The FDA process for selling cosmetics to the U.S. is the first step in the export process. If you want to export cosmetics or food products to the U.S., the FDA (Food and Drug Administration) registration and labeling review will be the first step in the process. These registrations and compliance documents are mandatory, especially if you want your product to be listed on major sales channels such as Amazon, Walmart, or chain supermarkets.
You can also refer to our article , “Selling Pet Food in the U.S. on Amazon: A Guide to FDA, AAFCO, and Approval,” which covers this topic in detail.
In this article, we explain in a simple way the FDA services and approximate costs required for only 1 product.
1. The FDA Process for Selling Cosmetics in the U.S.: Facility Registration and U.S. Agent
The facility where cosmetic products are manufactured must be registered with the FDA. During this FDA process, an official representative (U.S. Agent) must be appointed in the U.S. for foreign manufacturers.
Price: $625
This registration applies to the entire facility and is renewed annually.
2. FDA Label & Content Compliance Review
A label compliant with FDA regulations must include the ingredient list (INCI format), warning statements, and allergen disclosures. Your product’s label will be reviewed by our team of experts and revised if necessary.
Price: $425
This service is for 1 product. We’ve covered the details of this topic in our article, “FDA Labeling and Customs Consulting Guide: Exporting Frozen Food to the U. S.”
3. FDA Food Facility Registration & U.S. Agent
If you have a food supplement, syrup, capsule or similar product, your manufacturing/packaging facility must be registered with the FDA. An agent is also mandatory, again in the US.
Price: $475
(Applies to food products, not cosmetics.)
4. FDA Product registration(MoCRa)
Registering your cosmetic product with the FDA's voluntary product registration system (MoCRa) adds extra trust to your brand and gives you an advantage on platforms like Amazon.
Price: $150
FDA Registration and U.S Agent Service Prices
| Service | Price (USD) |
| Cosmetic Facility Registration & U.S. Agent | $625 |
| Label & Content Compliance Review | $425 |
| Product Registration (MoCRa) | $150 |
| Total | $1.200 |
Is FDA Required for Selling on Amazon?
Yes. Amazon verifies FDA registrations and label compliance for both food and cosmetic products. These documents are required, particularly during the product listing process or in post-sale reviews. Our article titled “FDA Registration, GMP Compliance, and the Customs Process for Exporting Vegetable Oils to the U. S.” may be helpful.
Frequently Asked Questions, FDA Registration, and Exports to the United States
Is there an FDA certificate? Is there really a "certificate"?
No, technically, there is no physical "FDA certificate". What is actually done is registration to the FDA system. When this FDA process is completed, there is an approval number and registration transcript received from the system; companies refer to this as "FDA registration".
What is FDA registration?
FDA registration is when food, supplement or cosmetic manufacturers exporting to the US register their production facilities or products with the FDA. Thanks to this registration, there are no problems with US customs and your product can be listed on platforms such as Amazon.
Is FDA registration mandatory?
Yes. FDA registration and appointment of a U.S. Agent is a legal requirement for all companies that will ship food, supplements or cosmetics to the US.
Does an Amazon sale require FDA registration?
Yes. Amazon requires FDA registration, label compliance and product safety documentation in the seller panel, especially for food and cosmetics. Sales cannot be started or may be stopped with missing documents.
How to get FDA label approval?
Details such as product content, allergen declaration, origin information and nutritional values are examined according to FDA standards. If the label is not appropriate, it needs to be revised. Our expert team provides this service.
How many days does the FDA process take?
It is usually completed in 1 to 3 weeks. U.S. Agent assignment, registration and label inspection are carried out together.
You can review our FDA registration and certification page.
