Last month, FDA issued a series of Warning Letters to drug manufacturers concerning talc used in drug products. The nine Warning Letters allege violations of current Good Manufacturing Practices and conclude that the drugs are adulterated under the Federal Food, Drug, and Cosmetic Act. The letters redact the names of the drugs at issue, but talc is an inactive ingredient in many drugs, including SPF products, antiperspirant-deodorants, and antifungal powders.
In each letter, FDA alleged that the 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 can result in contamination. The letters also stated that asbestos is a known human carcinogen when inhaled.
FDA made clear that it expects manufacturers to follow the methodology contained in the United States Pharmacopeia's talc monograph when conducting asbestos testing. The letters noted that USP recently revised the talc monograph to include updated technical requirements for asbestos testing.
Although FDA acknowledged that manufacturers may rely in part on supplier certificates of analysis, it emphasized that such reliance is permissible only if the manufacturer establishes the reliability of the supplier's test results through initial and periodic validation. FDA also asked firms to commit to conducting at least one specific identity test for each incoming component lot.
Although the Warning Letters are directed to specific firms, they provide broader lessons for manufacturers and private label distributors of talc-containing drug products—and potentially of talc-containing cosmetics. Companies should consider reviewing whether their products contain talc, and if so, whether their specifications and test methods align with the recently revised USP talc monograph. Companies should also ensure that they are exercising sufficient oversight and verification of supplier testing. These measures will help companies avoid a similar Warning Letter and will put companies in the best position to defend against demand letters or lawsuits from the plaintiff's bar.
Please contact Venable's Food and Drug Law team if you have any questions about FDA's recent Warning Letters or talc testing expectations.