FDA's stated reasons: Immunogenicity risk Could trigger immune reactions Impurities Compounded versions may be contaminated Lack of characterization Don't fully understand the molecules No human safety data Haven't been properly tested Reported adverse events Some have documented side effects The DOJ Prosecution: $1.79 Million Forfeiture In a landmark case, the Department of Justice prosecuted Tailor Made Compounding LLC for distributing unapproved peptides including BPC-157
Observed Side Effects (From Clinical Trials) In the Lancet 2021 Phase 2 trial (n=706), at the highest 4.5 mg/week dose, 88% of participants reported at least one side effect and 63% reported a GI-specific event
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The BPC 157 research did not provide direct conclusive evidence that the chemical is produced within the neuron or is present in it as a precursor molecule, released eliciting a response on the receptor on the target cells on neurons and being removed from the site of action once its signaling role is complete
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