Offering retailers a look through formulators’ eyes, VR provides case studies highlighting how the selection of branded ingredients makes for markedly better products.
Life Extension Primes the Immune Category With Paractin
Serving the industry for 32 years, Florida-based Life Extension prides itself as being a leader in the antiaging and longevity field, of which it considers immune support an essential component. As the supplement immune category has come a long way over the years since vitamin C and echinacea, Susie Rockway, PhD, CNS, executive director of product development, explains the company’s thorough approach and how it developed Immune Protect with PARACTIN®.
“One important aspect of Life Extension is that we search for ingredients that are ideally novel to our market and that have science to support claims; the goal is to have at least two clinically validated studies testing the ingredient of interest,” she said, noting that the complex formulation process begins with investigating ingredient safety studies. “We research all the relevant human physiology factors and mechanisms of action. Then we investigate where and how it is made or grown; what are the active parts of the plant and the purification processes.”
With all that, Life Extension then works with vendors to provide that specific ingredient; it tests samples to make sure they match what the vendor says about the ingredient (i.e., activity, purity, concentration) as well as for micros and heavy metals.Once these measures are satisfied, it formulates a specific product using the ingredient.
Seeking to drive the immune category forward, Life Extension wanted to create a product combining patented ingredients that have been clinically shown to boost immune function, increasing the body’s natural ability to combat challenges. It already had a proprietary, patented form of beta glucan that was shown to activate the host system’s primary defenders by activating complementary systems, and enhancing macrophages and natural killer cell function.“The immune cell-priming capabilities of this highly purified yeast derivative exceed those of all other sources of immune supplements tested to date,” said Rockway, adding that Life Extension also wanted to provide a standardized extract of camu camu (Myrciaria dubia or wild crafted berry), one of the richest natural sources of vitamin C.
The final piece of the puzzle came from another Florida-based company, HP Ingredients, that at the time had Recently launched PARACTIN®, a patented extract of Andrographis paniculata, an herb used in Asia for thousands of years to help with inflammatory factors, that provides significant seasonal support. Among the active compounds of Andrographis paniculata is andrographolide, a phytochemical that exerts powerful immune-boosting effects on the human body.
And with that, Immune Protect with PARACTIN, a formula with a patented blend of these andrographolides that helps suppress damaging inflammatory cytokines and eases symptomatic discomfort, was born. “The novelty of PARACTIN and the other ingredients in Immune Protect is the ability to prime the immune response, so macrophages and other immune-related cells are ready to battle any challenges,” said Rockway. “It normally can take days for the immune response to be at its peak, but if the immune system is prepared to destroy invading pathogens, there is less opportunity for infection.”
According to Annie Eng, president of HP Ingredients, at low dose of 25 mg, PARACTIN boosts the immune response and helps reduce occurrence of common cold. At 10 times the dose (250 mg), PARACTIN works by inhibiting NfkappaB, the key regulator of the immune and inflammatory response system, and help with reducing the duration and severity of symptoms of common cold. “Since andrographis is an immuno-modulator, it is imperative that the dosage is correct. We have studied PARACTIN extensively to know the correct dosage,” she said.
While the product has been on the market since 2006, HP Ingredients continues its research, which is published in reputable journals, enabling the company to provide valuable tools to its finished product partners that they can use in their marketing materials to support the health claims of their products, according to Eng. This research also led to PARACTIN receiving a patent from the U.S. Patent office for the treatment of Alzheimer Disease, AIDS, autoimmune disease that comprises of rheumatoid arthritis, lupus exanthematous, multiple sclerosis, asthma, allergic reaction, systemic dermatomyocytis, psoriasis, osteoarthritis, diabetes mellitus and metabolic syndrome.
“Life Extension distributes the most scientifically advanced health supplements and specially made formulas in the marketplace. We try to get that material or match it to use in our formulations; often this ingredient has clinicals behind it because it was patented for this use,” said Rockway. “Once the product is made by one of our qualified contract manufacturers, it is thoroughly retested to be compliant with cGMP regulations. In other words, it has what we claim it has.”
Max Muscle USA Finds Weight-Loss Winner With Advantra Z
Legality, safety and efficacy are issues Phillip W. Harvey, PhD, RD, FACN, CNS, chief science officer with California based Max Muscle USA, admits being very sensitive to; prior to joining the sports nutrition and weight-loss product manufacturer more than six years ago, he was with the Natural Products Association. “There were lots of discussions about branded vs. knock-off ingredients, borrowed or pirated science, and synthetic substitutes for natural ingredients,” he said, noting that his formulation strategy has always been to utilize branded ingredients.“I think it’s important to support those companies that invest capital into intellectual property in studying their ingredients and ensuring their legality, safety and efficacy.”
Advantra Z®, a patent protected bitter orange (Citrus aurantium) extract for stimulating thermogenesis and suppressing appetite from New Jerseybased Nutratech, Inc., was the first branded ingredient Harvey used with Max Muscle. “In examining various ingredients, I quickly understood Nutratech and its culture, why the company invests in its ingredients, the science and due diligence necessary to meet our safety and efficacy requirements, as well as DSHEA compliance,” he said. “When you’re competing with hundred of products, it’s important to work with a company that stands behind its branded ingredient.”
Bob Green, president of Nutratech, Inc., recalled first encountering Harvey at a nutrition conference many years ago. “At the time, Max Muscle was using generic bitter orange extracts in its formulas, so our first step was to make them aware of the benefits of using Advantra Z,” he said, explaining that with generic bitter orange extracts, the percentage of synephrine varies batch to batch, and they may include synthetic synephrine or m-synephrine, which has the potential for raising blood pressure in humans. “The quality is inconsistent, the supply is unreliable and there is virtually no clinical support,” said Green.
“Conversely, Advantra Z contains only p-synephrine, a stable isomer of synephrine (the dominant amine), and we guarantee standardized amounts of p-synephrine in every batch. This is crucial because p-synephrine primarily stimulates beta 3 receptors, which increase thermogenesis and lipolysis, but do not affect blood pressure.” The company also guarantees the consistent quality of Advantra Z by working exclusively with foreign suppliers who are in line with U.S. GMPs.
While Max Muscle has utilized Advantra Z in eight products over the years, one of its newest is Emerge, a slenderizing system formulat-Ed to inhibit appetite, promote the release of fat from stored fat cells and accelerate the burning of fat for fuel.Unlike most weight-loss supplements delivered in tablet or capsule form, Emerge is a powdered drink formula, so taste, aroma and stability are especially important.
“The formulation process begins with looking at the science behind the ingredients and putting them together in a cutting-edge formula. Then comes the hard part: finding a way for the ingredients to mix easily in liquid and, most importantly, taste good,” said Harvey, noting that Nutratech had the manufacturing capabilities Max Muscle needed to provide Advantra Z as a very fine, concentrated powder, which lends itself to better mixing and enables a manufacturer to more easily mask the bitter orange taste.
But Advantra Z also exceeded Harvey’s expectations in terms of the scientific support it offered: More than 30 research studies support the safety and efficacy of bitter orange and its dominant amine, p-synephrine. “Not only are most of these clinical studies, the majority have used Advantra Z rather than generic bitter orange extracts because of its consistent quality,” said Green.
But quality comes at a price, and it’s one Harvey feels is worth paying if the finished product delivers results.
“Any manufacturer has to be sensitive to cost, but at Max Muscle, we focus first on solutions. If a product achieves its goal, then the cost isn’t as much of an issue for the consumer. So we educate retailers and consumers on the ingredients we use and how they work together to provide this solution,” said Harvey, adding that he creates a comprehensive product data sheet for every supplement the company makes, detailing benefits of the various ingredients in the formula. “If one of those ingredients is a branded ingredient where the company has invested in research, safety data studies, etc., we celebrate it and explain ‘The Advantra Z Advantage’ in our promotional materials.”
Jarrow Formulas’ Smart Choice With Cognizin
At California-based Jarrow Formulas, Inc., most new product ideas start in its R&D group where they’re passed to the sales and marketing team to decipher whether there is a true need in the marketplace. Then it’s back to R&D for more scrutiny until it reaches a stage at which a prototype is produced, according to Dallas Clouatre, PhD, R&D consultant with Jarrow.
“The manufacturing prototype is necessary to determine the difficulty in production. It is not unusual for an R&D prototype to need to be reworked several times before all such issues are resolved,” said Clouatre, noting that stability is a major concern. “Not all ingredients play nice together. If real time stability testing rather than accelerated testing is required, many months can be added to the creation of a new product.”
Like most companies, Jarrow Formulas tries to not duplicate itself with its product offerings. Of course, differentiation is a major reason for bringing in a branded ingredient. “We may discontinue the previously existing product or we may fold the branded ingredient into an entirely new formula,” said Clouatre. “Many of the items in the Jarrow ‘optimizer’ formulas were born in this fashion.”
Jarrow Formulas has long recognized the value as well as the necessity in investing in branded ingredients, and Citicholine (CDP Choline)/Cognizin®, supplied by New York-based Kyowa Hakko USA, Inc., is a good example. A proprietary form of citicoline developed using a patented fermentation process, Cognizin is a potent brain-health nutrient that’s been shown in human clinical trials to support mental energy, focus, attention and recall.* A pure, allergen- free GRAS ingredient that’s stable and effective, Kyowa launched Cognizin 10 years ago, when there were no commodity alternatives available at that time. “Hence, Jarrow Formulas’ utilization of branded ingredients often has been a function of its cutting-edge position in the industry,” said Clouatre, adding that the ingredient satisfied two important criteria: in-depth science and assurances of great quality control.
The company initially introduced Cognizin as a standalone product, but soon afterward it became an anchor ingredient in Neuro Optimizer®, which remains one of the leading formulas in the entire brain health category in the industry, according to Clouatre. Jarrow Formulas looked at a half dozen potential alternatives and also complementary nutrients when creating Neuro Optimizer, yet decided to make Cognizin the formulation’s lead ingredient along with six supporting ingredients (phosphatidylserine, alpha lipoic acid, acetyl L-carnitine, L-glutamine and taurine).
“In this case, Cognizin not only was a branded ingredient, but also was virtually the only item occupying its particular niche,” he said. “The only reasonable alternative, alpha-glycerolphosphate (GPC), was only available as a liquid at the time and thus not suitable for capsules and tablets. Even today with GPC now available in powder form, Cognizin remains the better choice for Neuro Optimizer due to space issues.”
Jarrow sought to create a uniquely effective product, and the use of the branded ingredient was intended to reinforce in retailers’ and consumers’ minds that the company is at the cutting edge of new product introductions.In the end, the company feels both of these goals were well served.
“The inclusion of branded CDP Choline accomplishes two ends: First, these formulas continue to boast the most effective ingredient(s) available,” said Clouatre. “Second, the key ingredient’s quality is evidenced by the fact that the brand-holder has a stake in maintaining that quality.”
Savesta Sees Potential With AstaREAL
Savesta’s formulation process can range from several months to a number of years, according to Ken Jones, a researcher with the Californiabased company who is also on the advisory board of the American Botanical Council.
“At first, there may only be one or two ingredients for consideration. Later in the process, several more may become the subject of ongoing research and interest. Along the way, each candidate is weighed against the other for everything from history of use to dosage, safety and efficacy,” Jones explained, noting that other important criteria include the number and quality of human clinical trials, and whether the evidence remains limited to in vitro and animal studies.
Historically, Savesta had focused solely on using the standardized botanical extracts manufactured in its own facility in Bangalore, India. The first product that will feature branded ingredients on its label is the company’s vision formula, SeeWell™, which will be available to retailers in September, just before Natural Products Expo East.
According to Jones, throughout the formulation of SeeWell, the selection of ingredients was predicated upon the backing of well-controlled human clinical studies. At least a dozen different suppliers were considered, but few supply the ingredient as Savesta needed or could meet the necessary criteria of randomized, double-blind, placebo-controlled trials.
For the astaxanthin used in SeeWell, AstaREAL® from New Jersey-based Fuji Health Science was the ideal choice.“Not only was it backed by multiple, well-controlled clinical trials, but the pricing was competitive and the manufacturer could supply the form required for encapsulation,” said Jones. “The excellent reputation of both the manufacturer and the product itself provided the assurance of high quality that customers of the Savesta brand of products have come to expect.”
A wholly owned subsidiary of Fuji Chemical from Toyama, Japan, Fuji Health Science has been supplying nutritional and pharmaceutical ingredients in North America for 15 years.AstaREAL is its flagship product worldwide and the brand name is widely recognized as the premier astaxanthin on the market, according to Joe Kuncewitch, national sales manager.
“Fuji has sponsored more than 50 studies on AstaREAL, the majority of these being human clinical trials,” he said. “We have conducted 10 human studies with AstaREAL specifically demonstrating the reduction of eye fatigue brought on by overuse of VDT’s (video display terminals) or computers.AstaREAL astaxanthin was significantly shown to reduce asthenopia (eye fatigue), improve accommodation (focus) and increase visual acuity (sharpness).”
In addition to Fuji investing millions of dollars conducting research and developing intellectual property for AstaREAL over the years, the company’s state-of-the-art production facility is an indoor, closed cultivation system, which produces the most consistent quality, highest potency astaxanthin yield, according to Kuncewitch. This particular aspect solidified Savesta’s final decision.
“For our company, there are also ethical and environmental considerations, such as the endangerment of the plant and conditions surrounding the harvesting process, whether in India or another region of the world where it must be sourced. On top of all of those, there are legal aspects, such as the claims allowed in a given country and intellectual property considerations,” said Jones. “Being the leader in the field of astaxanthin research and having namebrand recognition, there was no question that it would be well received.”
As with all of Savesta’s products, it offers full color sell sheets that discuss the science behind the claims made including the fact that these particular ingredients were used in some of the clinical studies that established their benefit. And in terms of the higher cost that is typically associated with branded ingredients over their generic counterparts:
“I think using branded ingredients helps to shorten the quality discussion with our retailers. They increasingly understand the higher cost on quality products that contain ingredients backed by science,” said Ken Seguine, vice president of consumer products for Savesta. “It is one more element that helps to establish our position as a quality company. Again and again our message is efficacious doses of clinically validated ingredients, and so far retailers have been favorably impressed with our selections.”