Certificate of Free Sale vs. Certificate to a Foreign Government

There is no universal certificate for every product. Product category, U.S. regulatory status and the importing authority’s instructions determine the correct document.

Quick comparison

• Certificate of Free Sale (COFS): under FDA’s food program, limited to dietary supplements, medical foods and foods for special dietary use.
• Certificate to a Foreign Government (CFG): for certain products that may be legally marketed in the United States.
• Certificate of Exportability (COE): for specific products not marketable in the U.S. that meet a legal export pathway.

When a Certificate of Free Sale applies

FDA’s food COFS is not the general certificate for every food. FDA also does not issue a document titled Certificate of Free Sale for cosmetics; its cosmetics export document is titled “CERTIFICATE.”

When a CFG applies

For conventional foods, additives, food-contact substances and infant formula meeting applicable requirements, FDA offers a CFG. Medical devices must meet the relevant marketing, establishment registration, listing and authorization or exemption conditions. A CFG does not automatically mean “FDA approved.”

When a COE is used

A COE is for products that cannot legally be marketed in the United States but satisfy a specific export provision. It does not make every noncompliant product exportable.

The certificate does not replace importing-country requirements

The foreign authority may also require product registration, importer licensing, local labeling, testing, translation, apostille or authentication. Confirm the exact certificate name before applying.

Does it need an apostille?

Not always. If a federal certificate requires an apostille for a Hague country, the route generally runs through the U.S. Department of State. A state-issued certificate follows the issuing state’s route.

Common mistakes

• Requesting a generic “free sale” certificate before classifying the product.
• Confusing it with a company Certificate of Status.
• Treating facility registration as FDA approval.
• Sending a federal document to Florida for apostille.
• Assuming the certificate guarantees import approval.

Frequently asked questions

Are COFS and CFG the same?

No. FDA offers them for different categories and situations.

Does FDA issue a COFS for cosmetics?

Not under that title. Confirm what the receiving authority accepts.

Must it always be apostilled?

No. It depends on the country, authority and filing.

Does it guarantee product registration?

No. The importing country makes its own decision.

Official sources

• FDA — Food Export Certificates
• FDA — Medical Device Certificate Types
• FDA — Cosmetics Export Certificate FAQs