USA Cosmetics Registration MoCRA | FDA Compliance for Italian Companies
Selling cosmetics in the United States is a great opportunity for Italian companies, but it requires compliance with specific regulations imposed by the Food and Drug Administration.
With the introduction of MoCRA (Modernization of Cosmetics Regulation Act), regulations have become stricter, making facility registration, product listing, and compliance with new safety and labeling requirements mandatory.
In this guide you will discover everything you need for the cosmetics registration in the USA and how we can support you in the process.
What is MoCRA and why it is essential for selling cosmetics in the USA
He MoCRA it is the most important regulatory reform in the US cosmetics sector in recent decades.
This legislation introduces key obligations for all companies that want to market cosmetic products in the United States:
- FDA cosmetic facility registration
- cosmetics product listing
- label adjustment
- adverse event management
- stricter controls by the FDA
Companies that fail to comply with these rules risk:
- import ban
- product recall
- sanctions and warning letters
Who needs to register cosmetics in the USA
MoCRA registration is mandatory for:
- cosmetics manufacturers
- brand owner (including private label)
- companies that sell on Amazon USA
- distributors/importers
👉 Italian companies must also comply with these obligations, even if they manufacture in Europe.
MoCRA requirements: what you need to do to be compliant
1. FDA Facility Registration
To sell cosmetics in the USA, it is necessary to:
- get a FEI (Facility Establishment Identifier)
- register the facility with the FDA
- update the registration every 2 years
2. Cosmetics Product Listing
Each product must be registered with the FDA with:
- Ingredients (INCI)
- product category
- company data
- information about the Responsible Person
3. FDA compliant labeling
The labels must include:
- product name
- net quantity
- ingredient list
- Warnings
- adverse event contacts
4. Adverse event management
Companies must:
- monitor product safety
- report serious events within 15 days
- keep records up to date
5. US Agent for foreign companies
Non-US companies must appoint a US Agent, which serves as the contact point with the FDA.
Warning: when a cosmetic becomes a drug (OTC)
One of the most common mistakes concerns product classification.
If a cosmetic contains:
- SPF (sunscreen)
- therapeutic claims
could be classified as OTC drug, with much more complex requirements.
👉 A preliminary assessment is essential.
U.S. Cosmetics Registration Services (MoCRA)
Link2America supports Italian companies in all aspects of FDA compliance management.
✔ Preliminary MoCRA Analysis
- check products and variants
- cosmetic vs OTC classification
- Identification of Critical Issues
✔ FDA Facility Registration
- FEI request
- facility registration
- periodic updates
✔ Cosmetics Product Listing
- Product Registration
- Variant Management
- technical support
✔ US Agent Service
Assistance with the appointment of a U.S. Agent for foreign companies.
✔ Responsible Person Support
Assistance with managing regulatory obligations.
✔ Label Review
Preliminary verification of compliance with FDA regulations.
Why choose Link2America
We are an operational partner in the United States for Italian companies looking to enter the U.S. market.
We support you with:
- firsthand experience in the U.S. market
- hands-on and operational approach
- network of local professionals
- support in Italian and English
FILL OUT THE QUESTIONNAIRE
FAQ – U.S. Cosmetics Registration
How much does it cost to register a cosmetic product in the U.S.?
It depends on the number of products and the complexity of the project.
Is a US Agent always required?
Yes, it is mandatory for non-U.S. companies.
How long does registration take?
It depends on the completeness of the data and the number of products.
Can I sell on Amazon without registration?
No, compliance with regulations is necessary to avoid blockages.
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