In April, the U.S. Food and Drug Administration (FDA) released the results of its 2023 sampling assignment, testing for asbestos in talc-containing products. The results confirmed the absence of asbestos in all 50 samples tested, marking the third consecutive year of asbestos-free talc products in the United States. While this news is reassuring for industry participants, the legal landscape remains complex due to ongoing litigation. This article explores the legal implications, potential risks, and regulatory changes related to asbestos detection in cosmetic talc products.
Background
Talc is a naturally occurring silicate mineral widely used in cosmetics for its moisture-absorbing properties. The FDA began investigating talc safety in 1971 after asbestos was detected in talc powder. Although methodology and technology for testing have advanced, concerns about asbestos contamination have persisted for decades. The FDA’s most recent round of testing was performed by AMA Analytical Services, Inc., which was selected for its extensive background in asbestos testing and accreditation for analysis of asbestos in bulk materials through the National Institute of Standards and Technology. According to the FDA, cosmetic products were selected by the FDA based on product type, price range, popularity with the general public, marketability to children and women of color, and third-party reports of potential asbestos contamination. The samples were double-blinded and provided to AMA for analysis. Recent FDA testing provides valuable insights, but legal challenges continue to impact manufacturers and suppliers, especially regarding the reliability of the testing methodology.
In December 2022, Congress passed the Modernization of Cosmetics Regulation Act of 2022 (MoCRA), which created a new framework for the FDA’s regulation of the cosmetics industry and imposed new requirements, including, inter alia, regulations about adverse event recordkeeping and reporting, facility registration and product listing, good manufacturing practices, safety substantiation, fragrance allergen labeling, facility suspension, records access, and mandatory recall authority. Most notably, MoCRA mandates standardized testing methods for detecting and identifying asbestos in talc-containing cosmetic products. Manufacturers must adapt to these regulatory shifts. Before the implementation of MoCRA, the most recent detection of asbestos occurred in 2019 in Johnson & Johnson baby powder, which led to a recall.
MoCRA requires cosmetics manufacturers to utilize state-of-the-art test methods to look for the presence of asbestos in talc-based products, and the FDA has stated its intent to promulgate proposed regulations to establish and require standardized testing methods for detecting and identifying trace amounts of asbestos. However, the $86 billion personal care products industry remains largely self-regulated. To ensure the safety and labeling of these products, the FDA relies mostly on companies and the individuals who market them. American women use an average of 12 products containing 168 different chemicals daily, and men use an average of 6 products containing 85 different chemicals daily. While most consumers support strict regulation, talc powder falls under the umbrella of only 9 cosmetic products regulated by the FDA.
The Litigation Landscape
Recent FDA testing results are persuasive but will not completely shield companies from litigation. More than 75,000 lawsuits have been filed against talc manufacturers and suppliers in federal courts involving allegations of ovarian cancer or mesothelioma in connection with exposure to talc. This includes multidistrict litigation consisting of over 50,000 cases as of June 2024, pending before Judge Michael A. Shipp in the U.S. District Court for the District of New Jersey.
Jury verdicts in talc cases have reached astronomical amounts, creating significant legal risks.
Since March 2019, juries in California, Missouri, New Jersey, and New York have awarded plaintiffs over $5 billion in damages related to talc contamination lawsuits. These lawsuits allege that manufacturers knew about potential asbestos contamination in their products but failed to warn consumers or change their formulas.
In a 2018 landmark case, a Missouri court ruled in favor of 22 plaintiffs who alleged that asbestos contamination within Johnson & Johnson’s talcum powder products contributed to their development of ovarian cancer, resulting in damages of nearly $4.7 billion. The Court stated that Johnson & Johnson “misrepresented the safety of these products for decades.” Robert Ingham, et al. v. Johnson & Jonhson, No. 1522-CC10417-01 (Mo. Cir. Ct. Dec. 19, 2018). The appellate court rejected most of the arguments raised on appeal but found the trial court erred in finding personal jurisdiction over Johnson & Johnson (J&J) and Johnson & Johnson Consumer Companies, Inc. (JJCI) for certain claims. This reduced J&J’s actual damages to $125 million and punitive damages to $715.9 million, and JJCI’s actual damages to $500 million and punitive damages to $900 million, emphasizing how courts have upheld significant portions of damages awards in talc cases. While the FDA’s sampling results have indicated an absence of asbestos contamination for the past three years, legal challenges may persist, particularly as plaintiffs question the credibility of the sample sizes, research, and testing methodology.
However, several large jury awards against talc manufacturers have been reversed on appeal upon findings of excessive damages awards and improper scientific evidence. In 2023, a federal appeals court in New Jersey tossed a $223 million jury award to four mesothelioma patients who claimed they developed cancer from using Johnson & Johnson baby powder. The appellate court ordered a new trial after concluding that the lower court permitted jurors to hear improper scientific testimony and “failed to fulfill its ‘gatekeeping role’ of assessing whether the plaintiffs’ experts based their testimony on sound science.” Talc manufacturers have also sued researchers who linked their products to cancer, alleging the research was “junk science” motivated by the researchers’ financial gain from serving as expert witnesses in lawsuits. The manufacturers claim these researchers created a “false narrative” about the safety of talc and have sought monetary damages and corrections to the published studies. In addition to remaining informed about the FDA’s forthcoming standardized asbestos testing protocols for talc-containing cosmetics, manufacturers should be aware that any deviation from FDA-approved protocols may be propounded as evidence of non-compliance, possible contamination, or product safety issues.