The Short Version
This claim is false on both of its core assertions. Neither BPC-157 nor TB-500 holds FDA approval for any therapeutic indication — the 2026 Category 1 reclassification permits compounding under physician oversight but is explicitly not FDA approval. The "scientifically proven" claim is equally unsupported: human evidence consists only of small, uncontrolled pilot studies, with no large-scale randomized controlled trials, and there is no human clinical evidence for anti-aging effects.