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It is not FDA-approved and has not been evaluated by the FDA for safety or effectiveness

While the IOM had based B12 needs on the amount required to correct hematological parameters for people with pernicious anemia, the EFSA had almost 20 more years of research to draw on, and concluded that the most suitable approach was basing needs on biomarkers (serum B12, holotranscobalamin, MMA, and homocysteine)

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doi: 10.1016/j.ekir.2022.12.014 130 DhillonS