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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

These data were first presented by Nakul Ganju, MD, of Howard University Hospital, Washington, DC, at the 2026 Crohns and Colitis Congress on Friday, January 23, 2026, in Las Vegas, Nevada

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