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Repare Skincare was cited for selling unapproved new drug products, including TCA chemical peels (up to 100% strength) and Glycolic Acid chemical peels (70%), in violation of sections 505(a) and 301(d) of the FD&C Act. The company's website contained drug claims indicating these products were intended to treat wrinkles, acne, and skin imperfections, establishing them as drugs requiring FDA approval rather than cosmetics. The FDA expressed significant public health concern because these potent chemical peel products pose risks of serious skin injuries including burns, wounds, scarring, and other damage that have required emergency room visits, dermatology care, and surgical intervention.