MoCRA Cosmetic Compliance 2025: FDA Registration & Listing

A New Era for Cosmetic Compliance

2025 marks a regulatory turning point with the FDA’s full enforcement of the Modernization of Cosmetics Regulation Act of 2022 (MoCRA), transforming the landscape for cosmetic manufacturers, importers, and contract partners. It is the most significant update to the U.S. cosmetics regulatory framework in over 80 years. Facility registration and product listing are no longer voluntary, and the FDA’s enhanced oversight brings both new opportunities and risks for market leaders.

This newsletter details the MoCRA evolution, key FDA obligations, enforcement trends, global comparisons, and practical compliance strategies to help industry professionals navigate this rapidly changing landscape in 2025 and beyond.

Cosmetic Regulatory Milestones in the US

Key Intelligence

MoCRA significantly expands the FDA’s authority, allowing suspension of facility registrations if public health risks are found—a first in U.S. cosmetics regulation history.
Adverse event reporting now requires brands to notify the FDA of serious health-related complaints within 15 business days, accelerating the FDA’s safety response.
The Act closes regulatory gaps, aligning cosmetic oversight closer to that of foods, drugs, and medical devices, establishing a new standard of accountability.
Foreign companies must designate and maintain active U.S. Agents responsible for FDA communications, compliance records, and adverse event coordination.
The FDA’s expanded database provides public access to cosmetic product and facility data, increasing transparency but also reputational exposure for non-compliant companies.

Case Study: Rising FDA Enforcement Highlights MoCRA Compliance Gaps

• A recent analysis from Registrar Corp in November 2024 revealed that 48% of imported cosmetics sold at America’s top 25 retailers were not compliant with MoCRA registration and listing requirements.
• FDA logged 5,000+ consumer health complaints in 2023, including severe reactions and permanent injuries.
• This non-compliance spanned over 135,000 products, posing consumer safety risks, including severe allergic reactions and permanent injuries reported to the FDA.
• In response, the FDA has aggressively ramped up enforcement actions, including warnings, product recalls, and requests for rapid corrective measures.

FDA Regulatory Requirements

Requirement	Who Must Comply	What’s Required	Frequency
Facility Registration	Domestic and foreign manufacturers/processors	FDA Establishment Identifier (FEI) + FDA Form 5066 via Cosmetics Direct	Every 2 years
Product Listing	Responsible Person (named on label)	FDA Form 5067 + ingredient details	Annual + upon changes
Foreign Facilities	Must appoint a U.S. Agent	Serve as FDA contact	Continuous
Exemptions	Some small businesses, drug/device overlaps	Documented exemptions	Reviewed annually

For a detailed guide on obtaining and understanding the importance of the FEI number, see our article: How to Apply for Your FDA FEI Number?

“The agency will rely on registration and listing to identify risky products, facilitate recalls, plan inspections, and enforce compliance.”Linda Katz, M.D., M.P.H., Director, FDA Office of Cosmetics & Colors

2025 Enforcement Snapshot:

As of January 1, 2025, the U.S. FDA reported a nearly 20-fold increase from the pre-MoCRA Voluntary Cosmetic Registration Program (VCRP) totals of 5,176 facilities and 35,102 products:
• 9,528 active cosmetic product facility registrations, including both domestic and foreign manufacturing sites.
• 589,762 unique cosmetic product listings registered under the mandatory MoCRA requirements
• Foreign facilities constitute a significant share, with China accounting for about 44.7% of registered establishments.

Strategic Global Comparison

Country	Jurisdiction	Facility Registration	Product Listing	Responsible Person	Labeling	Exemptions
	U.S. Food and Drug Administration (FDA)	Mandatory biennial	Annual full ingredient listing	US Responsible Person required	Contact info required on label	Small business exemptions apply
	European Medicines Agency (EMA) / European Commission	No; Responsible Person (RP)	Notification via Cosmetic Product Notification Portal (CPNP)	RP required	RP address and batch code	Limited; mostly R&D related
	Medicines and Healthcare products Regulatory Agency (MHRA)	No; RP required	Notification via UK Submit Cosmetic Product Notification (SCPN) Portal	RP required	RP address and batch code	Similar to the EU
	Health Canada (HC)	No; cosmetic notification form	Notification within 10 days of sale	Manufacturer or importer	Label contact is often required	Few, varies by province
	National Medical Products Administration (NMPA)	Registration or filing varies	Registration or filing required	Chinese RP	Local labeling, testing required	None; strict enforcement

Why This Matters Beyond Compliance

From a marketing and commercial perspective, facility registration and product listing are reshaping how brands operate:

Supply chain leverage: Retailers and distributors are increasingly asking for proof of listing as part of vendor qualification.
Consumer trust: In an era of transparency, being able to say “Our products are fully FDA-listed” is becoming a brand value proposition.
Operational discipline: Companies that build robust change-control processes are discovering fewer product launch delays.

Closing Thoughts

As MoCRA continues to reshape the cosmetics landscape, expect the FDA to step up its oversight with smarter tools and data-driven enforcement. This means greater transparency and a closer look at product safety, labeling, and supply chains. For brands, staying ahead means building strong compliance programs, keeping U.S. Agent relationships active, and preparing for evolving requirements—both at home and globally. Embracing these changes isn’t just about meeting regulations; it’s about gaining trust, reducing surprises, and positioning your brand for long-term success in a rapidly changing market.

References

Pharma Focus

Registration & Listing of Cosmetic Facilities and Products in the US