The FDA process for selling cosmetics in the U.S. comes up at the very first step of exporting. If you plan to export cosmetic or food products to the United States, FDA (Food and Drug Administration) registrations and label review, the FDA process, will be among the first things you need to address. To place your product in large sales channels such as Amazon, Walmart or retail chains, these registrations and compliance documents are generally required.
You can also read our related article, Selling Pet Food on Amazon US: FDA, AAFCO and Approval Guide.
In this article, we outline the FDA services needed for a single product and their estimated costs in plain terms.
1. FDA Process for Selling Cosmetics in the U.S.: Facility Registration and U.S. Agent
The facility where the cosmetic products are manufactured needs to be registered in the FDA system. During this FDA process, foreign manufacturers also need to appoint an official U.S. Agent as the FDA's point of contact.
Price: $625
This registration covers the entire facility and is renewed periodically.
2. FDA Label and Ingredient Compliance Review
An FDA-compliant label should include the ingredient order (INCI format), warning statements and allergen declarations. Your product label is reviewed by our expert team and revised where needed.
Price: $425
This service covers 1 product. We cover the topic in more detail in our article FDA Label and Customs Service Guide: Exporting Frozen Food to the U.S..
3. FDA Food Facility Registration and U.S. Agent
If you have a dietary supplement, syrup, capsule or similar product, your manufacturing or packaging facility needs to be registered with the FDA. A U.S. Agent is also required in this case.
Price: $475
(Applies to food products, not cosmetics.)
4. FDA Product Listing (MoCRA)
Listing your cosmetic product with the FDA under MoCRA can add credibility to your brand and may help on platforms such as Amazon.
Price: $150
FDA Registration and U.S. Agent Service Prices
| Service | Price (USD) |
| Cosmetic Facility Registration and U.S. Agent | $625 |
| Label and Ingredient Compliance Review | $425 |
| Product Listing (MoCRA) | $150 |
| Total | $1.200 |
Is FDA Registration Required to Sell on Amazon?
Yes. Amazon checks FDA registrations and label compliance for both food and cosmetic products. These documents are often requested during product listing or in post-sale reviews. Our article FDA Registration, GMP Compliance and Customs Process for Exporting Vegetable Oils to the U.S. may also help.
Frequently Asked Questions: FDA Registration and Exporting to the U.S.
Is there an FDA certificate? Is an actual “certificate” issued?
No, technically there is no physical “FDA certificate.” What actually takes place is registration in the FDA system. When registration is complete, you receive a confirmation number and a registration record from the system; companies commonly refer to this as “FDA registration.”
What is FDA registration?
FDA registration is the process by which food, supplement or cosmetic manufacturers exporting to the U.S. register their production facilities or products in the FDA system. This registration can help avoid issues at U.S. customs and allows your product to be listed on platforms such as Amazon.
Is FDA registration mandatory?
Yes. For any company shipping food, dietary supplements or cosmetics to the U.S., FDA registration and the appointment of a U.S. Agent are legal requirements in the FDA process.
Do you need FDA registration to sell on Amazon?
Yes. For food and cosmetic products in particular, Amazon asks for FDA registration, label compliance and product safety documents in Seller Central. Missing documents can prevent a listing from going live or may lead to sales being paused.
How do you get your label FDA compliant?
Details such as ingredients, allergen declarations, country of origin and nutrition facts are reviewed against FDA requirements. If the label does not comply, it needs to be revised. Our team of specialists provides this service.
How long does the FDA process take?
It is usually completed within 1 to 3 weeks. The U.S. Agent appointment, registration and label review are handled together.
You can visit our FDA registration and certification page.
