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Based on how the products were promoted, the FDA regards the products as unapproved new drugs and misbranded, with labels that provided inadequate directions for use

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Lonial S, Waller EK, Richardson PG, Jagannath S, Orlowski RZ , Giver CR, Jaye DL, Francis D, Giusti S, Torre C, Barlogie B, Berenson JR, Singhal S, Schenkein DP, Esseltine DL, Anderson J, Xiao H, Heffner LT, Anderson KC

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Overexposure to these reducing agents can lead to whats termed as reductive stress, which bears similarities to oxidative stress [216]