A Certificate of Free Sale is an official U.S. document stating that a product is legally sold and distributed in the United States, and foreign customs authorities use it to confirm that imported goods meet the same standards American consumers rely on. Depending on what you export, the certificate comes from the U.S. Food and Drug Administration, a state department of agriculture or health, or a local Chamber of Commerce. Without the right one, shipments can be held, rejected, or destroyed at the border.
What the Certificate Proves
The certificate is official proof from a U.S. authority that your product is not banned, restricted, or manufactured solely for export. It tells the importing country’s regulators that the goods listed comply with applicable U.S. laws and can be freely purchased by American consumers. Foreign regulators treat it as a baseline assurance: if a product clears the U.S. market, it meets a minimum threshold for theirs.
Not every country requires one, and the format that satisfies a given customs office varies. Some accept a chamber-issued certificate; others insist on one from the FDA or a state regulatory agency. Confirm with your buyer or the importing country’s authority which document they actually need before you apply.
Who Issues Your Certificate
The issuing body depends entirely on what you are exporting.
FDA-Regulated Products
The FDA certifies products it regulates domestically, and it uses different centers and portals for different categories. Conventional foods, food additives, and infant formula go through the Human Foods Program using the eCATS portal. Dietary supplements, medical foods, and special dietary foods use the Certificate Application Process module within the same system. Cosmetics go through the CAP module within CFSAN eCATS, accessible through FDA Industry Systems.
Medical devices are certified through the Center for Devices and Radiological Health using a separate portal called CECATS. Pharmaceutical products are handled by the Center for Drug Evaluation and Research, which issues electronic Certificates of Pharmaceutical Product. Animal feed, animal drugs, and veterinary devices are certified through the Center for Veterinary Medicine.
State-Regulated Food and Agricultural Products
Many food and agricultural products are certified at the state level rather than federally. State departments of agriculture and state health departments issue certificates of free sale for food products produced or processed in their jurisdictions. The USDA Foreign Agricultural Service maintains a directory of state-level contacts.
General Consumer Goods
Products outside FDA or state regulatory oversight, such as furniture, textiles, electronics, or industrial equipment, are typically certified by Chambers of Commerce or world trade centers. These chamber-issued certificates attest that the listed products are legally manufactured and freely sold in the United States, but they are distinct from certificates issued by regulatory authorities like the FDA.
Picking the Right Certificate Name
“Certificate of Free Sale,” “Certificate for Export,” and “Certificate to a Foreign Government” are not interchangeable. The FDA draws sharp distinctions, and asking for the wrong document can delay a shipment by weeks.
- Certificate to a Foreign Government covers conventional foods, food additives, food contact substances, and infant formula that meet federal requirements for U.S. marketing. This is the most common FDA-issued food export certificate.
- Certificate of Free Sale is available only for dietary supplements, medical foods, and foods for special dietary use. The FDA does not charge a fee for this certificate type.
- Certificate of Exportability is used for food products that may not fully comply with U.S. marketing requirements but meet the importing country’s standards.
- Certificate of Pharmaceutical Product is issued for approved or licensed drugs in a format that follows World Health Organization guidelines.
- For cosmetics, the FDA does not issue a “Certificate of Free Sale.” It issues a document titled simply “Certificate” through its cosmetics export certification system.
Check the importing country’s requirements first, then match those requirements to the correct certificate type.
How to Apply
All FDA export certificate applications are submitted electronically. You create an account through FDA Industry Systems to reach the relevant portal: CFSAN eCATS for food products, CECATS for medical devices, CDER’s electronic system for drugs.
Each application requires the product’s trade name as it appears on the label, your business name, and your facility registration number. The destination country must be specified on every application. For food certificates, the FDA bases certification on information available at the time of issuance, including attestations you provide.
State agency applications vary. Some accept online submissions; others require a physical mailing with a self-addressed, prepaid return envelope. Typical requirements are your company name and address, product descriptions, and any state-issued registration or permit numbers.
Chamber of Commerce applications are the simplest. You provide company details, the receiving international company’s contact information, product descriptions, and the shipment value. Some chambers require your business to be registered in their state.
Fees
FDA export certificate fees are capped by statute at $175 per certificate. The first certificate in a request costs $175 across all FDA centers. Additional copies within the same request cost less, and the discount varies by center:
- Food products (HFP): $175 first, $155 second, $100 each additional
- Medical devices (CDRH): $175 first, $85 each additional
- Drugs (CDER): $175 first, $90 second, $40 each additional
- Biologics (CBER): $175 first, $175 second, $85 each additional
- Veterinary products (CVM): $175 first, $155 second, $70 each additional
The FDA does not charge a fee for the Certificate of Free Sale issued for dietary supplements, medical foods, and foods for special dietary use.
State agency fees for food and agricultural certificates are lower, with most falling in the $20 to $86 range depending on the state. Chamber of Commerce certificates tend to cost $100 to $125, with member discounts sometimes available.
How Long It Takes
FDA food export certificates are usually processed within a few days, though timing varies with how many products are on the application, whether additional information is needed, and the agency’s workload. Medical device export certificates through CDRH are issued within 20 working days of the application, per the statutory framework, and delivered electronically as downloadable PDFs. Chamber of Commerce certificates are the fastest, with many chambers offering same-day or next-business-day processing.
Authentication After Issuance
Getting the certificate issued is only half the process for many exporters. Depending on the destination country, you may also need to authenticate or legalize the document before foreign customs will accept it.
If the importing country is a member of the Hague Apostille Convention (currently 129 member countries), your certificate needs an apostille. For FDA-issued certificates, that apostille comes from the U.S. Department of State in Washington, D.C., which charges $20 per document. The apostille certifies the authenticity of the signature and eliminates the need for further legalization.
For non-Hague countries, the process runs through four steps: notarization (if the document does not already bear an official agency signature), state-level certification from the Secretary of State, authentication from the U.S. Department of State, and legalization by the embassy or consulate of the destination country. State apostille or certification fees range from roughly $2 to $26 depending on the state. Embassy legalization fees vary widely by country. Skipping any step means the importing country’s customs office will reject the document.
How Long the Certificate Stays Valid
Certificates of free sale expire. Certificates of Pharmaceutical Product expire 24 months from the date of issuance. For other certificate types, a two-year validity period is common, though the specific expiration depends on the issuing authority and the importing country’s requirements. Some countries will not accept a certificate older than six months regardless of what the issuing agency considers valid. Check with your buyer or the destination country’s import authority before relying on an older certificate.
How Foreign Customs Verifies Your Certificate
FDA-issued medical device certificates include a built-in verification system. Each CDRH-issued certificate carries a QR code on the first page that directs any reader to the FDA’s online verification portal, where the certificate number confirms the document’s status.
Foreign governments can also verify certificates directly through the FDA’s FURLS Export Certificate Validator at access.fda.gov. The system checks whether the certificate is currently in effect and generates a verification PDF. If the certificate has been withdrawn, the PDF displays a “Withdrawn” watermark. If expired or invalid, the system returns an error.
Because verification is remote and live, a certificate can be invalidated after issuance if your product’s registration status changes. Keep your FDA registrations current so a valid-looking certificate does not fail verification at the destination.