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FDA Open For Comments


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#1 LDJofDenver

 
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Posted 06 August 2011 - 08:48 AM

Was announced past week that the FDA will await more comments before finalizing regs on gluten free food labeling.

One last chance to let them know your experience and what needs to be done to protect people with Celiac Disease.

I submitted comment that if it were peanuts, they would not allow a product to state "Peanut Free" on the label, if on the back of the jar, in small print, it said "Processed in a Facility That Also Processes Peanuts"! Why should that be different with gluten? I've been nailed so many times by products like that, until I finally started only buying prepared foods that state "Certified Gluten Free." Really, why should it be OK to double me over with abdominal cramps, sending me back and forth to the bathroom, making me sick to my stomach, kill all the living villi in small intestine, and open me up to a multitude of other auto immune diseases?

How to contact:

The docket will officially open for comments after noon on Aug 3, 2011 and will remain open for 60 days.
To submit your comments electronically to the docket go to www.regulations.gov
1. Choose “Submit a Comment” from the top task bar
2. Enter the docket number FDA-2005-N-0404 in the “Keyword” space
3. Select “Search”
To submit your comments to the docket by mail, use the following address:
The Division of Dockets Management
HFA-305
Food and Drug Administration
5630 Fishers Lane, Room 1061
Rockville, MD 20852
Include docket number FDA-2005-N-0404 on each page of your written comments.
  • 1
Diagnosed 8-8-08 (I think I'll remember that date!)
Positive blood panel
Endoscopy a little later on confirmed, via Small Intestine Biopsy
Adult son diagnosed Celiac in his late 20s
Suspect my Mother undiagnosed Celiac

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#2 Takala

 
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Posted 06 August 2011 - 10:30 AM

I think the use of the "low gluten" category they are contemplating, for food over 20 ppm to 100ppm, has the potential to be highly problematic. In Europe, specifically the UK, they use this "Codex wheat starch" in a lot of processed foods and their government claims that this is "suitable for all people following a gluten free diet" - but here on this site and elsewhere I've read a lot of comments that celiacs and gluten intolerants just can't tolerate the stuff. You could have a product labeled erroneously "gluten free," but it would still not be "wheat free."

I see absolutely no reason whatsoever to start out with a base grain that is the poison, and then attempt to process it enough that it would supposedly be "safe," when in the world there are so many alternative grains and roots to make starch out of. It is a combination of cheapness and insanity. Almost all of the "celiac disease experts" that are declaring this garbage "safe" from their scientific perches in theoretical land do not have the disease, and are not therefore familiar with the bad reactions to hidden gluten from a first person knowledge point of view. These reactions may not be immediate for many people with celiac, and instead show up gradually as other, severe symptoms mimicking other diseases. They also do not acknowledge the prevalence of the disease, nor the increasing incidence of it and the increase in gluten intolerance, non celiac version- a lot has changed since 2008.

http://www.education...t-wheat-starch/
Controversial aspects of the gluten free diet - all about wheat starch

In some countries, including those in the United Kingdom and Scandinavia, specially manufactured gluten-free foods may contain what is often referred to as "Codex wheat starch." This wheat starch has been specially processed to remove all but trace amounts of protein. Codex wheat starch is an example of a food that naturally contains gluten but has been rendered "gluten free" or "gluten-reduced" through processing and complies with the Codex Standard for Foods for Special Dietary Use for Persons Intolerant to Gluten, an international standard described later in this chapter. While Codex wheat starch still contains very small amounts of gliadin (the harmful prolamin protein of wheat), it is viewed as safe by celiac disease experts in the countries that allow its use.

At present, in the United States, foods containing wheat starch are not recommended for people with celiac disease, and U.S. manufacturers of gluten-free foods do not use wheat starch in their products. However, this may be changing. Under the Food and Drug Administration's (FDA's) proposed rule on use of the term gluten free for labeling purposes, food labeled gluten free would be allowed to contain wheat starch as long as the gluten content of the final food product was less than 20 parts per million.
__*__

In 2004 Finnish gastroenterologist Pekka Collin and colleagues tested twenty-six wheat-starch-based "gluten-free" flours and baked goods for gluten. Of these, only thirteen contained less than 20 parts per million of gluten (or 2 milligrams per 100 grams of product). Nine products contained between 20 parts per million and 100 parts per million of gluten, and two products contained between 100 parts per million and 200 parts per million.


This being the United States involved, it is entirely possible that under the guise of "doing better" they will let the food lobby that is more concerned with profit, and the importer lobby write the rules and actually manage to make the situation worse. And we need our standards here to be better. We have the numbers, we are a large country, with probably more celiacs and gluten intolerant people than anywhere else in the world, we need to flex that muscle into insisting we get safety rules, not a slacking off, and not end up getting wheat starch sneaking into our gluten free foods.

I do not agree with the conclusion in the article I linked to, which said "as a nutrition scientist" they agreed in theory that tested foods could contain the processed wheat starch. I think it is a TERRIBLE idea.
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#3 RollingAlong

 
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Posted 06 August 2011 - 06:40 PM

well said.

What really concerns me, is the idea that only a third of all celiacs are healed after 5 years on the gluten free diet
http://www.celiac.ni...ssueDamage.aspx

If you look at celiacs with "good adherence" to the diet, the number goes up to 43%. The unhealed celiacs have a higher mortality rate than the healed as it says here - "The researchers found that regardless of age or sex, adults with celiac disease whose intestinal tissues experienced recovery were less likely to die from all causes than were men and women with persistent damage"

So, what is the problem with the nearly 60% of celiacs with "good adherence?" Is it that the standard for gluten free is set too high?
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#4 thleensd

 
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Posted 15 August 2011 - 02:11 PM

Gluten-free needs to mean gluten-free! Low gluten to me is 20ppm. If testing and good manufacturing practices are available to make products with no gluten (how low can they detect it now?) they should do it.

I am unhappy at the suggestion that 20ppm is gluten free. It is most certainly not (see peanut comments...people seem to "get" that). Gluten free should NOT be exploited as a marketing gimmick for fad dieters, but a medically necessary piece of information for those of us that need it. There is no point in labeling something gluten free when it is not.
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#5 lovegrov

 
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Posted 16 August 2011 - 05:39 AM

Gluten cannot be tested to zero. I think 5 ppm is the lowest that's practical and 3 ppm is possible.

richard
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#6 Takala

 
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Posted 17 August 2011 - 07:11 AM

So, what is the problem with the nearly 60% of celiacs with "good adherence?" Is it that the standard for gluten free is set too high?


no, it would be the opposite. one scenario is that they are getting cross contaminated anyway, and are not as truly gluten - free as they thought they were being.

Remember, these adherence evaluations were done by having them interviewed - they said what they were eating - then they were biopsied to see if the intestinal mucosa had fully healed after certain periods of time.

So what happens after 6, 7, 8, 10 + years out, do you still have the same results ?

Plus I didn't read the actual study, just the link from here, who knows what other circumstances were going on, what sorts of medication they were taking, were they smoking, drinking, etc, are they in a mixed household, are they eating a lot of processed foods, etc.
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#7 kellynolan82

 
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Posted 19 August 2011 - 07:24 PM

I, for one, think that oats should definitely be excluded from the gluten free diet. They are out for us in Australia and New Zealand and are not permitted in Canada either! Seeing as though so many coeliacs have issues with pure oats, there really is no real need for them. In addition, if gluten free products are processed on the same line os those containing pure oats, the risk goes up. I don't want to burst the bubbles of Bob's Red Mill and the granola companies out there but something really needs to be done about this. I think the inclusion of oats in the gluten free diet is a bad one personally. Any other thoughts. I plan to write to them in a few days time.
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#8 Gemini

 
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Posted 22 August 2011 - 08:37 AM

I, for one, think that oats should definitely be excluded from the gluten free diet. They are out for us in Australia and New Zealand and are not permitted in Canada either! Seeing as though so many coeliacs have issues with pure oats, there really is no real need for them. In addition, if gluten free products are processed on the same line os those containing pure oats, the risk goes up. I don't want to burst the bubbles of Bob's Red Mill and the granola companies out there but something really needs to be done about this. I think the inclusion of oats in the gluten free diet is a bad one personally. Any other thoughts. I plan to write to them in a few days time.


You certainly have a right to your opinion but I can assure you that many Celiacs can tolerate pure oats just fine and as they are a good source of fiber and other nutrients, I wouldn't go so far as to exclude them from a person's diet. I don't buy anything with oats added, which is processed, because I can make much better stuff at home, from scratch. I eat good quality gluten-free oatmeal with zero problems and I have healed amazingly well so I will continue to eat them. Just because some countries do not include them doesn't mean they are right. Maybe this line of thinking was devised before high quality gluten-free oats became mainstream?
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#9 kellynolan82

 
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Posted 22 August 2011 - 08:57 AM

You certainly have a right to your opinion but I can assure you that many Celiacs can tolerate pure oats just fine and as they are a good source of fiber and other nutrients, I wouldn't go so far as to exclude them from a person's diet. I don't buy anything with oats added, which is processed, because I can make much better stuff at home, from scratch. I eat good quality gluten-free oatmeal with zero problems and I have healed amazingly well so I will continue to eat them. Just because some countries do not include them doesn't mean they are right. Maybe this line of thinking was devised before high quality gluten-free oats became mainstream?


We have a lot of oats, here in Australia, that are of high quality and pure. Probably more than most countries. These are labelled as 'Wheat Free' and many brands that label these oats as such will make it clear on their websites (e.g. Freedom Foods) as such.

I don't have a problem with celiacs consuming oats, it's just that I don't think they should be labelled as 'gluten free' if they have potential to do the same celiac damage that wheat, rye and barley do. And there is evidence that this is indeed the case for at least 1 in 7 coeliac individuals (those who say it only affects 1 in 20 celiacs are probably wrong!).

My issue is that if pure oats become more and more mainstream, gluten free foods that don't contain oat ingredients may be processed on production lines that produce these so-called 'gluten free oats'. We all know how even a very small amount of gluten can be enough to cause problems in some celiacs. As there is clear evidence that at least 15% of celiacs have an issue with oats, a number of these individuals will almost certainly have issues with even traces of these so-called 'gluten free' oats (e.g. Udi's gluten free bread - is it processed on the same equipment that produces their gluten free granolas that are made of pure oats?).

I personally believe that the USA should be working to get in line with the current 'gluten free' legislation in Canada, New Zealand and Australia. I think some of this older legislation, to this day, holds some validity that some of us may not realise. :unsure:

Sorry if I come across as argumentative, I don't mean to be. I would just like to see the FDA take a few steps ahead so that all of North America is in-line with their gluten free legislation. I think it would be much easier for all you guys over there. And, of course, you could always still enjoy your 'pure' wheat free oats if you can tolerate them too! A win win for all ;)
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#10 kellynolan82

 
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Posted 22 August 2011 - 09:04 AM

I submitted comment that if it were peanuts, they would not allow a product to state "Peanut Free" on the label, if on the back of the jar, in small print, it said "Processed in a Facility That Also Processes Peanuts"! Why should that be different with gluten?


You raise a valid point! <_<

But there's an even more interesting issue here in Australia with regard to peanuts. Our laws regarding 'nut free' and 'peanut free' labelling are not as strict as our gluten free regulations. There is no FSANZ regulation over the term 'nut free' here in Australia and therefore products only have to be naturally nut free to bare this label. If there's cross-contamination, this is ok as long as it is stated on an advisory label below the ingredient listing. Some say we ought to be as strict about 'nut free' labelling as we are about our own 'gluten free' legislation.

I'm glad we have such strict labelling laws regarding gluten and I believe the USA FDA should adopt the same legislation that we have, in my opinion. Maybe they could allow 20ppm gluten but I would keep everything else the same ;)
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#11 Gemini

 
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Posted 22 August 2011 - 01:50 PM

We have a lot of oats, here in Australia, that are of high quality and pure. Probably more than most countries. These are labelled as 'Wheat Free' and many brands that label these oats as such will make it clear on their websites (e.g. Freedom Foods) as such.

I don't have a problem with celiacs consuming oats, it's just that I don't think they should be labelled as 'gluten free' if they have potential to do the same celiac damage that wheat, rye and barley do. And there is evidence that this is indeed the case for at least 1 in 7 coeliac individuals (those who say it only affects 1 in 20 celiacs are probably wrong!).

My issue is that if pure oats become more and more mainstream, gluten free foods that don't contain oat ingredients may be processed on production lines that produce these so-called 'gluten free oats'. We all know how even a very small amount of gluten can be enough to cause problems in some celiacs. As there is clear evidence that at least 15% of celiacs have an issue with oats, a number of these individuals will almost certainly have issues with even traces of these so-called 'gluten free' oats (e.g. Udi's gluten free bread - is it processed on the same equipment that produces their gluten free granolas that are made of pure oats?).

I personally believe that the USA should be working to get in line with the current 'gluten free' legislation in Canada, New Zealand and Australia. I think some of this older legislation, to this day, holds some validity that some of us may not realise. :unsure:

Sorry if I come across as argumentative, I don't mean to be. I would just like to see the FDA take a few steps ahead so that all of North America is in-line with their gluten free legislation. I think it would be much easier for all you guys over there. And, of course, you could always still enjoy your 'pure' wheat free oats if you can tolerate them too! A win win for all ;)



No...you did not come across as argumentative at all. You were expressing your opinion that I don't entirely agree with. ;) The oats I buy are batch tested and, I believe, tested down lower than 20ppm. That would be enough to make me sick. If there were any amount of gluten in them over what can be tested accurately today, I would get sick. I tolerate them very well so I have to assume that they are pretty much gluten-free. I am a highly symptomatic Celiac so it makes it easy for me to know. You will never have zero gluten, unless you want to eat just meat, fruits and veggies for the rest of your life. The vast majority of Celiacs can tolerate 5 ppm with no intestinal damage or symptoms. If this were not true, no one would heal. I don't hear stories of large amounts of Celiacs staying sick and not getting better on the gluten-free diet...most I know have done very well, including myself.

If you are worried about more than one food being processed with the oats, I doubt that will happen for plain bags of gluten-free oats.
The gluten-free oats are generally sold by companies that produce oatmeal only on those lines and keep everything separate. If they change that, they may lose customers. I don't worry too much about "what if's" and just buy what I deem as safe for me to eat. If you don't want to eat them and feel they aren't safe for you, that's fine. I just don't want the government getting involved too much with food that is safe for me...they only ever screw things up. :blink:
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#12 U Gluten Free

 
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Posted 22 August 2011 - 02:14 PM

Was announced past week that the FDA will await more comments before finalizing regs on gluten free food labeling.

One last chance to let them know your experience and what needs to be done to protect people with Celiac Disease.

I submitted comment that if it were peanuts, they would not allow a product to state "Peanut Free" on the label, if on the back of the jar, in small print, it said "Processed in a Facility That Also Processes Peanuts"! Why should that be different with gluten? I've been nailed so many times by products like that, until I finally started only buying prepared foods that state "Certified Gluten Free." Really, why should it be OK to double me over with abdominal cramps, sending me back and forth to the bathroom, making me sick to my stomach, kill all the living villi in small intestine, and open me up to a multitude of other auto immune diseases?

How to contact:

The docket will officially open for comments after noon on Aug 3, 2011 and will remain open for 60 days.
To submit your comments electronically to the docket go to www.regulations.gov
1. Choose "Submit a Comment" from the top task bar
2. Enter the docket number FDA-2005-N-0404 in the "Keyword" space
3. Select "Search"
To submit your comments to the docket by mail, use the following address:
The Division of Dockets Management
HFA-305
Food and Drug Administration
5630 Fishers Lane, Room 1061
Rockville, MD 20852
Include docket number FDA-2005-N-0404 on each page of your written comments.


Thanks for posting this.
People also need to check out the FDA's own Hazard Assessment report. It seems that almost no-one is referring to this important document:

Health Hazard Assessment for Gluten Exposure in Individuals with Celiac Disease: Determination of Tolerable Daily Intake Levels and Levels of Concern. May 2011.

The 93-page report is a bit heavy-going, but it shows how thorough the FDA has been on the question of gluten safety. The final sentence is very interesting, and relevant to this forum:

In sum, these findings indicate that a less than 1 ppm level of gluten in foods is the level of exposure for individuals with celiac disease on a GFD [gluten-free diet] that protects the most sensitive individuals with celiac disease and thus, also protects the most number of individuals with celiac disease from experiencing any detrimental health effects from extended to long-term exposure to gluten.


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#13 Takala

 
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Posted 22 August 2011 - 05:40 PM

Can you edit your post to say that is a 93 page FDA pdf download.

They also say they need to research rye and barley.... and that individuals vary greatly in sensitivity and this may be based on genetics (duh!).
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#14 T.H.

 
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Posted 23 August 2011 - 06:07 PM

In sum, these findings indicate that a less than 1 ppm level of gluten in foods is the level of exposure for individuals with celiac disease on a GFD [gluten-free diet] that protects the most sensitive individuals with celiac disease and thus, also protects the most number of individuals with celiac disease from experiencing any detrimental health effects from extended to long-term exposure to gluten.



While it's great that the FDA is working on creating a standard, at the same time, as someone who falls in the category that's mentioned above, I can't say I'm feeling that the FDA is helping me and my family stay safe. Because they didn't choose the option that kept people the safest. They chose the option that kept some people relatively safe, but allows companies to make a LOT of money.

I find it irritating that one of the reasons listed for choosing 20ppm is that if they don't, companies won't make as much gluten-free food, and without all the gluten-free food, people won't stay on the diet as strictly.

Because, yeah, I voted for the FDA to be my parents instead of a regulatory body, didn't I? Or, wait....no, guess not. Not such a strong argument, IMHO, although I suppose it sounds better than: you folks don't have half as much influence or power as the companies who are making money off of you.

Yeah, I'm a bit pessimistic about the FDA at this point, and maybe I'm painting them with a darker brush than is really warranted. But probably because this is the second thing my family got the shaft for. They just finished re-examining food dyes and concluding: yeah, they do cause harm to SOME people, but not everyone, so putting any warnings on them would just be bad for business. Sucks to be you, those of you who react to the dyes.

Feels like they just said the same thing to a whole bundle of Celiac folks: We know you're out there, all you sensitive celiac guys and gals. Oh, and you refractory celiacs who aren't healing eating all this 20ppm food. We know you have trouble with this food, too. Too bad, so sad, sucks to be you.

Just disappointing as heck.
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#15 Takala

 
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Posted 23 August 2011 - 09:14 PM

Shauna,

There is an election coming up, and they do respond to public pressure, if you can articulate this to a wider audience. They've timed this latest "consideration" that they might get around to it, to coincide with "if you re elect some of us... we could get around to doing something not as well done as in other countries, but y'all should be grateful we did something."

Well, making something worse under the pretense of making it better, just doesn't cut it.

You would be amazed and infuriated if you knew who was regularly working against better labeling for gluten free standards, and the general public will be with us, if we continue to make the argument with accuracy. The FDA is no better than the people who appoint them, and they are appointing them frequently out of private businesses, who are more interested in financial speculation for the future than what they could be doing here and now.
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