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FDA – Cosmetics

MoCRA Registration + FEI (One Package)

Fee: $499 / year

Under MoCRA, facilities that manufacture or process cosmetics for the US market register with FDA and renew the registration every two years. FDA uses the FEI number as the facility registration number; the FEI is obtained before registration. Every cosmetic product on the market is listed with its ingredients, and the listing is updated annually. FDA issues no certificate for registration.

Who Is Obligated?

Domestic and foreign facilities that manufacture or process cosmetics, and the Responsible Person in charge of product listing. Foreign facilities name a US Agent for registration. Some small businesses are exempt, but the exemption does not apply to certain products, such as those used around the eye, injected, or intended to last for an extended period.

What We Do

  • We assess the registration and exemption status of your facility and products.
  • We apply for the FEI number.
  • We file the facility registration and product listing on your behalf.
  • We serve as your designated US Agent.
  • We track the annual listing update and the biennial renewal.

What You Receive

  • FEI number
  • Facility registration details
  • Product listing records
Fill in the application formAsk a question firstAll United States services

FDA Cosmetic Facility Registration (MoCRA) and FEI Application

Facility, responsible person, brand, and product category details for the FDA registration of your cosmetic manufacturing facility under MoCRA and its FEI number.

  1. 1 Preliminary Information
  2. 2 Facility
  3. 3 Brands and Products
  4. 4 Responsible Person and Billing
  5. 5 Submit
1. Preliminary Information
Where is the facility located? *
Requested action *
Might your company qualify for the small business exemption? *

We will assess the exemption conditions together when reviewing your application.

Your details are used only to prepare your application. An unfinished application is kept in this tab.

Frequently Asked Questions

Are facility registration and product listing the same thing for cosmetics?
No, they are two separate obligations. Facility registration is renewed every two years; every product on the market is listed with its ingredients, and the listing is updated annually. In this package we handle both.
What is an FEI number?
It is the facility number FDA uses in cosmetic facility registration, and it is obtained before registration. The FEI application is included in this package.
I am a small manufacturer. Could I be exempt?
Some small businesses are exempt, but the exemption does not apply to certain products, such as those used around the eye, injected, or intended to last for an extended period. We assess your status based on your product list.
What does my fee cover, and when is it renewed?
Our fee is for the US Agent service and is renewed annually; in this package we are designated as your US Agent. The FDA facility registration is renewed every two years and the product listing is updated annually; we handle these as part of our US Agent service.

Sources: FDA: Registration and Listing of Cosmetic Product Facilities and Products; FDA Guidance: Registration and Listing of Cosmetic Product Facilities and Products (Aralık 2024); FDA: MoCRA.