MoCRA Compliance for Private Label Brands
As the responsible person under MoCRA, private label brands bear the primary regulatory burden — even when products are made by contract manufacturers. Know your obligations.
Quick answer: Private label cosmetics MoCRA compliance
Under MoCRA, the "responsible person" is the entity whose name appears on the product label — for private label brands, that means you, not your contract manufacturer. The responsible person must register facilities, list all products with FDA, report serious adverse events within 15 business days, and ensure adequate safety substantiation for every formulation.
MoCRA Obligations for Private Labelers
Under MoCRA, the name on the label determines who is responsible. For private label brands, that means you — not your manufacturer — are the responsible person with primary compliance duties.
Responsible Person Designation
Private labelers are the 'responsible person' under MoCRA — the entity whose name appears on the label bears primary compliance obligations.
Facility Registration
Even if you don't manufacture, facilities that pack or hold cosmetics must register. You must also verify your contract manufacturer's registration.
Product Listing
The responsible person must list every cosmetic product with FDA, including all variants (shades, sizes, fragrance types).
Adverse Event Reporting
As the responsible person, private labelers must report serious adverse events to FDA within 15 business days and maintain records for 6 years.
Safety Substantiation
The responsible person must ensure adequate safety substantiation exists for every product. This cannot be delegated entirely to the contract manufacturer.
Label Compliance
INCI ingredient declarations, net quantity, responsible person contact info, warnings, and proper product identity are all required on labels.
Compliance Challenges for Private Label Brands
Private labelers often lack in-house regulatory expertise, making MoCRA compliance particularly challenging.
- Understanding that 'private labeler' means you are the responsible person with full regulatory liability
- Verifying that your contract manufacturer has valid FDA facility registration and proper cGMP
- Managing product listings for large catalogs with dozens or hundreds of SKUs and variants
- Setting up adverse event intake and reporting processes when you lack a regulatory team
- Obtaining adequate safety substantiation from contract manufacturers for every formulation
- Navigating state-level cosmetic regulations (California SB 484, MN, OR) alongside federal MoCRA
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MoCRA Registration
Facility registration and complete product listing for your entire private label catalog
Responsible Person Support
Guidance on your obligations as the MoCRA responsible person, including AE reporting setup
Label Review
Comprehensive cosmetic label compliance review against FDA and state requirements
US Agent Services
Required US Agent for foreign brands selling into the US market
Automation Benefits with Assurentry
- Bulk product listing management — upload your entire catalog and track listing status per SKU
- Automated renewal reminders for facility registration (biennial) and product listing updates
- Adverse event intake forms and tracking with 15-business-day deadline alerts
- AI-powered label review checking INCI names, required statements, and claim compliance
- Contract manufacturer compliance verification and documentation management
Frequently Asked Questions
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