Gnosis S.p.A. announced that the US Food and Drug Administration (FDA) has positively finalized its determination that Mythocondro®, the Non-Animal Chondroitin Sulfate, has a granted GRAS Status (Generally Recognized as Safe) for the proposed uses as a food ingredient.
The GRAS Status was reached after the voluntary notification presented by Gnosis to FDA Center for Food Safety & Applied Nutrition, where the innovative vegetarian alternative of CS was subjected to a complete quality and safety testing supported by published clinical data. The overcome of animal-derived CS limits will result in an innovative new suite of fermentation-derived animal-free finished products whose quality, purity, reliability and functionality should be highly attractive to the global market.
Based on the information provided by Gnosis, as well as other information available to FDA, the agency concluded the evaluation with “no questions”.
With this new important achievement the US market opens its doors to Mythocondro®, also suitable for people with dietary restrictions related to religious and animal supply issues. Mythocondro® is under registration in several countries; in Europe the Novel Food Approval by EFSA is ongoing.
Mythocondro® is the first Non-Animal Chondroitin Sulfate (CS) obtained through a fermentation-based manufacturing process providing a reliable and reproducible source of product and marks a major step forward for the category. Mythocondro® solves any concerns related to the production origin, the possible presence of transmissible infective agents, the contaminations and adulterations typical of animal-derived raw materials and promises to completely change the global CS industry.