Does an FDA Certificate of Free Sale go to the Secretary of State or the U.S. Department of State?

It goes to the U.S. Department of State, Office of Authentications. The certificate carries the signature of the U.S. Food and Drug Administration, a federal agency, and the HCCH competent authority listing for the United States assigns federal-agency documents to the Department of State. State Secretaries of State are designated only for documents issued inside their own jurisdiction. Our price is $120 per apostille, all-inclusive.

That single sentence is the most expensive thing companies get wrong. An export manager in Texas, holding a certificate signed in College Park, Maryland, sends the package to Austin because Austin apostilles everything else the company files. Austin has no jurisdiction over an FDA signature, the package comes back unprocessed, and a container sits while the clock on the importer’s registration window keeps running.

A Secretary of State cannot apostille an FDA-signed document, and no amount of notarisation changes that. If the signature on the page belongs to a federal agency, the only office in the United States that can issue the apostille is the Department of State’s Office of Authentications.

What is the FDA Certificate of Free Sale, and is it the certificate you actually need?

A certificate of free sale is documentary evidence that a product is legally sold in the open market of its country of origin. Importing ministries ask for it before they will register a product, clear a shipment, or admit a bidder to a tender. FDA does not require you to have one — the agency says so plainly — and holding one is not FDA approval. The demand comes from the buyer’s side of the ocean.

The complication is that “Certificate of Free Sale” is used loosely in trade and precisely by FDA, and the two usages do not match.

Food, supplements and special dietary use

Within the Center for Food Safety and Applied Nutrition (CFSAN), the Certificate of Free Sale is scoped to dietary supplements, medical foods, and foods for special dietary use. Conventional foods, food additives, food contact substances and infant formula are covered by the FDA Certificate to Foreign Government instead. If an importer’s letter asks for “free sale” but your product is a conventional food, you most likely need the CFG.

FDA will, on request, add a “Certificate of Free Sale” subtitle to a Certificate to a Foreign Government. When it does, the agency still treats the document as a CFG. That subtitle is often exactly what satisfies a foreign registry that will not accept any other wording — ask for it at application stage, not afterwards.

Cosmetics

FDA states directly that it does not issue Certificates of Free Sale for cosmetics. Every FDA-issued cosmetic export certificate is titled simply “CERTIFICATE,” applied for through the Certificate Application Process module in CFSAN eCATS. FDA also will not issue cosmetic export certificates for products manufactured outside the United States, for raw or bulk materials, or for products whose intended use is not solely cosmetic — an acne cleanser carries a drug claim and falls outside the programme. Cosmetics exporters still get a federally signed certificate that apostilles the same way; it just does not say “free sale” on it, and you should warn your in-country agent of that in advance. For a market that is not in the Convention, see how the chain runs when legalizing an FDA Certificate of Free Sale for Nigeria.

How do you get the certificate from FDA in the first place?

Applications for most CFSAN export certificates go through the CFSAN Export Certification Application and Tracking System (eCATS), reached through FDA Industry Systems at access.fda.gov/oaa. Set the account up before you need it; the account creation is not instant and it is a bad week to discover that when a tender closes.

Two application-stage details decide whether the file moves or stalls. First, the certificate type you select routes the application to the office inside FDA that handles it — choose the wrong type and the file lands with the wrong reviewers. Second, you must identify the manufacturer. You do not have to be the manufacturer to request a certificate, but you do have to name one, which means distributors and private-label brands need the manufacturing facility’s details on hand before they start.

FDA has not published a turnaround figure we can quote here, and the numbers circulating on commercial sites conflict with each other. Plan from the application date rather than the issue date, and treat the FDA stage as the long pole in the schedule. The same applies at the Department of State: check the current processing status on the Office of Authentications page at travel.state.gov before you commit to a shipping date.

Federal or state? The document checklist for an export filing

Most export packages are mixed. The FDA certificate is federal; the corporate papers that travel with it usually are not. That means two parallel filings, not one, and it is the point most pages blur. Our explainer on federal versus state documents in a business apostille filing goes further on the corporate side.

On every notarised item in that table — the corporate resolution, the power of attorney, the commercial contract — the apostille certifies the notary’s commission and signature. It says nothing about whether the contents are true, accurate or enforceable. Companies get caught out when a foreign registry queries a contract and someone answers “but it’s apostilled.” That answer addresses a different question than the one being asked.

What is the correct sequence, and what breaks if you reverse it?

1. Confirm what the importer actually requires. Get the requirement in writing from the registry, ministry or tender office: certificate type, required wording, recency window, and whether an apostille or consular legalization is expected. Build backwards from that.
2. Select the right certificate type in eCATS. Free Sale, Certificate to Foreign Government, or the cosmetic certificate. The type you pick routes the file inside FDA, and a wrong selection costs you the whole FDA cycle.
3. Apply through CFSAN eCATS with the manufacturer identified. Name the manufacturing facility, list the products exactly as they will appear on the import paperwork, and request any subtitle wording now rather than later.
4. Receive the FDA-signed certificate and check it line by line. Product names, manufacturer address and destination country must match the shipping and registration documents character for character. A typo discovered after the apostille is attached means starting again at FDA.
5. File with the Office of Authentications on Form DS-4194. Name the destination country on the form. Submissions go by mail to 44132 Mercure Cir., PO Box 1206, Sterling, VA 20166-1206, or in person at the Washington, DC location. The agency filing fee is included in our flat price.
6. Ship the apostilled original, or route it to the consulate. For Convention countries the apostille completes the chain. For non-member countries the Department of State issues an authentication certificate instead, which then goes to that country’s embassy or consulate.

Reverse any two of those and something concrete breaks. Apostille before verifying the importer’s required wording and you pay for an apostille on a document the registry will not take. Apply to FDA before confirming the recency window and the certificate may age out while it sits on a desk. Notarise the FDA certificate in the hope of “strengthening” it and you have added a state-level signature to a federal document, muddying which authority is being asked to act.

Certified copy, notarised copy, or FDA original?

Submit the certificate FDA issued to you. A notary public certifies signatures and administers oaths; a notary is not in a position to certify that a photocopy of a federal agency record is a true copy of that record, and a notarised photocopy introduces a notary’s signature where the federal signature needs to be the operative one. The county-clerk-then-Secretary-of-State chain some states impose is a path for notarised private instruments — it has no role here, because the Department of State takes FDA-signed documents directly.

On digital signatures: CFSAN issues through a web-based system, and whether the Office of Authentications will accept a self-printed, digitally signed FDA certificate or expects an FDA-issued wet-ink original is not something we will state without a primary source confirming it. Treat it as a live question. Ask the importer whether a digitally signed copy satisfies them, and if a wet-ink original is required anywhere in the chain, resolve that with FDA before the certificate is issued rather than afterwards. Our page on business and export apostilles for FDA certificates and corporate documents covers the packaging decisions in more detail.

How recent must the certificate be, and can you file several at once?

No U.S. authority imposes an age limit on the document. The Hague Convention does not set one, and the Department of State does not publish one. Every recency rule you will meet comes from the receiving side — an importing ministry that will only accept documents issued within three months, a product registry that works to six. The clock almost always runs from the FDA issue date, which means a slow apostille stage eats into a window that was already running.

Multiple documents can go in one submission, and for an export or market-entry filing that is the normal pattern: the FDA certificate alongside a certificate of good standing, articles of incorporation, a corporate resolution appointing a local agent, and a power of attorney. Each item receives its own apostille certificate. The constraint is jurisdictional, not numerical — federal documents to the Department of State, state and notarised documents to the relevant Secretary of State. A single courier envelope containing both will not be processed as one filing, because no single office can act on all of it.

Common reasons an apostille request is rejected

• Sent to a Secretary of State. The commonest and the costliest. FDA signature, federal jurisdiction, Department of State only.
• Wrong certificate type requested from FDA. Asking for Free Sale on a conventional food, or expecting a “Certificate of Free Sale” for cosmetics when FDA titles those documents “CERTIFICATE.”
• Product outside the programme. Cosmetics manufactured outside the United States, raw or bulk materials, or products carrying drug claims are not eligible for FDA cosmetic export certificates.
• “Return for Action” at CFSAN. This status means FDA needs more information before the application can proceed; it stalls silently if nobody is monitoring the eCATS queue.
• Form DS-4194 missing, unsigned, or missing the destination country. The form is a required part of the submission, and the destination determines whether you get an apostille or an authentication certificate.
• Destination country misidentified as a Convention member. Verify on the HCCH status table before filing; for recent accessions, check the entry-into-force date too.
• A photocopy or unnecessarily notarised version submitted instead of the FDA-issued certificate.
• Mismatched product or company names. If the certificate, the invoice and the registration dossier do not agree, the registry rejects the file even though the apostille itself is valid.
• Certificate aged past the registry’s window while sitting in a queue nobody was tracking.

Requirements differ by country and by registry, and the authority receiving the document always has the last word on whether it accepts what you send.

What to do next

Pull the importer’s written requirement and check three things against it: the certificate type FDA will actually issue for your product category, the recency window measured from the FDA issue date, and whether the destination is a Convention member. Once the FDA certificate is in hand, start an order with us and we will file it with the Office of Authentications on Form DS-4194 at $120 per apostille, all-inclusive — agency filing fee covered, no per-page add-ons. If corporate documents are travelling with it, tell us which state each one came from and we will run the two filings in parallel.