Promax Nutty Butter Crunch and LS Peanut Butter Cookie Dough bars are labeled gluten-free and are certified gluten-free by the Gluten-Free Certification Organization (GFCO) but barley malt extract is included in the ingredients list in the soy protein crisps used in the products.

http://www.promaxnutrition.com/products/core-flavors/nutty-butter-crisp

http://www.promaxnutrition.com/products/ls-flavors/peanut-butter-cookie-dough

The good news: This month (March, 2012) the company begins production on reformulated bars that will no longer include a soy protein crisp containing barley malt extract.

Please read the entire post, including manufacturer statement at http://www.glutenfreewatchdog.org/blog.php?id=8. The information on the Promax bars is added as an addendum after the information on Balsamic Four Onion Spread.

Background: Over the past two years there have been numerous blog posts about “high” amounts of gluten in human breast milk. This has led to some speculation (as well as outright “this is fact” statements) that cow’s milk may contain gluten. Consequently, I have received questions regarding whether this is true.

Research articles on gluten in human breast milk: Based on searches of Pub Med there appear to be only two original research articles (plus a chapter in a thesis) on the topic of gluten in breast milk.

• Chirdo et al. Presence of high levels of non-degraded gliadin in breast milk from healthy mothers. Scand J Gastroenterol. 1998;33:1186-1192. Available at: http://www.ncbi.nlm.nih.gov/pubmed/9867098
• Troncone et al. Passage of gliadin into human breast milk. Acta Paediatr Scand. 1987;76:453-456. Available at: http://www.ncbi.nlm.nih.gov/pubmed/3300148
• Hopman et al. Presence of gluten protein in breast milk: implications for the development of celiac disease In Gluten intake and gluten-free diet in the Netherlands. 2008 (thesis). Available at: http://tinyurl.com/836j4a2  Note: this research was never submitted to a peer-reviewed journal for publication.

Research findings: For the first two cited articles, I have read only the abstracts. While I do not believe in commenting on articles I have not read in full, it is important to point out that despite the title of the first article (i.e., “Presence of high levels of non-degraded gliadin in breast milk…”), the mean amount of gliadin found in the human breast milk samples was 178 ng/ml which is 178 parts per billion or 0.178 parts per million. In my opinion this is NOT a large amount of gliadin. In the second cited article, gliadin was found in breast milk in amounts ranging from 5 to 95 ng/ml or 5 to 95 parts per billion or .005 to .095 ppm.

In the Hopman thesis, researchers used a competitive assay (used to assess gluten fragments) to determine the amount of various gliadin and glutenin peptides, including an epitope that is part of the celiac toxic 33-mer. As with the two other studies cited, peptides were found in breast milk in exceedingly small amounts measured in ng/ml (parts per billion). The mean levels of the three gliadin peptides were 0.132 parts per million; 0.129 parts per million; and 0.404 parts per million. The mean level of glutenin peptide was 0.045 parts per million.

In other words, human breast milk may contain exceedingly small amounts of gluten peptides.

Note: For those of you concerned about the implications of breast feeding on the development of celiac disease, this is the concluding statement from Hopman, “In the present study we show that low amounts of T cell stimulatory epitopes of gluten, both from gliadin and glutenin, are present in breast milk of mothers on a normal diet. Since oral tolerance to food antigens is induced early in childhood, in the period infants are breast-fed, these peptides might be involved in the induction of gluten tolerance.”

In other words, the tiny fragments of gluten that may be found in human breast milk may serve a protective role in preventing celiac disease.

It is very important to point out that the gluten peptide content of human breast milk has been studied very little. One of the above mentioned studies used a sandwich assay to detect peptide fragments. The other study and the thesis used competitive assays. The sandwich assay is not ideal for detecting peptide fragments. The competitive assays used in these publications have NOT been formally validated (defined as having undergone a multi-laboratory performance evaluation with results published in the peer-reviewed scientific literature). As a result, more research is needed in this area before any definitive statements can be made about the gluten peptide content of breast milk.

Research articles on gluten in cow’s milk: Based on a review of Pub Med, only one study has been conducted on the gluten peptide content of cow’s milk (Dekking et al. Intolerance of celiac disease patients to bovine milk is not due to the presence of T-cell stimulatory epitopes of gluten. Nutrition. 2009;25;122-123). Researchers fed dairy cows increasing amounts of wheat. They then tested milk samples for gluten and gluten derived peptides at levels down to detection limits of 1 to 3 ppm gluten. The study authors concluded that “no gluten or gluten fragments could be detected above background in any of the bovine milk samples.”

The competitive assay used in this study has not been formally validated. The sandwich assay (i.e., R5 ELISA) used in this study has been formally validated.

Conclusion: Please continue to enjoy your milk!

I would like to thank the cereal chemists and researchers consulted for this article.

© 2012 by Tricia Thompson, MS, RD. All rights reserved. This article may not be reprinted, reposted, or republished without the express written permission of Tricia Thompson

The study behind the article

Colgrave ML, Goswami H, Howitt CA, Tanner GJ. What is in a beer? Proteomic characterization and relative quantification of hordein (gluten) in beer. J Proteome Research. October 2011. The study is available at: http://pubs.acs.org/doi/suppl/10.1021/pr2008434

Study authors tested three types of beer: regular beer made with barley malt; gluten-free beer made without barley malt; and what the study authors call low gluten beer. This last type of beer, which the authors state is classified as containing less than 10 parts per million of gluten, is made with barley malt using proprietary methods that reportedly reduce the level of hordein (the problematic protein in barley).

Investigators found that of the beers included in the study, all regular varieties made with barley malt contained hordein; none of the gluten-free varieties made without barley malt contained hordein; and both of the so-called low gluten beers contained hordein.

This study was conducted in Australia which may explain some of the word choices that led to confusion. In the United States, beer containing barley malt is regulated by the Tobacco Tax and Trade Bureau (TTB). In January 2011, I was told by the TTB that, “the Bureau considers labels that declare a product to be “gluten free” or lead to the impression that a product is safe for those who suffer from celiac disease as making health claims, which are prohibited.” In other words, what the study calls “low gluten beers,” meaning those beers made using barley malt but reportedly processed to reduce gluten content, can not be labeled gluten-free in the US.

Note: Many of you are probably aware of a Spanish import made using barley malt with packaging that inferred (maybe still infers) gluten-free status (gluten-free neck tag, bottle cap with a crossed out stalk of wheat). Sometimes products slip through the cracks. Undoubtedly, this also is contributing to the confusion.

What those of us in the gluten-free community generally refer to as “gluten-free beer” does not contain barley malt. Therefore it is not considered a malt beverage under TTB regulations and instead is regulated by the FDA. “Beer” regulated by the FDA can be labeled gluten-free but it can not contain barley malt.

Hopefully this all makes sense. It can be rather confusing when there are two regulatory agencies involved!

©Copyright 2012 by Tricia Thompson, MS, RD. All rights reserved. No part of this article may be reproduced without the prior written permission of Tricia Thompson.