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ISIS.GOLD sold unapproved new drug products, specifically "TCA 100% Trichloroacetic Acid" and "Whitening SA Peels" containing salicylic acid and hydroquinone, through its website in violation of sections 505(a) and 301(d) of the FD&C Act. The company's website made drug claims such as removing wrinkles, acne scars, warts, and hyperpigmentation, establishing these products as drugs requiring FDA approval. The FDA determined these potent chemical peels posed public health risks due to reports of serious skin injuries including burns, wounds, and scarring that required emergency room care and surgical intervention.