MoCRA Facility, Listings & Labels — Without the Guesswork
We help cosmetic brands, labs and importers get MoCRA-ready with clean facility & product listings, compliant labels and claims, safety substantiation dossiers, and Responsible Person programs that stand up under FDA and marketplace scrutiny.
Why MoCRA Changed the Game
MoCRA moved U.S. cosmetics into a more regulated era: required facility & product listings, adverse event tracking, responsible persons, and clearer expectations for safety and claims. The risk now isn’t only FDA—it’s retailers, marketplaces and insurers asking if you’re actually compliant.
- Facility & product visibility: FDA wants to know who makes what, where, and under whose responsibility.
- Labels & online claims: MoCRA intersects with 21 CFR 701/740, “drug vs cosmetic” boundaries, and platform policies.
- Safety substantiation: not every product needs clinicals, but you do need a defensible rationale and documentation.
- Responsible Person obligations: adverse event intake, recalls, and communication pathways must be real, not theoretical.
Cosmetics & MoCRA Programs
Same services and price bands you’re using—just structured as clear programs.
Facility & Product Listings (MoCRA)
Typical range: $450–$1,500 per item
For brands, labs and importers that need MoCRA facility and product listings set up correctly the first time.
- Account setup, FEI/DUNS alignment, facility listing in FDA systems
- Product listing with ingredients & Responsible Person details
- Guidance on U.S. Agent and documentation you should retain
Label Review & Claims Cleanup
Typical range: $350–$1,200 per SKU
For SKUs with artboards, boxes and websites that need to stop flirting with “drug-like” claims.
- 21 CFR 701/740 formatting, warnings and font hierarchy review
- “Drug vs cosmetic” line: language that belongs on OTC vs cosmetic
- Website & marketplace claims sweep (e.g. Amazon, TikTok, Shopify)
Safety Substantiation Dossier
Typical range: $1,500–$4,500
For hero products, complex actives, or retailer-required safety dossiers.
- Ingredient review and margins of safety framework
- Use of literature, historical use and supplier data where appropriate
- Testing strategy recommendations (stability, irritation, sensitization, etc.)
Responsible Person Program
Typical range: $900–$2,500
For brands that need more than a name on a label—they need a real process.
- Complaint handling and serious adverse event workflows
- Recall decision tree and communication templates
- Basic SOP set for MoCRA-aligned cosmetics operations
Who We Help
DTC & Indie Cosmetic Brands
Fast-growing brands that need MoCRA basics, label fixes and documentation before retailers or FDA start asking questions.
Contract Manufacturers & Labs
U.S. and international labs needing facility listings, documentation templates and clearer responsibility boundaries with clients.
Marketplace-Heavy Brands
Amazon, TikTok and multi-marketplace sellers needing claims cleanup that satisfies both regulators and platform policies.
Derm, Medspa & Cosmeceutical Lines
Borderline “cosmeceutical” products that must carefully separate cosmetic positioning from OTC/device territory.
Private Label & Importers
Distributors that carry international brands into the U.S. and need MoCRA, labeling and Responsible Person clarity.
Multi-Brand Portfolios
Houses of brands that need scalable MoCRA processes, templates and portfolio-level risk visibility.
How We Run MoCRA Engagements
Simple phases, clear artifacts, and a record of what you did and why.
Map Facilities & SKUs
We inventory facilities, brands, products and channels to see what’s in scope and what MoCRA actually expects.
Find the Hot Spots
Identify missing listings, risky claims, thin safety support or weak Responsible Person processes.
Execute the Plan
Submit facility/product listings, redline labels & claims, draft safety rationale and core SOPs.
Keep It Up to Date
Set simple rules for new SKUs, new facilities and issue handling so MoCRA compliance stays part of your normal workflow.
Cosmetics & MoCRA FAQs
Do all my products need to be listed under MoCRA?
Most cosmetic products sold in the U.S. now require product listings, but there are nuances when a product is really a drug, device or OTC. We review your catalog and categorize what belongs where before filing.
Can’t my designer just “make the label pretty” and be done?
Design is important, but FDA and retailers care about required elements, warnings, font size and claims. We redline artboards so they stay on-brand and align with 21 CFR 701/740 and MoCRA expectations.
What does “safety substantiation” actually mean in practice?
It doesn’t always mean new clinical trials. Often it’s a structured use of ingredient data, supplier info, historical use and targeted testing. We right-size the approach to your product’s risk profile and distribution.
Are these pricing ranges fixed?
No. They’re typical working bands. After a short discovery call we give a fixed or milestone-based quote, driven by SKU count, artwork complexity, how much exists already, and your timelines.
Talk Through Your MoCRA Plan
Share how many facilities, brands and SKUs you have, and where you sell. We’ll outline a simple, sequenced plan with clear deliverables and a quote that matches your stage.
Based in Charleston, SC • Supporting brands, labs and importers worldwide
Prefer direct email? info@verusfda.com