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No Clinical Oversight Not manufactured under FDA-regulated quality or clinical standards

But notably, the FDA made this statement in a release about bulk drug substances (ingredients used to make medicines) that it considers to pose potential significant safety risks, so KPVs lack of safety studies is a red flag in the FDAs eyes

Ranked from strongest to weakest translational support, the evidence is: In-vivo rodent tissue-repair studies (strongest systemic-route evidence)

More studies are necessary to determine what factors may underlie the link

One solution to this problem of B12 deficiency is to supplement with B12 shots