<<Disclaimer: Verify this information before applying it to your situation.>>

Here are the comments I received re: the gluten free standard:
   
  The FDA recently released a proposal for the labeling laws recommending that the limit for a gluten-free label be set at less than 20 PPM.  Currently, I believe that research suggests most celiacs can tolerate 200 PPM daily of contamination by gluten.  To see the full FDA proposal go to www.csaceliacs.org and search "gluten free label".
   
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The FDA is proposing less than 20 ppm - based on one study and its histologic findings as Gluten free.  As a celiac, the long term consequences and the probability of many celiacs to consume many fold that amount of gluten in one serving - from many different "GF" items in a day - are of serious concern.  

To me, gluten free is just that - gluten free - and I do not need to tally how many servings of items of GF I have had - that do contain 20 ppm gluten.  The molecular basis of CD leads me to speak plainly about GF meaning GF - whether it is milk, a pear or rice flour.  I know when I prepare my own foods at home that they are indeed GF - then I feel the 
best without nagging tummy discomforts.  
  
To me, gluten is like a "touch of pregnancy"  - you either are, or or not?  While trying to appease industry, I find it a dis-service to celiac patients.  Who will monitor and know that 20 ppm is just that, or less, or more?  I am not convinced that a short term trial is adequate 
evidence that a decade of exposure may prove dead wrong.  
   
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  Discussions on regulatory levels of gluten in "glutenfree" products are a topic at the meetings of the Codex Alimentarius commitee on food for special dietary uses (CC NFSDU). At the moment there is no consensus about thresholds. Nordic countries like Finland propose a 100 ppm level, which will make it possible to use wheat starch in the production of GF products, which gives products with better taste and structure. This is of course an important factor in getting good compliance to the GF diet. On the 
other hand, hardliners (like Italy and Spain) are in favour of 20 ppm as a threshold for all products (see also reference at the end). In the framework of the Codex Alimentarius, a 20 ppm limit is proposed for GF foods which are "glutenfree by nature", like cornstarch- or rice-based products. This is likely to be accepted in the next meeting.  The USA is seeking comments and scientific input on setting a regulatory limit and I assume the outcome of these discussions will also be used in defining the USA stance on Codex thresholds. It is for sure that zero tolerance for gluten in GF food isn't an option because of the 
ubiquitous presence of wheat in the food industry. Have a look at: Federal Register 2795 Vol. 72, No. 14 Tuesday, January 23, 2007 http://www.fda.gov/ohrms/dockets/default.htm , and type or paste Docket No. 2005N-0279 in the search box.  Or go to: www.fda.gov/OHRMS/DOCKETS/98fr/05n-0279-npr0001.pdf 

The CSA applies zero tolerance on their CSA recognition seal (a 3 ppm limit) which is the detection limit of the currently used R5 ELISA method. I.m.h.o. this is nonsense because an ELISA is always prone to false positive results at the detection limit (likewise we cannot be sure that if we perceive a sweet taste this is caused by sugar! Glycerol, thaumatin, aspartam and lead-acetate may taste as sweet...a rose by any name....)

Recent research on gluten todicity may also be found in: Catassi et al. AmJ Clin Nutr 2007; 85:160-6. A prospective, double-blind, placebo-controlled trial to establish a safe gluten threshold for patients with celiac disease. 
  
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The point I was trying to make was that if you ingest gluten regularly such as by using low gluten hosts and then have a gluten accident or two, eat out and maybe get a bit of cross contamination, and then the labeling law for gluten free becomes "up to 20 ppm is gluten free" and you eat several foods labeled as such a day, how much gluten are you 
really getting? 

It is my understanding that there is still no definitive answer as to how much gluten per day is safe for a celiac to consume. I did read that Dr. Catassi presented preliminary results of a multicenter study that showed that "A gluten daily dose of 50 mg seems to be able to induce minimal histological changes in most treated celiacs."    What does that actually mean?   Does that mean that less than 50 mg is a safe amount to ingest daily?  How do we know exactly how much is safe?    Wouldn't it take a long term study of celiacs actually 
eating 50 mg per day of gluten to determine whether it is actually safe or not?  How do we know what health issues lie ahead for those who continue to ingest gluten -- even in small amounts like this?

Most celiacs that I know have been misdiagnosed for so long that they are/have been REALLY sick and I would think that any amount of gluten would be detrimental to their health.  
  
The last article that I read from Gluten Free Living regarding the communion hosts was in Volume 9, No. 2, "Low Gluten, no gluten, At what point does it matter?"  It stated that the gluten content of the low gluten wafer was actually 100 ppm.   It further said that Tom Sciacca states that "PPM's are not very meaningful in themselves but provide a gauge or measurement that helps us understand minute amounts."   If that is the case, then what 
is the sense of the labeling law being set at less than 20 ppm?

My thought is that one should try to be as gluten free as humanly possible because we are going to make mistakes or accidentally get glutened in some unknown way occasionally.   Since no one can say what the "safe" amount of gluten ingestion for a celiac actually is,  I 
would think that the only safe amount is ZERO!  That may not be possible in the real world, but does it make sense to knowingly ingest any amount of gluten, however minute?

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  Thanks,
  Michelle Azimov
  Ventura, CA
   
  PS - I spoke with the scientist who helped develop Mr. Krispers.  He said they run the product on separate lines and have only one other product that contains wheat in the facility.  They test each batch because they feel they want to pass that information on to consumers.  ~80%+ of the time, they test GF.  Less than 20% of the time, they get 20 or 50 or 60 ppm in a batch.  They picked the number <100 ppm for their label to avoid having to discard too many batches, from a cost standpoint, and it seemed to be an acceptable standard.  They think when it tests positive, it may be from supplier ingredients (although the suppliers claim they supply GF ingredients) or from x-contamination from the wheat in the building.  I think it is really no different from eating a gluten free food from Kraft, or Gen Mills or another big company; they just don't test for gluten.

 
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