Regulations

FDA Sends Warning Letter to Revlon

Letter cites a September 2025 request related to talc testing at the company's Oxford, NC facility.

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By: Christine Esposito

Editor-in-Chief

The US FDA sent a warning letter to Revlon following the beauty company’s reply to a September 2025 request for records and other information pursuant to the Federal Food, Drug and Cosmetic Act.

FDA’s June 2, 2026 letter stated that Revlon could not demonstrate it adequately tested incoming talc for asbestos at its Oxford, NC manufacturing facility.

According to the FDA, Revlon reported that testing was conducted by its supplier, and was not independently verified. The Agency noted that relying on a supplier’s certificate of analysis is permitted only if the manufacturer validates the reliability of those results. FDA said it also found that identity testing performed on talc did not fully conform to current USP testing methods.

The letter also noted Revlon’s quality unit approval of talc specifications fell short of USP standards. It reportedly had missing assay and impurity limits and microbiological specifications for yeast and mold. The supplier’s COA reportedly listed microbial results only as “conform” without quantitative data, according to the letter.

FDA said Revlon needed to respond in writing within 15 working days with an outline of corrective actions, and also needed to submit testing results on retained talc samples (or finished product testing, if retains are unavailable) within 30 days.

The letter from FDA also cited USP’s revised talc monograph, which includes updated asbestos-testing requirements, is scheduled to become official in June 2026.

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