In an action that underscores the ongoing mesothelioma and ovarian cancer risks posed by talc-containing products, the U.S. Food and Drug Administration has issued nine Warning Letters to drug manufacturers for failing to properly test talc used as an ingredient in their products for asbestos contamination. The FDA is demanding heightened scrutiny of asbestos testing practices across the pharmaceutical and cosmetic industries.
Mesothelioma-Causing Asbestos Found in Drug Products After Manufacturers Skip Adequate Testing
Though consumers don’t realize that SPF sunscreen products, antiperspirant-deodorants, antifungal powders, and other cosmetic products contain talc, they are increasingly aware that the mineral has been blamed for thousands of cases of mesothelioma and ovarian cancer. The FDA’s Warning Letters, issued last month, allege violations of current Good Manufacturing Practices, saying that each manufacturer failed to ensure that talc was appropriately tested for asbestos. The letters stated that “talc and asbestos are naturally occurring minerals that may be found in close proximity in the earth” and that this proximity can result in contamination.
It is this geological reality that has been the basis of tens of thousands of mesothelioma and ovarian cancer lawsuits filed against Johnson & Johnson and other talc product manufacturers. The agency’s letters also explicitly stated that asbestos is a known human carcinogen and ,when inhaled, the primary cause of mesothelioma.
FDA Insists on Proper Talc Testing Methodology to Prevent Mesothelioma
The FDA’s letters made clear it expects manufacturers to follow testing methodology contained in the United States Pharmacopeia’s recently revised talc monograph, which includes updated technical requirements for asbestos testing. While manufacturers may rely in part on supplier certificates of analysis confirming their talc is asbestos-free, the FDA emphasized this is permissible only if the manufacturer establishes the reliability of the supplier’s test results through initial and periodic validation—not simply by accepting paperwork that could mask mesothelioma-causing contamination.
Talc-containing drug products and cosmetics that have not been properly tested for asbestos have been blamed for exposing users to m asbestos fibers and causing mesothelioma and ovarian cancer. The FDA Warning Letters make clear that pharmaceutical and cosmetic companies must review whether their products contain talc and whether their testing specifications align with the updated USP talc monograph requirements.
If you or someone you love has been diagnosed with mesothelioma or ovarian cancer, the Patient Advocates at Mesothelioma.net are here to help. Call us today at 1-800-692-8608 to learn more.
