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If a product is marketed for human use, it may be regulated as a drug regardless of labeling

E61.1 (Iron deficiency) is the correct ICD-10-CM code in that scenario, not D50.9

The detrimental effects of B12 deficiencysuch as hyperhomocysteinemia and impaired methylationare well-established and can negatively impact oocyte quality and embryo viability [19, 20], which is consistent with the lower pregnancy rates we observed at low B12 levels

But theyre not yet proven to work, and there have been no large-scale clinical trials on humansnot even safety data

Regulatory status matters because cosmetics, compounded peptides, investigational products, and approved prescription drugs are not evaluated under the same standards