As regulatory scrutiny of per- and polyfluoroalkyl substances (PFAS) continues to intensify at both state and federal levels, cosmetics and personal care product manufacturers face growing legal and compliance challenges. To help industry stakeholders understand the evolving regulatory landscape, potential litigation risks, and strategies for mitigation, CosmeticsDesign U.S. spoke with three attorneys from MG+M The Law Firm who focus on environmental and toxic tort litigation.
MG+M Partner Amanda Cachaldora, and Associates Marissa Steiner and Gabriella Marki, are trial attorneys with extensive experience in products liability and high-stakes toxic tort litigation. Amanda represents companies in the cosmetics industry and focuses on claims involving talcum powder, asbestos, and emerging contaminants, including PFAS, in high-risk, multi-jurisdictional litigation. Marissa handles cases involving talc, asbestos, benzene, and PFAS, and has prior experience as National Coordinating Counsel for a global cosmetics company, representing personal care product manufacturers, distributors, and retailers nationwide. Gabriella focuses on complex talc, asbestos, benzene, and PFAS cases, providing strategic counsel and vigorous defense.
Together, they offer insight into how PFAS-related regulations, research, and lawsuits may impact the cosmetics industry now and in the years to come.
CDU: From regulatory and legal perspectives, what do manufacturers and suppliers need to understand about how per- and polyfluoroalkyl substances (PFAS) are currently identified in cosmetic and personal care product formulations?
MG+M The Law Firm (MG+M): At the outset, both manufacturers and suppliers need to understand what PFAs are, where they are found, how they are created and/or occur (both naturally and with intervention) and the triggers that affect their volatility. While several states retain similar definitions of PFAS within their current legislation, there is no universally recognized definition within both regulatory and scientific communities.
For example, California’s PFAS-Free Beauty Act of 2022, Colorado’s Perfluoroalkyl and Polyfluoroalkyl Chemicals Consumer Protection Act of 2022, Minnesota’s 2023 PFAS Reporting Law, Oregon’s Toxic-Free Cosmetics Act of 2023, Vermont’s 18 V.S.A. § 1671 – 1695 and Washington’s Toxic-Free Cosmetics Act of 2023 collectively define PFAS as “a class of fluorinated organic chemicals containing at least one fully fluorinated carbon atom.”
In contrast, the U.S. Environmental Protection Agency’s definition of PFAS is significantly narrower and focuses on the specific organization of the chemical substance and structure, whereas the Organisation for Economic Co-operation and Development’s definition of PFAS is broader in order to permit inclusion of a greater number of chemicals.
The absence of a universal PFAS definition complicates regulatory compliance and litigation, as companies face inconsistent standards across jurisdictions. In the cosmetics industry, this lack of clarity can lead to challenges in product formulation and labeling, potentially increasing liability risks.
For manufacturers and suppliers, distinguishing PFOA and PFOS from other PFAS chemicals is crucial, as these compounds have been more extensively studied and regulated, affecting legal strategies and outcomes.
It is important to note there are currently no federal regulations or recommendations regarding specific tests to demonstrate the safety of individual products or ingredients in personal care products with respect to PFAS. Moreover, there is no standardized or universally accepted testing method at either the federal or state level.
There are also various methodologies for testing consumer products for PFAS, such as liquid chromatography-mass spectrometry (LC-MS) and gas chromatography-mass spectrometry (GC-MS). The EPA Method 1633A (LC-MS) was developed for environmental samples, but it is now being used to reveal PFAS runoff from consumer products.
Congress has ordered that the Secretary of Health and Human Services assess the use of PFAS in cosmetic products per the Modernization of Cosmetic Regulation Act of 2022 (MoCRA). Therefore, it is expected the Food and Drug Administration (FDA) will publish by December 29, 2025, its report on the safety of PFAS in cosmetics products, which is anticipated to encompass recommendations on reporting structures and risk evaluation.
We have already seen a brief discussion of PFAS from the agency in its May 16, 2025 “The MAHA Report.” The FDA’s December report may provide more insight on how it expects manufacturers and suppliers to identify or quantify PFAS in cosmetic and personal care formulations.
CDU: As noted above, several U.S. states and the federal government have introduced or proposed legislation regulating PFAS in cosmetics. Which developments are most likely to impact manufacturers in the near term, and how might requirements differ across jurisdictions?
MG+M: From regulatory and legal perspectives, both manufacturers and suppliers need to be aware of increased scrutiny and rapidly changing regulations surrounding the utilization of PFAS. Notably, there has been more of an increase in regulatory efforts on the state level than on the federal level.
Several states—including California (PFAS-Free Beauty Act of 2022 and the Toxic-Free Cosmetic Act of 2020), Colorado (Perfluoroalkyl and Polyfluoroalkyl Chemicals Consumer Protection Act of 2022), Connecticut (An Act Concerning the Use of PFAS in Certain Products), Maine (PFAS in Products Law and Act to Stop PFAS Pollution), Maryland (Toxic-Free Cosmetics Act of 2023), Minnesota (2023 PFAS Reporting Law), Oregon (Toxic-Free Cosmetics Act of 2023), Vermont (18 V.S.A. § 1671-1695) and Washington (Toxic-Free Cosmetics Act of 2023)—have implemented regulations, ranging from significant reporting requirements to outright bans of PFAS in personal care products.
Other states, including Massachusetts, Michigan, New Jersey and New York, are also working on restricting PFAS, among other chemicals, in personal care products. If manufacturers are distributing their products nationwide, it is vital to be aware of and comply with each of the state’s varying regulations.
For example, California and Colorado legislation banned specific products containing intentionally added PFAS, including cosmetics, beginning on January 1, 2025. Phase-out years of cosmetic products with intentionally added PFAS currently range from 2025 to 2028.
On the federal level, while there is no outright ban of PFAS in personal care products, several lawmakers have pushed for bills to be passed to commence a federal regulatory standard or framework—most recently, the No PFAS in Cosmetics Act. Manufacturers can expect to see a possible framework for future federal legislation after the release of the MoCRA report.
As the varying current and proposed legislation is re-identifying what constitutes “safe” versus “dangerous” utilization of PFAS in products and is continually amending its guidance through new scientific research and studies, manufacturers and suppliers need to closely monitor the legislation throughout the country (and even internationally) to ensure their products adhere to the rapidly changing landscape.
CDU: What are the most significant ongoing research initiatives related to PFAS in cosmetics, and how might emerging scientific findings shape future regulatory action or litigation?
MG+M: The most significant ongoing research initiative related to PFAS in cosmetics is the U.S. Department of Health and Human Services’ National Toxicology Program research on the specific health effects of PFAS on rodent and cell-based test systems.
Though the research is ongoing, the study has revealed (1) both long- and short-chain PFAS affected the same organs; (2) increased numbers of tumors were found on subjects exposed to perfluorooctanoic acid (PFOA) during gestation or post-weaning; (3) exposure to PFOA and perfluorooctanesulfonic acid (PFOS) suppressed the release of certain immune signaling molecules in human cell lines; (4) PFAS affect neurodevelopment by targeting neuron cells; and (5) PFAS affected mitochondrial function in rats.
Depending on the outcome of this and future studies, it’s possible that we see additional regulatory action in the future regarding unintentionally present PFAS in personal care products.
CDU: How have recent talc-related lawsuits shaped the strategies that plaintiffs and defendants may use in potential PFAS litigation in the cosmetics industry?
MG+M: Plaintiffs in potential PFAS litigation may allege that manufacturers were negligent in failing to ensure product safety and neglected to warn consumers about the risks associated with PFAS exposures. Plaintiffs may seek extensive discovery from manufacturers and suppliers regarding their level of knowledge pertaining to possible harm due to exposures to PFAS.
Based on information obtained from that discovery and the ongoing regulatory and scientific fields, plaintiffs may claim that future defendants had a duty to warn consumers of the potential of harm of exposures to PFAS.
Like talc lawsuits, the strength of PFAS cases may rely heavily on scientific studies and expert testimony demonstrating the presence of PFAS in products and a causal link between PFAS exposure and alleged health issues. There will continue to be significant scientific developments in the coming years as public health issues surrounding PFAS continue to get heightened scrutiny.
Inspired by talc defense tactics, defendants in PFAS cases may emphasize rigorous product testing and comprehensive documentation of manufacturing processes and quality control measures to demonstrate product safety and adherence to industry standards and regulations.
Alternative and medical causation defenses have been key in defending talc and asbestos cases. Drawing parallels from talc litigation, defendants will likely need to challenge the alleged link between PFAS exposure and specific health conditions by presenting alternative risk factors and highlighting limitations in the scientific research linking PFAS to health issues.
One significant difference between developing defenses with regard to differential diagnoses in PFAS litigation, as opposed to talc litigation, is that there are a multitude of diseases that are casually associated with PFAS exposure, while asbestos-related talc cases focus mainly on two signature diseases: mesothelioma and ovarian cancer.
Thus, challenging causation with regard to PFAS will potentially be more difficult and time-consuming given the sheer number of alternate causes, and given the disease variation.
A major point of contention in talc litigation has involved methodology of analytical testing methods, which will likely be a significant factor as PFAS litigation continues to unfold. Beyond just challenging plaintiff expert opinions, it will likely be critical in PFAS litigation for manufacturers and suppliers to begin developing experts and expert strategy.
If PFAS-containing cosmetic products are eventually regulated as over-the-counter drugs and fall under an FDA monograph, defendants might leverage federal preemption as a defense against state law tort claims, mirroring a strategy explored in talc cases.
It is important to note that the legal landscape surrounding PFAS in cosmetics and personal care products is still evolving, with new scientific research constantly emerging. The specific strategies employed in future PFAS litigation will depend heavily on these ongoing developments.
CDU: What proactive steps can cosmetics and personal care product companies take now, such as reformulation, supply chain audits or enhanced testing, to reduce the risk of future PFAS-related claims?
MG+M:
Reformulation
- Proactively Identify and Replace PFAS Ingredients: Conduct a comprehensive review of all product formulations and raw material inputs to identify the presence of intentionally added PFAS.
- Embrace PFAS-Free Alternatives: Explore and implement readily available and emerging PFAS-free alternatives with similar functionality.
- Research and Development: Allocate resources to discover and develop new PFAS-free ingredients and formulations.
- Consider Third-Party Certification: Partner with experts and certification bodies to validate PFAS-free product claims and build consumer trust.
Supply Chain Audits
- Establish a Clear PFAS Policy: Develop and communicate a comprehensive PFAS policy to all suppliers that outlines your company’s acceptable levels for various chemicals, including PFAS.
- Supply Chain: Identify all suppliers, including those involved in producing raw materials, packaging and components. Conduct thorough risk assessments to pinpoint suppliers with a higher risk of PFAS presence.
- Require Certifications and Testing: Request certifications of analysis from raw products suppliers and manufacturers and consider conducting regular testing of materials received from suppliers to confirm the absence of PFAS.
Enhanced Testing and Data Management
- Implement Robust Testing Protocols: Utilize validated analytical methods such as LC-MS and GC-MS to accurately detect and quantify PFAS in raw materials and finished products.
- Beyond Targeted Analysis: While targeted analysis for known PFAS is important, consider non-targeted analysis methods using high-resolution mass spectrometry (HRMS) to identify a broader range of PFAS compounds, including unknown ones.
- Maintain Detailed Records: Document all aspects of PFAS testing, including methodologies, results and mitigation efforts. This information will be crucial for demonstrating compliance and addressing potential claims or lawsuits, specifically with regard to mitigating the risk of punitive damages.
- Stay Informed About Testing Advancements: Monitor the development of new PFAS testing methodologies and their applicability to cosmetic and personal care products. Participate in discussions and initiatives with industry and regulatory groups focused on PFAS to stay informed and influence the development of future regulations, especially with regard to cosmetics.
Regulatory Monitoring and Compliance
- Actively monitor the rapidly evolving PFAS regulatory landscape at both the state and federal levels. The regulatory landscape is constantly evolving, especially on a state-by-state basis.
- Given the lack of a comprehensive federal ban, companies must understand and comply with varying state-specific bans, restrictions, reporting obligations and definitions of “intentionally added” PFAS.
- Where possible, align internal processes with the most stringent applicable regulations to ensure broader compliance.
- Establish systems to efficiently collect and report the required information in jurisdictions with PFAS reporting mandates.
Proactively addressing PFAS concerns and getting ahead of the litigation will be crucial to mitigating risk, especially with regard to punitive damages. By implementing these proactive steps, cosmetic and personal care product companies can effectively navigate the evolving PFAS landscape, mitigate potential risks and maintain a competitive edge in a market increasingly focused on safety and sustainability.
CDU: Given the trajectory of PFAS regulation and litigation, what trends should industry stakeholders be preparing for over the next 5 to 10 years?
MG+M: Industry stakeholders should expect a continued expansion of PFAS regulations, moving beyond the traditionally targeted chemicals (PFOA and PFOS) to encompass a wider range of PFAS compounds. States are increasingly leading the way in regulating PFAS in various products, including personal care products. They should also expect more stringent reporting requirements for PFAS manufacturing, importation and use across supply chains.
States, particularly California, Maine and Minnesota, are implementing stricter regulations and bans on PFAS in consumer products, which can often precede or even exceed federal action.
Lawsuits against PFAS manufacturers will likely continue to seek compensation for environmental damage, particularly water contamination, as well as personal injury claims linked to PFAS exposure from products in a wide range of industries. It is important to follow key trials and potentially large settlements in ongoing multi-district litigation (MDL) cases, which could influence future litigation and damage awards.
DuPont’s recent $2.5 billion settlement of PFAS claims brought by the state of New Jersey, along with 3M’s settlements with New Jersey and Minnesota, highlight the significant risks posed by PFAS litigation. Such high-value settlements may cause more plaintiff firms to engage in PFAS litigation while at the same time heightening public awareness of such claims.
While the cosmetics industry will face vastly different allegations than DuPont or 3M did, personal injury lawsuits may pose significant risk, as demonstrated by nuclear verdicts from such lawsuits in cosmetic talc litigation.
We expect a rise in lawsuits targeting companies for deceptive marketing practices, specifically those making unsubstantiated claims about products being PFAS-free or environmentally friendly. These types of lawsuits, known as consumer fraud, have been the main focus of recent product-related PFAS lawsuits.
As more scientific research is conducted with on PFAS and disease causation, industry stakeholders should be preparing for personal injury cases to eventually become more prevalent. Personal injury lawsuits will almost certainly result in more significant defense costs and increased damages than consumer fraud cases do.
It is possible that litigation will spread beyond traditional manufacturers to include retailers, importers and suppliers for a variety of industries. This is a common pattern time and time again in mass toxic tort litigation.
With regard to asbestos, the target defendants initially were the most significant manufacturers of asbestos-containing products. Eventually, the major asbestos manufacturers went bankrupt, leading to a continuously expanded pool of viable defendants. The trend of expanding defendants continues more than 40 years later, to this day typically involving defendants that are far more attenuated from any real source of exposure compared to those who were significant players in the asbestos industry.
We have seen the same trends in talc litigation. When cosmetic talc litigation was in its infancy, only a handful of manufacturers and suppliers were sued in a case. As the litigation has evolved, the number of defendants and the types of defendants have expanded significantly.