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It has not been evaluated or approved by the U.S
Chemically it is not a peptide at all, so the peptide dosing mental model only partly applies: the reconstitution math is identical, but the route options are broader (a small molecule can survive and be studied by mouth in a way most peptides cannot)
The benefit comes from replacing whats missing, not from extra B12 on top of normal levels
It is a designation used primarily by the FDA (Food and Drug Administration) for products, often in vitro diagnostic (IVD) components like reagents or instruments, that are in the laboratory research phase of development and are not intended for clinical diagnostic use
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