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The United Kingdom National Quality Assessment Scheme for Haematinic Assays warns against false B12 results and the risk of neurological damage: In the event of any discordance between clinical findings of B12 deficiency and a normal B12 laboratory result, then treatment should not be delayed

(Czechia) using validated analytical methods and laboratory testing protocols

Oral and rectal routes of administration also remain prohibited

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Because ESI often adds one or more protons (H, mass ~1.008), the instrument will detect ions like [M+H] at m/z 1420.5, [M+2H] at m/z 710.75, or [M+3H] at m/z 474.1

The FDA approval process isn't bureaucratic red tape, it's patient safety infrastructure