The U.S. Food and Drug Administration (FDA) sent a warning letter to Revlon Group Holdings LLC on June 2, citing failures to properly test some products for cancer-causing chemicals or mold contamination [1, 2]. The FDA classified one Revlon product as higher risk due to potential contamination with a known human carcinogen, although the agency redacted details on the specific product and contaminant involved [1, 2].
The agency criticized Revlon's quality control processes for allowing yeast and mold levels above standard limits and for failing to test for multiple impurities [2]. While Revlon's supplier performed analyses on product components, the FDA said the company did not verify the reliability of the supplier's testing methods [2]. The FDA emphasized manufacturers' responsibility to "sample, test, and examine, as appropriate, drug components before use in production" [2].
Revlon responded that it stands by the safety of its products and is cooperating with the FDA to resolve the issues raised [2]. However, the FDA demanded a comprehensive assessment and remediation plan to restore proper quality control functions at Revlon [2]. FDA warning letters are among the agency's strongest regulatory rebukes and failing to address them can result in export restrictions [2].
Revlon is also facing ongoing litigation over alleged cancer links to its hair relaxer products, which the company disputes [2]. In 2023, Revlon denied consumer claims connecting the hair relaxers to cancer [2].
The FDA warning suspends on June 2 marks a critical compliance deadline for Revlon to submit its corrective action plans and ensure product safety standards are met.
