JB Exchange Inc./Justified Laboratories Warning Letter Details

Summary

JB Exchange Inc./Justified Laboratories was warned for selling unapproved new drugs—"Skincell Advanced Mole Skin Tag Corrector Serum" and "Skincell Mole Skin Tag Corrector Serum"—through their website in violation of sections 505(a) and 301(d) of the Federal Food, Drug, and Cosmetic Act. The products made disease treatment claims (mole and skin tag removal) without FDA approval, and no over-the-counter drugs are legally permitted for these uses. The FDA emphasized significant safety concerns, noting that self-treatment of moles could delay cancer diagnosis and that consumers might forgo proven medical treatments, while such products risk causing injuries and scarring.