OmniActive Health Technologies announced today that its Lutemax(R) line of free lutein and lutein esters have successfully achieved self-determined GRAS (Generally Regarded as Safe) status. The process involved an intensive review of safety and toxicology data by an independent panel of highly qualified scientists with extensive regulatory, pharmacology and toxicological experience.
"Achieving self-affirmed GRAS status for our Lutemax line of free lutein and lutein esters assures our food and beverage customers that they can safely use these clinically validated ingredients in an array of foods and beverages aimed at improving consumers' overall eye health," stated Hiren Doshi, Vice President, OmniActive Health Technologies. "With eye health being a top concern for the aging population and a new NMI health and wellness trends study showing that a growing number of consumers are interested in the health benefits of lutein-fortified foods and beverages, this announcement comes at the perfect time."
As part of the self-determination process, the expert panel was provided extensive ingredient information including the background of the ingredient, usage history, summary of anticipated daily intake and literature research. Upon completion of the material review, the panel then conducted a safety assessment. OmniActive is also currently in the process of securing self-affirmed GRAS status for its newest offering, Lutemax 2020(TM), which delivers the only complete source of both lutein and zeaxanthin isomers in significantly higher concentrations, for convenient and more beneficial nutrient availability to the eyes.
OmniActive's Lutemax line offers manufacturers a safe and effective way to create products to target individuals looking to improve their eye health through foods and beverages they consume on a daily basis including cereals, energy bars, juices, non-carbonated beverages, energy drinks and meal replacement bars. Additionally, fortifying products with Lutemax lutein ingredients does not affect the taste profile or aroma of the end product.
OmniActive's Lutemax ingredients are manufactured under a fully integrated supply chain process that starts with the cultivation of marigold flowers and continues through the extraction and manufacturing. The company has established a dedicated group of farmers in India that grow marigolds with no use of feed-grade additives and preservatives or pesticides such as ethoxyquin. This vertically integrated process helps to enhance quality, purity and performance of the raw material. Once harvested, the marigolds are dehydrated and extracted into oleoresins in dedicated facilities under food-grade standards. Lutein is then isolated and purified from the marigold oleoresin using GRAS solvents in OmniActive's cGMP, HACCP and ISO-22000 certified facility.
About OmniActive Health Technologies:
OmniActive Health Technologies, Ltd. (www.omniactives.com) supplies a range of innovative, scientifically validated, active natural ingredients for healthcare, food and personal care applications.
OmniActive has a wholly owned US subsidiary, OmniActive Health Technologies, Inc. in Short Hills, NJ, and conducts operations from its manufacturing, R&D and corporate facilities at Pune, Mumbai, Thane and Cochin, India. OmniActive's manufacturing facilities are certified for the quality and food safety management systems under ISO-22000(2005) and cGMP standards.