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A 2025 European Journal of Clinical Nutrition commentary on the NICE guideline argued that the diagnostic threshold and clinical awareness still need to be tightened further, especially around pernicious anaemia, which is still under-recognised in primary care

It has been handled as a supplement/food-type ingredient via a self-affirmed GRAS characterization (a safety framing, not efficacy or drug approval), was reviewed unfavorably for the FDAs 503A compounding bulks list in 2024, and is prohibited in sport by WADA

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For a person with a confirmed deficiency, the documented dangers of leaving it untreated generally outweigh the rare, minor risks of the injections themselves