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Isola, J
It is not a drug, food, dietary supplement, or cosmetic, and has not been approved by any regulatory authority
have raised hopes for possible reclassification, although no changes have occurred yet
This is technically purer than most commercial serums, but carries two risks: no preservative (bacterial growth on open wounds) and no pH buffering (the solution may be too acidic or alkaline)
No regulatory body has cleared this formulation for any health application
This approach has recently been given approval by the European Medicines Agency (EMA) and services are being set in selected European centres
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