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Antioxidants can be divided into endogenous antioxidants, such as antioxidant enzymes: superoxide dismutase (SOD), catalase (CAT), and glutathione peroxidase (GPx), as well as exogenous antioxidants, which mainly include non-enzymatic antioxidants such as vitamin C, vitamin E, carotenoids, ubiquinone, and flavonoids (110)

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And so FDA is going to need to use a different lens. Unlike FDA approval of a new drug, which requires years of clinical trials demonstrating safety and effectiveness, placement on the 503A Bulks List answers a different regulatory question