Labeling, gluten thresholds, and my philosophy of gluten exposure

November 25, 2009

This is my response to the email on 11/23/09 by thecraeg

[jhinsf@...] regarding my post about mislabeled beef jerky. Sorry it is

so long, but this is a very important topic for celiacs, and we all need to

understand and discuss these issues. I don’t claim to have the last word

on any of this; there aren’t any simple, easy answers on any topic

regarding celiac disease. I do think we need to be very careful not to make

decisions based on incomplete or inadequate information.

My recommendation to the FDA was to have a tiered labeling

system where “gluten-free” would mean no gluten-containing

ingredients and produced in a GF facility and tested to the lowest practical

level (currently 3 ppm). Products with no gluten-containing ingredients that

are produced in a shared facility where contamination and ingredients are

strictly controlled and are tested regularly (to 3 ppm) would be labeled

“no gluten ingredients”. Products that contain wheat but test less

than 20 ppm would be labeled “low gluten”. Anything else could not

make any claim regarding gluten (other than “may contain” or

“contains”).

This makes it clear what the status of the product is and lets

the consumer decide what level of exposure they will accept. Anything else

leaves celiacs guessing about what they are buying unless they study the label

and call the manufacturer. The tiered system also rewards manufacturers who go

to the trouble of catering to celiacs with gluten-free facilities and strict

controls by giving them special designations. To set the bar to the lowest

common denominator will discourage those manufacturers and many may change

their practices or go out of business, making the highest standard of

gluten-free food less available. So while we may increase the number of foods

labeled “gluten-free”, we will decrease the availability of foods

produced with strict standards and increase the amount of gluten consumed by

celiacs.

Make no mistake, the FDA has chosen current system because it is

easy. Easy for manufacturers, easy for the FDA. The needs of celiac consumers

were not a priority in this decision. So while the FDA has “dumbed us

down, ” assuming that consumers would be confused by a tiered system, I

think they have only made it more confusing by not giving us the information we

need.

With regard to the statement in the post I am responding to:

Studies the world over have shown that levels of 20 ppm of

gluten are safe for celiac.

I

was surprised to hear this, and immediately searched the internet to see what

information I could find to support it. What I did find was mostly that there

is still considerable controversy about how much gluten it takes to cause

measurable harm to celiacs, and quite a bit of variation between celiacs as to

how much it takes to make a particular individual sick.

Here is a sampling of what I found:

http://www.medscape.com/viewarticle/578637_1

Systematic Review: Tolerable

Amount of Gluten for People With Coeliac Disease (8/2008)

Results: Thirteen

studies (three randomized controlled, one cohort, two crossover, and seven

cross-sectional) met the inclusion criteria. The daily amount of tolerable

gluten varied widely between studies. Whilst some patients tolerated an average

of 34-36 mg of gluten per day, other patients who consumed about 10 mg of

gluten per day developed mucosal abnormalities. The effect of the consumption

of ‘gluten-free’ products with different degrees of gluten

contamination was also inconsistent.

Conclusions: The amount

of tolerable gluten varies among people with coeliac disease. Although there is no evidence to suggest a single definitive

threshold, a daily gluten intake of <10 mg is unlikely to cause

significant histological abnormalities.

This is a recent review of 13 studies that concludes that

reactions differ among celiacs. Note that they conclude that 10 milligrams of

gluten per day is “unlikely” to cause “histological

abnormalities”. 10 milligrams is 1/400th of a teaspoon.

“Unlikely” is hardly a confidence builder as to the strength of the

conclusion. This means that 1/400th of a teaspoon of gluten per day

is unlikely to cause intestinal damage to celiacs.

This is an article that discusses the difference of opinions

among support groups regarding the FDA definition of GF:

http://www.celiactoday.com/Community/Opinions_Differ_as_US_FDA_Prepares_To_Define_What_‘GlutenFree’_Means

In the celiac.com article referenced

in the post I am responding to, I noted that the comments below the article by

Clavarino, a member of the association who sponsored the study,

has a completely different take on the study than the author of the article. I

copied her comments below because they point out so many interesting results of

the study that were not emphasized in the actual conclusion of the study. Her

emphasis on the results is that more study is needed, a far different one than

reaches, which is that because cross contamination is common, we

shouldn’t worry about every little crumb of gluten. To me, this is like

saying you shouldn’t worry about every little x-ray because radiation is

everywhere. My concern is that it’s not the first or second x-ray that

causes the damage; what should concern us is the cumulative effect of how may

x-rays a particular individual has over a certain period of time and how many

x-rays a person may absorb before sustaining damage. Everyone should read this

very carefully, especially to note that some “healthy” Italian

celiacs participating the study (about 1/5th) who regularly consumed

products containing 20 ppm gluten had intestinal damage even before the study

began.

From the celiac.com article Research

Study on the Establishment of a Safe Gluten Threshold for Celiac Disease

Patients: Comments by Clavarino:

I read with interest your

remarks about the Catassi/Fasano study. As an active member of the AIC (Association

of Italian Celiacs), sponsors of the study, and as the person responsible for

revising the language of the text for publication…the study does raise

some serious queries about background gluten contamination and its impact on

the celiac intestine. When the authors remark that the IELs do not show a

difference among the three groups of celiacs on long term gluten free diet

(though not compared to the non celiac disease controls), they point out that

the villous height/crypt depth ratio is a more valid and more

sensitive marker of gluten trace contamination in celiacs on long-term dietary

treatment. They also remark that " Despite the restricted criteria adopted

in this study, the baseline duodenal biopsy

results showed evidence of histologic damage

(decreased median Vh/cd count and increased median IEL count in adult celiac

disease patients receiving long-term dietary treatment. Furthermore, 4 of 49

subjects had to be excluded from the protocol because severe enteropathy(obscuring

the possible effects of the micro challenge) was detected at the baseline

evaluation. These results confirm that an abnormal smallbowel morphology persists

in a significant proportion of celiac disease patients treated with a

gluten-free diet, despite full resolution of their symptoms... " (due

to) " ... the ongoing ingestion of gluten, either deliberate or inadvertent,

causing persistent inflammation in the small-intestinal mucosa... "

etc.

As all medically diagnosed

Italian celiacs receive a free monthly allowance of naturally (i.e. no wheat

starch) gluten free products containing less than 20 ppm from the Italian

government health service, and as all the volunteers for the study considered

themselves to be healthy (otherwise they would certainly not have volunteered),

the finding that 4 out of 49 had to be excluded for severe enteropathy and that

histologic damage persists in a significant proportion of adult celiac disease

patients on long-term gluten-free diet, besides the other findings of the study

(i.e. that 50 mg of gluten per day for only 3 months of trial results in

measurable intestinal damage, while there was significant improvement in the

placebo group during the strictly monitored trial) is not reassuring. In the

light of the Catalan study on the amount of gluten-free dietary foods actually

consumed by celiacs in Europe - together with the constant risk of involuntary

background contamination and the varying degrees of individual sensitivity -

the absolute maximum threshold of ppm in gluten-free products must be kept

below 20 ppm. This is a very far cry from the current wording of the Codex

Alimentarius which is based on the old standard of the nitrogen content in

food.

I hope that these words may

help to clarify the importance of the work done by Profs. Catassi and Fasano,

the Association of Italian Celiacs, the study by the Catalan research group

(previously cited on your website), and the need for further research and

information as to the impact of micro-traces of gluten on celiac disease and

its complications so as to ensure that celiacs may make fully informed

decisions about their dietary choices.

In another Celiac.com article, “FDA’s gluten-free

proposal will benefit millions of Celiacs”, references what

appears to be the same study when he states, “The study, conducted by members of the ACDA at the University of

land and referenced by the FDA, concludes that celiacs can safely tolerate

up to 20 parts per million (ppm) of gluten a day.” This

is a bit surprising, since 20 ppm is not a measurement of a safe daily amount

of gluten; it is a measure of how much gluten a particular food contains, and

the study made no such conclusion. I think we need more than one study with 49

patients in Italy before we can reliably state what amount of gluten any celiac

can safely consume.

As to “gluten phobia”, my philosophy of gluten has

been developed through trial and error by feeding my celiac family for over 20

years. Everything I do, I do for a reason born of actual experiences and

years of trial and error. When flours from the bulk bin made them sick, I

switched to Bob’s Red Mill packaged flours; when Bob’s Red Mill

flours made them sick (because at the time they shared the same grinding stone

and facilities with gluten grains) we bought a grain mill and 25 lb bags of

organic brown rice to grind our own. When Sesmark rice crackers made them sick,

we ate and Sons which did not. When I found that some bags of Bearitos

Crunchetos made them sick, and some did not, I realized that even within the

same product, cross contamination could occur in some batches and not in others

(even within the same batch, the first product off a shared line could be more

contaminated than what went through at the end of the batch), I began to take

cross contamination more seriously. After several vacations ruined by being

sick, I realized that no matter how many questions we asked or how carefully we

ordered, eating out 3 meals a day was going to result in gluten overload. Even

this year I began to suspect that something at one of our favorite restaurants

was making them sick; I put off the investigation because I did not want to

discover we couldn’t eat there anymore. My kids paid the price and I am

still kicking myself for not listening to my instincts sooner (especially since

the offending ingredient was easy to avoid). All these things and many, many

more I have learned the hard way, and all these experiences and many, many more

have shaped my actions and attitudes about how to keep a celiac healthy.

Because gluten is everywhere and because I want my kids to live

in the world and not isolated from it, that is precisely why I am adamant that

at home we eat only foods that I know are safe. I know there is no way I can

protect my family from every molecule of gluten. I also know that the amount

of gluten they can eat without showing symptoms (I can only hope that

any sub-clinical damage is not enough to do significant damage) is as

vanishingly small as 1/400th of a teaspoon a day. Thus, the game is

this: my goal is to keep the gluten load below the level of harm. To this end,

what they eat at home must be as close to zero gluten as I can make it. If I

start adding foods at home that contain 200 or 20 or 10 or 5 PPM gluten and

they eat these things day after day, then the base level changes: they will

already be compromised when they go out in the world and will reach the level

of harm that much faster.

I am not looking for some impossible-to-meet ideal. All I would

ask for is a labeling system that gives celiacs the information they need to

make informed choices about the food they buy. Then I can make choices

appropriate for my family and my philosophy of gluten exposure and feel

confident of what I read on the label. I only feel lucky that the

Farmer’s Market actually listed the wheat in their product, which allowed

me to avoid it. And I have learned that I can no longer assume a product that

proclaims itself to be “gluten-free” on the label is one I would

feel safe feeding to my family. I hope in the future other manufacturers will

list all wheat, barley rye, and oats on their labels, but I suspect that sooner

or later I will find my kids getting sick from some product labeled gluten-free

only to find out that it contains unlisted gluten that tested as containing

less than 20 ppm by some lab but did not pass my family’s gut test. If

this is gluten-phobia by someone’s definition, bring it on. I

don’t think it disrupts my or my family’s lives or makes us

unhealthy in any way.

Pam Newbury

November 26, 2009

Thank you, Pam!I and my wife, a severe celiac who was transfused 8 times (16 pints) the first year after CS was diagnosed (gluten levels took a long time to go down) and who has been on ProCrit (to increase red cell production) for the last year, have been long aware that even very small amounts of inadvertent gluten can have a major impact on her. Sometime duriing a trip last year, despite all of our precautions, she was glutened. All of a sudden her hemoglobin and hemocrit dropped, she was anemic again, and had to start ProCrit.How how or low a level of gluten was in the supposedly GF food she ate? We don't know. We also read, as librarians who have also researched the issue, that "systematic review" you cited from the 08/28/08 issue of Alimentary Pharmacology & Therapeutics. It is about as good as information about the issues of appropriate gluten levels gets. The FDA is under such pressure by the food industry that I'm not surprised when compromises that endanger the health of consumers are made. This is one of them. If my wife can not trust "gluten-free" labels because of their compliance with "FDA standards," then we will not buy the products. As for going out, well, we still do but to very few places and only if we contact them first and find out about their kitchen practices.As for the total amount of gluten that someone consumes during the course of a day, this can be exponentially greater if prepared foods comply with a 20ppm level rather than a 3ppm level. This exacerbates the situation for someone like my wife but may be disadvantageous to almost anybody with CS.I think your

kids are lucky to have somebody who is so "gluten phobic" as you, as we are all muddling through a situation that still lacks sufficient research. It is absolutely better to be obsessively safe than sorry. HogleFreelance academic librarianInstructor, online researchEmail: jjhogle@...Web: (under de- and re-construction) www.blueroom.comReality ain't what you think it isArt Graphics & Photographs[http://www.blueroom.com/realityaint.htm]From: Pam Newbury <pknewbury@...> Sent: Wed, November 25, 2009 3:53:19 PMSubject: [ ] Labeling,

gluten thresholds, and my philosophy of gluten exposure

This is my response to the email on 11/23/09 by thecraeg

[jhinsfgmail (DOT) com] regarding my post about mislabeled beef jerky. Sorry it is

so long, but this is a very important topic for celiacs, and we all need to

understand and discuss these issues. I donâ€™t claim to have the last word

on any of this; there arenâ€™t any simple, easy answers on any topic

regarding celiac disease. I do think we need to be very careful not to make

decisions based on incomplete or inadequate information. My recommendation to the FDA was to have a tiered labeling

system where â€œgluten-freeâ€ would mean no gluten-containing

ingredients and produced in a GF facility and tested to the lowest practical

level (currently 3 ppm). Products with no gluten-containing ingredients that

are produced in a shared facility where contamination and ingredients are

strictly controlled and are tested regularly (to 3 ppm) would be labeled

â€œno gluten ingredientsâ€. Products that contain wheat but test less

than 20 ppm would be labeled â€œlow glutenâ€. Anything else could not

make any claim regarding gluten (other than â€œmay containâ€ or

â€œcontainsâ€). This makes it clear what the status of the product is and lets