FDA Certificate of Free Sale Apostille

Issuing agency

U.S. Food and Drug Administration

We can obtain it?

No — the manufacturer or distributor requests it

Certification first?

No — the FDA-issued certificate is authenticated as issued

Also known as

CFS, Certificate to Foreign Government, CFG, export certificate

An FDA Certificate of Free Sale confirms that a product is legally marketed in the United States — the assurance foreign regulators and importers require before allowing it into their market. Exporters of food and beverages, dietary supplements, cosmetics, and medical devices run into this requirement constantly.

What makes this document different from most on our site: the destinations that demand it are frequently not Hague Convention members, so the apostille often isn't the finish line.

What an FDA Certificate of Free Sale is

The FDA issues export certificates confirming that a product may be legally marketed in the United States, and in some cases that the manufacturing facility meets applicable U.S. requirements. Related certificates — the Certificate to Foreign Government (CFG), Certificate of Free Sale (CFS), and Certificate of Exportability — cover different product categories and circumstances. For human drugs, the equivalent is the Certificate of a Pharmaceutical Product (CPP).

Which certificate applies depends on the product and whether the facility has been inspected — worth confirming before you apply.

Why it needs authentication abroad

A foreign regulator or customs authority cannot verify an FDA certificate on its own. Authentication by the U.S. Department of State certifies it as genuine — as an apostille for Hague Convention countries, or as an authentication certificate followed by embassy legalization for everyone else.

Getting the certificate from the FDA

The exporting manufacturer or distributor requests the certificate from the FDA through its export-certification system; fees apply and vary by certificate type and product center. We can't request it on your behalf, but once the FDA issues it, we handle the authentication chain end to end.

Why the destination matters more here than anywhere else

On most documents we handle, the apostille is the finish line. With export certificates it often isn't: a large share of the countries that require a Certificate of Free Sale are outside the Hague Convention, which means the certificate needs Department of State authentication and then legalization at that country's embassy or consulate in Washington.

That matters for planning. Embassy legalization adds days to several weeks depending on the consulate, some embassies require the document in their language, and some require additional supporting paperwork from the exporter. Shipments held at a foreign port waiting on paperwork are expensive, so we scope the whole chain up front rather than discovering it midway.

Document preparation requirements

• Submit the FDA-issued certificate exactly as issued.
• Do not notarize it — notarizing a federal document invalidates it for authentication.
• Don't laminate, staple across the text, highlight, or annotate it.
• Confirm the certificate type matches what the foreign regulator asked for.
• Tell us the destination country up front — it determines the entire route.

The step-by-step process

1. Tell us the destination

   Before anything else — the destination decides whether this is an apostille or a full legalization chain, and what it will cost and take.

2. Request the certificate from FDA

   The manufacturer or distributor applies through the FDA's export-certification system.

3. Send it to us & we review

   We verify the certificate is in a form the Department of State will authenticate.

4. Federal authentication in D.C.

   We hand-deliver the certificate to the Office of Authentications with the federal authentication request and fee.

5. Embassy legalization, where required

   For non-Hague destinations we forward the authenticated certificate to that country's embassy or consulate for final legalization.

6. Certified translation, where required

   Where the regulator requires the document in their language, we arrange certified translation so it arrives ready to file.

Common rejection reasons — and how to avoid them

Common uses

• Food and beverage export registration — clearing product into a foreign market.
• Dietary supplements — registration and import licensing abroad.
• Cosmetics — market authorization in regulated jurisdictions.
• Medical devices — supporting registration with a foreign health authority.
• Government tenders and distributor agreements — proving U.S. marketing status.

Hague vs. non-Hague countries

Pick your destination below, or see all countries we serve.

Official references: FDA — Export Certificates · U.S. Department of State — Authenticate Your Document. Government fees are set by these agencies and are separate from our service fee.