Marketing Immunity

Carefully vetting ingredients and crafting a clear, truthful message can be the keys to boosting immune modulating supplement sales.

A December 2009 update on www.flucount.org reported that over a monitored seven-day span, 951 new swine flu deaths (an average of 136 deaths/day) had been reported from 62 nations around the world, and the five most affected nations that week were the United States, Russia, Turkey, China and India. While cold and flu season has always been a trigger for consumers to buy immunity products, with statistics like this on just about every news broadcast nationwide, as 2009 came to a close, consumers began actively seeking Protection for themselves and their families, regardless of the season.

But as reports diminished, it seemed consumers fell back into old habits— only seeking immune support when the weather changed or the holidays kicked in. Then a changing health care system coupled with economic struggles shifted shoppers into a prevention mindset, and the natural products market has benefited by producing the products meeting consumers changing needs.

“A number of market studies indicate that immune health is one of the most important benefits that consumers want,” said Richard Mueller, president and CEO of Biothera (Eagan, MN).“This means continued rapid growth in foods, beverages and supplements that deliver real immune health benefits,” he said, adding that market growth will continue as consumers have become more savvy about ingredients that deliver “added health benefits.”

Trends

The economy is one of the greatest factors weighing on everyone’s minds— forcing shoppers to seek affordable ways to maintain their health, according to Dr. Joosang Park, vice president of scientific affairs with BioCell Technology LLC (Newport Beach, CA). “Consumers look for natural and economical ways of staying healthy as scientific research accumulates the evidence for the importance of maintaining a balanced Immune system in reducing allergies, fighting infectious agents and preventing chronic inflammation,” he said.

But the economy also has manufacturers on the lookout for the most costeffective ways to create efficacious products.

Park expressed that his company has taken a unique approach to satisfying both consumers’ and manufacturers’ needs. In 2007, BioCell Technology introduced its first immune health ingredient, i-Sabi® derived from Wasabia japonica, a source for the well-known sushi condiment.I-Sabi, has been shown though inhouse and independent studies to harbor diverse properties that can provide a simple and economical solution to maintaining a healthy immune system.

“In the first phase of a study, i-Sabi containing 6-HITC (methyl sulfinylhexyl isothiocyanate) as its bioactive compound stimulated natural killer (NK) cells and suppressed pro-inflammatory over-expression of cox2 with cox1 remaining intact,” explained Park. “i- Sabi’s key active compounds have been shown to contain Nrf2-mediated liver detoxification and to inhibit the growth of pathogenic bacteria. These studies suggest that i-Sabi can help maintain immune health in multiple ways.”

Normally, 6-HITC is non-existent in intact Wasabi plants, but BioCell has pioneered a way to produce it, according to Park. “The so-called myrosinaseglucosinolate system needs to be activated for the enzyme to cleave glucosinolate into 6-HITC and indole. BioCell Technology developed a proprietary process in producing i-Sabi so that it contains a high amount (>15,000 ppm) of 6-HITC,” he said, adding that the ingredient can be formulated into a combination or marketed as a standalone product.

In addition to this economical trend, Eric Weaver, chief scientific officer with Proliant Health and Biologicals (Ankeny, IA), which introduced its trademarked ImmunoLin® ingredient 10 years ago, highlighted that consumers are looking for products linking other heath conditions to the immune system. “For instance, the health of the gut and GI tract are now known to be important to healthy immune function,” he said. “A ‘leaky gut’ leads to inflammation, which is being linked to major health conditions such as obesity and heart disease.”

Weaver explained that Proliant has always focused on its ingredients’ ability To help maintain a healthy gut and it has recently begun to look at ImmunoLin’s endotoxin neutralization characteristics as one mechanism for lowering inflammation. ImmunoLin is supported by several clinical studies and the company is in the process of launching a clinical evaluation in patients with immune compromise.

Modulating Momentum

Perhaps the largest trend identified was that consumers are looking for products that modulate their immune systems rather than simply boosting them.

“Vitamin C has historically been a popular choice to boost the immune system,” said Bob Davies, president and CEO of APS BioGroup (Phoenix, AZ). “However, vitamin C actually has little to do with the systemic human immune system, rather vitamin C is just a water soluble antioxidant. Its sales have dipped due to the presence of other strong immune ingredients that balance the immune system—as opposed to boosting the immune system. Recently, dedicated immune products have resulted in increasing category growth.

“We must stop using the term ‘boost-Ing the immune system’ and start talking about ‘balancing the immune system,’” Davies continued. “Who wants to boost an already overactive or over-sensitive immune system as in the case of allergies or autoimmune conditions?”

APS BioGroup’s Immulox® is a proprietary immune balancing product derived from colostrums. Colostrum has been heavily researched in the last 50 years and has produced very positive immune balancing results, according to Davies. “The component of colostrum that is most essential for this function is proline-rich polypeptides (PRPs),” he said. “PRPs are small sequences of amino acids of between 500- 2,900 molecular weight.These ‘peptide messengers’ in colostrum tell the body to balance, as opposed to stimulate the immune system.This is due to the PRPs unique ability to up-regulate the immune system to combat Environmental toxins or infections, or down-regulate the immune system to reduce the symptoms commonly associated with allergies or various auto-immune disorders. The PRPs help create a homeostatic, well-balanced immune system.”

APS BioGroup has a patent in the process required to derive Immulox (concentrated PRPs) powders and liquid sprays from colostrum. Its colostrum and Immulox products are kosher, halal and GMP certified to appeal to and serve a large consumer base, Davies added.

In 1992, Daiwa Health Development (Gardena, CA) developed a highly bioavailable low-molecular weight arabinoxylan ingredient, called rice bran arabinoxylan compound (RBAC) with powerful immune-modulating properties. Launched in 1996, RBAC is the proprietary ingredient that comprises the retail product Known as PeakImmune4® dietary supplement now available nationwide, and the company has actively educated the market and consumers on the importance of natural killer activities as an important factor of the immune system.

“RBAC has been clinically shown to support the immune system by tripling Natural Killer (NK) cell activity using a patented manufacturing technology.

This premise is widely accepted as the benchmark for the immune category,” said Ron Marzoli, the company’s vice president of North American sales, adding that Daiwa products are manufactured in state-ofthe- art facilities in Japan under strict quality control and environmental protection standards. “Many immune formulations or ingredients impact only one or two mechanism activities.
RBAC is the true broad-spectrum biological immune modulator. It is capable of modifying many immune system components and thus is superior on a cost-performance basis.”

The company’s new direction includes studying the effect of RBAC on dendritic cells. An in-vitro study ‘Biobran-augmented maturation of human monocytederived dendritic cells’ demonstrates that increasing the speed of maturation of dendritic cells helps strengthen the immune system.

Challenges

While the consumer is more actively looking to keep their immune systems healthy, it is still a hurdle to get them to think about it all year, not just during cold-and-flu season.

“Our bodies are under Constant challenge that knows no holiday, so supplementing with immune support every day makes sense.

Biothera is working to redefine the immune health as a year-round category rather than a seasonal one,” said Mueller.

Biothera entered the food and beverage market in 2007 with the introduction of Wellmune WGP®,“ its flagship immune health ingredient for foods, beverages and supplements. The company has continued to conduct, present and publish statistically significant clinical research demonstrating that Wellmune WGP can lower the incidence of upper respiratory tract infection symptoms as well as improve overall health. “In the case of Wellmune WGP, our ingredient activates innate immune cells called neutrophils—the largest population of immune cells in the body—to more quickly find and kill foreign challenges. The body produces billions of neutrophils, which have a life span of only two or three days, so priming them requires daily consumption of Wellmune WGP.

“We see ingredients that only have seasonal benefits losing ground to ingredients that can be used daily as consumers look for yearround immune health protection,” he added.

Biothera’s recent research includes a clinical study that found that Wellmune WGP helped protect moderately to high stressed women against cold/flu symptoms while increasing their energy levels. Another recent study found that highly stressed hospital workers in Japan reported improved psychological well-being after taking Wellmune WGP. The first study was presented in early November 2010 at American College of Nutrition Annual Meeting in New York City, and the latter peer-reviewed study was published in Biotherapy, the official journal of the Japan Society for Biological Therapy.

Another obstacle, according to Aage Lauridsen, sales manager with Proliant Health and Biologicals, is in the manufacturers’ vetting of ingredients and how they’re conveying their product’s message. “The selection of efficacious ingredients and delivering that message to the consumer is the industry’s greatest challenge in all product categories, but the immune product category is particularly encumbered by products and companies that continue to use marketing rather than high-quality, proven ingredients,” he said.

And when we begin to look at marketing messages, inevitably the concern of claims and regulatory scrutiny quickly follow.

In response to increased FDA and FTC oversight, companies are putting a stronger emphasis on science, Lauridsen added. “As the FTC and/or FDA continues to penalize companies for unsubstantiated claims, more companies are spending more money and resources on providing all the necessary evidence to qualify the claims they make,” he continued. “Consumers are becoming more informed by the day, they are beginning to search deeper for the answers to their questions about natural products, and the ‘placebo effect’ is short-lived in this category.”

Biothera’s Mueller agreed: “Increased regulatory scrutiny of immune health claims for foods and beverages undoubtedly will have an effect on manufacturers.
Biothera strongly believes that regardless of product category, claims must be supported by published, peer-reviewed clinical research,” he said. “In addition, regulatory agencies and manufacturers’ R&D departments are becoming more focused on whether an ingredient’s mechanism of action is well understood.”

Bill Pine, vice president of Improve USA, Inc. (DeSoto, TX), said the onus falls on the industry to make sure that it is not bringing undue inquiry on itself.“Marketing’s challenge is to make sure we do not make claims that will lead to the FDA assuming we have a new unapproved drug,” he said. Improve USA, Inc. produces a unique aloe powder through a proprietary dehydration process on the inner fillet of the aloe leaf using low temperatures. The resulting DaltonMax 700® Aloe Powder, which is rich in the large polysaccharides with an Average molecular weight of over one million Dalton, is supported by university studies that have shown that the polysaccharides with a molecular weight of one million Dalton and larger activate the macrophage, which directs the activity of the body’s immune system.

“The natural products in our industry are really in position to aid the consumer in maintaining good health and we need to make sure we don’t over step our enthusiasm and do ourselves harm,” Pine added. “There are products in our industry that can improve the consumer health as well as maintain good health.
We just need to be sure we properly state the proposed outcome.”