The FDA’s regulatory landscape for cosmetics continues to evolve, and 2025 has already brought significant developments under the Modernization of Cosmetics Regulation Act of 2022 (MoCRA). For contract manufacturers and brand owners, staying informed isn’t just about compliance—it’s about staying competitive.
Here’s a breakdown of the most recent updates and what they mean for your business.
1. Mandatory Registration and Listing: The Numbers Are In
As of January 1, 2025, the FDA has received:
9,528 active facility registrations
589,762 unique product listings
This marks a dramatic increase from the previous Voluntary Cosmetic Registration Program (VCRP), which had only 5,176 facility registrations and 35,102 product listings. The shift from voluntary to mandatory registration has significantly expanded the FDA’s oversight.
What it means for you:
If you haven’t registered your facility or listed your products, you’re already behind. These are now legal requirements under MoCRA, and non-compliance could lead to enforcement actions.
2. Increased Transparency and Public Data Access
The FDA has made registration and listing data publicly available, including:
Facility locations by state and country
Product listing volumes
Submission methods (e.g., Cosmetics Direct, ESG, SPL)
What it means for you:
Your registration status is now part of the public record. This transparency can affect your reputation with retailers, partners, and consumers.
3. Enforcement Trends Under the New Administration
Despite broader political shifts, MoCRA remains in full effect. The FDA is actively monitoring compliance and has signaled that enforcement will continue to ramp up.
What it means for you:
Don’t assume regulatory leniency. The FDA is watching—and the data shows they’re prepared to act.
4. How to Adapt: Legal and Strategic Recommendations
To stay ahead of these changes, contract manufacturers and brand owners should:
✅ Audit your registration and product listings to ensure accuracy and completeness.
✅ Review your labeling and marketing claims to avoid misbranding.
✅ Update Quality Agreements to reflect MoCRA responsibilities.
✅ Maintain documentation for safety substantiation and adverse event reporting.
How I Can Help
As an attorney focused on FDA regulatory compliance, I help clients:
Navigate MoCRA registration and listing
Draft and review Quality Agreements
Prepare for FDA inspections
Respond to enforcement actions
📩 Need help adapting to the latest FDA changes?
Let’s talk. I offer tailored legal support for contract manufacturers and brand owners navigating the evolving regulatory landscape.
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