Navigating FDA Compliance Together
Under the Modernization of Cosmetics Regulation Act (MoCRA), foreign cosmetic manufacturers must designate a U.S. Agent. We serve as your official representative and FDA contact ensuring your cosmetic facility and products meet all MoCRA requirements.
Cosmetic Facility Registration
Cosmetic manufacturers and processors must register their facilities with the FDA.
- New Facility Registration (MoCRA)
- Biennial Renewal
- Responsible Person Designation
- Registration Amendments
Cosmetic Product Listing
Every marketed cosmetic product must be listed with the FDA, including its full ingredient list, within 120 days of entering the U.S. market.
- Individual Product Listing
- INCI Ingredient Verification
- Multi-Product Portfolio Listing
- Annual Product Listing Updates
Cosmetic Label Review (INCI)
Cosmetic labels must list ingredients by INCI name and meet MoCRA’s labeling and claims requirements before they reach the shelf.
- INCI Ingredient List Review
- MoCRA Label Compliance
- Claims Review
- Net Quantity & Mandatory Elements
Responsible Person Designation
We handle the entire filing on your behalf accurately and on time.
- Responsible Person Services
- Serious Adverse Event Reporting
- Product Safety Records
- FDA Recall & Mandatory Recall Support
Cosmetic Registration Renewals
MoCRA requires cosmetic facility registrations and product listings to be renewed on separate schedules: facility registration every two years, product listings every year.
- Biennial Facility Renewal
- U.S. Agent Annual Renewal
- Product Listing Renewal
- Registration Amendments
Why Choose FDA Entry?
- Fast Turnaround: Most registrations completed within 24 to 48 hours. We understand time-to-market matters.
- Expert Team: Regulatory specialists with decades of combined FDA experience at your service.
- Transparent Pricing: Clear, upfront pricing with no hidden fees. Know exactly what you’re paying for.
- Secure & Confidential: Your proprietary information is protected with enterprise-grade security protocols.
Cosmetic FAQs
Any foreign facility that manufactures or processes cosmetic products for distribution in the United States must designate a U.S. Agent as part of its FDA facility registration. The U.S. Agent must reside or maintain a place of business in the U.S. and serves as the FDA’s official point of contact for that facility. This requirement was established under the Modernization of Cosmetics Regulation Act of 2022 (MoCRA).
These are two separate roles under MoCRA. The U.S. Agent handles FDA communications and inspection coordination for a foreign facility. The Responsible Person is the manufacturer, packer, or distributor whose name appears on the product label, and is accountable for product safety substantiation, product listing, and adverse event reporting. A Responsible Person does not need to be based in the U.S., but a foreign Responsible Person must still designate a U.S. Agent. Many companies need both roles filled and assume one covers the other, which is a common compliance gap.
Yes, if your facility manufactures or processes cosmetic products for the U.S. market. This applies to both domestic and foreign facilities under MoCRA. Registration must be updated within 60 days of any material change, such as a change in ownership, facility address, or U.S. Agent.
Facility registration must be renewed every two years. Product listings, which include the full ingredient list for each marketed product, must be updated annually, and within 120 days of any product reformulation or labeling change. These are two different clocks, so tracking both matters.
The FDA can suspend your facility’s registration, which makes it illegal to distribute cosmetics from that site in the U.S. The agency also has authority to issue a mandatory recall if a product is found to be adulterated or misbranded and poses a serious health risk and the company has refused to recall voluntarily. Other enforcement tools include warning letters, product seizure, and injunctions.
Yes. The Responsible Person must report any serious adverse event (one resulting in death, hospitalization, significant disability, birth defect, or infection) to the FDA within 15 business days of becoming aware of it. Safety and complaint records must be retained for six years to support these reporting obligations.