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The FDAs position, stated explicitly in warning letters, is that RUO disclaimers are a ruse to avoid FDA scrutiny. If a product is being marketed in a way that implies human use through claim language, testimonials, dosing guidance, or the product category itself the disclaimer is legally irrelevant

doi: 10.1016/j.ejmech.2015.01.014

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Payer LCD policy requires a specific anemia code and a documented hemoglobin below 10 g/dL for ESA claims