Law360 recently published an expert analysis predicting that there might be a rise in cosmetic product liability claims. Although in the public eye with recent talc ovarian cancer litigation against pharmaceutical giant Johnson and Johnson resulting in attention-grabbing verdicts totaling $724 million, there are fewer product liability claims over cosmetics and beauty products than other products and devices that are under U.S. Food and Drug Administration (FDA) oversight.
Cosmetics are historically and currently subject to less regulation than food and drugs — for example, the FDA does not test or approve products, it cannot order a mandatory recall, and manufacturers are not required to report adverse events. However, attitudes are changing. The public is questioning the FDA’s perceived lack of control. The internationally noted media coverage of the talc trials and subsequent questions over talc’s safety are just one example of many of the media’s bringing attention to potentially dangerous personal care products.
Law360 reported that this year bills were introduced in both the House and Senate that propose significant changes to the regulation of cosmetic products. This legislative reform is supported by many in the industry, including the The Personal Care Products Council, a national trade association that represents 600 U.S. and international companies that manufacture and distribute personal care and cosmetics products.
Senator Dianne Feinstein, D-Calif., commented in her press release of May 11, 2017, that “[d]espite the universal use of these products, none of their ingredients have been independently evaluated for safety,” and that “we urgently need to update the nearly 80-year-old safety rules” governing cosmetic and beauty products, said Law360.
Both bills propose that manufacturers of cosmetic products would have mandatory requirements to report serious adverse events to the FDA. Drug and device manufacturers are already required to do so. Serious adverse events include: death, “life-threatening experience,” inpatient hospitalization, persistent or significant disability, congenital anomaly or birth defect, or significant disfigurement. There is also proposed mandatory reporting for events that could have resulted in these serious consequences without early medical intervention.
Although there is not currently mandatory reporting, in December 2016 the FDA addressed the issue by announcing that the Center for Food Safety and Applied Nutrition would provide quarterly public data extracted from adverse event reports for cosmetics with the intent to encourage more reporting.
In its Constituent Update of Dec. 6, 2016, the FDA stated that it “anticipates that this increased transparency will help spur the submission of more detailed reports from consumers, health care providers and other members of the public.”
The Law360 article said, “It is reasonable to expect that increased disclosure of cosmetic adverse event information will spur increased litigation regarding such products.”
The Senate and House bills vary in details such as giving FDA authority over mandatory recalls, but both propose significant reform, and, based on the industry support and changing public opinion about the safety of cosmetic products, it looks like some kind of reform in this area is not too far in the future.