West Chicago, IL (June 28, 2005) – On June 23, 2005 Chrysantis™, Inc., the maker of the only natural zeaxanthin on the market, was informed that the FDA has accepted their New Dietary Ingredient (NDI) submission, which allows Chrysantis zeaxanthin to be legally sold as a dietary supplement.
Says Chrysantis General Manager Manuel Pavon, “We are pleased that this significant milestone has been achieved and we can proceed with marketing EZ Eyes™, our natural zeaxanthin, to help in the prevention of AMD and to promote healthy vision”.
Under DSHEA, any supplement ingredient not marketed in the US prior to October 15, 1994 must submit an application (NDI) to FDA at least 75 days prior to its being sold. The Chrysantis’ NDI application includes toxicology and other Chrysantis-sponsored studies demonstrating the safety of zeaxanthin for use at the recommended dosage. It also includes epidemiological and other scientific evidence proving that consumption of natural zeaxanthin at the recommended dosage is safe for the general population in the United States. The FDA has responded that the information submitted provides a reasonable basis for the ingredient to be considered safe.
Working with Chrysantis on this application were Anthony Almada and Chris Noonan of IMAGINutrition, who provided extensive biomedical research support from their company’s proprietary research database BioActiva®; and Patrick Noonan, who coordinated the filing of the submission to the FDA. In 1997 Patrick filed the first NDI application ever submitted, which was accepted.
“To bring a new ingredient to market within the guidelines of DSHEA requires specific information be researched, gathered, and submitted in the right format,” says Almada. “Less than 30% of the NDI applications submitted receive a favorable response, often because the information is not complete.”
Chrysantis is a wholly owned subsidiary of Ball Horticultural Company based in West Chicago, IL. It is dedicated to developing high-quality plant-based products for dietary supplement manufacturers and the functional foods industry that will enhance human health. Family-owned Ball Horticultural Company has been researching, breeding and selling the highest-quality flower seed varieties for 100 years. The company’s understanding of the compounds that are responsible for flower color (carotenoids, anthocyanins, flavonoids) led to the creation of Chrysantis, Inc., which aims to bring those products to market.
For more information, call 630 588-3474 or visit www.Chrysantis.com.
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