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The Federal Food, Drug, and Cosmetic Act (FDCA) is clear: new drugs may not be introduced into interstate commerce unless they have received FDA approval

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27 CLINICAL BENEFITS OF NAD+ RESTORATION These impressive preclinical results have now shifted the focus to human clinical trials with the hope of translating the benefits of NAD+ restoration to humans ( see Table, Supplemental Digital Content 1 , which shows human clinical trials that have measured NAD+ levels and clinical outcomes after NAD+ restoration, Notable observations so far include a trend towards an improvement in indicators of cardiovascular function including lower systolic blood pressure and aortic stiffness, 28 a promising reduction in the levels of circulating inflammatory cytokines in older males after only 3 weeks of NAD+ restoration 29 and an NAD+-associated increase in mitochondrial function and decreased proinflammatory factors in heart failure patients