HyPhyto Inc. announced its CardioCare phytosterol for functional foods and beverages achieved self-affirmed GRAS (generally recognized as safe) status. The process involved a review of safety and toxicology data by an independent panel of scientists with regulatory, pharmacology and toxicological experience. HyPhyto CardioCare phytosterol contains the same sterols that are the basis for the FDA health claim, "Sitosterol, campesterol and stigmasterol in quantities that exceed the minimum required content."
“Achieving self-affirmed GRAS status for our CardioCare phytosterol assures our customers that they can safely use this unique ingredient to provide the proven benefit of reduction in dietary cholesterol that occurs when plant sterols are consumed," said Richard Staack, HyPhyto CEO.
CardioCare phytosterol is manufactured with current good manufacturing practices (cGMP) and meets or exceeds all FDA requirements for safety.