The US MoCRA Roadmap: What Nail Brands Need to Know
Ensuring Safety, Compliance, and QC & Documents for the Next Era of Professional Nail Care.
Introduction to MoCRA
The Modernization of Cosmetics Regulation Act of 2022 (MoCRA) is the most significant expansion of the FDA’s authority over cosmetics since 1938. For US nail brands sourcing internationally, MoCRA transforms "compliance" from a best practice into a strict legal requirement for market access.
1. Mandatory Facility Registration & Product Listing
Under MoCRA, every facility that manufactures or processes cosmetic products for the US must register with the FDA. Furthermore, "Responsible Persons" (the brand owner or distributor) must list each cosmetic product, including its ingredients and location of manufacture.
At NEW NAIL, we maintain active facility registration and provide our partners with all necessary data for their individual product listings.
2. Safety Substantiation: The New Gold Standard
Perhaps the most critical pillar of MoCRA is the requirement for "Adequate Substantiation of Safety." Brands must maintain records proving that their products are safe for their intended use. For gel polish, this includes:
- Toxicological Risk Assessments (TRA): Evaluating individual monomers and photoinitiators.
- Stability Testing: Ensuring the formula does not degrade into harmful components over time.
- Impurity Analysis: Screening for heavy metals and restricted solvents.
3. Labeling and Adverse Event Reporting
Labels must now include a US address or phone number for reporting serious adverse events. Brands must also report any serious health incidents related to their products to the FDA within 15 business days.
We support our clients by reviewing their label artwork to ensure all MoCRA-mandated contact information and fragrance allergen disclosures are correctly placed.
4. Summary of Compliance Deadlines
| Requirement | Deadline | Status for NEW NAIL Clients |
|---|---|---|
| Facility Registration | July 1, 2024 | Completed & Verified |
| Product Listing | July 1, 2024 | Support Documentation Ready |
Professional FAQ for US Buyers
Q: What are the MoCRA requirements for nail polish specifically?
Answer: Beyond facility registration and product listing, nail brands must focus on safety substantiation. This includes ensuring pigments and photoinitiators (like TPO alternatives) meet FDA safety thresholds.
Q: Does MoCRA apply to small salon brands?
Answer: Yes. While some "small businesses" have exemptions for GMP, they are not exempt from product listing, safety substantiation, or adverse event reporting.