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They cannot by themselves establish: A safe human amount A safe route of administration Long-term human safety Interaction risks Reproductive or developmental safety Clinical effectiveness Which individuals, if any, might be suitable for an authorised use The number of animal papers should not be presented as equivalent to a programme of large, well-controlled human clinical trials

Ideally, wrote Davis in a follow-up email, the government agency will spell out its specific concerns about each peptide, and then describe what data would be needed for the FDA to overturn its prohibitions

Larger vials carry lower per-mg costs because fixed costs (vial, lyophilization, Janoshik testing, the COA, shipping) spread across more material

the FDA-approved formulations are pre-filled and require no syringe math