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Consumers are demanding gluten-free foods, but what of gluten-free dietary supplements?
A market for gluten-free nutritional supplements exists and is growing. As awareness of and education around celiac disease, the autoimmune condition that causes ingested gluten protein to damage intestinal villi, grows, more individuals are diagnosed via blood test and subsequently prescribed a gluten-free diet. Many of these diagnosed individuals are also advised by clinicians to support their gluten-free diets with supplements to fill nutrient gaps specifically caused by removing gluten from the diet.
And beyond the current 1% of the U.S. population who are believed to have celiac disease, up to 6% of the general population may have non-celiac gluten sensitivity, says Jennifer North, vice president, National Foundation for Celiac Awareness (NFCA). These people would benefit from following a gluten-free diet and a corresponding supplementation regimen, as well.
A third group of what North refers to as “lifestyle eaters” are increasingly trying a gluten-free or reduced-gluten diet because of perceived health benefits or because they feel unwell and are experimenting with diet to try to solve the problem.
These groups combined make up a community of gluten-free consumers who present a distinct market for manufacturers and marketers of nutritional supplements.
Opportunities for Industry
Among the opportunities for supplement manufacturers, the first relates to the individual’s need for supplementation that comes with a new celiac disease diagnosis. Amy Jones, MS, RD, LD, chief clinical dietitian, Mary Rutan Hospital (Bellefontaine, OH), explains that those with celiac disease are “at risk for nutritional deficiencies at the time of diagnosis,” which result from “poor absorption of nutrients related to the intestinal villi damage that is the hallmark of celiac disease. Of particular concern to patients,” she says, “are calcium, folate, iron, B12, and vitamin D.” Jones and North add that if a person has had undiagnosed celiac disease for many years, which is typical, “significant time and proper supplementation” may be required to correct the deficiencies.
Of course, a gluten-free diet requires that dietary supplements be gluten-free. “It is important,” Jones points out, “for patients to feel confident that the supplementation not only provides the nutrition they need but is also free of gluten itself. I encourage my patients only to buy supplements specifically labeled ‘gluten-free.’”
Supplements labeled “gluten-free” must comply with FDA’s rule regarding gluten-free labeling as of August 2014. This rule states, among other things, that the gluten-free label can apply only to foods and supplements that do not contain an ingredient that is: 1) a gluten-containing grain, 2) derived from a gluten-containing grain that has not been processed to remove gluten, or 3) derived from a gluten-containing grain that has been processed to remove gluten if the use of that ingredient results in the presence of 20 ppm or more gluten in the finished food or supplement.
With the growing gluten-free consumer base, North says, comes a huge responsibility for industry. “All of the starches and binders used in supplement manufacturing, anything that comes from a grain-based source, has the potential to be contaminated with a gluten-containing grain because of the way grains are produced and transported in the United States,” North warns. “And,” she adds, “even some non-grain ingredients carry risk. We were talking with a supplement manufacturer who told us its most gluten-contaminated incoming ingredient was orange peel, of all things.”
Increasingly, supplement manufacturers looking to sell to the gluten-free consumer community have options for sourcing gluten-free ingredients, particularly excipients. Lew Hendricks, technical service manager, calciums, at Innophos Inc. (Cranbury, NJ), says that demand for his company’s gluten-free excipients, including the calcium-phosphate–based A-TAB and DI-TAB, is steady, and that Innophos gets many customers asking for the company’s Gluten Free Statement (available at the Innophos website).
Susan Freers, technical manager, Grain Processing Corp. (Muscatine, IA), says there are “actually numerous gluten-free excipients” available for use in vitamin and mineral tablet and capsule formulations. These include maltodextrins, pregelatinized starches, modified starches, and corn-syrup starches. She adds that customer demand for gluten-free excipients has increased in the last five to ten years, and that supplement formulators face fewer challenges than food manufacturers do in producing “totally gluten-free finished products,” as there are more gluten-free ingredient options available in general.
Jungbunzlauer Inc.’s market development manager, health & nutrition, Rocio Aramburo (based in Newton Center, MA), agrees with Freers that formulating gluten-free supplements is “not challenging” and that there is a wealth of ingredients from which to choose that are free of gluten and for which “cross-contamination is not an issue.” Aramburo points to Jungbunzlauer’s tricalcium citrate ingredient, TCC TB, as one such example.
Gluten-free supplement manufacturers must always proceed with caution. “So many variables occur throughout production,” North continues, “but when you market to the gluten-free community and you put gluten-free on your label, you have a responsibility to diligently track every incoming ingredient, to test throughout the production process, and to ensure that any co-manufacturers you are working with understand global food-safety principles and how gluten can impact the production process.”
North’s words aren’t just rhetoric. Gluten presence has historically been detected in products a shopper might reasonably expect to be gluten-free.
On the food side, a 2014 FDA-conducted study1 published in Food Chemistry, for instance, found that 19.4% of food products tested positive for gluten, when in fact their ingredient labels, while not necessarily declaring “gluten-free,” did exclude wheat, rye, and barley from their ingredient lists. (On a brighter note, of the products that were labeled specifically as gluten-free, FDA testing happily found that an accurate 98.9% did in fact meet the legal definition.)
Turning specifically to dietary supplements, Columbia University (New York City) researchers recently disclosed at the 2015 Digestive Disease Week meeting in Washington, DC, that eight of the probiotic supplements the researchers tested that were labeled as gluten-free actually contained trace amounts of gluten. (The researchers said they tested probiotics specifically because an earlier study2 conducted by the same team found that probiotics are the most popular dietary supplement celiac disease patients chose to take to aid their symptoms.)
Commenting on these findings, the International Probiotics Association (IPA) released a statement noting that only one of the probiotic products in the study labeled gluten-free contained levels of gluten above FDA’s regulatory threshold of 20 ppm. The IPA also cautioned: “The detection of low levels of gluten using a more sensitive method, however, does not necessarily mean that products present any health risk to people with [celiac] disease. The authors of the study themselves acknowledged that there was no risk from the one product they found above the ‘gluten-free’ labeling limit, [noting] ‘It is unlikely that contaminated probiotics can lead to that amount [that causes intestinal damage] unless patients are ingesting mega-doses.’”
The association said it is working with the researchers to “understand the findings and explore into more detail the results” and stated that manufacturers should adhere to accurate gluten-free labeling and use accredited labs and methods to test to ensure that contens remain below gluten-free labeling limits. It also noted the availability of certified ingredients. “Probiotic bacteria require complex growth media that contain a range of ingredients, but these can be controlled for the presence of gluten and other allergens,” it concluded.
Do It Right or Not at All
If there is a consensus most share, it is this. As NFCA’s North summarizes: “If a company wants to be of interest to gluten-free consumers, the bottom line is that they must test their products rigorously and make the gluten-free claim if they can. If they can’t consistently make the claim, then they shouldn’t, and they should train their customer service representatives to know why the claim is not being made.” Considering that the Columbia University researchers found in their initial study2 that up to 23.6% of 423 Celiac disease patients in the study took dietary supplements to address celiac symptoms, the message is that those with celiac disease are using supplements and need accurate gluten disclosures.
The roughly $10.5-billion gluten-free product market experienced growth of 44% from 2011 to 2013, according to NFCA and market-research group Mintel, and is expected to see growth of 48% through 2016, when sales are forecast to total $15.6 billion. As the gluten-free market grows, successfully and responsibly seizing these opportunities will require industry to invest the time, effort, and resources needed to formulate, manufacture, and market truly gluten-free products that meet the dietary needs of the gluten-free community as well as consumer demand for trustworthiness, transparency, and regulatory compliance.
Photo credit: Country Life sells a wide range of gluten-free supplements, including Maxi-Skin Collagen + C&A. The company says it is the first and only certified gluten-free supplement brand in the U.S. by the Gluten-Free Certification Organization (GFCO). Photo courtesy of Country Life.
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