Press Room
Chrysantis™ NDI Application Gets Green Light
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West Chicago, IL (June 28, 2005) — On June 23, 2005 ChrysantisTM, 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 EyesTM, 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."
For more information, call 630 588-3474.
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