MoCRA Compliance & FDA Cosmetic Registration Support
The US cosmetics regulatory landscape changed permanently with MoCRA. RABT Global helps facilities and brands meet every new obligation — registration, listing, safety substantiation, and adverse event reporting — without missing a deadline.
Facility registration, product listing, safety substantiation, and US Agent services.
The Modernization of Cosmetics Regulation Act (MoCRA) introduced the first mandatory facility registration and product listing regime for cosmetics sold in the United States, along with new safety substantiation, adverse event reporting, and recordkeeping obligations. RABT Global manages the full compliance workflow for domestic and international brands selling into the US market.
What’s Included
Facility Registration
Registration of manufacturing and processing facilities with FDA under MoCRA.
Cosmetic Product Listing
Preparation and submission of product listings, including ingredient and category information.
US Agent Services
Acting as your designated US Agent for FDA correspondence, as required for facilities outside the United States.
Safety Substantiation Documentation
Compiling the “adequate substantiation of safety” record MoCRA requires for every marketed product.
Adverse Event Reporting Support
Establishing and managing the serious adverse event reporting process, including recordkeeping.
Fragrance Allergen Disclosure Readiness
Preparing labeling and documentation ahead of upcoming fragrance allergen disclosure requirements.
Why It Matters
- Facilities that fail to register or list products risk FDA enforcement, including product detention at the border
- International brands need a US Agent on file to remain compliant
- Safety substantiation and adverse event systems must be in place before, not after, a complaint arises
Our Process
MoCRA Readiness Assessment
We assess your current facility, product, and documentation status against MoCRA requirements.
Registration & Listing
We prepare and submit facility registration and product listings.
Safety & Reporting Systems Setup
We build out your safety substantiation file and adverse event reporting process.
Ongoing US Agent Representation
We remain your point of contact with FDA for as long as you need us.
Get MoCRA-Compliant
Meet every MoCRA obligation — registration, listing, safety substantiation, and reporting — with RABT Global managing the process.