Ovarian Cancer Patients Sue Manufacturer of Talc-Based Powder

When multiple lawsuits alleged that the use of pure talcum in baby powder products increased chances of ovarian cancer, industry practices in cosmetic regulation were brought into question. The status of regulatory practices in the Personal Care Products Council became intrinsically linked to whether talc was a valid product, and whether companies using the products had been aware prior to lawsuits that exposure to the powder might increase the risk of ovarian cancer. Someone knowledgeable of the Food and Drug Administration with knowledge of product-specific duties to warn the public of possible dangers was consequently asked to testify.

Question(s) For Expert Witness

1. Please briefly describe your cosmetic regulation experience as it relates to the FDA.

2. Are you familiar with the history of studies and scrutiny regarding pure talc and its association with ovarian cancer?

Expert Witness Response E-065690

I have spent almost thirty years in regulatory roles with the Food and Drug Administration, focusing on medical devices, pharmaceuticals, and cosmetics. I am familiar with industry regulations and have some toxicology experience with cosmetics . The FDA is typically very hands-off when it comes to cosmetics, and there isn’t a tremendous amount of regulatory history as a consequence. Typically, they don’t intervene unless a clear problem is presented, and let the cosmetics industry regulate itself. Only within the last 15 years has the FDA gotten involved regulating cosmetics, and so far they have only intervened when imports were involved. Potential issues with talc have been known for decades; the FDA did some studies by collecting retail samples, but participation was voluntary and they have not issued any warnings.