Update July 12, 2013.

I don’t know about all of you but I am getting a little fatigued from the beer “issue.” BUT …

Last evening I was forwarded some documents related to Craft Brew Alliance (Omission). According to the email included with these documents they are not considered confidential and will be in the public domain soon (when they are, I will post the links). When I have more information regarding how the scientific community views the information contained in these documents I will pass it along. In the meantime, one of the documents reads in part:

“Given our commitment to scientific inquiry and the advancement of analytical gluten detection methods, Omission has been working with several international laboratory groups that have expertise in using LC/MS techniques to detect gluten. Earlier this year, one of our partners, DSM Food Specialties, completed research on our products. The results show that Omission beers are devoid of known toxic epitopes, the specific peptide sequences and reactive sites in gluten molecules that cause reactions in the human small intestine. These same beers were tested using the R5 Competitive ELISA and were found to lack any measureable gluten content. Mass spectrometry currently is not scientifically validated or conclusive, but this method holds much promise, and may eventually become an important alternative for the detection and verification of gluten.”

With release of this information it appears that Omission is trying to respond to issues raised by some in the scientific community, including:

Health Canada: “Recent tests by Canada’s public health agency found gluten fragments in beers from Spain and Belgium that use a gluten-removal process similar to Craft Brew’s. It’s unclear whether the fragments are a health concern, Health Canada spokeswoman Blossom Leung said via email.” Source: http://tinyurl.com/l6naj2f

An author of the competitive R5 ELISA validation study:  In personal email correspondence I was advised that the detection of gluten fragments by the R5 antibody is still under discussion because LC-MS can detect fragments in beers that have been found to be gluten-free by ELISA.

Steve Taylor, PhD:  His comments can be read below in the original post and also at the link above.

I am NOT very knowledgeable about mass spectrometry and liquid chromatography and can not offer an opinion at this time on the information released by Omission. It will be helpful if Omission submits their research to a peer-reviewed scientific journal for evaluation. Hopefully those exceedingly well-versed in testing hydrolyzed/fermented foods and beverages for gluten will comment soon.

………………………………………….

I’d said all I wanted to say about Omission Beer and other “gluten removed” barley malt-based beverages but then a quote from Steve Taylor, PhD, Co-Director of the Food Allergen Research and Resource Program (FARRP) caught my eye. In the article “Gluten-removed or gluten-free: Craft Brew Alliance presses Omission beer’s case” by Brent Hunsberger of The Oregonian, Dr. Taylor is quoted as stating, “I’m concerned that there might be big pieces of gluten protein left in this beer that are still potentially hazardous.”

Bottom Line: If Steve Taylor is concerned about this beer containing gluten then all individuals with celiac disease should be concerned about drinking this beer.

Background: Many of you have been following the controversy over whether Omission Beer should be allowed to label its barley malt-based beer gluten-free. Under the interim policy on the labeling of alcoholic beverages released by the Tobacco, Tax, and Trade Bureau (TTB) in May of 2012, the answer is no. Instead the TTB interim policy allows the statement, “Processed or treated or crafted to remove gluten” for products made with wheat, barley, rye, or crossbred varieties of these grains OR any ingredients derived from these grains IF these grains or ingredients have been processed (or treated or crafted) to remove all or some of the gluten.

Both the Food and Drug Administration (FDA) and the TTB appear to be on the same page when it comes to assessing the gluten content of fermented or hydrolyzed foods. The FDA writes in its August 3, 2011 Federal Register Notice regarding gluten-free labeling that, “FDA recognizes that for some food matrices (e.g., fermented or hydrolyzed foods), there are not currently available validated methods that can be used to accurately determine if these foods contain < 20 ppm gluten.” The TTB writes in their interim policy on gluten content statements that they agree “with FDA that there are no scientifically valid methods for accurately measuring the gluten content of fermented products…”

BUT Craft Brew Alliance, the manufacturers of Omission Beer disagrees. On April 15, 2013 three members of Craft Brew Alliance along with a representative from the law firm Patton Boggs, LLC met with two members of the Office of Management and Budget/Office of Information and Regulatory Affairs. The OIRA reviews draft regulations including the proposed gluten-free labeling rule. It is the case that the TTB and not the FDA regulates malt-based beer including Omission. However, based on my read of reporting done on this issue Craft Brew Alliance wants FDA to acknowledge in the final gluten-free labeling rule that a scientifically valid test for accurately measuring the gluten content of fermented and hydrolyzed products DOES exist.

So is there a scientifically valid test for measuring the gluten content of fermented and hydrolyzed products? The competitive R5 ELISA is used to assess foods that are highly hydrolyzed or fermented. It appears that the competitive R5 may have finally been validated. The AACC International very recently published a technical report on the findings of a collaborative study on the competitive R5 ELISA. One of the study authors sent me a pre-print version of the paper. This international collaborative study to validate the competitive R5 ELISA (Ridascreen Gliadin Competitive R7021, R-Biopharm) was jointly run by the Prolamin Working Group and AACCI. This multi-lab performance trial involved 16 labs and 7 foods/beverages. By means of comparison, when the sandwich R5 ELISA (Ridascreen Gliadin R7001, R-Biopharm) was validated in a collaborative trial with the Prolamin Working Group, 20 labs and 12 food samples were involved.  To the best of my knowledge neither the FDA nor the TTB has commented publicly on this collaborative trial.

Regardless of assay validation, Dr. Taylor raises another important issue in The Oregonian that has gone largely unstated… The R5 ELISA detects the amino acid sequence QQPFP. This sequence may be broken apart by the enzyme used by Craft Brew Alliance to “remove” barley protein from Omission beer. If this is the case, the sequence will not be detected when this product is tested using the R5 ELISA. BUT this does not mean the beer is free of other toxic peptides.

Something to think about: Beer seems to elicit an emotional reaction in individuals with celiac disease. Would we be having this discussion if the product in question was soy sauce? Probably not but the issue is the same. Omission contains hydrolyzed barley protein and soy sauce contains hydrolyzed wheat protein. Some in the soy sauce industry claim the wheat protein in their product is completely hydrolyzed because this is the only way to achieve the umami flavor characteristic of the condiment. How would individuals with celiac disease feel if soy sauce containing hydrolyzed wheat protein was allowed to be labeled gluten-free?

Note: I have written extensively on why historically it has been so difficult to test hydrolyzed products for gluten including at http://www.glutenfreedietitian.com/newsletter/gluten-free-labeling-of-alcoholic-beverages-update/ and http://www.glutenfreedietitian.com/newsletter/beer/

For more information see Gluten-removed or gluten-free: Craft Brew Alliance presses Omission beer’s case by By Brent Hunsberger of The Oregonian http://tinyurl.com/l6naj2f

© June, 2013 by Tricia Thompson, MS, RD. All Rights Reserved. 

 

Omission Beer: The controversy over gluten-free labeling of malt-based beverages continues