The Modernization of Cosmetics Regulation Act (MoCRA), enacted in 2023, has already set a new standard for the U.S. cosmetics industry. While there isn’t a separate legislative act labeled “MoCRA 2025,” the implementation of MoCRA continues to evolve, with several key provisions already in effect and additional changes anticipated later this year. In this blog post, we break down what’s currently active, what’s coming, and what these developments mean for manufacturers, suppliers, and consumers.
Since late 2023 and early 2024, several critical components of MoCRA have been successfully implemented, creating a more transparent and safer marketplace for cosmetic products.
Facility Registration
Cosmetic manufacturers and processors are now required to register their facilities with the FDA and renew their registration every two years. This measure ensures that all entities involved in the production of cosmetic products are accounted for and subject to regular oversight, which helps maintain high safety and quality standards.
Product Listing
Every cosmetic product sold in the U.S. must be listed with the FDA. This listing includes detailed information on product ingredients, which not only promotes transparency but also assists in tracking and responding to any safety concerns. With a complete product listing, consumers and regulators can quickly identify products that may need further review.
Safety Substantiation
Under MoCRA, companies must provide robust safety data to support their cosmetic formulations before they hit the market. This requirement moves the industry toward a more proactive safety approach, ensuring that any potential risks are evaluated and mitigated in advance.
Adverse Event Reporting and Mandatory Recall Authority
Manufacturers are now obligated to report any serious adverse events associated with their products. Additionally, the FDA has been granted mandatory recall authority, which means that if a cosmetic is deemed unsafe, it can be swiftly removed from the market to protect consumer health.
Furthermore, strict recordkeeping requirements are now in place—companies must maintain adverse event records for up to six years (three years for some small businesses) and the FDA can suspend facility registrations if products are found unsafe, underscoring the importance of robust internal compliance systems.
Professional Use Labeling
New labeling requirements have been introduced for products intended for professional use. These labels provide essential information about proper handling and usage, reducing the risk of misuse and ensuring that professionals are well-informed about the product’s safety and performance parameters.
It’s important to note that MoCRA includes specific exemptions for small businesses. Companies that qualify—typically those with average gross annual U.S. sales below a defined threshold—may be exempt from some registration and listing requirements. Also, key deadlines, such as the July 1, 2024 deadline for facility registrations and product listings, are critical for compliance planning.
While the above measures have been implemented, there are several important areas that remain in the rulemaking phase. These pending regulations are expected to be finalized later in 2025 and will further refine the regulatory framework for cosmetics:
Talc-Containing Cosmetics
New testing methods are under development to ensure that cosmetic products containing talc are free of asbestos. Since talc is naturally mined from areas that can also contain asbestos, the risk of contamination has long been a concern. The forthcoming testing standards will help assure consumers that products like baby powders and makeup are safe for daily use.
Good Manufacturing Practice (GMP) Requirements
The FDA is working on finalizing GMP regulations specific to cosmetics manufacturing. These guidelines will establish uniform procedures for production, quality control, and recordkeeping, ensuring that cosmetic products are produced consistently and safely. Final GMP standards will be critical for reducing the risk of contamination and other manufacturing defects.
Fragrance Allergen Labeling
New labeling rules for fragrance allergens are also in the pipeline. Fragrances are a common source of allergic reactions for many consumers. The updated labeling requirements will provide clearer information on which allergens are present, empowering consumers to make more informed choices, especially those with sensitive skin or allergies.
The continued evolution of MoCRA means that cosmetics companies must remain proactive. Here are some key implications:
Increased Compliance Requirements: Companies will need to invest in enhanced testing, quality control systems, and updated labeling practices to meet the new standards.
Supply Chain Considerations: Manufacturers may need to review their supply chains to ensure that all raw materials and ingredients comply with the new testing and manufacturing standards.
Consumer Transparency: With more detailed product listings and labeling, consumers will have better access to information about product safety, leading to increased trust and potentially higher demand for products that meet these rigorous standards.
Competitive Advantage: Brands that quickly adapt to these changes may gain a competitive edge by positioning themselves as leaders in safety and transparency.
Although there is no new “MoCRA 2025” legislative act, the ongoing implementation of MoCRA is set to bring significant changes to the cosmetics industry throughout this year. With many of the foundational requirements already in place, the finalization of new testing methods for talc, GMP regulations, and fragrance allergen labeling will further enhance product safety and transparency. Staying informed and proactive is key for manufacturers and suppliers as they navigate this evolving regulatory landscape, ensuring that they continue to meet consumer expectations and regulatory demands in 2025 and beyond.
