Participants:

• Hannah Braye, DipCNM, BANT, CNHC, Registered Nutritionist, Senior Technical Advisor, ADM Protexin, Doral, FL, www.bio-kult.com

• Hank Cheatham, Vice, President of Marketing and Sales, Daiwa Health Development, Gardena, CA, www.dhdusa.net

• Don Edwards, Vice President of Sales and Marketing, Health Plus, Chino, CA, www.healthplusinc.com

• Dan Lifton, CEO, Quality of Life Labs, Purchase, NY, www.maypro.com

• Kellyann Petrucci, MS, ND, Medical Advisor, Genexa, Beverly Hills, CA, www.genexa.com

• John Quilter, Vice President & General Manager, Kerry Functional Ingredients & Actives, Mayfield Heights, OH, www.ganedenprobiotics.com

• Ingrid Rickers, MS, MBA, Director of Research and Development, MegaFood, Manchester, NH, www.megafood.com

• Jennifer Weinhardt, BS, MS, Sr. Research & Development Specialist, Bluebonnet Nutrition Corporation, Sugar Land, TX, www.bluebonnetnutrition.com

According to the Digestive Health-US, 2018 report from market-intelligence firm Mintel, total U.S. retail sales for the digestive health market reached $5 billion, slightly increased from 2016 and up 11.6 percent between 2013 and 2018. However, says Mintel, most of the increase came from prescription digestive drugs becoming over-the-counter (OTC) remedies in the antacids segment.

In fact, Mintel predicts that digestive health sales, overall, could flat-line in the coming years due to private-label pressure and, perhaps ironically, to people eating healthier and needing fewer antacid products.

According to the Nielsen/TABS Nutritional Survey Tracker, in the last quarter of 2018 FDM (food-drug-mass market) retailers continued to stock more probiotic products, however TABS’ data indicate that sales growth in the category did not increase.

In any case, Mintel shows that 15 percent of adults are regular users of probiotic supplements.

Mintel notes, “To grow the user base, probiotic brands should promote digestive health benefits alongside traditional benefits, like improved general well-being and immune system support. These secondary benefits are likely to appeal to non-users who haven’t entered the category through traditional digestive health needs.” Mintel adds, “The opportunity exists to encourage stronger category engagement through proactive and preventive treatments.”

Supported by market data provided by Robert Baldwin of TABS Analytics and by category insights provided by the Mintel Group, Vitamin Retailer’s (VR) panel of eight industry experts sheds more light on the category, and breaks down both its dynamics and market challenges, providing context and insights that you can use to do much more than just “go with the flow” in your digestive category management.

VR: What are the biggest, or most interesting, trends you see in natural products for digestive health today? What is the state of the market?

Quilter: One-size-fits all products are out; customization is in. Nowhere is this trend more evident than in the field of nutrition and digestive health, where today’s consumers are taking their well-being into their own hands by seeking out targeted health solutions aligned with their requirements. In fact, research indicates that 71 percent of consumers globally find the concept of products customized to their individual health needs to be very or somewhat appealing.

Petrucci: As consumers become more aware of the products and foods they put into their bodies, we’ve started to see a shift in how they address digestive health. Many now prefer to address the root cause of digestive discomfort rather than simply manage the symptoms. Certain natural products have grown in popularity, such as probiotic and prebiotic supplements. Consumers are also more aware of the potentially toxic chemicals and fillers present in foods, cosmetics and medicines. New, cleaner options for addressing symptoms of digestive issues are gaining in popularity, while traditional digestive medicines are on the way out.

Lifton: While digestive health, as a category, appears to have grown for the last few years, a lot of that growth has been in the Rx-to-consumer channel, not as much in traditional digestive products. Curiously, as consumers eat better, data show their reliance on antacids drops. People appear to be more interested in gut health and being proactive, and less interested in being reactive by taking OTC (over-the-counter) heartburn meds.

Braye: Digestive conditions, such as irritable bowel syndrome (IBS), irritable bowel disease (IBD), gastro-esophageal reflux disease (GERD), constipation, hemorrhoids, diverticulitis, gallstones, hepatitis and pancreatitis are thought to affect around 60 to 70 million Americans. Despite the high prevalence, many people are dissatisfied with current treatments and their potential side effects. As a result, many are turning to complementary therapies and supplements for relief. In particular, the digestive health, and [especially] the probiotic market, continues to expand at a rapid rate.

Cheatham: People look to digestive remedies to help with the side effects of unhealthy diets and stressful lifestyles. These trends are likely contributing to the increased popularity of fiber and probiotics supplements, according to Euromonitor International. Dietary supplements and health and wellness products positioned for digestive health are among the most popular platforms by value, trailing behind only general health/well-being, weight management for health and wellness and [dietary supplements for] heart health.

VR: Approximately 2,400 years ago, Hippocrates was credited as saying “All diseases start in the gut.” We do know that 70 percent of our immune system is housed in the gut. Assuming there is a basis to Hippocrates’ quote, is the converse true: that all health begins in the gut? If so, why?

Petrucci: I believe so. Look at it like this: A healthy gut is needed for a healthy immune system and a healthy immune system is needed to ward off disease. This has been a hot topic for both scientists and in the media, and for good reason. There is strong evidence that the gastrointestinal system is more than a tract for digesting food and distributing nutrients. Microbiome projects worldwide have been launched with the goal of understanding the roles that these symbiotic microorganisms play and their impact on human health. Our individual microbiomes help determine our unique DNA, predisposition to diseases, body type or body weight, and much more. It’s been said by some researchers that the majority of all diseases can be traced in some way back to the health of the microbiome. So, I’m convinced that the backbone of good health is a healthy intestinal tract.

Weinhardt: There’s a close connection between the bacteria in your colon and the immune system—and probiotics have been linked to enhanced immune responses, such as to flu vaccines. Several studies, including one published in 2012 in the British Journal of Nutrition, have found that certain probiotic strains boost measures of immune response—but whether this translates into any clinical benefits is uncertain. Studies have been inconsistent, for example, as to whether taking probiotics will actually curb colds and other upper respiratory infections. A 2011 Cochrane review concluded that probiotics may help prevent such infections, though there were limitations in the studies and no data for older people.

Edwards: Since the gut is such a huge part of our overall system, of course it is central to our overall balance. These feet of tubing contain more microorganisms than we have cells in our bodies. Add to this our cleansing organs and you have an incredible system which, when running well, can support our overall health. Sometimes, because we do not have time or enough focus on our bodies, regular supplementation can help keep things [working] better.

Quilter: On a fundamental level, good gut health can contribute to an overall sense of day-to-day well-being. But there is also emerging clinical evidence that probiotics can help strengthen the immune system, which suggests that our gut is indeed at the very heart of the mechanisms the body uses to fight off illness.

VR: Back in the 1930s, health-food stores were focused on very simple digestive cleansing. A 1938 ad for a product called “Toxelim” was billed as “BULK! For Constipation.” It promised retailers that it would sweep “the intestinal tract clean.” Are we still focused on heroic, or mechanical, measures like this? If not, where is the science pointing today?

Lifton: I would like to think that all responsible manufacturers and marketers today avoid this kind of thinking today. Since World War II, science has been showing us that our bodies are replete in “germs:” on our skin and in our bodies. Maintaining a balance of bacteria is key, making sure that our beneficial bacteria are maximized while our pathogenic bacteria are held in check.

Rickers: First, I hope that we are no longer wanting to “sweep” the intestinal tract clean; rather, we want as many beneficial “bugs” as possible to colonize our intestine. The more diversity we see in our gut flora, the healthier is our GI (gastrointestinal) tract and the better our overall health can be. When it comes to heroic measures like this, I think that we now know more about the gut and that the gut is central to our overall health; for this reason, I feel that the gut has become a heroic area of interest in itself.

Braye: The most appropriate course of action to help improve someone’s digestion will depend on the factors that are contributing to each individual’s symptoms. For example, national consumption surveys indicate that only about 5 percent of the American population meet recommendations for daily fiber intake. So if someone suffers with constipation due to lack of fiber, then increasing fiber intake through food and supplements can be very effective. Similarly, if someone’s symptoms are exacerbated by dehydration, drinking more water may be a simple solution. However, increasingly, research is highlighting the importance of the composition of bacteria in the gut and its role in many aspects of gut health.

Cheatham: Researchers have only just begun to identify methodology to define a healthy microbiome, and as this investigation evolves, growth in the market will occur, not only in personalized medicine, but overall. There is evidence that many chronic metabolic diseases do, in fact, begin in the gut. This association has a lot to do with the different gut bacteria residing in one’s digestive tracts, as well as the integrity of the gut lining.

VR: Speaking about science, can you talk generally about strides in innovation that have recently been made in the ingredients (and formulas) that are today featured in digestive health supplements?

Weinhardt: In this day and age, everyone always assumes that the higher the number (of anything) the better quality the product—it’s a clever little marketing tool that makes us think we are getting more. Sometimes though, more is actually less! For instance, there is no use going for a product that advertises a really high number of probiotic strains in the product if those strains are not well researched. Remember, they are not all the same. The best thing to do is choose the product that contains complementary strains, which work well together and are tested to survive together in a capsule. Tests on low quality probiotics have shown that various strains can compete against each other forcing less resilient strains to die off in a capsule before consumption.

Edwards: Of course, the most recent strides are in probiotics and other ingredients designed to support the microbiome. This is still an open area with many opportunities and plenty of questions still [to] be answered. While it is being explored, Health Plus is still focused on a more basic process which is feeding the system itself. Since probiotic strains number in the thousands, we have focused our efforts on feeding them all instead of adding specialized ones into the consumer digestive system.

Quilter: In the U.S., probiotics were popularized by the dairy category, with more than half of all yogurt sold being fortified with probiotics. But novel approaches in probiotic technology are allowing manufacturers to provide probiotic options that consumers want beyond traditional formats such as dietary supplements and yogurt. The big step forward in recent years has been the emergence of spore-forming probiotics like GanedenBC30. Spore-formers are much more resistant to the extremes of pH, heat, cold and pressure than vegetative probiotic cells, making them a better fit for the fortification of everyday foods and beverages.

VR: It has been said that digestive health is an “as needed” category—that digestive health products are not taken on a regular basis, but mainly when consumers want to tackle a specific digestive issue, such as heartburn, stomach upset, constipation, diarrhea, etc. Is this still accurate? If not, please explain.

Petrucci: I agree 100 percent with the saying, “An ounce of prevention is worth a pound of cure,” and we must be certain that our digestive system is healthy and functioning properly to draw the essential nutrients out of the foods we eat. Digestive enzymes, prebiotics, and probiotics will definitely help us get the most nutrition out of the food we eat. When we’re out of balance and certain symptoms flare, those symptoms can make us uncomfortable and we should consider all remedies to treat these symptoms. For example, untreated heartburn can cause damage in the esophagus lining and lead to Barrett’s esophagus disease, a serious complication of GERD (gastroesophageal reflux disease). Several meta-studies have concluded that probiotics may help prevent some common side effects of antibiotic treatment and mitigate the effects of antibiotics (which kill both beneficial bacteria and problem-causing bacteria). However, I firmly believe you need to focus on the systemic problems as to why specific digestive issues exist.

VR: Regarding probiotics and prebiotics, what are the most exciting developments in the science and technologies behind these ingredients? Delivery forms? What do manufacturers and retailers need to know?

Weinhardt: The most exciting development, in my opinion, is the ability to DNA verify the probiotic strains being used in a formula. Not all are created equal. All of the strains and starter cultures found in Bluebonnet’s Advanced Choice SingleDaily Probiotics have been genetically identified and characterized through a highly sensitive tool used in molecular biology to detect DNA polymorphisms, called amplified fragment length polymorphism (AFLP), by the Belgian Coordinated Collections of Microorganisms (BCCMTM). This is important because characterization of the strain diversity of lactic acid bacteria (LAB) species has only really begun in the last decade or so. The Belgian repository began in 1983.

It has since grown to become one of the largest and most well-known biological resource centers (BRCs) that specializes in bacteria worldwide. It receives an excellent international recognition as repository of important groups of bacteria and for its strong expertise in bacterial characterization—specifically, intestinal microbiota in health and disease (with emphasis on bifidobacteria).

VR: What are a few of the biggest obstacles or rate-limiters to the digestive health category, if any, and why? If possible, how can these challenges be tackled?

Cheatham: If a probiotic was not manufactured in clean, regulated conditions, as per cGMP (current good manufacturing practice) guidelines then in all likelihood it will not only be ineffective, but it could be potentially hazardous!

There are five factors which impact our grade of each probiotic, and they are:

1.Price – this one is self-explanatory.

2. Potency – too many companies leave their probiotics sitting around gathering dust to the point that over 50 percent of the brands tested had zero live cultures remaining. Potency is the percentage of live cultures discovered upon testing the brand. Many companies store their probiotics too long.

3. CFU (colony-forming units) – represents the total count of all of the bacteria in the probiotic, very important because probiotics are only efficacious in adequate amounts.

4. Strains – total number of different types of bacteria in each probiotic, varies greatly and, along with strain diversity, affects the types and levels of benefits.

5. Strain Purity – a combination of the effective concentration of the strains within the probiotic and the functional quality of the active cultures (the ability of the bacteria to perform its specific job).

Braye: Regulatory constraints regarding what manufacturers can say about their products to consumers can make communicating the target, action and potential benefits of products tricky, often causing increased confusion for consumers.

Lifton: The idea that digestion support is only for “triage” is now old hat. We also need to do a better job, as an industry, in making sure that probiotic products have science that supports multiple benefits, including immune health.

VR: Please spotlight one to two products or proprietary ingredients that you are most excited about and why. For non-manufacturers, what do you believe consumers are most interested in, digestive health-wise?

Weinhardt: Bluebonnet is now offering five advanced, multi-strain/high potency probiotic formulas. Whether customers are looking for daily support to help maintain long-term digestive health and immunity, or they have specific digestive needs, Bluebonnet’s Advanced Choice SingleDaily Probiotics have something for them. This line offers, 10, 30 and 50 Billion CFU strengths, as well as 10 and 50 Billion CFU strengths for probiotic formulas geared to adult women.

Quilter: GanedenBC30 is a patented spore forming probiotic strain with research-supported benefits and formulation abilities. It is a unique and well-established probiotic that is the perfect for use in personalized nutrition products targeted at a wide spectrum of consumer groups. GanedenBC30 has made it possible to innovate with probiotics in beverages such as instant hot and iced coffee, dairy and dairy alternatives, vegetable and fruit juices, enhanced waters, shakes, energy drinks and kombuchas. For foods, snacks such as trail mixes, savory snacks and puffs, baked goods, nutritional bars, gummy snacks, and peanut and nut butters are now popular probiotic fortified innovations.

Lifton: Our ProbioPure product features the probiotic, Morinaga BB536, a proprietary strain of Bifidobacterium longum that provides help for occasional constipation, diarrhea, abdominal discomfort, gas and bloating. It features 12-month viable shelf life and improves the body’s ratio of good bacteria.

Our Peptisol product features ginger root extract, artichoke leaf extract and GutGard, licorice root extract. All of these ingredients work together to relieve occasional indigestion and heartburn and promote healthy, more regular, bowel function.

Edwards: Our company has been marketing digestive products for over 30 years. During this time, we have created natural basic-to-the-system products which continue to be our best sellers. Our Colon Cleanse products are centered on psyllium husk, which is the best fiber ingredient available. Our very best-selling products are our Super Colon Cleanse natural laxatives, which are for those who have a constipation issue. Our brand-new products are focused on digestion and cleansing other organs. These new products all include turmeric powder/extract and other ingredients to lower inflammation while benefiting digestion, heart and joints.

Petrucci: We are particularly excited about one of our newest products, Genexa Heartburn Fix. Heartburn Fix is a chewable calcium carbonate antacid made with organic and non-GMO (genetically modified organism) ingredients that provides soothing relief for symptoms of heartburn, acid indigestion, and sour stomach. Heartburn Fix is free of artificial dyes, flavors, gluten, lactose and other potentially harmful inactive ingredients often found in other heartburn remedies.

Braye: Bio-Kult Migréa is a unique triple action, multi-strain probiotic supplement targeting the digestive tract and the head. It is formulated with 14 strains of live bacteria plus magnesium and vitamin B6, both of which contribute to the normal functioning of the nervous system and the reduction of tiredness and fatigue. B6 also contributes to the regulation of hormonal activity and homocysteine metabolism.

Bio-Kult Infantis is a scientifically developed, advanced probiotic formula for babies, toddlers and young children. Each sachet contains seven strains of live bacteria, Preplex prebiotic (FOS and gum acacia), omega-3 fatty acids and vitamin D3 to contribute to the normal function of the immune system. The probiotics and prebiotics in Bio-Kult Infantis were shown in human clinical trials to significantly reduce the symptoms of colic in infants from two weeks old and, in some cases, to completely eradicate the symptoms. It has also shown benefit in those infants with both constipation and diarrhea, and in childhood dermatitis.

Cheatham: Daiwa Gastro Health is powered by IgY Max, a polyvalent antigen-specific IgY product targeting 26 of the most common human-relevant pathogens. Other IgY products only target one pathogen and therefore are monovalent. IgY Max, the active ingredient in Daiwa Gastro Health, is a unique digestive and immune function element that promotes GI health by increasing gut wall integrity, improving bowel function and reducing non-beneficial bacteria adherence and in doing so, functions much like a prebiotic.

However, it is slightly different from a prebiotic in that it in addition to favorably altering the composition of the microbiome, it supports the digestive tract lining, promotes proper microbial adhesion, supports immune system health, supports the body’s natural defenses and promotes proper cytokine balance.

Rickers: I am excited around a new strain of probiotics called BLIS that shows some great research in children. Additionally, I think D-limonene is going to see some growth in the digestive category in the near future; what’s old is new again.

VR: What predictions do you have for the future of the digestive health category? In what direction(s) would you like to see it go, and why?

Lifton: I would like to see probiotics, more broadly proactive digestive health, emerge as the most important part of the category. However, I would like the marketplace and the playing field to not get hung up on CFUs but to, instead to be focused on the most effective, and clinical science-backed ingredients in the best, more bang for the buck, formulas.

Petrucci: Expect to see a growth in preventative digestive health products, such as probiotic and prebiotic supplements. Concern with overall gut health is on the rise, accompanied by a shift toward clean living. As consumers eliminate—or at least limit—exposure to artificial ingredients and toxins, clean and organic options will become more accessible. This shift will affect many different categories, but we definitely expect to see an impact on the OTC digestive health product industry.

Braye: The gut-brain axis, and in particular how digestive health and the balance of bacteria in the gut may affect brain health, is an exciting and rapidly evolving area of research. The gut-brain axis is a bi-directional communication system between the gut and the brain. It consists of a number of neuronal, immune and hormonal pathways, all of which may be influenced by our gut bacteria. Changes to the gut microbiota resulting from [lifestyle factors] have been implicated in anxiety, autism, depression and dementia. This has led to research into “psycho-biotics,” the name given to supplemental bacteria thought to have a positive effect on both digestive health and brain function. While still in their infancy, the hope is that in the future, we will be able to tailor psycho-biotic treatments to a range of psychological and mental health issues.

Quilter: Branded probiotic ingredients have a big role to play in educating consumers and earning their trust in the digestive health category. But just giving an ingredient a fancy name is nowhere near sufficient. Consumers attracted to a branded ingredient tend to be more informed and curious about the story behind the brand—specifically, what benefits it offers and information supporting its safety and efficacy. It’s no secret that, because information is now at their fingertips, consumers are smarter, more skeptical and much more selective than they used to be. They now expect transparency of information from manufacturers about the products they choose to buy. VR

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