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FDA approval requires formal clinical trials, safety and efficacy review, labeling approval, and manufacturing validation under a New Drug Application (NDA) or Biologics License Application (BLA)

Even considering all of these factors you need to understand that checking vitamin B12 levels in the serum still isnt the best way to evaluate for B12 deficiency

292 In addition, intermittent hypoxia induces the sympathetic nervous system to increase vascular resistance, down-regulates expression of the kallikrein-kallistatin vasodilator pathway, and activates the renal renin-angiotensin-aldosterone system to cause vasoconstriction