The U.S. Food and Drug Administration (FDA) has issued a warning letter to Revlon’s manufacturing facility in Oxford, North Carolina, citing significant deficiencies in quality control systems and testing procedures related to talc-containing “over-the-counter (OTC) drug products.”
The June 2 warning letter follows the FDA’s review of records submitted by the facility, and details alleged violations of Current Good Manufacturing Practice (CGMP) regulations, raising concerns about how the company verifies the safety and quality of ingredients used in certain products.
At the center of the agency’s findings is talc, an ingredient that has remained under intense regulatory and legal scrutiny for years due to the potential risk of asbestos contamination. While talc and asbestos are distinct minerals, they can occur naturally in close proximity underground, creating a risk of contamination if materials are not properly sourced and adequately tested.
According to the FDA, Revlon’s Oxford facility failed to demonstrate that it appropriately tested incoming talc (used in the manufacture of certain OTC products) for identity, purity, strength, and quality. The agency noted that while suppliers conducted asbestos testing on talc ingredients, Revlon did not provide evidence that the results were independently validated, a requirement under federal manufacturing regulations.
Importantly, the warning letter does not state that asbestos was found in Revlon’s products. Instead, the agency’s concerns relate to the company’s own testing and quality assurance processes. The FDA emphasized that manufacturers cannot rely solely on supplier certificates of analysis without establishing the accuracy and reliability of those tests through their own verification procedures. Revlon needs to provide sufficient evidence that the ingredients meet the required safety specifications before they are used in production.
Beyond the talc-related findings, regulators also cited broader shortcomings within the facility’s quality control systems. The FDA stated that the site’s quality unit failed to ensure that testing procedures and specifications were scientifically sound and aligned with current standards outlined by the United States Pharmacopeia (USP), a private, non-profit scientific organization. The agency further noted deficiencies in microbiological specifications and documentation practices used to approve raw materials for manufacturing.
The warning letter also highlighted concerns about the release of certain OTC drug products near their expiration dates. According to the FDA, multiple product lots were distributed with only a few months of shelf life remaining, including at least one batch released approximately one month before expiry. The agency noted that discontinued and expired products were later observed for sale online.
In response, the FDA has requested extensive corrective actions by Revlon, including testing retained samples of talc ingredients or finished products, conducting a comprehensive risk assessment of products currently within their expiration dates, and reviewing supplier qualification procedures. The company has also been asked to provide an update on its efforts to reformulate products containing talc and to transition to alternative ingredients.
The timing is notable, as the USP recently updated its talc monograph, introducing revised technical requirements for asbestos testing that are scheduled to take effect this month. The changes reflect growing expectations around ingredient verification and contaminant testing across the pharmaceutical and personal care supply chain.
The FDA withdrew its proposed rule on talc testing in December of last year, leaving uncertainty around future regulatory requirements despite continued concerns over potential asbestos contamination. The FDA has not given an update on when it will submit a new proposed rule.
As manufacturers continue to navigate heightened oversight of talc and other high-risk ingredients, the FDA’s letter to Revlon underscores a broader industry shift toward stronger testing protocols, supplier accountability, and reformulation strategies designed to mitigate both regulatory and reputational risks.