The Maypro Group has secured New Dietary Ingredient (NDI) status for its proprietary lychee extract, Oligonol, and foresees a wide array of market applications for the antioxidant.
The company says it has received a letter from the US Food & Drug Administration (FDA) confirming the agency is not contesting use of Oligonol as a dietary supplement ingredient, thereby giving the company the go ahead to market its innovative product primarily for skin health and cosmeceuticals.
Maypro claims its ingredient is unique because it makes use of a patented technology that boosts polyphenol bioavailability and in turn enhances anti-oxidant performance.
"This is actually the first industrially produced low-molecular-weight polyphenol ingredient," Dan Lifton, Maypro director of business development, told NutraIngredients-USA.
Based in Purchase, New York, the supplier and distributor in turn represents other nutraceutical ingredient manufacturers from Japan. It has specialized in ingredients such as coenzyme Q10, chondroitin, glucosamine, alpha- lipoic acid and AHCC medicinal mushroom for the US market. The group conducts research for proprietary and branded ingredients through its subsidiary, Quality of Life Labs.
Oligonol has been under development for five years, and the facility for manufacturing it was only constructed in Sapporo, Japan last year, according to Lifton. In addition, the company was waiting for NDI notification for the US market.
"We've just started approaching brand manufacturers and we've had positive feedback," said Lifton.
According to Maypro, the high molecular weight of many polyphenols hinders their absorption by the body. However, the company's affiliate supplier in Japan, Amino Up Chemical, has developed a production process that involves oligomerization, which shortens polyphenol polymers into monomers and oligomers for increased bioavailability.
Based on research at its facilities in Japan, the group claims Oligonol contains almost 40 percent of the absorbable polyphenols - monomers, dimmers and trimers - compared with the less than 10 percent it claims is channeled through polyphenols that are not refined with this process.
Over and above the ground-breaking potential it sees for its proprietary ingredient, Maypro said the market potential for Oligonol is huge due to the fact it can be applied to such a wide variety of health conditions. Nonetheless, the company will hone in on specific marketing targets to begin with.
"The primary focus for our marketing will be skin improvement," said Lifton. "But other areas will be metabolic syndrome, anti-inflammation, and vasodilation capacity."
The company plans to market the ingredient for use in products along two streams to begin with: anti-aging and 'beauty from within'.
The ingredient is already available in topical solutions, according to Lifton, and Maypro also wants to expand into functional foods after hitting the dietary supplement market.
Under DSHEA (the 1994 Dietary Supplement Health and Education Act) any dietary ingredient not marketed in the US before October 15 1994 must be notified as an NDI 75 days before entering the market - a process that involves submission of scientific data to the FDA. If the federal agency has no objection, the ingredient has the green light for use in supplements.