Essential MoCRA Compliance Steps for Foreign Brands Entering the US Cosmetics Market
- Axentra compliance
- Dec 2, 2025
- 4 min read
Entering the U.S. cosmetics market offers a huge opportunity for foreign brands, but it comes with strict regulatory requirements. The Modernization of Cosmetics Regulation Act of 2022 (MoCRA) sets new standards that every cosmetic product must meet before it can be sold in the United States. For brands manufacturing products outside the U.S., compliance is not just about marketing or sales—it’s about ensuring your product passes customs inspections and avoids costly delays or seizures.
This post breaks down five critical steps foreign brands must follow to launch their first cosmetic product in the U.S. market under MoCRA. These steps will help you move your product from the factory floor to the FBA warehouse without regulatory setbacks.
1. Zero-Defect Labeling is Your Launch Guarantee
Your product label is the first checkpoint for U.S. Customs and Border Protection (CBP). Even minor errors can lead to your shipment being detained or seized. This risk remains even if your brand qualifies for the small business exemption under MoCRA.
Mandatory Labeling Requirements
Responsible Person (RP) Details
Your label must include the full name of the Responsible Person, which is your foreign company, and a valid U.S. street address. A P.O. Box is not acceptable. Axentra Global Pharma Compliance LLC and Registrar Corp , EAS Consulting group , Freyr , can give your the most cost effective solution for resolving this issue .
Adverse Event (AE) Contact Information
The label must clearly display one contact method for reporting adverse events. This can be a phone number or an email address monitored by the RP.
Ingredient Listing
All ingredients must be listed in descending order of predominance using their proper names. This helps customs and consumers verify product safety.
Net Quantity of Contents
The exact amount of product in the container must be stated in both metric and U.S. customary units.
Warning Statements
If your product requires warnings (e.g., for eye irritation), these must be prominently displayed.
Failing to meet any of these labeling checkpoints can result in your shipment being held at customs, delaying your launch and increasing costs.
2. Appoint a U.S.-Based Responsible Person
MoCRA requires every cosmetic product sold in the U.S. to have a Responsible Person located in the country. This RP acts as the official contact for the FDA and other regulatory bodies.
What the RP Does
Ensures product compliance with MoCRA regulations
Maintains product records and ingredient information
Handles adverse event reports and communicates with the FDA
Coordinates product recalls if necessary
How to Appoint an RP
If your company does not have a U.S. office, you can hire a third-party compliance service or legal representative to serve as your RP. This person or entity must have a physical street address in the U.S. and be reachable during business hours.
3. Register Your Facility and Products with the FDA
Under MoCRA, foreign manufacturers and importers must register their facilities and products with the FDA before selling in the U.S.
Register the manufacturing site(s) where your cosmetic products are made
Provide detailed information about your facility, including location and contact details
Submit a list of all cosmetic products you plan to sell in the U.S.
Include product names, categories, and ingredient information
This registration process helps the FDA monitor product safety and traceability. Failure to register can result in import refusals.
4. Prepare for Adverse Event Reporting and Record Keeping
MoCRA requires brands to maintain records of all cosmetic products and report any serious adverse events to the FDA within 15 business days.
What Counts as a Serious Adverse Event?
Death
Life-threatening experiences
Hospitalization or significant disability
Congenital anomalies or birth defects linked to product use
How to Comply
Set up a system to collect and document adverse event reports from consumers or healthcare professionals
Train your team or RP to recognize and report these events promptly
Keep records of product formulations, manufacturing processes, and distribution for at least three years
Being proactive in adverse event management protects your brand and ensures regulatory compliance.
5. Ensure Customs Compliance and Prepare Import Documentation
Customs clearance is a critical step for foreign brands. MoCRA compliance alone does not guarantee smooth entry if customs paperwork is incomplete or inaccurate.
Key Customs Requirements
Submit a Cosmetic Product Importer Entry with accurate product descriptions and Harmonized Tariff Schedule (HTS) codes
Provide proof of FDA facility and product registration
Include labeling samples or photos if requested by CBP
Work with a customs broker experienced in cosmetic imports
Tips for Avoiding Delays
Double-check all documentation before shipment
Use clear, consistent product names and descriptions
Maintain open communication with your customs broker and RP
Final Thoughts
Launching a cosmetic product in the U.S. as a foreign brand requires careful attention to MoCRA compliance. From zero-defect labeling to appointing a U.S. Responsible Person, registering with the FDA, managing adverse events, and preparing customs documentation, each step is essential to avoid costly delays and regulatory issues.
Start your launch by reviewing your product labels and confirming your U.S. RP. Then, register your facilities and products with the FDA. Build a system for adverse event reporting and work closely with customs brokers to ensure smooth import clearance.
Taking these steps seriously will help your brand enter the U.S. cosmetics market confidently and compliantly. Your next move is to consult with a regulatory expert or compliance service to tailor these steps to your specific product and business model.
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