U.S. Regulatory Update: MoCRA, PFAS, Lead in Cosmetics, and Formaldehyde Restrictions

As we look toward 2025 and beyond, the U.S. cosmetic industry will see a significant increase in global regulations. While the U.S. may not be the first to implement changes, it could soon lead the way in regulatory complexity, not only due to the Modernization of Cosmetics Regulation Act (MoCRA) but also through other significant updates. Here’s a closer look at the current landscape.

The Rise of State-Level Regulations

Without federal preemption, individual U.S. states are increasingly passing their own ingredient regulations, creating a regulatory patchwork. This trend could mirror the situation in the European Union (EU) before the passage of EC 1223/2009, when each EU country could ban or restrict ingredients at will. This made it difficult for brands to create one product formula that complied across the region. A similar scenario may unfold in the U.S. over the next few years, with states regulating ingredients in ways that could force product reformulations.

U.S. Regulatory Changes in Motion

1. MoCRA: A New Era for Cosmetics Regulation

In 2024, the U.S. Food and Drug Administration’s (FDA) Office of Cosmetics and Colors focused on implementing the Modernization of Cosmetics Regulation Act of 2022 (MoCRA). Starting in July 2025, the product listing portal will officially open. This, combined with a renewed focus on safety substantiation, has already proven to be a resource-intensive process for both domestic and international brands. By 2025, the FDA is expected to step up enforcement, inspecting facilities and issuing penalties, such as warning letters and mandatory recalls, for non-compliance. Foreign brands may even face customs holds on their imported products.

MoCRA mandates several significant regulations, including the creation of guidelines for Good Manufacturing Practices (GMP), fragrance allergen labeling, and testing methods for detecting asbestos in talc-containing products. On December 27, 2024, the FDA issued proposed testing methods for detecting asbestos in talc, marking an important development in consumer safety.

1. Formaldehyde and Fragrance Allergen Restrictions

Formaldehyde and formaldehyde-releasing chemicals in hair smoothing and straightening products were slated for a ban in 2024. However, this has been delayed multiple times and is now scheduled for March 2025. Additionally, fragrance allergen labeling regulations, initially due in June 2024, have been postponed until January 2025. The exact details of these regulations remain unclear, but their eventual publication could significantly affect brands, particularly those dealing with fragrance formulations.

1. CARES Act Fees and Color Certification Increases

The FDA has also been given the authority to collect user fees from over-the-counter (OTC) product manufacturers as part of the Coronavirus Aid, Relief, and Economic Security (CARES) Act. These fees support the OTC monograph program (OMUFA), which recently funded the development of a new IT system for the electronic availability of OTC monographs.

Additionally, starting December 9, 2024, the FDA increased its fees for color certification services. The new fees will add $0.10 per pound for straight colors, including lakes, and similar increases will apply to repacks of certified color additives and mixtures.

1. FDA Reorganization: A New Focus on Science and Ingredients

The FDA’s Office of Cosmetics and Colors has moved from the Center for Food Safety and Applied Nutrition (CFSAN) to the Office of the Chief Scientist (OCS). This reorganization aims to provide more strategic leadership, enhance scientific research, and better coordinate regulatory policies across various product categories, including cosmetics. The move is expected to support more integrated and well-researched ingredient regulations, potentially streamlining the regulatory process for emerging ingredients.

2024: A Preview of State Regulations for 2025

In 2024, the U.S. cosmetic industry got a preview of what’s likely to unfold in 2025 and beyond, with states taking the lead in regulating certain ingredients. Per- and polyfluoroalkyl substances (PFAS), lead, and formaldehyde donors are among the top targets for state regulation, with 1,4-dioxane also gaining attention.

1. PFAS: Undefined and in Limbo

A major hurdle in complying with PFAS regulations is the lack of a uniform federal definition. Various states have adopted different definitions for PFAS, making it difficult for brands to remain compliant. Some states, such as California, have their own regulations on PFAS in personal care products, with other states following suit. The U.S. Environmental Protection Agency (EPA) is expected to release draft regulations soon, but until a national standard is established, brands must navigate this complex patchwork of state regulations.

1. Lead Limits in Cosmetics

Several states, including California, Colorado, Maryland, Minnesota, and Washington, have enacted regulations limiting lead levels in cosmetics. Most states have set the limit at 10 parts per million (ppm), aligning with the FDA’s approved level for colorants. However, Washington has set an especially stringent limit of 1 ppm for lead in cosmetics, a move that could prompt other states to adopt similar standards. This decision was based on findings from a study of 50 low-cost cosmetic products, which found lead concentrations ranging from 1 ppm to 5.55 ppm in certain makeup products. The Washington Department of Ecology’s action is particularly notable for its focus on reducing exposure to harmful chemicals, particularly for people of color.

1. Formaldehyde and Formaldehyde Donors: Stricter State Regulations

California and Washington have already banned formaldehyde and formaldehyde-releasing chemicals in hair smoothing products as part of their Toxic-Free Cosmetics Acts, effective January 1, 2025. Maryland and New York have also passed similar restrictions. While this regulatory shift is not unexpected, it could have significant implications for companies in the hair care industry, especially for those who rely on formaldehyde or formaldehyde donors as preservatives. Other countries, like Saudi Arabia, are also stepping up their testing requirements for formaldehyde in hair care products, adding to the global complexity of compliance.

Looking Ahead: A More Complex Regulatory Landscape

The cosmetic industry is entering a more regulated future, with increased attention on ingredient safety and transparency. As the U.S. continues to navigate the implementation of MoCRA and states introduce their own ingredient-specific regulations, companies will need to adapt quickly to keep up with these changes. The patchwork regulatory environment may be challenging, but with careful planning and strategic regulatory compliance, brands can continue to thrive in an increasingly complex global marketplace.