U.S. FDA Unveils Latest Data on Facility Registration and Product Listing under MoCRA

On March 15, 2025, the U.S. Food and Drug Administration (FDA) published its first statistical report on cosmetic facility registrations and product listings under the Modernization of Cosmetics Regulations Act of 2022 (MoCRA).

As of January 1, 2025, the FDA’s database shows that 9,528 cosmetic manufacturing facilities have completed the required registration process, with 589,762 cosmetic products now listed under the MoCRA framework. These figures represent a major leap in market transparency compared to the previous Voluntary Cosmetic Registration Program (VCRP), which recorded far fewer registrations over its 51-year history (1972–2023).

The data also reveals robust participation from international manufacturers, particularly from China. Chinese facilities account for 4,260 registered establishments, representing 44.71% of all global registrations and 55.10% of all foreign facility registrations. This strong showing underscores the scale of China’s cosmetic manufacturing sector and the global industry's proactive approach to the new U.S. regulatory requirements.

Chemlinked Comments

The FDA’s release of these statistics offers the first clear snapshot of the cosmetics industry's adoption of MoCRA. It suggests that the new regulatory framework is achieving its goal of creating a more comprehensive and transparent database of market participants. Importantly, all cosmetic companies must complete facility registrations and product listings under MoCRA, as no data was automatically transferred from the discontinued VCRP system. Companies that previously participated in VCRP must now re-register under the mandatory MoCRA framework.

In addition, several other key MoCRA requirements are also fully in effect, including mandatory adverse event reporting and strict recordkeeping requirements, new labeling rules requiring domestic contact information, additional labeling requirements for professional-use products, and safety substantiation obligations. ChemLinked strongly recommends that all companies selling cosmetics in the U.S. market conduct a comprehensive compliance review to ensure adherence to current MoCRA requirements. Special attention should be given to maintaining up-to-date facility and product information, as the FDA has begun actively enforcing registration and listing obligations.

Looking ahead, additional MoCRA requirements, including the finalization of Good Manufacturing Practice (GMP) standards expected by the end of 2025, will continue to reshape the U.S. cosmetics regulatory landscape. Stakeholders should closely monitor FDA announcements for further developments regarding this transformative regulatory framework.

#Webinar

U.S. State Legislations for Cosmetics: An In-Depth Look at CaliforniaCalifornia has long been a pioneer in regulatory matters, setting stringent standards across various industries, including cosmetics. The state’s approach to cosmetics regulation is known for its comprehensive and often more stringent requirements compared to federal standards. This includes a focus on product safety, ingredient transparency, and environmental impact. California's regulations play a significant role in shaping the wider U.S. market, and the state has also led the charge on sustainability and health-related concerns, with laws addressing toxicity, labeling, and ingredient restrictions.In this webinar, Lily Li, a Senior Regulatory Specialist from REACH24H will provide a comprehensive overview of California’s cosmetics regulatory framework, covering key legislative actions like the California Safe Consumer Program and the California Proposition 65 law, along with recent efforts to restrict specific harmful chemicals. We will also explore how these regulations affect companies both in California and across the U.S. By the end of this session, participants will gain a clear understanding of the regulatory landscape for cosmetics in California and be better equipped to navigate these requirements in their operations.Notes:The webinar livestreaming is freely available to all users. You are welcome to register for and participate in the webinar.Kindly be aware that the access to the slides, recording, and Q&A collection is limited to ChemLinked premium members only [Upgrade now].

Further Reading

• U.S. FDA’s Enforcement for Facility Registration and Product Listing Begins on July 1, 2024

• U.S. FDA Updates the Guidance on Cosmetic Facility Registration and Product Listing

• U.S. FDA Sets New Schedules for MoCRA Rulemakings: GMP, Fragrance Allergens, and Asbestos Testing Included

• Webinar: US MoCRA Compliance Focus: Major Updates and Steps for Being Prepared

• Featured: Navigating US Cosmetic Regulations: MoCRA and Beyond