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Dietary supplements are not evaluated by the FDA for safety or efficacy the way prescription medications are

because rigorously controlled human safety data specific to the TB-500 fragment does not exist, its longer-term risk profile, including possible immune reactions, remains unknown Evidence snapshot: Evidence for TB-500 itself is preclinical, drawn mainly from cell-culture and animal studies (a 1999 rat wound-healing study and later rodent cardiac- and tendon-injury models), with a 2026 scoping review describing the musculoskeletal literature on thymosin beta-4 and TB-500 as sparse and largely preclinical