Updated Oct. 19, 2017: A study published in July 2017 supports the concerns raised in this article. Researchers at the Columbia University’s Celiac Disease Center found “no scientific” basis for claims that the enzymes in these dietary supplements degrade gluten. Dr. Benjamin Lebwohl, the study’s author, and his team are calling for greater FDA oversight and want doctors to ask celiac disease patients if they’re taking the supplements.
“Don’t avoid gluten, digest it with Glutagest!” Eat pizza and s’mores with no worries, suggests the company’s Facebook page. Meantime its website says: “Glutagest quick dissolve probiotic capsules target and break down the gluten from food by actively splitting gluten proteins into smaller good proteins that are easily absorbed by your body.”
If you have celiac disease or non-celiac gluten intolerance, it would be a dream come true if, instead of following a strict gluten-free diet, you could indulge in gluten-laden pizza simply by popping some supplements. However, the supplement claims don’t pass the reality check of celiac and gluten intolerance experts.
With the rise in popularity of gluten-free diets, it was only a matter of time before supplement makers flooded the market with products claiming to ease the woes of those who must avoid gluten. Glutagest and another product called Gluten Cutter are among a growing list of aids being aggressively marketed to consumers and health professionals.
“It is important to note that commercial enzyme and probiotic supplements, promoted to ‘digest’ gluten, have not been proven clinically to treat celiac disease,” says dietitian Shelley Case, author of Gluten Free: The Definitive Resource Guide. “They should not be used by those with celiac disease as a replacement for the gluten-free diet or to treat inadvertent gluten contamination,” she stresses.
Renowned celiac disease expert and researcher Dr. Alessio Fasano, a gastroenterologist and director at the Center for Celiac Research at Mass General Hospital for Children in Boston, is extremely concerned about these products. He fears that those who require a gluten-free diet will become less vigilant about avoiding gluten and may put their health at risk.
Fasano is of the view that these alternatives to the gluten-free diet would need the scrutiny of the U.S. Food and Drug Administration (FDA) and “this stuff most definitively does not fulfill these criteria.”
As a dietitian, I too thought a regulatory approval process would also be required. But it turns out that this is not the case. I reached out to the FDA to inquire about the evidence used to obtain marketing approval. Press officer Lyndsay Meyer said the FDA does not require any scientific evidence to be submitted.
According to the FDA, a supplement company can make any claim as long as it’s within the scope of what a human body can do. Meyer explains using an analogy to a supplement promoting hair growth. “Since hair growth is a natural human function, you can make the claim the supplement promotes hair growth, but you cannot include a claim about any treatment, such as the product can be used to treat alopecia (hair loss).”
In other words, you can put a supplement on the market, and make any claim you want as long as it does not treat any condition.
Meantime in Canada, the Health Canada agency is in the process of updating regulations that may help to halt the marketing of dubious products. But currently, as in the United States, companies do not need to disclose scientific evidence.
I reached out to the makers of both supplements to see if they could provide scientific verification. After repeated voicemails to Core Science Medica in West Palm Beach, Florida, I was finally able to reach a spokesperson. When asked if he could provide me with the research on Gluten Cutter’s ability to break down gluten, he curtly told me to look it up online and that, since the company was privately held, he did not have to provide this information. Three conversations with others at the company ended in the same manner.
Kyla Czerwinski of Exzell Pharma, the makers of Glutagest, did provide some research on the probiotic contained in the supplement. However, while Glutagest is marketed to those with non-celiac gluten sensitivity, the company has no completed studies on the impact of taking the supplement on the group with that condition.
As for Gluten Cutter, it is licensed to help digest protein among other actions. After I asked Health Canada to look into the product’s claim to break down gluten on the actual package, Maryse Durette, a senior media relations adviser, stated: Although gluten is a protein, this extension to ‘breaking down gluten’ exceeds the approved claim.” She said the regulatory agency would contact the manufacturer “to ensure its marketing is in line with Health Canada’s marketing authorization.” In other words, they will need to cease making the gluten claim in Canada.
Fasano is closely watching the ongoing research on possible compounds to break down gluten, but notes scientists have not yet found solutions. While awaiting news for any breakthroughs, it’s key for those with celiac disease or non-celiac gluten sensitivity to consult only reliable sources such as expert health professionals or trusted sources before making any dietary changes.
Rosie Schwartz is a dietitian in private practice and author of The Enlightened Eater’s Whole Foods Guide. Visit www.rosieschwartz.com. This article was first published in the Spring 2017 issue of Allergic Living magazine.