What is an FDA Certificate of Free Sale?
"Certificate of Free Sale" (CFS) is the name many importing countries use for an official document showing that a product is legally sold in the United States. FDA issues several kinds of export certificates. Which one you need depends on the product and on what the importing country asks for.
Which certificate applies to your product?
| Product | FDA certificate | FDA fee |
|---|---|---|
| Conventional food, food additives, food contact substances, infant formula | Certificate to Foreign Government | $175 for the first certificate |
| Dietary supplements, medical foods, foods for special dietary use | Certificate of Free Sale | No fee |
| Food that can't be sold in the U.S. but may be legally exported | Certificate of Exportability | $175 for the first certificate |
| Cosmetics | Certificate for Cosmetics | Check FDA's current fee |
| Medical devices | Certificate to Foreign Government (CDRH) | Set by FDA |
| Drugs | Certificate of Pharmaceutical Product (CDER) | Set by FDA |
Food fees from FDA's food export certificate page. Additional certificates for the same products in the same request cost less.
Cosmetics with drug claims, such as acne treatment, are not eligible for the cosmetics certificate. They are regulated as drugs.
Who asks for one?
Many importing countries ask for a U.S. export certificate as part of product registration or customs clearance. Requests are common in the Middle East, Southeast Asia, Latin America and Africa. Requirements differ by country and product, and some countries also want the certificate authenticated or apostilled.
How to obtain an FDA export certificate
- Confirm the exact document. Ask the importing country's authority or your buyer which certificate they need, in what format, and whether it must be apostilled.
- Check eligibility. The product must meet U.S. requirements. For example, food facilities generally need a valid FDA registration, and a device must be cleared or approved where that applies.
- Apply online. Food, dietary supplement and cosmetic certificates are requested through FDA's online export certificate applications. Device and drug certificates go through their own FDA centers.
- Pay the FDA fee, where one applies.
- Authenticate if required. If the destination country needs an apostille, send the issued certificate for authentication.
A Regovant certificate is not an FDA certificate
Regovant gives every registration client a certificate of registration that confirms their FDA registration number and U.S. Agent. It's useful for buyers and importers, and anyone can check it on our verify page. It is not issued by FDA and does not replace an FDA export certificate when a country asks for one.
How Regovant can help
We check which certificate fits your product, prepare and submit the application, and follow it through. Export certificate assistance is $269 per certificate, plus any FDA fee.