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doi: 10.1016/j.jnutbio.2020.108524 115 XiongHChenZLinBXieBLiuXChenCet al

Officially, the FDA cites: Insufficient large-scale clinical trials Concerns about consistency, sourcing, and manufacturing standards The need to meet formal drug approval requirements Critics argue (fairly) that this system: Favors large pharmaceutical companies Makes it hard to approve naturally occurring peptides Leaves promising, low-risk compounds in regulatory limbo The short version: This FDA restrictive regulatory change of mind wasnt driven by a sudden safety scare, it was driven by regulatory process and economics

[PubMed] [Google Scholar] 30.Lomaestro B, Malone M

Le is a board-certified family medicine physician with over 20 years of clinical experience