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Bruijn JA, Mihm Jr MC, Barnhill RL

In reviewing the content of the claims in this batch of warning letters, most of the concerning language on online websites advertising these products that was flagged by the FDA is unsurprising, including: Named the brand product as a comparative reference or therapeutic equivalent Stated the compounded product was a generic of the brand product Included efficacy claims for the compounded product Used the words FDA-approved in the advertising copy But some of the language that was flagged by the FDA was less direct, with the FDAs expressed concern being that the advertising may have given the impression of FDA approval

Onishi N, Yuasa H, Tanaka S, et al