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Fda Comment Period Open For 20 Ppm Standard For Gluten Free


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#1 padma

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Posted 15 August 2011 - 09:04 AM

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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#2 thleensd

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Posted 15 August 2011 - 02:06 PM

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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Negative blood tests (following gluten light diet)

Still healing with time, harmony, and good food.
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#3 lovegrov

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Posted 16 August 2011 - 05:41 AM

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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#4 dilettantesteph

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Posted 16 August 2011 - 06:22 AM

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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#5 padma

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Posted 16 August 2011 - 07:49 PM

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....l AJCN 2007.pdf
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#6 padma

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Posted 16 August 2011 - 08:01 PM

I forgot to add this info that the CDF sent to me: Celiac Center – University of Maryland – Alessio Fasano, MD;
Celiac Disease Program – University of Chicago – Stefano Guandalini, MD

I was told these are the primary researchers who are doing celiac tolerance studies in the US. I haven't had time to find and read their studies, but will do so in the next few days. If any of you find links to their studies, if you could post the links, then we could all read them.
There are probably studies in other countries, too. Wonder what their conclusions are?
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#7 dilettantesteph

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Posted 17 August 2011 - 04:15 AM

The Fasano group publications.

http://celiaccenter....ublications.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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#8 lovegrov

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Posted 17 August 2011 - 07:23 AM

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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#9 T.H.

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Posted 17 August 2011 - 08:41 AM

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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Gluten free since August 10, 2009.
21 years with undiagnosed Celiac Disease

23 years with undiagnosed sulfite sensitivity

25 years with undiagnosed mast cell activation disorder (MCAD) 

 

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Son: gluten intolerant
Father, brother: celiac positive


#10 dilettantesteph

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Posted 18 August 2011 - 05:25 AM

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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#11 padma

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Posted 18 August 2011 - 09:09 PM

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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#12 dilettantesteph

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Posted 19 August 2011 - 05:54 AM

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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#13 RollingAlong

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Posted 20 August 2011 - 01:26 PM

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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#14 RollingAlong

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Posted 20 August 2011 - 02:24 PM

http://ultimateglute...celiac-disease/

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

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Posted 21 August 2011 - 08:21 AM

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 “Tolerable Daily Intake” as 0.4 mg “gluten”, which corresponds to a gluten concentration of 1 ppm.
This is in sharp contrast to the proposed 20 ppm FDA standard for labeling a food as “gluten-free”.
The FDA has chosen to define “gluten-free” with respect to the current limits of detection, rather than on the basis of safety.
There is a substantial degree of uncertainty as to whether the current ELISA test for “gluten” is an accurate measure of gluten’s clinical effects in different individuals.
The current state of clinical science is insufficient to confidently define what is biologically gluten-free.
FDA standards should create a margin of safety, and err on the side of caution.
Setting a lax standard of “gluten-free” may actually pose a greater health risk than no standard at all.
FDA should instead create an interim designation of “Low-Gluten”, using currently available assays. This would be valuable today to people with mild gluten sensitivity, while balancing the needs of manufacturers.
“Low Gluten” foods may still be unsafe for many highly sensitive celiacs.
FDA regulations should be geared to amount per serving rather than a simple ppm concentration.
We recommend that the celiac community argue against the FDA’s proposal as it stands, but support a Low-Gluten” labeling, instead.
More sensitive, validated assays need to be developed in order to support a future labeling standard of “gluten-free” that is based on predicted health risk
Larger clinical trials of celiac patients are required in order to establish the threshold of gluten sensitivity, and the variation from person to person.
Conclusion
We realize that this opinion may be controversial, but we believe that it would be better for the FDA to adopt no labeling standard for “gluten-free” foods than a poorly-designed one. Please help develop the public dialog by using the Comment Section below. (We can also be reached privately).

If you chose to give your feedback to the FDA, we encourage you to read the relevant reports first. Instructions for public comment can be found at:

http://www.regulations.gov/#!submitComment;D=FDA-2005-N-0404-0135
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