To date, over 75,000 lawsuits have been filed in federal court against manufacturers and suppliers of talc products.

On April 5, 2024, the U.S. Food and Drug Administration (FDA) confirmed that its third-party testing of cosmetic talc products for 2023 identified no traces of asbestos in any of the 50 cosmetic samples tested.

FDA’s 2023 results, which were reported in a Cosmetics Constituent Update, are consistent with its testing for 2022 and 2021, which also failed to detect asbestos in any of the 50 cosmetic samples tested for those years.

Although FDA’s testing results may come as welcome (if unsurprising) news to many industry participants, questions about potential contamination of cosmetic talc have persisted for decades, with jury verdicts in talc cases skyrocketing into the high millions of dollars.

This Alert identifies what supply chain participants need to know about allegations of asbestos contamination in talc-containing cosmetics, as well as significant regulatory changes affecting asbestos detection and identification in talc as the result of the 2022 federal Modernization of Cosmetics Regulation Act (MoCRA).

Background

Talc, also known as talcum or magnesium silicate, is a naturally occurring silicate mineral mined from underground deposits. Because talc is the softest mineral known to man, it has been used in cosmetics manufacturing for centuries to absorb moisture, prevent caking, enhance opacity or to improve a product’s “feel.”

In its natural form, talc can be found in locations that contain deposits of asbestos, another naturally occurring silicate mineral that is a human carcinogen. FDA has acknowledged the potential for asbestos contamination and advised supply chain participants to take caution in identifying talc mining sites and to prevent asbestos contamination in cosmetic products.

The FDA’s Authority Over Cosmetics

The Federal Food, Drug and Cosmetics Act (FDCA) authorizes FDA to regulate and ensure the safety of cosmetics, broadly defined to include perfumes, body powders, eye and facial makeup, cleaning shampoos and deodorants.

Under the FDCA, cosmetic products and ingredients, with the exception of color additives, must be safe when consumers use them according to product labeling or customary use, and must not be misbranded or adulterated.

Although FDA does not require pre-market approval over cosmetics, companies and individuals who manufacture or market cosmetics are legally responsible for making sure their products are safe for use and free of harmful adulterants or contaminants before they go on the market. 

FDA’s 2023 Testing

According to FDA, the cosmetic products were selected and purchased by FDA and then blind samples were transferred to AMA Analytical Services Inc., a third-party contractor, for testing using polarized light microscopy (PLM) and transmission electron microscopy (TEM). 

FDA’s Interagency Working Group on Asbestos in Consumer Products—an interagency working group formed in 2018 to support the development of standardized testing methods for asbestos—previously recommended utilizing both PLM and TEM methods to identify and report the presence of asbestos and other similar particles in its January 2022 white paper outlining scientific opinions on the testing of talc-containing cosmetic products to ensure reliable detection and identification of asbestos particles.

FDA selected the products for testing based on several factors, including type of product, price range, visibility on social media, marketing towards to children and women of color and, if any, third-party reports of potential asbestos contamination.

FDA selected AMA because of its expertise and experience in asbestos testing and its accreditation for analysis of asbestos in bulk materials through the National Institute of Standards and Technology administered National Voluntary Laboratory Accreditation Program. According to FDA’s website, AMA has similarly been awarded contracts with FDA to test talc-containing cosmetic products for the presence of asbestos since September 2019.[1]

As detailed by FDA’s Summary of Results for 2023, the types of products tested ranged from root touch-up powders to foundation powders, bronzing powders, loose and pressed powders and setting powders.

Potential Liability for Asbestos-Contaminated Cosmetics

Despite the FDA’s recent sampling data indicating a lack of asbestos contamination, the plaintiff’s bar continues to pose a significant legal risk to companies manufacturing cosmetics that potentially could be contaminated with asbestos, as illustrated by several recent “nuclear” verdicts.

To date, over 75,000 lawsuits have been filed in federal court against manufacturers and suppliers of talc products, alleging that they caused ovarian cancer, particularly when applied by women to the genital region, or when contaminated with asbestos, caused mesothelioma, a rare cancer that can be associated with asbestos exposure. This includes multidistrict litigation consisting of over 50,000 cases alone as of April 2024, which is currently pending before Judge Michael A. Shipp in the U.S. District Court for the District of New Jersey.

Since March 2019, jurors in state courts in California, Missouri, New Jersey and New York have awarded over $5 billion in damages to plaintiffs in cases based on alleged talc contamination, claiming that defendant manufacturers knew about potential asbestos-contamination but failed to warn consumers or otherwise alter their formulas.

Several of these awards have been overturned on appeal and criticized as excessive or lacking basis. For example, last year, a three-judge panel of a New Jersey appeals court overturned a $223 million jury award and ordered a new trial after concluding that the lower court improperly permitted jurors to hear evidence that plaintiff’s use of allegedly contaminated talc-based products exposed him to asbestos and caused him to suffer mesothelioma. Instead, the panel concluded that the lower court failed to fulfil its “gatekeeping role” of assessing whether the plaintiffs’ experts based their testimony on sound science.

In other circumstances, companies have pursued injurious falsehood, fraud and Langham Act claims against the authors of studies who asserted that talc-containing products can cause cancer and later served as plaintiffs’ expert witnesses in numerous trials.[2] Asserting that their research was based on “junk science,” they alleged that the authors—who subsequently earned millions of dollars in testifying fees—were financially motivated and created a “false narrative” about the safety of talc-containing cosmetics. The companies have sought monetary damages as well as a retraction or correction about the studies’ findings.

Upcoming Changes to FDA’s Authority Over Talc

On December 23, 2023, Congress enacted MoCRA, the most significant update to FDA’s authority to regulate cosmetics since the FDCA in 1938.

As part of MoCRA, Congress directed FDA to issue a proposed rule on standardizing testing methods for detecting and identifying asbestos in talc-containing cosmetic products by December 2023.

Although the December 2023 deadline passed, FDA sent its proposed rule for review to the Office of Management and Budget in early January 2024. MOCRA further requires FDA to issue a final rule 180 days after the close of the public comment period for the proposed rule.

Additionally, MoCRA contains numbers of new provisions intended to address possible asbestos contamination of cosmetics. For example, MoCRA now:

• Requires any facility that manufactures or processes cosmetic products intended for sale in the United States—irrespective of whether the facility is located in the United States—to register with FDA by July 1, 2024, while authorizing FDA to suspend a facility’s registration if it determines that (1) a product manufactured or processed at that facility has a “reasonable probability of causing serious adverse health consequences to humans” and (2) reasonably believes that other products manufactured or processed by the facility may be similarly affected;
• Requires manufacturers, packers and distributors of cosmetics intended for sale in the United States to submit to FDA lists of products and ingredient information, including location of manufacture and the ingredients of any fragrances or flavors by July 1, 2024;
• Effective as of December 29, 2023, imposes greater recordkeeping obligations regarding product safety substantiation, documenting adverse events, and reporting and following up on serious adverse events—with an expanded definition of what constitutes a serious adverse event;
• Imposes new labeling requirements, including providing contact information for adverse event reporting;
• Requires FDA to enact regulations addressing good manufacturing practices (GMP) in line with international requirements, such as those practices set forth in the International Organization for Standardization’s standard for cosmetic GMPs, ISO 22716:2007 (which the EU requires) or by certain voluntary certifying organizations like the National Sanitation Foundation, with a proposed rule no later than December 29, 2024, and a final rule by the end of 2025; and
• Authorizes FDA to conduct mandatory recalls if it determines that: 1) there is a reasonable probability that cosmetics are adulterated or misbranded under the FDCA; and 2) exposure will cause serious adverse health consequences.

Conclusion

Despite few instances involving known contamination by asbestiform fiber and FDA’s continued lack of evidence detecting asbestos contamination in talc-containing cosmetics, supply chain participants should be aware of the continued risk posed by talc litigation. Not only do allegations of asbestos contamination in talc-containing products continue to be a focus of litigation, they pose the risk of so-called nuclear verdicts and attendant litigation costs. Although FDA’s 2023 sampling results continue to show a lack of asbestos contamination in talc-containing cosmetics, there may be challenges to introducing the results or the tests into evidence, namely that the results are not relevant because they are blinded, not specific to particular products or the sampling size is too small to be significant.

Companies should be aware not only of FDA’s forthcoming proposed rule standardizing asbestos testing in talc-containing cosmetics, but also the possibility that plaintiffs may seek to use any deviation from FDA’s standardized test, or failure to document compliance with FDA-approved methods, as evidence that products are contaminated or not safe for use.

For More Information

If you have any questions about this Alert, please contact Sharon L. Caffrey, Sean K. Burke, Alyson Walker Lotman, Kelly A. Bonner, any of the attorneys in our Fashion, Retail and Consumer Branded Products Industry Group or the attorney in the firm with whom you are regularly in contact.

Disclaimer: This Alert has been prepared and published for informational purposes only and is not offered, nor should be construed, as legal advice. For more information, please see the firm's full disclaimer.