- Chemical Regulation. Chemical regulation in the personal care industry is expanding, with significant developments such as Washington State's HB 1047, the Toxic-Free Cosmetics Act. Starting Jan. 1, 2025, the Act will prohibit the sale of cosmetics containing certain chemicals, including a one part per million lead restriction. This law allows a one-year sell-through period for retailers with existing stock. However, the Washington Department of Ecology has signaled that it recognizes feasibility concerns about the lead standard and may create temporary alternative compliance pathways. On Dec. 19, 2024, the Washington Department of Ecology announced it is commencing its rulemaking to implement the Act and expects to have final regulations by the end of 2026. Meanwhile, regulation and litigation around per- and polyfluoroalkyl substances (PFAS) are increasing, with new laws in California, Colorado, and Minnesota banning cosmetics with intentional PFAS starting January 2025.
- California’s Proposition 65 Litigation. In 2024, manufacturers and retailers of cosmetics and personal care products faced extensive Proposition 65 (Prop 65) enforcement from private "bounty hunter" organizations, resulting in nearly 5,000 Prop 65 notices of violation. The enforcements have primarily targeted titanium dioxide (TiO2) and diethanolamine (DEA), with the TiO2 litigation involving around 140 coordinated cases potentially being dismissed based on dispositive motions, and the Personal Care Product Council successfully obtaining a preliminary injunction against new TiO2 lawsuits based on a First Amendment theory. DEA enforcement is in early stages, with over 900 violation notices issued and new lawsuits being filed every week. Additionally, significant developments at the chemical listing stage include bisphenol S (BPS) becoming penalty-eligible under Prop 65 by the end of 2024, and the potential listing of isoeugenol (a fragrance constituent) and talc under Prop 65 in 2025.
- Alleged Health Risk Litigation and Important Preemption Decisions. Similar to 2024, key personal injury and class action litigations related to alleged health risks from cosmetics and personal care products, such as those involving talc, dry shampoo, benzoyl peroxide, and hair relaxers, will continue to pose significant risks to companies. Talc litigation remains substantial despite FDA tests showing no asbestos in cosmetics, with new medical monitoring claims expected to be litigated in 2025. Consumer class action lawsuits targeting undisclosed PFAS in cosmetics are also on the rise, with varying legal outcomes, often hinging on the adequacy of plaintiffs’ allegations. Benzoyl peroxide lawsuits, following the denial of a multi-district litigation (MDL) in August, will proceed in separate courts amid proliferating benzene contamination allegations. The Hair Relaxer MDL, concerning alleged endocrine disruptors like phthalates and parabens in fragrances, has advanced past initial motions and is entering discovery, with the litigation progressing towards class certification briefing and bellwether trials in 2025. In these and other litigations, key issues such as preemption will continue to be hotly litigated. Recent preemption opinions in various courts, such as the dismissal of putative class claims involving benzoyl peroxide product labeling as preempted by federal law, will influence ongoing and future litigation in the cosmetics and personal care sectors, with further legal debates expected in 2025.
- EPR. Extended Producer Responsibility (EPR) laws are expanding across the United States, posing operational challenges for consumer-packaged goods companies by shifting the cost of waste management from municipalities to producers of single-use packaging. Minnesota recently became the sixth state to enact a broad packaging EPR law, joining California, Colorado, Maine, Oregon, and Maryland in requiring producers to manage the end-of-life disposal of their packaging. Companies are encouraged to join the Circular Action Alliance, which administers EPR programs in several states. Moreover, companies should carefully review their obligations under each of these state laws to ensure compliance, including assessments related to California's requirement of 100% recyclable or compostable single-use packaging by 2032. Additionally, California has passed the first U.S. textile EPR law for leather goods and other textiles, establishing a framework similar to packaging EPR laws and instituting a statewide collection and recycling program.
- The Future of MoCRA Is Uncertain. While certain elements of the Modernization of Cosmetics Regulation Act of 2022 (MoCRA) were implemented and became mandatory in 2024, such as the registration of manufacturing facilities and listing of products and ingredients, the recent election may slow down the further implementation of MoCRA requirements in 2025. Under MoCRA, the FDA was tasked with issuing new regulations to implement good manufacturing practices, establishing testing methods for safety, and adding labeling requirements for fragrance allergens and serious adverse event reporting, all of which were expected to be on the agenda in the upcoming year. Whether the new administration and new people in charge of the FDA will have the same interests in furthering the mandates of MoCRA will be watched closely by companies in the cosmetics and personal care products industries in 2025.
About the authors:
Nilda M. Isidro is a shareholder in the firm’s New York office and a member of the firm’s Pharmaceutical, Medical Device & Health Care Litigation practice. Nilda focuses her practice on the representation and defense of product companies, with an emphasis on pharmaceutical, medical device, and consumer product litigation.
Alexandra “Ally” Lizano is a member of the Environmental Practice in the firm’s Sacramento office. Ally counsels public and private sector clients through the complexities of environmental laws and regulations. Her practice also includes consumer product defense and regulatory compliance in California.
Madeline Orlando is a member of the International Trade Practice in the firm’s Sacramento office. Madeline has wide-ranging experience advising clients on virtually all facets of regulatory and compliance, including both state and federal consumer product, environmental, and agriculture, food, and beverage regulatory issues.
Justin J. Prochnow is a shareholder in the firm’s Denver office and a member of the firm’s Food, Beverage & Agribusiness Practice. Justin assists companies with regulatory, business, and legal needs in the beverage, food, dietary supplement, cosmetic, medical device, and OTC industries.
Will Wagner is a shareholder in the firm’s Sacramento office and a member of the firm’s Litigation Practice. Will focuses his practice in the areas of consumer product defense and regulatory compliance in California, including the defense of consumer claims involving California’s unique Proposition 65 and consumer false advertising class actions.