needed by the small percentage of extremely sensitive folks. I mean, we couldn't even get the industry to list all gluten instead of just wheat.

richard

I have to agree with Richard. But, there must be some way to warn super sensitives about possible sources of cc without scaring off the typical celiacs/gluten intolerants. I think to some degree, that is what we are trying to do here. Even here it isn't working very well. How could we ever implement something legally required?

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And actually, the data is already going to be skewed before they even START the trials, when you think about it.

Because in this study - and in every one I've ever found that is looking at safe gluten levels - the researchers try to get participants who have healed on their gluten free diet. Except we all know that their gluten free diets aren't ZERO gluten. They are a certain amount of gluten.

So assuming the majority of the population eats a certain number of gluten-free products, that means that any celiacs who can't heal while eating this low level of gluten (20ppm) are automatically excluded from the study.

The only super sensitives the study is going to get are going to be those who are eating whole foods, avoiding processed gluten-free products, etc...

So we have no way of even knowing how many sensitive celiacs there may be, because we almost never get into the studies. :rolleyes:

I honestly wouldn't care sometimes, except these same studies are being used to make decisions about the celiac population as though they ARE completely representative of us. And they aren't, obviously.

This is accurate thinking. The skewed stats ARE being used to set standards.

I find it interesting that I would write a long post about this subject, in great detail and only a small portion (from the middle) of it showed up in the email to everyone on this thread, This is what they posted: " read one of the studies done about levels of tolerance for gluten. The one out of 49 people was so ill from the amount they were giving the subjects that he refused to complete the study, therefore, he is not included in the statistics... If in every study the people drop out because they are too ill to continue, you can see where that would skew the data." How could the rest be left out? Like the part where I think some of the people on this site are from inside the big corporations that make up Codex?

The cost of testing is negligible. I have many friends who are chemists and they assure me that every company already has a quality assurance lab. They already have spectrometers to test for many substances. Are we so gullible to believe that cost is the prohibiting factor? Please give some solid stats to support your position if it is true.

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With my experience trying to locate safe food to eat, I think that is where the costs would be high. Farmers would need to be trained. Fields would have to be cleaned up, techniques changed. New equipment purchased, new facilities built.

I have started trying to grow everything myself due to lack of availability of foods which I can reliably eat without issues. Even at home I am having problems. My slug bait contained gluten. Then my garden got flooded with a heavy rain and that has caused problems.

The question is: why should all celiacs/gluten intolerants have to bear the additional cost of producing safe food for just a few of us? I doubt the number is as low as 0.0001%, but even if it is 10%, why should the other 90% have to pay the price?

I would be satisfied at this point for super sensitivity to be acknowledged and for us to be allowed to exchange tips. When I was figuring this all out, the existence of super sensitivity was completely denied on this board and that caused me to be sick for many months longer until finally my GI doctor suggested it to me. Even then it was very hard to get information on what to do; where gluten might be hiding for a super sensitive.

I am repeatedly amazed at how others will insist that it must be something else. People who have never even met me think that they know more about my health issues than my doctors and I do. Wow.

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I hadn't realized it was your doctor who introduced you to the idea of super sensitivity; that's heartening.

I would be thrilled to see a standard of 5ppm. It is within the reach of testing and there are some products now that are certified to that standard by CSA. They could change their program to certify to 3ppm and the rest of the market could stay at 5ppm.

Perhaps we would see an increase in the number of celiacs who heal after "good adherence" to the diet.

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http://ultimateglutenfree.com/2011/08/fda-20-ppm-regulation-gluten-free-food-celiac-disease/

This is a statement from 2 biochemists who oppose the proposed standards along with a detailed explanation of why.

Thanks for finding this. It is excellent. Note that the FDA research has found that 1 ppm is what is recommended by researchers.

Here is their summary:

Summary:

The FDA has developed an internal report which recommends a

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It would certainly be a bad idea to make gluten free be a level that is unsafe. Could we super sensitives be the canaries in the coal mine?

Wouldn't surprise me. Although with more and more celiacs not healing after years on the diet, I would not be surprised if we're just the lucky ones who don't heal AND react noticeably enough that we can actually tell what to avoid.

How much more difficult would it be to react to low levels of gluten and NOT have a noticeable reaction?

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No, no, no, no, and NO on the "low gluten" category.

This is horrible, and this is the only thing we are going to get with the commercial, for - profit mindcast in DC, if they think that they can palm off a "low gluten" category on everyone.

I may not be a "super sensitive," but I am in complete sympathy with them, as I'm certainly not a "silent, latent, can't tell when it has gluten" type, either. I have also gotten sick off of many foods already supposedly labeled "gluten free," so I deduct from this that the current, voluntary standards are quite lax and imaginative as to what is gluten free or not.

Food manufacturers need the option of being able to say on their labels they have tested and their product is below 20 ppm.

Food manufacturers and importers absolutely must not be allowed to make or import food out of wheat, rye, or barley processed starch and be able to include this processed wheat starch in the food, and still call it gluten free. If wheat, rye, or barley is in a food, it needs to be noted on the label, such as contains: vinegar, source, corn and/or wheat.

While we are at it, it is also scandalous that the medicine and supplement makers, over the counter and prescription, don't have to call these out, either. Some of the OTC pharmaceutical products are doing it voluntarily, but there are so many grain fillers being used now it is mind boggling.

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My other concern with the safe threshold study is that it lasted for 90 days. Is that long enough?

http://www.ajcn.org/content/85/1/160.long

In this study, the participants were ones who were healthy already eating a 20 ppm gluten limit diet. It isn't a surprise that most of these participants were found able to tolerate it.

Also, "One patient (challenged with 10 mg gluten) developed a clinical relapse."

They must have had one of us in the study, but he was eliminated because he got sick. I don't see how someone can be eliminated from a study with a very small number of participants, yet the conclusion was that these amounts of gluten are safe.

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They must have been throwing out the highs and lows (extremes) and going for the mean average. (Been decades since I had statistics, hope that made sense) but by using a small number of participants, if they would have expanded it to be a representational sample, it would have meant a large number of people would have been shown to be getting sick on the 10 ppm.

That would have looked bad. Hence "one of you" got chucked out, as you said.

Doesn't this drive one nuts thinking about it.

We all are the canaries in the coal mine, I've said this before, because there is no way of telling how many more people are going to be influenced by their environmental stresses (such as pollution or infections) to trigger into not tolerating gluten proteins in the world's most popular grain - currently.

Monsanto's Round Up is designed to kill pigweed - which is closely related to amaranth. Which the Native Americans cultivated. http://en.wikipedia.org/wiki/Amaranth#Nutritional_value

Yet their focus is now on adapting crops to the herbicides, instead of looking to grow crops that don't need it.

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And actually, the data is already going to be skewed before they even START the trials, when you think about it.

Because in this study - and in every one I've ever found that is looking at safe gluten levels - the researchers try to get participants who have healed on their gluten free diet. Except we all know that their gluten free diets aren't ZERO gluten. They are a certain amount of gluten.

So assuming the majority of the population eats a certain number of gluten-free products, that means that any celiacs who can't heal while eating this low level of gluten (20ppm) are automatically excluded from the study.

The only super sensitives the study is going to get are going to be those who are eating whole foods, avoiding processed gluten-free products, etc...

So we have no way of even knowing how many sensitive celiacs there may be, because we almost never get into the studies. :rolleyes:

I honestly wouldn't care sometimes, except these same studies are being used to make decisions about the celiac population as though they ARE completely representative of us. And they aren't, obviously.

Good point, T.H.

While the patient who dropped out of the trial may indeed be clinically significant , it is usual for a trial design to be fixed at the start, so that only data from patients who complete all the steps of a trial can be included in the final data.

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As best I can tell, even a 5ppm standard won't help the super sensitives, but I am very concerned that their existence be acknowledged and accomodated in institutional settings, even if they can not participate in the modern, processed food system.

My other concern is, I've been calling them the "miniscule minority," but I wonder if the group is really that small. I suspect that many celiacs, who eat 20 ppm foods, would do better at a lower level.

And wasn't that what the study said - that the level that caused gut damage was higher than the level that caused symptoms? It is sure a lot easier to go on symptoms than to get endoscopies all the time!

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As best I can tell, even a 5ppm standard won't help the super sensitives, but I am very concerned that their existence be acknowledged and accomodated in institutional settings, even if they can not participate in the modern, processed food system.

My other concern is, I've been calling them the "miniscule minority," but I wonder if the group is really that small. I suspect that many celiacs, who eat 20 ppm foods, would do better at a lower level.

And wasn't that what the study said - that the level that caused gut damage was higher than the level that caused symptoms? It is sure a lot easier to go on symptoms than to get endoscopies all the time!

So true.

I read all the time about celiacs suffering from other conditions, which I suffered from too, until I got off the standard gluten free diet.

There have also been studies published where they checked celiacs with endoscopies and a lot of them still got positives on the standard gluten free diet.

I guess the problem with going on symptoms rather than endoscopies is that is isn't scientific. It is subjective. Since there wasn't a positive endoscopy, you must not be experiencing those symptoms after all.

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And actually, the data is already going to be skewed before they even START the trials, when you think about it.

Because in this study - and in every one I've ever found that is looking at safe gluten levels - the researchers try to get participants who have healed on their gluten free diet. Except we all know that their gluten free diets aren't ZERO gluten. They are a certain amount of gluten.

So assuming the majority of the population eats a certain number of gluten-free products, that means that any celiacs who can't heal while eating this low level of gluten (20ppm) are automatically excluded from the study.

The only super sensitives the study is going to get are going to be those who are eating whole foods, avoiding processed gluten-free products, etc...

So we have no way of even knowing how many sensitive celiacs there may be, because we almost never get into the studies. :rolleyes:

I honestly wouldn't care sometimes, except these same studies are being used to make decisions about the celiac population as though they ARE completely representative of us. And they aren't, obviously.

Good point.

The problem may be ethical rather than technical: it may not be ethical to give gluten to people who are already known to be extremely sensitive. Each research center has an "Institutional Review Board" which reviews the risks and benefits of a given study.

A safety study is different from a therapeutic drug trial

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