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The specific concerns were not fully detailed publicly but likely related to the limited US-standard clinical trial data and the peptide's widespread use exceeding the evidence base recognized by FDA standards

Trends Pharmacol Sci

Rather than being a pharmaceutical development, this tripeptide occurs naturally in human blood plasma, with concentrations around 200 ng/mL at age 20 that decline to approximately 80 ng/mL by age 60

Targeting NF-B pathway for treating ulcerative colitis: Comprehensive regulatory characteristics of Chinese medicines

8 ClinicalTrials.govNCT02637284 PCO-02: Phase I safety and pharmacokinetics trial of oral BPC-157 (early-stage human study)