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Heres what this means (Source): GRAS status allows AOD9604 to be sold as a nutrient supplement in conventional and functional foods, drinks and dietary supplements in the USA As such it is exempt for these designated food uses from further pre-market approval requirements of food and drink ingredients in the USA. However, a 2014 study examining AOD9604s metabolism in vitro makes this important clarification: AOD9604 is not approved for use in humans although the oral form of the peptide has been granted GRAS status or generally recognized as safe by the US Food and Drug Administration (FDA)