Certificate of Free Sale: Which FDA Export Certificate Your Supplement, Cosmetic, Food or Device Needs

FDA COMPLIANCE · EXPORTS

Updated November 2026. U.S. brands expanding to Amazon or retail stores abroad, or selling to a foreign distributor, are often told to “send a Certificate of Free Sale” before the first order can clear customs or be registered locally. This guide explains which FDA document fits each product type, how to apply, what it costs, how long it takes and what to check before you start. It is general information, not legal advice.

What is a Certificate of Free Sale?

Foreign governments and importers often want official assurance that a product exported from the United States can lawfully be marketed here, or that it meets specific U.S. requirements. An export certificate is FDA’s attestation about the product’s regulatory or marketing status, based on the information available when the certificate is issued, including statements the applicant makes. Some countries review the certificate as part of registering or importing the product.

“Certificate of Free Sale” is the name buyers and governments use most, but FDA reserves that title for a few product types. Other FDA certificates serve the same purpose under different names, so the first step is matching your product to the right document.

Which FDA export certificate does your product need?

• Dietary supplements, medical foods and foods for special dietary use: Certificate of Free Sale. No FDA fee. Available for both packaged and bulk finished dietary supplements.
• Conventional foods, food additives, food contact substances and infant formula: Certificate to a Foreign Government if the product can be marketed in the United States, or a Certificate of Exportability if it is made only for export under section 801(e) of the FD&C Act. Fees are $175 for the first certificate, $155 for the second and $100 for each additional certificate for the same products in the same request.
• Cosmetics: a document titled simply “CERTIFICATE”. FDA does not issue Certificates of Free Sale for cosmetics.
• Medical devices: Certificate to Foreign Government for devices that can be legally marketed here, Certificate of Exportability for some that cannot, and a CFG-NE for devices made outside the U.S. and shipped to another country.
• Human drugs: electronic Certificate of Pharmaceutical Product (eCPP), in the World Health Organization format. OTC sellers should confirm with FDA’s drug export office which document their product qualifies for.

Some foods are certified by other federal agencies instead, including dairy, seafood, honey, egg products and alcoholic beverages. Check with the importing country or your importer before applying, because applying for the wrong certificate type gets the application rejected.

How do you get a Certificate of Free Sale for dietary supplements?

Supplement brands apply online through FDA Industry Systems:

1. Create or use an FDA Industry Systems account. The same login family is used for food facility registration.
2. Open the export certification system (now called HFP eCATS for the Human Foods Program, formerly CFSAN eCATS) and choose the Certificate Application Process (CAP) module.
3. Select “Dietary Supplement” as the certificate type and enter the exporter, the manufacturer and the products. You do not have to be the manufacturer, but you must identify it.
4. Upload labels and supporting documents in English, or with English translations, and show a clear link between the manufacturer and each product, for example a signed letter on the manufacturer’s letterhead if the label does not name it.
5. Choose the number of copies and submit.

FDA says requests are usually processed within a few days, depending on the number of products, whether the application is complete and its workload. There is no expedited option. If FDA needs more information, the status changes to “Return for Action” and you get an email explaining what is missing. A status of “Processed” means the certificate package is ready to download and print. Old certificates cannot be updated, but you can clone a past application and submit it again.

Two supplement-specific limits matter. FDA will not issue a CFS when information readily shows the products cannot be legally sold here, for example if they are under seizure or the firm is under injunction. And products containing N-acetyl-L-cysteine (NAC) do not meet the dietary supplement definition, so they must go in a separate CAP application for a different certificate. If you are unsure whether an ingredient is lawful in a supplement, read our guides to new dietary ingredient notifications and GRAS first.

How do cosmetic export certificates work?

Cosmetic exporters also apply through the CAP module. FDA’s cosmetic certificates come in two forms: product-specific, listing every product by brand and product name exactly as it appears on the label, or general, with no product list. FDA suggests confirming that the importing country accepts a general certificate before requesting one.

• FDA does not issue cosmetic certificates for products made outside the United States, or for raw or bulk materials.
• Products with drug claims, such as sun protection, acne or dandruff treatment, hair growth or skin lightening, are drugs under U.S. law and need the drug route instead.
• FDA says cosmetic requests may take several weeks, and cosmetic certificates are a service it provides as resources permit. Some state health departments and trade groups also issue cosmetic certificates that certain countries accept.

Because product-specific certificates must match your labels exactly, keep your MoCRA product listings and cosmetic labels consistent before you apply.

What about medical devices and OTC drugs?

Device certificates are requested through CDRH’s export system, CECATS, using the same FDA Industry Systems account as establishment registration. Every establishment involved in making the device must have a listing for it in its registration, and the system pulls those listings directly, so a missing or inactive listing stops the application. FDA may charge a fee when it processes the request within 20 working days. See our guide to device registration and listing.

Drug certificates are issued as eCPPs through CDER’s export system, for approved or licensed drugs and for unapproved drugs that meet certain legal requirements. The fee is up to $175 for certificates issued within 20 days of receipt, and each eCPP expires 24 months after issue. Your drug establishment registration and NDC listing need to be current first; our guide on how to get an NDC number for an OTC product explains that step.

How does a foreign buyer verify the certificate, and what about apostilles?

Most FDA food certificates are issued as PDFs, and anyone who receives one can check it on FDA’s online verification portal for food and cosmetic export certificates. Drug eCPPs have their own verification page. If the importing country wants an apostille or authentication, the exporter requests it from the U.S. Department of State with the original certificate and Form DS-4194. FDA cannot change the standard wording of its certificates and does not notarize them, though extra language can be requested on some food certificates.

What should you check before applying?

• The exact document the importing country wants, its name and whether it must list products.
• Your U.S. filings. Food and supplement facility registration, cosmetic facility registration and listing, drug or device registration and listing, all current and matching the manufacturer on the application. Our FEI vs registration number guide explains which identifiers to have ready.
• Labels that match the application and make only claims allowed for the product category.
• The importing country’s own rules. FDA says it is the exporter’s responsibility to comply with them.

How Eva Commerce helps

Eva Commerce does not issue export certificates. FDA, other federal agencies and some state or private bodies do. What we handle is the U.S. groundwork every certificate application relies on: food and supplement facility registration, MoCRA facility registration ($440 every 2 years) and product listing ($100 per product, one time, with updates free for the same product), OTC NDC listings ($290 per product), device registration and listing, U.S. Agent service for foreign facilities ($250 a year) and label review. Published prices for every FDA service are on our FDA compliance services page.

Eva also runs Amazon, Walmart, TikTok Shop and Shopify growth, so the labels and listings you export match the ones you sell. Book a call or call 858-315-2020 to check your filings before you apply for an export certificate.

Frequently asked questions

Does FDA issue a Certificate of Free Sale?

Yes, but only for dietary supplements, medical foods and foods for special dietary use. Other FDA-regulated products receive differently named export certificates, such as a Certificate to a Foreign Government for foods and devices.

How much does an FDA Certificate of Free Sale cost?

FDA does not charge a fee for a Certificate of Free Sale. A Certificate to a Foreign Government for conventional foods costs $175 for the first certificate, $155 for the second and $100 for each additional one in the same request.

How long does it take to get a Certificate of Free Sale?

FDA says food and supplement export certificate requests are usually processed within a few days, depending on completeness and workload. Cosmetic certificate requests may take several weeks, and there is no expedited option.

Can I get a Certificate of Free Sale for cosmetics?

Not under that name. FDA issues cosmetic export documents titled “CERTIFICATE,” only for cosmetics made in the United States and not for raw or bulk materials. Some countries accept certificates from other issuers.

Is a Certificate of Free Sale proof of FDA approval?

No. FDA says issuing a certificate does not mean it has found the product in full compliance with the law, and FDA can still take regulatory action against products covered by a certificate.

Can Eva Commerce help with a Certificate of Free Sale?

Eva does not issue certificates, but keeps the registrations, listings, U.S. Agent service and labels that applications depend on accurate and current. Book a call or call 858-315-2020.

Sources: FDA, Food Export Certificates; FDA, Export Certification FAQs; FDA, Online Applications for Export Certificates for Food; FDA, Cosmetics Export Certificate FAQs; FDA, Online Applications for Export Certificates for Cosmetics; FDA, Exporting Medical Devices FAQs; FDA, Electronic Certificates of Pharmaceutical Product; FDA, Online Verification of Export Certificates for Food. General information, not legal advice.

Related Eva guides: FDA compliance services, FDA registration certificate guide, do supplements need FDA approval, FDA registration vs approval, food facility registration renewal, FDA registration and U.S. Agent guide.