Although many food, beverage, beauty food and dietary supplements companies value FDA-approved GRAS more highly, the self-affirmation indicates the confidence Maypro and its Japanese partner that supplies the branded ingredient have in the quality of the science backing its efficacy and safety.
The ingredient, Oliginol, is supplied by Amino Up Chemical Co. Ltd in Japan, and is found in one-shot juice drinks, cookies, chocolates and dietary supplements there and marketed primarily on its ability to benefit skin health, heart health and boost endurance and recovery for athletes.
Products bearing the ingredient are endorsed by about 50 mostly Japanese athletes but the number is growing along with its sports nutrition credentials.
“The self-affirmed GRAS will help us broaden exposure for Oliginol in the US and we have a meeting with the FDA this month to attain FDA-certified GRAS,” said Maypro director of business development, Dan Lifton.
“We have engaged the services of a top agency to assist us compiling our dossier for the FDA certification and hope to attain it soon.”
He said the US market was in an infant state in regard to lychee despite the fact Oliginol had been on the market as a New Dietary Ingredient and therefore available in the form of supplements since 2007.
Other lychee extracts from other companies are also present but Lifton said the extraction process used with Oliginol meant its polyphenols levels were up to three times higher than other lychee forms.
In one study, Oliginol was ranked second behind strawberries in a survey of polyphenol content among a selection of fruits.
Another recently completed study about to be submitted for peer review demonstrated skin benefits from cosmeceutical applications in a sample group of 80.
“There is a lot of education that needs doing and we are engaging in radio advertising and PR. There have been some very encouraging articles and awareness is starting to build,” Lifton said.