A feel-good market for digestive health

As the US awakens to the concept, market potential is great, but the road to success is littered with obstacles. James Townsend explores how companies in this field are positioning themselves for growth

The gut-health market, or as some more decorously call it, the digestive-health market, is showing real signs of vigour nowadays.

A wide range of digestive-health products—probiotics, enzymes, prebiotics—is experiencing growth. Frost & Sullivan has forecast the US market for products intended to bolster or replace probiotics in the gut to reach $394 million by 2010. Datamonitor recently called probiotics the biggest category in the $21.3 billion US functional-foods market. Nutrition Business Journal estimated that US consumer sales of digestive-enzyme supplements amounted to $182 million in 2006.

Marc Lallond, VP of business development for Montreal-based Harmonium International, one of the world's largest suppliers of probiotic bacteria lines, says his company is expanding every six months to keep up with demand. Surprisingly, he says that the strongest markets are not in Japan, where functionality is more often accepted, but in places such as Italy, Eastern Europe, Canada and the United States.

National Enzyme Company reports great growth in the international market (as well as in the US), with the strongest growth in Australia and New Zealand. In June, NEC announced a strategic partnership with Wedar Biotechnology to feature NEC's BioCor line of enzymes in the Chinese market. In the past, Wedar has successfully promoted NEC's Nattozimes, which provide cardiovascular or anti-inflammatory support, to customers in both China and Taiwan.

Not there yet

So what stands between the companies who create digestive-health products and the realization of these dazzling sales projections? First, it's the complicated nature of gut health. For instance, in probiotics, research shows that among the hundreds of strains of bacteria, different strains have effects on differing health conditions, and these may vary according to the age or the person taking them.

Combine this with the fact that probiotics interact differently with different prebiotics, or fibres, and that digestive enzymes may interact differently with all of them, and you have the potential for a nearly perfect storm of consumer confusion.

"The market for natural gastrointestinal health remedies is definitely catching on in the US," says Nena Dockery, technical resources manager at NEC, "but consumer education is very much needed." Lallond says he spends most of his time educating Harmonium's distributors, who in turn must educate their customer base, health food stores. Sylvie Morin, marketing manager-Americas for probiotics maker Institut Rosell, believes that health professionals can play a lead role in educating consumers about digestive-health products.

The recent launches by Dannon, Kelloggs (Kashi), Nestlé, and others have stimulated demand for probiotics, says Ariella Gastel, senior business development manager, health and nutrition at Danisco, which manufactures the prebiotic fibre Litesse polydextrose, and the Howaru probiotics line. "Unlike in the EU and Asia, digestive health is still not 'table talk' except for maturing adults. However, by these companies providing tasty products with digestive-health benefits, consumers are definitely catching on."

Alberto Trujillo, US national education manager at FloraHealth, one of the distributors of Harmonium's bacteria lines, says it is essential to educate the public by creating brochures for point-of-sales education, as well as to run magazine ads and get information out to the media through print and radio interviews. "For a small company like ours," he says, "we have to rely heavily on word of mouth, and educating the retailer."

Trina O'Brien, marketing manager at GTC Nutrition, maker of the prebiotic NutraFlora short-chain fructo-oligosaccharides, says her company has lauched a comprehensive media programme that includes "news segments, radio news releases and podcasts, web communications, primary consumer research, event sponsorship, and more. We've secured over eight million consumer media relations in 2007 as a result of our outreach," she says.

"Also, key customers and organisations have partnered with GTC Nutrition to bring our bone-health message to consumers—Horizon Organic, NuVim and the National Osteoporosis Foundation have provided products and support to our cause."

Importance of science

Most everyone agrees that getting the word out about digestive-health products depends upon good, substantiated research that provides the potential for natural alternatives to pharmaceutical treatments.

"The largest challenge for all ingredients and foods marketing to gut health is clinical substantiation," Gastel says. "Statistically significant, gold-standard studies cost a lot but are necessary to prove efficacy and to permit health or marketing claims."

Dockery agrees. "The cost, though, of doing legitimate, publishable research is high, and the realizable benefits are sometimes elusive," she says. "In addition, without strong IP protection, which adds an additional cost, it is difficult to maintain exclusivity of any positive results gained from the research."

NEC's BioCor line, for instance, is based on a study the company did with TNO (Netherlands Organization for Applied Scientific Research). It was the first quantitative evidence proving the efficacy of supplemental enzymes, Dockery says.

Despite the expense, Dockery says it is essential to do this to distinguish the company's products. "Patent protection is a large financial commitment for which there is no absolute guarantee of a return on the investment. However, it can be worth it, particularly if the ingredient or use of that ingredient is very novel and the patent is broad enough to discourage intentional or unintentional infringement."

Rosell's Morin says ultimately it should all pay off. "Strategic alliances and collaboration between companies in the probiotics industry, research centres, health professionals are playing a very important role for the progression of the knowledge on those beneficial ingredients for human health."

Marketing claims

Since January, the FDA has allowed labels on functional foods to bear structure/function claims (SFCs), provided that the claims are substantiated by scientific data (See sidebar below). This gives manufacturers the opportunity to showcase and promote their products to consumers and boost their sales. SFCs are not required to be submitted to the FDA for approval. Yet, the supportive documentation for the claim has to be available in case of an audit.

Quality assurance also comes into play here. For instance, to sell one's product in Australia, the product must be certified by the Therapeutic Goods Administration, Australia's equivalent to the FDA. "They have very strict ingredient and manufacturing guidelines," Dockery says, "and NEC gained TGA certification in 2003, something we are very proud of."

Safety is yet another issue. "Ingredients such as digestive enzymes have a long history of safe use," Dockery says, "but there is always the concern that an individual will have an unexpected response to an ingredient or product, either an allergic reaction or a response triggered by an undisclosed pre-existing condition."

Regulatory hurdles

Consumers are not the only ones in need of education. Trying to educate regulatory agencies about a subject as complex as probiotics is difficult, Lallond says.

"There is not enough research information on the many strains of bacteria that are present in the human system to effectively legislate them," Lallond says. He reports he's currently in conversations with European legislators. "They already are headed down the wrong road by working with single-strain formulations for specific health claims," he says. "They're looking at a particular strain as if it were a new molecule, but every person has a widely varying set of gut bacteria, much like differing fingerprints, and these work together—or don't work, as the case may be, from one individual or one age group to another."

Therefore, he says, regulators need to understand that multistrain formulations should be allowed soft health claims (such as 'promotes immune health') based on many decades of traditional, safe use, rather than single-strain results. Lallond says Harmonium is hoping to gather together with other suppliers and health food stores, through its distributors, to get these messages out.

Two new regulations will affect the US dietary-supplements industry by the end of 2007. "The new law governing adverse event reporting and record keeping [the Dietary Supplement and Nonprescription Drug Consumer Protection Act] officially goes into effect December 22, 2007," Dockery says, "and will change the way that adverse reactions involving dietary supplements and OTC drugs are recorded and reported to the FDA.

"For many companies still struggling with the regulations involving allergen labelling, the new supplement GMPs will be yet another challenge. These changes, along with the recent incidents of adulteration involving ingredients and products from China, highlight the importance of having a well-trained QA/QC department."

Broadening the market

Another key to success will be expanding delivery systems. For now, digestive-health products are delivered predominantly in the form of capsules or in milk and yoghurt, but they are beginning to be added to certain cheeses and fruit drinks. Other methods are being developed to enable the timed release and subsequent absorption of nutrients into circulation in the body.

Such advances present some challenges, however. In a blend of ingredients, Dockery says, sometimes the ingredients will interact undesirably with each other. Others, including probiotics and digestive enzymes, are adversely affected by external factors such as humidity and warm temperatures. As a result, there is a growing trend toward developing methods to protect nutrients. Methods to coat, micro-encapsulate or granulate are currently being perfected to enhance the way supplements are delivered and utilized in the body.

Rosell has patented Probiocap, a micro-encapsulation technology that improves probiotics survivability during food processing, tablet compression and gut acidity. Rosell also uses an enterocoating technology to protect probiotic strains from gut acidity.

"Many food companies are just starting to research the benefits of combining different gut-health ingredients," Gastel says. "Supplement companies, however, have combined different ingredients as a way to differentiate their products from the competition. We believe there are benefits to combining different fibres if you want different textures and functional benefits."

A positive gut feeling

Despite the apparent obstacles to bringing digestive health into the mainstream, the feeling of success is in the air. Combined efforts of competing companies to innovate and educate are creating synergies that could make the market even greater than predicted.

Structure/function claims now exist for digestive-health foods
Dannon was the first functional-foods company to capitalise on the January 2007 rule change by the FDA, making it easier for food manufacturers to market structure/function claims (SFCs) on labels. The company's Activia probiotic-enhanced yoghurt line—with the structure/function claim 'helps with slow intestinal transit time'—reached a healthy $100 million in the first year.

Other manufacturers have followed suit by marketing their own probiotics-containing products (with or without an SFC on the product) including Dannon DanActive Immunity ('helps strengthen your body's defenses'), Naked Juice Probiotic ('helps promote a healthy digestive and immune system'), Lifeway Kefir, Kashi Vive Probiotic Digestive Wellness Cereal, and Stonyfield Farm yoghurt/smoothies.

The FDA's ruling said that added ingredients that produce a health-specific benefit may bear structure/function claims on the label, provided that these claims are substantiated by scientific data. These claims describe the role of substances intended to affect the normal structure or function in humans ('maintains digestive health'), and may not link the relationship to a disease or health-related condition.

For further information about structure/function claims, see www.cfsan.fda.gov/~dms/labstruc.html.

— Loana Carabin, MD

Loana Carabin, MD, is a medical consultant for the Burdock Group, which provides solutions for safety assessment and regulatory compliance. www.burdockgroup.com

Nutrition Business Journal Estimates
Gut health condition-specific supplements sales ($mil) in us





















Digestive enzymes










Psyllium (fibre)










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