FDA Cosmetic Facility Registration and Listing Fee
The Modernisation of Cosmetics Regulation Act (MoCRA) is now mandatory for all cosmetic manufacturers marketing their products in the United States. Below is the fee structure for FDA Establishment Registration and Cosmetic Product Listing, covering all the necessary compliance activities. This service helps manufacturers, exporters, and traders meet FDA requirements efficiently and affordably.
We offer efficient and cost effective FDA Cosmetic Facility Registration and Listing support, leveraging extensive experience in assisting manufacturers, traders and exporters ranging from startups to large enterprises, both within the US and internationally. Our in-depth regulatory knowledge and experience as a US Agent ensure a seamless registration process. View our competitive pricing below, complete the necessary forms, or proceed with a direct payment to begin
Our Pricing
| # | Service | Fee (USD) |
|---|---|---|
| 1 | FDA Cosmetic Facility Registration | $100 |
| 2 | Annual US Agent Service (Mandatory for Foreign Manufacturers and Exporters Only) |
$650 |
| 3 | Cosmetic Listing (Per device) | $650 |
# We offer discount on bulk cosmetic listing – $550 for above 5 AND $ 450 for above 8 Nos
# We offer expedited service for all customers with a processing timeline of just 8 to 14 working days
| # | Service | Fee (USD) |
|---|---|---|
| 1 | Primary / Secondary Label Review | $950 Per device (14 working days) |
| 2 | IFU / User Manual Review | $1500 per device (30 working days) |
Frequently Asked Questions
When must existing cosmetic manufacturing or processing facilities register with the FDA under MoCRA?
Existing facilities that were already engaged in manufacturing or processing cosmetic products for distribution in the United States before the enactment of the Modernization of Cosmetics Regulation Act of 2022 (MoCRA) must register each facility with the FDA no later than 1 year after the date MoCRA was enacted.
What is the FDA registration timeline for new cosmetic facilities under MoCRA?
New facilities that begin manufacturing or processing cosmetic products for distribution in the U.S. after the enactment of MoCRA must register with the FDA within 60 days of starting such activities, or within 60 days after the registration deadline, whichever is later.
How many FDA registrations does a contract manufacturing facility need under MoCRA?
Only one FDA registration is required for a contract manufacturing facility, even if it manufactures or processes cosmetic products for multiple companies or for itself. A single registration covers all cosmetic manufacturing or processing activities conducted at that facility.
Who is responsible for listing cosmetic ingredients with the FDA under MoCRA?
The responsible person (typically the manufacturer, packer, or distributor whose name appears on the product label) must submit a Cosmetic Product Listing to the FDA. This must be done no later than one year after the enactment of the Modernization of Cosmetics Regulation Act of 2022 (MoCRA), or within 120 days of first marketing the product in the United States if it is introduced after the Act’s enactment.