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In the U.S., suppliers must comply with FDA Good Manufacturing Practices (GMP), and products should carry a GRAS (Generally Recognized As Safe) designation if marketed as dietary supplements
Li J, Jia H, Cai X, Zhong H, Feng Q, Sunagawa S, Arumugam M, Kultima JR, Prifti E, Nielsen T, et al
Practical advice: Most denials that are going to be overturned get overturned at the internal review stage
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The prior authorization request asks specifically: "Does the patient have a diagnosis of type 2 diabetes mellitus (A1C 6.5% or fasting glucose 126 mg/dL)?" If the answer is no, the request auto-denies
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