If you export food, dietary supplements, cosmetics, drugs, or medical devices, the importing country’s regulator usually wants proof that the product is legally sold in the United States. The FDA issues export certificates for exactly this, and most destinations require them apostilled or legalized before customs will clear the shipment.
These are federal documents, so certification comes from the U.S. Department of State rather than any state authority. That trips up exporters who assume their state of incorporation is involved.
The certificate names vary by product category and by what the importing country asked for. A Certificate of Free Sale, a Certificate to Foreign Government, a Certificate of Exportability, and a Certificate of a Pharmaceutical Product all serve related but distinct purposes. Getting the wrong one certified is an expensive way to lose two weeks.
Export paperwork is usually deadline-driven, because a shipment is waiting. Tell us the deadline when you order and we will tell you honestly whether it is achievable rather than taking the job and hoping.
At a glance
Which certificate do you need?
| Certificate | Typical products | Purpose |
|---|---|---|
| Certificate of Free Sale | Food, supplements, cosmetics | Confirms the product is freely sold in the U.S. |
| Certificate to Foreign Government | Devices, drugs | Confirms the product meets U.S. requirements and may be exported |
| Certificate of Exportability | Products not marketed in the U.S. | Confirms the product may be legally exported |
| Certificate of a Pharmaceutical Product | Pharmaceuticals | Follows the WHO format many regulators expect |
The importing country’s regulator decides which certificate satisfies them. Ask your importer or distributor to confirm the exact certificate name before you request it from the FDA, because the names are similar and the documents are not interchangeable.
How exporters usually get caught out
- Wrong certificate type. A Certificate of Free Sale will not satisfy a regulator who asked for a Certificate to Foreign Government.
- Sending it to a state. FDA certificates are federal and go to the U.S. Department of State.
- Non-Hague destinations. Much of the Middle East and parts of Asia require full embassy legalization, which adds weeks. Build that into your shipping schedule.
- Product lists that do not match. The products named on the certificate must match the shipment and the registration filing exactly.
- Validity windows. Some regulators only accept certificates issued within a recent window, so certifying an old one wastes the fee.
- Translation requirements. Many importing regulators require a certified translation of both the certificate and the apostille.
How it works
Step 1
Confirm the certificate with your importer
Get the exact certificate name the destination regulator requires, and whether they need an apostille or full legalization.
Step 2
Obtain it from the FDA
Your regulatory team or agent requests the certificate. We certify it once issued.
Step 3
Federal apostille or legalization
Apostille for Hague countries, or the full chain through the destination’s embassy for everywhere else.
Step 4
Translation and delivery
Certified translation where required, then shipped tracked, or sent directly to your agent abroad.
FDA Certificate Apostille: common questions
Do FDA certificates go to a state or the federal government?
Federal. The FDA is a federal agency, so certification comes from the U.S. Department of State. No Secretary of State can apostille one.
Which certificate does my importer need?
Only they or the destination regulator can say. The names are close and the documents are not interchangeable, so confirm the exact wording before requesting anything from the FDA.
Can you apostille several certificates at once?
Yes, and that is common for exporters. Bulk orders are priced per document and submitted together, which is faster than sending them one at a time.
My destination is not a Hague member. What changes?
An apostille will not be accepted. The certificate needs federal authentication followed by legalization at that country’s embassy, which typically adds two to six weeks. Plan the shipment around it.
How current does the certificate need to be?
Many regulators only accept certificates issued within a recent period, often six or twelve months. Check before certifying an older certificate, because the apostille does not refresh its issue date.
Official sources
Requirements, fees and processing times are set by the authorities below and can change without notice. Verify anything time-critical directly with them.
FDA food export certificates · Export certification FAQ · Medical device export certificates · CBER biologics export
Ready to get started?
Shipping to a deadline? Tell us the date and destination and we will confirm what is achievable before you commit.
Related: USDA certificates · Federal apostille · Embassy legalization · Certified translation