FDA WARNING_LETTER - Repare Skincare - March 31, 2024

On July 25, 2024, the FDA issued a Warning Letter to Repare, LLC, following a March 2024 review of their website, repareskincare.com. The FDA observed the sale of numerous chemical peel drug products, including Trichloroacetic Acid (TCA) and Glycolic Acid products (e.g., "100% TCA Skin Peel" and "GLYCOLIC ACID 70%").

The FDA determined these products are unapproved new drugs, violating sections 505(a) and 301(d) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. 355(a) and 331(d). The products are considered drugs under section 201(g)(1) of the FD&C Act due to claims on the website indicating intended use for diagnosis, cure, mitigation, treatment, or prevention of disease, and/or to affect body structure or function. Examples of such claims include targeting wrinkles, acne, imperfections, tattoo removal, stimulating collagen, reducing fine lines, fading scars, and reversing signs of aging.

The FDA states these products are not generally recognized as safe and effective for their claimed uses, classifying them as "new drugs" under section 201(p) of the FD&C Act. No FDA-approved applications are