No. Nicosan has never been proven to be harmful. FDA studies do not prove drugs (and Nicosan is not a drug) to be safe, they make a qualified, subjective decision if a drug is not harmful.
Remember the Hippocratic Oath, in part: "Physician do no harm "
Again, ad infinitum, real studies, real life studies have been done and Nicosan does no harm, side effects, if any are minor and people have seen relief.
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