The FDA has raised concerns about how manufacturers of over-the-counter (OTC) drug products test talc and control the risk of asbestos contamination. The concerns appear in several recent FDA warning and untitled letters to manufacturers.
According to GMP Compliance, the FDA identified similar deficiencies across the letters. These include inadequate testing of incoming talc, failure to verify the reliability of supplier testing, and testing methods or specifications that do not meet current requirements. The FDA also emphasized that talc used in drug products is generally expected to meet applicable U.S. Pharmacopeia (USP) requirements, including the current talc monograph’s specific test for asbestos.
FDA Untitled Letter Raises Concerns About Talc Testing in Florida
The FDA issued an Untitled Letter to Formulated Solutions, LLC, an OTC drug manufacturer in Largo, Florida. The company used talc as an inactive ingredient in certain drug products, including products the FDA considered higher risk because they could expose users to talc through inhalation or application to the genital area.
The FDA found that the company had not demonstrated appropriate testing of incoming talc for identity, purity, strength, and quality. Although supplier certificates of analysis included asbestos testing results, the company did not provide records showing that it had established the reliability of those results.
Formulated Solutions told the FDA that it had stopped manufacturing drug products containing talc. The FDA stated that if production resumes, the company should provide adequate documentation of its asbestos testing.
If you or a loved one has been diagnosed with an asbestos-related illness, visit our Florida mesothelioma lawyer page to learn more about our asbestos litigation services in the state.
FDA Warning Letter Identifies Talc Testing Deficiencies in North Carolina
The FDA issued a Warning Letter to Revlon Group Holdings, LLC concerning its facility in Oxford, North Carolina. The company manufactures OTC drug products containing talc, and the FDA identified significant CGMP violations related to talc testing and quality control.
The FDA found that Revlon had not demonstrated appropriate testing of incoming talc for identity, purity, strength, and quality. Revlon had indicated that its talc was tested for asbestos before use, but records showed that the testing was performed by the supplier rather than at the company’s facility. The FDA also found that Revlon had not provided sufficient evidence establishing the reliability of the supplier’s asbestos testing.
The Warning Letter also identified deficiencies in Revlon’s talc specifications and quality-control oversight. The FDA noted that the company’s specifications did not fully align with the current USP talc monograph, which includes a specific test for asbestos. The agency requested corrective actions, including asbestos testing of retained talc samples or affected finished drug products, as well as a risk assessment for products still within their expiration dates.
If you or a loved one has been diagnosed with an asbestos-related illness, visit our North Carolina mesothelioma lawyer page to learn more about our asbestos litigation services in the state.
About The Lanier Law Firm’s Asbestos Litigation Practice
The Lanier Law Firm has a long history of representing people affected by asbestos exposure and mesothelioma. The firm handles complex asbestos litigation involving a wide range of products and exposure sources, including cases involving asbestos-containing talc.
The firm represented 22 women and their families in litigation against Johnson & Johnson involving allegations that asbestos-contaminated talcum powder caused ovarian cancer. The Lanier Law Firm secured a $4.69 billion verdict for the plaintiffs. The firm continues to represent people in asbestos and mesothelioma litigation nationwide.
If you or a loved one has been diagnosed with mesothelioma or another asbestos-related illness, contact The Lanier Law Firm to learn more about your legal options.