Revlon Fails to Ensure Some Products Are Safe, FDA Warns

Revlon Group Holdings LLC didn’t properly test products for cancer-causing chemicals or mold, U.S. regulators warned the beauty giant in a letter posted Tuesday.

The Food and Drug Administration called one Revlon product higher risk because of its potential to be contaminated with a known human carcinogen in the letter dated June 2. The details of the product and the potential contaminant were redacted from the public version of the letter.

Revlon didn’t immediately respond to requests for comment.

Revlon told the FDA that its supplier analyzed product components, though the agency said Revlon had not verified the suppliers’ test methods were reliable, according to the letter.

In recent years, personal-care products such as spray-on sunscreens and antiperspirants, hand sanitizers and acne treatments have been recalled. The recalls were triggered by contamination with a carcinogen called benzene, which is linked to leukemia. The redacted FDA letter doesn’t indicate whether benzene was the carcinogen the agency was concerned about.

Revlon’s quality unit also failed to test for multiple impurities and permitted more yeast and mold than standard tests allow, the letter states. The agency asked for “a comprehensive assessment and remediation plan” to ensure Revlon’s quality unit can effectively function.

“As a manufacturer, you have a responsibility to sample, test, and examine, as appropriate, drug components before use in production,” the FDA wrote.

It’s the latest setback for closely held Revlon. The company was taken over by creditors three years ago as part of a bankruptcy process that capped years of creditor infighting. An earlier debt deal didn’t solve its struggles.

Revlon and several other beauty product makers faced allegations from consumers in recent years linking hair relaxers to some types of cancer. An attorney representing Revlon when many claims were made said in 2023 the company disputed any link between its hair relaxers and cancer. The litigation is ongoing.

A warning letter is one of the FDA’s strongest rebukes and failure to address the violations can lead the agency to restrict a company’s ability to export products. The agency asked Revlon to perform risk assessments on its products and conduct recalls if any are contaminated.

The letter was based on a records request by the FDA sent to Revlon’s Oxford, North Carolina, factory. The facility is the size of 12 football fields and is the company’s “largest and most advanced production” site, according to the company’s website. Besides its flagship brand, Revlon also sells Elizabeth Arden and Almay products, among other brands.

Top photo: Revlon products. Bloomberg.