Codex-prepared local review · editorial and translation review pending.
GLEI / EVENT
FDA reiterates concerns about commercial young-plasma claims
The agency restated that young plasma was not approved for the promoted wellness and disease uses.
In a reminder updating its February 2019 communication, FDA said it was not aware of evidence demonstrating effectiveness for the promoted young-plasma uses. It also noted the risks associated with plasma transfusion.
This event is the dated 2024 reminder, not a claim that the controversy began in 2024. It illustrates why commercial availability should be distinguished from regulatory authorization and clinical evidence.