There is no universal certificate for every U.S. export product. The correct name (Certificate of Free Sale, Certificate to a Foreign Government, or Certificate of Exportability) depends on the product's category, its regulatory status inside the United States, and what the importing country requires in writing. Confusing these three documents is one of the most common mistakes in preparing an export file.
| Typical use | Example categories | U.S. market status | |
|---|---|---|---|
| COFS | Certain "free sale" situations | Dietary supplements, medical foods, foods for special dietary use; some animal products | Eligible for legal sale in U.S. |
| CFG | Products legally marketable in the U.S. | Conventional foods, some medical devices | May be legally marketed in U.S. |
| COE | Products exportable under a special statutory route | Certain foods or devices not marketable domestically | Exportable under specific legal provisions |
Within FDA's export programs, COFS, CFG, and COE are distinct certificates used for different product categories and regulatory situations. Other agencies or state authorities may issue export certificates with different names and functions that don't necessarily match this FDA terminology.
Under FDA's food program, the COFS is not the general certificate for every food: it applies to the categories above. Important: the food COFS does not equate to a general determination that the company or product fully complies with FDA regulations; FDA expressly limits what this document actually certifies. Outside food, terminology shifts. FDA operates a separate export-certificate program for cosmetics; it is not the same COFS program used for dietary supplements and special-use foods, and issuance of that certificate likewise does not imply FDA approval. Medical devices follow their own naming and process as well, distinct from the food COFS.
For conventional foods, food additives, food-contact substances, and infant formula that meet applicable requirements, FDA offers a Certificate to a Foreign Government. For medical devices, the product must meet the relevant marketing conditions, establishment registration, device listing, and applicable authorization, clearance, or exemption with FDA. "Legally marketed" doesn't always mean "FDA approved." Depending on the product, legal marketing may result from clearance, approval, exemption, listing, or another applicable regulatory status, not necessarily from a premarket approval process.
The Certificate of Exportability is used for certain products that don't follow the same domestic marketing path as a CFG, but that may be legally exported under specific provisions. For food, the COE covers certain products that may not be legally marketed within the United States but that may be exported under section 801(e)(1). For medical devices, FDA has different classes of COE depending on the applicable legal basis: one route under section 801(e)(1) and another under section 802. It does not automatically make every noncompliant product exportable, and the pathway to obtain one varies by product type and by the reason the product cannot be sold domestically.
FDA's Center for Veterinary Medicine (CVM) also issues a Certificate of Free Sale, but for a different category: animal food, medicated feed, and animal drugs that meet applicable U.S. marketing requirements. Product category matters because different FDA centers administer their own, independent export-certificate programs.
Before requesting any of the three, it helps to answer three questions: (1) which FDA (or other agency) regulatory category does the product fall under; (2) is it currently sold in the U.S. market without restriction; and (3) what exact certificate name does the destination country's authority or importer require in writing? The third question matters as much as the first two: some countries use their own terminology that doesn't map cleanly onto FDA's naming, and submitting the wrong certificate, even if correctly issued and apostilled, can lead to rejection.
Regardless of which certificate applies, the foreign authority may also require product registration, importer licensing, local-language labeling, laboratory testing, certified translation, an apostille, or consular legalization. Confirm the exact certificate name with the importer or foreign regulator before applying to FDA or the relevant agency.
Not always. When the destination country is party to the Hague Apostille Convention and requires an apostille for a federal certificate, the route generally runs through the U.S. Department of State in Washington. A state-issued certificate, by contrast, follows the issuing state's own apostille route. Don't notarize the original federal document as a substitute for an apostille: these are separate processes, and notarization does not replace federal authentication.
Many FDA export certificates are now issued electronically and can be verified online. The foreign authority may accept that electronic verification directly, or it may still require apostille or authentication of the document. For certain FDA medical-device certificates, the U.S. Department of State requires the certificate to be printed in color before it will apostille or authenticate it; a black-and-white copy can be rejected for that reason, so it's worth confirming the print format before sending it out for apostille.
Consider a U.S. manufacturer of dietary supplements that already sells its product freely in stores within the United States and wants to export it to a South American country. Because the product is freely sold in the U.S. within the dietary-supplement category, a Certificate of Free Sale under FDA's food program would typically apply, not a CFG or a COE. However, the destination country's health regulator may require, in addition to the COFS, its own product health registration, an ingredient list in Spanish, and evidence that the manufacturing facility is registered with FDA. The COFS resolves only part of the file: it confirms the product is freely sold in the U.S., not that it automatically meets the receiving country's sanitary requirements.
Each FDA center manages its own certification application process, typically through an electronic system where the applicant identifies the product, the applicable regulatory category, and the destination country or countries. Processing times vary by center, request volume, and whether the submitted information is complete from the start, so it's worth starting the application well ahead of any export deadline rather than assuming a fixed turnaround.
One nuance that causes confusion is the difference between a product being actively sold in the United States and a product simply being authorized or eligible to be sold. The COFS is intended for the covered product categories when the products are eligible for legal sale in the U.S.; for dietary supplements, for example, FDA ties the COFS to that legal-sale eligibility and won't issue it if available information indicates the product isn't eligible. The Certificate to a Foreign Government, by contrast, focuses on whether the product may be legally marketed under the applicable regulatory framework, even if, for whatever reason, the company isn't actively selling it in the U.S. at that moment. This distinction, legal eligibility versus active selling, is what helps determine which of the two certificates applies to a specific product.
The supporting information required depends on the FDA center and certificate type; it is not uniform across programs. It may include establishment registration, device listing, clearance, approval or exemption status, product information, labeling, or other regulatory data, depending on the program. Gathering this information before starting the application, rather than assembling it on the fly, reduces the risk of an incomplete submission that has to be corrected and resubmitted.
Don't assume all FDA export certificates have the same validity period. Some FDA programs do assign a defined validity period; for example, the animal-related COFS is currently valid for two years from issuance, while other programs don't carry a fixed expiration date of their own. On top of that, the receiving country may impose its own maximum-age requirement at the time the document is submitted, regardless of what FDA sets. Always check both the issuing program and the receiving country before requesting the certificate too early.
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Informational content. Integramerica is not a law firm and does not provide legal advice. Requirements and final acceptance depend on the receiving authority. Integramerica coordinates document authentication and translation; it does not determine customs classification, product registration, FDA eligibility, origin qualification, or export licensing. Official requirements last reviewed: August 2026.
Not sure whether you need COFS, CFG, or COE? Send us the product, the destination country, and the importer's or regulator's instructions. We'll review the certificate type requested and the authentication route.
