Navigate MoCRA with Confidence
Ensure your beauty and skincare products are U.S.-compliant. Niikaz Global simplifies facility registration and product listing so you can focus on your brand’s global growth.
Get a Compliance CheckIs Your Brand MoCRA Ready?
The FDA now mandates that cosmetic facilities register and list every single product. From safety substantiation to serious adverse event reporting, the rules have changed.
We help beauty brands stay ahead of these regulations to avoid shipment holds, legal risks, and unnecessary delays.
What’s New Under MoCRA?
Compliance is no longer voluntary for many cosmetic businesses entering the U.S. market.
- Facility Registration is required.
- Product Listing is required for every SKU.
- Safety records and adverse event reporting must be managed properly.
Complete FDA Cosmetic Compliance Support
We handle the technical registration, listing, and compliance process so your beauty brand can move forward with clarity and confidence.
Cosmetic Facility Registration
Mandatory registration for facilities manufacturing or processing cosmetics for the U.S. market.
Product Listing (SPL)
Expert filing of product ingredients and categories using Structured Product Labeling format.
Labeling & Ingredient Review
We check packaging requirements including fragrance declarations and allergen labeling.
U.S. Agent Representation
Reliable U.S.-based communication support for international beauty brands.
Safety Substantiation Guidance
Helping you organize the data needed to prove your cosmetic products are safe.
Compliance Check
We help identify key gaps before your products face shipment or regulatory issues.
Simplify Complex FDA Cosmetic Rules
MoCRA has changed the way cosmetic brands must manage facility registration, product listing, labeling, safety records, and reporting obligations.
Niikaz Global acts as your dedicated regulatory partner, helping you manage the process clearly from initial audit to market launch.
Start Cosmetic ComplianceHow It Works
1. Consultation
We review your facility details, product type, ingredient list, and MoCRA compliance status.
2. Documentation
Our team prepares the required information for FDA cosmetic facility registration and product listing.
3. Registration & Listing
We submit your facility registration and product listing to support U.S. market compliance.
4. Compliance & Growth
Move forward with better confidence while maintaining labeling, safety, and reporting obligations.
FDA Cosmetics FAQ
1. What is MoCRA, and how does it affect my cosmetic business?
The Modernization of Cosmetics Regulation Act of 2022 (MoCRA) is a major expansion of FDA authority over cosmetics. It requires most cosmetic facilities to register with the FDA and every cosmetic product sold in the U.S. to be officially listed.
2. Which cosmetic facilities are required to register?
Any facility that manufactures or processes cosmetic products for distribution in the U.S. must register. This includes both domestic U.S. facilities and foreign facilities. Small businesses may be exempt from certain requirements, but safety substantiation records must still be maintained.
3. What is the deadline for Cosmetic Product Listing?
For products already on the market, the initial listing deadline has passed on July 1, 2024. For new products, listing must be submitted within 120 days of the product being marketed in interstate commerce. Listings must be updated annually with any changes.
4. Do I need a U.S. Agent for cosmetic registration?
Yes. If your facility is outside the United States, you must designate a U.S. Agent for FDA communications. Niikaz Global serves as your local voice, managing FDA inquiries and helping keep your registration active and compliant.
5. What are the new labeling requirements under MoCRA?
Labels must include a domestic address, domestic phone number, or electronic contact information where the Responsible Person can receive adverse event reports. Fragrance allergens and professional-use labeling requirements must also be managed properly.
6. How often must cosmetic facility registrations be renewed?
Cosmetic facility registrations must be renewed every two years. Many facilities that registered during the first major MoCRA wave in early 2024 may face renewal requirements in 2026.
7. What happens if I fail to report a Serious Adverse Event?
MoCRA requires the Responsible Person to report Serious Adverse Events to the FDA within 15 business days. Failure to report or maintain records may result in regulatory action, including products being considered misbranded or facility registration suspension.
Ready to Make Your Cosmetic Brand MoCRA-Compliant?
Avoid shipment holds, registration issues, and compliance confusion. Talk to Niikaz Global today for FDA cosmetic registration and product listing support.
Start Cosmetic Compliance