Revlon US

A group of consumers who purchased and used allegedly toxic hair relaxer products from Revlon, Inc., L’Oréal USA Inc., and other hair product companies can proceed with their proposed class action, after a federal judge denied Revlon’s motion to dismiss the proposed class action.

Your facility is registered with the United States Food and Drug Administration (FDA) as a manufacturer of over-the-counter (OTC) drug products. FDA has reviewed the records you submitted in response to our September 8, 2025 request for records and other information pursuant to section 704(a)(4) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) for your facility, Revlon – Oxford Facility, FEI 1021184, at 1501 Williamsboro St., Oxford, as well as subsequent correspondence.

1. Your firm failed to test samples of each component for identity and conformity with all appropriate written specifications for purity, strength, and quality (21 CFR 211.84(d)(1) and 21 CFR 211.84(d)(2)).

2. Your firm’s quality control unit failed to exercise its responsibility to ensure drug products are manufactured in compliance with CGMP, and meet established specifications for identity, strength, quality, and purity (21 CFR 211.22).

Based on a review of documents you provided, you released multiple lots of OTC drug products within a few months of expiry, including one released with only 1 month before the drug product expiry. Of note, FDA documented instances of drug products that you discontinued, and past your expiration date, for sale online well after they expired, which could be attributed to your practice of distributing drugs close to expiry.

In your response to our additional request for records you indicated that you would be reformulating your drug products containing talc. In response to this letter provide an update on your reformulation efforts to move to an alternative not associated with risks of talc.

FDA issued a warning letter to Revlon for inadequate testing of contaminants, including possible carcinogens, impurities, yeast, and mold.

WASHINGTON, D.C. – Representative Yvette D. Clarke (NY-09) led a letter signed by nine Members of Congress to CEO of Revlon Group Holdings LLC, Michelle Peluso, following the FDA’s recent findings that the cosmetics company failed to adequately test products for the presence of contaminants – including cancer-causing chemicals and mold – putting the health of its customers at risk, particularly its Black customers who are disproportionately represented in the beauty and personal care market.

An investigation conducted by CARB staff showed that Revlon imported a product that failed to meet the volatile organic compound (VOC) limit requirements for a personal fragrance (less than 20% fragrance) product. The same product failed to display the date of manufacturing. CARB documented both violations as they related to the Consumer Products Regulation.