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CSA Defends its Gluten-Free Endorsement of Omission Beer. Really?

By: Peter Olins, PhD, on November 27, 2013.

In last week’s blog we raised concerns that the Celiac Sprue Association (CSA) appears to have declared that Omission Beer is gluten-free and risk free. So, two days ago, I spoke at length with Mary Schluckebier (the Executive Director of the Celiac Sprue Association) about my questions and concerns about the CSA “Seal of Approval” for Omission Beer. This left me with more questions than answers, so I emailed Mary a list of 11 questions, which she has promptly responded to. My intent was to try to understand how this decision was reached.

Below, I share Ms. Schluckebier’s answers. However, I have a number of concerns that remain unresolved. With respect, I would like to highlight these differences of opinion. The responses where I still have concerns have been underlined, and colored red. My discussion of these concerns is shown in green. 

I look forward to pursuing some of these questions, and also encourage readers of this Q&A to share their comments. I sincerely hope that such dialog will help to restore confidence in the CSA.

-start of Q&A-

Q1: The press release from CSA on November 18, 2013, was titled: “Celiac Sprue Association Recognizes Omission Beer As Risk-Free For Celiacs” (http://goo.gl/YoGNAV). The term, “risk-free” seems to be a rather strong position for CSA to take, since the FDA has framed its recent gluten-free labeling in terms of gluten levels, rather than safety.

Q1 Answer: This was an unfortunate mistake: the press release was issued on our behalf by the brewer of Omission Beer, Craft Brew Alliance.

In a November 18, 2013 press release issued on behalf of the Celiac Sprue Association regarding its certification of Omission beer, Executive Director Mary Schluckebier was quoted as saying that “Omission Beer clearly meets our strict standards as a risk-free choice for celiacs”. While nothing has changed regarding the certification of Omission Beer, the use of the term “risk-free” in the previous press release was inaccurate and contrary to the long established policy of the Celiac Sprue Association. It is the policy of the Celiac Sprue Association to not use absolute terms such as “safe” or “risk-free” for any product that is not innately gluten-free and free of cross-contamination. (Also we use people with celiac disease, rather that celiacs.)
The Celiac Sprue Association apologizes for the previous misstatement.
Since 2004, products bearing the CSA Recognition Seal represent critical review of a company’s manufacturing practices and procedures to “reduce risk” for our gluten-free customer. Since there are currently no tests or methods which analyze a product to contain a specific level of gluten below 5 parts per million, the Recognition Seal Program of the Celiac Sprue Association certifies those companies producing products which represents the most risk-free or least risk to people with celiac disease. It is not clear if gluten is the only part of the grains affecting those with non-celiac gluten-sensitivity.
The Celiac Sprue Association’s Recognition Seal Program assists by providing people information that can be used in their own lifestyle risk management treatment of celiac disease. As always, the most sensitive test remains the person with celiac disease and others on a gluten-free diet. No man-made test takes into consideration all of the potential toxicity of the grains to those with celiac disease.

Q1 Discussion: I disagree with Mary’s opinion that personal experience is the most sensitive test of gluten safety. The available literature suggests that low-level gluten exposure may lead to intestinal damage that is not accompanied by physical symptoms. This may account for the fact that many celiacs heal very slowly, or incompletely, even when trying to adopt a gluten-free diet.

 

Q2: Today, November 26, 2013, the Omission Beer Facebook Page shows a graphic, dated November 18, 2013, declaring that Omission Beer is proud to be endorsed by the CSA, together with 667 “likes”. Does the CSA agree with this?

Q2 A: The CSA does not “endorse” any specific product, and has requested that this graphic be removed. Omission Beer said that this would take three days to accomplish.

Q2 Discussion: When I checked today, November 27, 2013, Omission Beer has still not taken down its “Proud to be endorsed by CSA” graphic on Facebook. This is the tenth day that this endorsement has been displayed. Sadly, I don’t get the impression that anyone is taking this matter very seriously.

Three days. Really.

The graphic also includes the phrase “Celiac Sprue Association’s Seal of Approval”, which I assume refers to CSA’s Recognition Seal. On the other hand, perhaps only a lawyer could argue the subtle distinctions between “Approval”, “Endorsed” and “Recognition”, so perhaps this graphic is accurate, after all?

 

Q3: The press release mentions that Omission Beer has developed a new kind of test (relying on the technique of mass-spectrometry) to detect potentially harmful peptides (fragments of protein) remaining in their product. What are the “celiac toxic amino acid fractions” in Omission Beer that you refer to?

Q3 A: Hordein, specifically those proteins with repeating patterns of glutamine and proline. There are thousands of sequences with patterns high in proline and glutamine present in specific repeating patterns that are known toxic or suspicious in the gluten containing grains. In barley it is called hordein. The process consisted of comparing the initial pre-fermentation structure of proteins with the ones remaining after the fermentation. The structure of the remaining proteins did not have the early repeating patterns with glutatmine and prolamins.

Q3 Discussion: I have worked on the biochemical properties of proteins for my whole career. However, from my exchanges with Ms. Schluckebier, and in the absence of seeing an actual experimental protocol, it is still not clear how this analysis was performed, or what assumptions were made.

Which specific members of the hordein family of proteins were analyzed? Which barley glutenins were examined?

(One small correction: the word “prolamins”, which are proteins, is confusing. I assume that this really refers to the amino acids “prolines”).

 

Q4: Little is known about the safety of glutenins in most grains, and little about barley hordeins. Can you be confident that looking for “known peptides” can be extrapolated as a measure of safety of barley-based beers?

Q4 A: Current Gluten ELISA’s are cross reactive with the major gliadins but not all of those in barley and rye. Mass spectrometry was set to provide a picture of the structure of all the proteins in a product. Research in celiac disease is in the pioneer stages and only a few years past the prescription of the banana diet. The amount of celiac disease research is much greater than that for non-celiac gluten related disorders.

Q4 Discussion: I don’t think that the question was answered. 

I don’t understand how a discussion of ELISA assays is relevant, since these do not measure toxicity. 

 

Q5: The FDA regulation currently relies on “sandwich ELISA” assay methods for detecting gluten, which have been rigorously “validated” by many international labs. How do Omission Beer’s mass-spectrometry results compare?

Q5 A: The FDA stated what criteria will be used to determine misbranding of a product. It did not require any testing by companies before they add the words gluten-free to a label. Mass spectrometry is a research level approach, and potentially extremely sensitive, but it is still mainly used as a research tool in gluten-free applications. It is at the cutting edge and has not been validated by other laboratories for gluten analysis. In most cases the ELISA type test has been all the detail the customers requested. The ELISA assays are cheap and easy to read compared with the equipment and experience required for mass spectrometry.

Mass spectrometry imaging is relied upon in a growing number of research applications. In PubMed the track for mass spectrometry testing was used as part of 4 research papers in 1948 to 17,388 in 2012 and 15,759 so far in 2013. For use specifically with protein analysis the research papers begin in 1967 with 7,713 in 2012 and 6,178 so far in 2013.

Q5 Discussion: I share Mary’s concern that the FDA does not actually require testing, but I don’t see how this is relevant.

The response seems to sidestep the fact that the FDA has stated that there is no validated assay for “hydrolyzed proteins”, such as beer or malt vinegar, etc. While it is great that “research-stage” technologies are being used to explore beer safety, the CSA Recognition Seal for Omission Beer implies that the CSA considers the FDA’s requirements to be too strict.

The mention of ELISA assays as being “cheap and easy to read” seems to be irrelevant to measuring gluten in beer, since these assays do not give a meaningful result for these fragments of gluten.

I do not understand the relevance of the sentences about mass-spectrometry as a general technology. Yes, MS has been used for decades for analyzing all kinds of biological molecules: the issue is how exactly it is being applied here.

 

Q6: Who within CSA has reviewed the mass-spectrometry data provided by Omission Beer and recommended that this beer receives the Seal of Approval?

A: The same review process was used to qualify Omission Beer as with any company. Outside reviewers are used as necessary.

Q6 Discussion: I don’t think that the question was answered. It is not clear why this information needs to be kept private.

 (Correction: I should have said “Recognition Seal”, not “Seal of Approval”—but this mistake seems to have been made by many other commentators on the Internet. It’s not clear if this makes any difference).

 

Q7: Have these results been reviewed by an outside academic laboratory?

A: No. However, Dr. Edward Dratz, a professor at Montana State university, states that, in principle, mass-spectrometry could ultimately be the preferred method for detecting gluten, but that the approach would need to be validated.

 

Q8: As a scientist, I am obliged to be skeptical: is there any way for me to see the actual data from Omission Beer? Will this be published in a scientific journal?

A: No, this is company confidential information, and I am not aware of any plans to publish it. However, similar data will be published in a peer review journal about the feasibility of a variety of new or innovative testing methods to determine potential gluten content in fermented products.

Q8 Discussion: The lack of transparency about the logic and data used to make this safety assessment is a great concern. (My own request of Craft Brew Alliance, about four months ago, to review their new testing results—even under a confidentiality agreement—received no response).

Perhaps I’m not being clear: I am not asking to see any details of a proprietary brewing process, but I think we have a right to know the rationale and method used for analyzing the product. Likewise, I don’t need to know exactly how “Company X” formulates its products, but it is reasonable to ask specifically what testing method is used by the CSA in order to receive the Recognition Seal.

Forgive me, but citing unpublished research that may be relevant to other unpublished research does not inspire a lot of confidence. 

 

Q9: There have been several anecdotal reports on the Internet claiming adverse reactions to this product. Obviously, there is no simple way to verify these. How many of these reports are you familiar with, and do you have any plan for how to follow up?

A: CSA encourages those who are suspicious of a product to report the information three places. 1. to the company or distributor; 2. the federal government who regulate the product safety, ( http://www.fsis.usda.gov/wps/portal/fsis/topics/recalls-and-public-health-alerts/report-a-problem-with-food ); 3. a copy to the Celiac Sprue Association, celiacs@csaceliacs.org for follow-up and support.

Q9 Discussion: I don’t think that this question was answered. The response did not address whether CSA was aware of how many anecdotal reports of adverse reactions had been made, or describe what kind of “follow-up and support” the CSA plans to offer.

Also, recommending that people with suspected adverse reactions approach the brewer or USDA is puzzling. Wouldn’t it be more appropriate to contact the FDA or TTB (which regulates beer labeling)?

 

Q10: On a slightly different topic, what is the CSA position on the “competitive ELISA” that Omission Beer shows on its website as supporting the safety of its product?

A: The competitive ELISA is probably more sensitive than the traditional assay for measuring gluten levels in fermented products, but has not been extensively validated. It does not report results in “ppm gluten” so the values obtained using this newer assay must be converted to ppm to determine product compliance with the familiar “20 ppm” cutoff set for FDA compliancy. These are all limited by being batch tests. G12 and A1 tests are looking more promising as the next generation tests for gluten analysis suitable in commercial industry. There are home kits of some of the gluten ELISA that are quite accurate.

Q10 Discussion: This was a most unsatisfactory response, since it implies that there IS a way to convert and compare assay results obtained with the “competitive ELISA” versus values form the “sandwich ELISA”. I strongly disagree, for reasons that I explained in two previous articles (Gluten-Free Beer: Does Omission Beer Deliver the Goods? — A Simple Guide for the Non-Biochemist, and Assay for Gluten in Barley is Flawed—Implications for Gluten-Free Labeling of Foods and Gluten-Free Beer ).

I am also puzzled by the mention of research-stage ELISA methods, based on different antibodies (called G12 and A1). Why is this relevant to the validation of a mass-spectrometry-based assay? Any test that is based on antibody detection will suffer from the same fundamental problems as seen with the commonly used antibody (R5).

I was also puzzled by the mention of “home kits” designed for testing gluten contamination. Surely, the CSA does not recommend these kits for testing products containing “hydrolyzed proteins”, such as barley-based beer?

 

Q11: Is there anything that you would like to add that would help clarify the CSA’s current assessment of Omission Beer as a suitable product for celiacs to consume?

A: All foods that are not naturally gluten-free and uncontaminated pose a risk, generally unknown. Each person consciously or unconsciously sets up a risk management plan to live with the dietary requirements. I encourage everyone to review the CSA Gluten-Free Self-management Plan to develop or review their personalized risk management plan for being gluten-free. No two celiac disease patients are the same and we know less about the dietary needs of those with non-celiac gluten disorders. As with other processed products considered for consumption in a gluten-free lifestyle Omission best fits in stage 2 of the plan. http://www.csaceliacs.info/glutenfree_diet_self_management.jsp

-end of Q&A-

Comments:

My biggest concern with the response from Mary Schluckebier is that there has been so little transparency about how exactly the decision to endorse this product was made. My old science mentor used to say: “In God we trust, all others must bring data”. This is in contrast to the previous approach by the CSA for Recognition Seal status, which appears to have relied on public, scientifically-validated, technologies for testing gluten levels. Frankly, the secrecy surrounding this process is almost guaranteed to generate suspicion among the celiac and scientific communities—even if it might be unwarranted.

Overall, I was disappointed by the responses from Mary Schluckebier: they left me with less confidence than I had at the outset, and I am sorry to say that I now have less confidence in the 1100+ products that already bear the CSA Recognition Seal.

I am now more convinced than ever that the CSA has relaxed its standards for assessing whether a product is “gluten-free”, and that this position directly contradicts the regulatory and scientific authority of the two bodies that are responsible for the safety of most “gluten-free” foods in the U.S. (the FDA and TTB).

On a personal level, it is still not clear to me that the CSA is taking the concerns of many members of the gluten sensitive community seriously.

The updated CSA website states, “CSA Recognition Seal products are tested using the most sensitive ELISA or best test presently available in the United States. Validation of “free of wheat, barley, rye and common oats” in ELISA tests with a lower limit of quantification of 5 parts per million or documented free of celiac toxic amino acid fractions.” What is missing here is CSA definitions for “the best test”or “celiac toxic amino acid fractions”.

I believe that it is important to support research on how to evaluate the safety of foods for people with celiac disease and gluten-sensitivity. However, science is a team effort, and progresses by having as many eyes as possible scrutinizing the data.  It seems obvious that so many of the issues about the new Recognition Seal could be cleared up by a simple change in transparency at the CSA: unfortunately, secrecy tends to breed suspicion.

Reviewing this post, I realize that my concern is with the use of the word “Seal”, which carries an implication of trust. I don’t believe that this word should be used for testing approaches which are experimental, even if they are promising and tantalizing.

Final Note: As I have stated several times before, I am glad that different brewers are exploring technologies to reduce gluten contamination in beers made from barley. My concern here is with how and why CSA seems to have decided to relax its testing standards. I usually refrain from questioning people’s motives, and try to focus more on actions, but in this case, whom does this really help?

6 comments to CSA Defends its Gluten-Free Endorsement of Omission Beer. Really?

  • Abigail

    I am outraged that CSA, a high profile, non-profit organization, can act with such a lack of transparency in how it makes decisions. Actually, I’m getting this awful feeling that Mary is the only one testing company products with an OTC gluten test in her kitchen and deciding what gets the CSA seal of recognition!

  • jeanne

    Your knowledge is invaluable to the celiac community. Much buzz & debate on social media questioning what happened to Celiac Sprue’s high standards on this one - it’s tough when the association you trust the most makes an endorsement (or whatever IT is) that make little sense. Been pointing some traffic to your site - thanks for supplying the scientific knowledge to support our insticts.

  • NoGluten

    CSA is my “go to ” choice when I am shopping. I read this and think it just seems so strange. Perhaps they’ve been glutened recently and are not doing their best thinking. Very much appreciate your time and effort.

  • Dick Lunde

    As a relatively recently diagnosed celiac, I’m puzzled by the use of parts per million in discussions of products that are nearly gluten-free. Surely there is a big difference in the amount of gluten consumed between consuming a couple of beers that are “less than 20 ppm” gluten and consuming a helping of a dish prepared with a couple of tablespoons of soy sauce that is “less than 20 ppm”. It would seem to me that a more appropriate way of expressing gluten risk would be in something like “micrograms per serving” or something like that which would relate to the actual amount of gluten (or the substances actually being measured) that would be likely to be consumed.

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