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Exporting food supplements from the US

For dietary supplements, the FDA issues one kind of export certificate: the Certificate of Free Sale, free of charge, requested through the CAP module of HFP eCATS. It does not attest to GMP compliance. US law does not require a certificate; the destination decides. Most shipments also need EEI filed in the AES.

Updated · Each section links to the official source it comes from

FDA certificate
Certificate of Free Sale
Fee
None
Where to apply
CAP module of HFP eCATS
GMP certificate from the FDA
Not issued
Products with NAC
A different certificate, by separate CAP application
Export declaration
EEI in the AES, above $2,500 per Schedule B line

Before the goods leave

The questions to answer, in the order they usually come up.

  1. 1Does the destination ask for a Certificate of Free Sale or another certificate? Read more
  2. 2Is each product a dietary supplement under the FD&C Act, with a Supplement Facts label? Read more
  3. 3Would a state, local or trade association certificate be accepted instead? Read more
  4. 4Is any product made only for export to the buyer's specification? Read more
  5. 5Does the shipment need EEI, and who files it? Read more

The rules, by area

What each area covers, the texts that set it, and what the official pages say.

The FDA Certificate of Free Sale

The only FDA export certificate for dietary supplements, also issued for medical foods and foods for special dietary use.

  • The Certificate of Free Sale is available only for dietary supplements, medical foods and foods for special dietary use, and the FDA charges no fee.
  • It covers packaged and bulk finished dietary supplements, and is requested through the Certificate Application Process (CAP) module of HFP eCATS.
  • Select "Dietary Supplement" as the certificate type for products that bear a Supplement Facts label.
  • The FDA does not issue one where information shows the products are not eligible for legal sale in the US, for example under seizure or injunction.
  • Issuing it does not mean the FDA has found the products in full compliance with the FD&C Act; the FDA does not approve dietary supplements.
  • Products containing N-acetyl-L-cysteine (NAC) do not meet the definition of a dietary supplement; a separate CAP application can be made for a different certificate.

How we help: Compliant Always keeps each certificate with the products and lots it lists, dated, and reads it against what the destination asks for. Ask about this

GMP attestations and other sources of certificates

What the FDA does not certify, and where else exporters may turn.

  • The FDA inspects dietary supplement facilities against CGMP requirements but does not issue any certification of CGMP compliance.
  • Because of the limited information it holds, the FDA issues no other type of export certificate for dietary supplements.
  • Companies may obtain certificates acceptable to a foreign government from state or local agencies with jurisdiction over their products, or from organisations such as trade associations.

How we help: Compliant Always keeps state, association and FDA documents side by side with the product, and shows which ones a destination has not yet been matched to. Ask about this

Supplements made only for export

A dietary supplement is deemed to be a food under the FD&C Act (21 U.S.C. 321(ff)), so section 801(e)(1) applies to supplements made for a foreign buyer.

  • Food intended for export is not deemed adulterated or misbranded if it meets the foreign purchaser's specifications, does not conflict with the importing country's laws, is labelled on the outside of the shipping package as intended for export, and is not sold in domestic commerce.
  • The exporter keeps records showing each condition, for 3 years after the date of exportation for food (21 CFR 1.101(b)).

How we help: Compliant Always keeps the buyer's specification and the export marking with each lot, dated, ready if the FDA asks. Ask about this

Export declaration: EEI in the AES

Electronic Export Information filed in the Automated Export System, the export component of ACE, before the goods leave.

  • The EEI is filed through the AES by the US principal party in interest (USPPI), its authorised agent, or the authorised US agent of the foreign principal party in interest, for exports of physical goods, including orders received over the internet (15 CFR 30.2).
  • No EEI is needed where the value under one Schedule B or HTSUSA number, from one USPPI to one consignee on one conveyance, is $2,500 or less, unless a licence is required (15 CFR 30.37(a)).
  • Shipments to Canada are exempt, except goods stored in Canada for a third country or moving through Canada to one (15 CFR 30.36).
  • Filed before departure: 24 hours before loading for vessel cargo, 2 hours before departure for air cargo, 1 hour before a truck reaches the border (15 CFR 30.4).
  • Each line carries a 10-digit Schedule B or HTSUSA number and, where it applies, the ECCN or EAR99 (15 CFR 30.6).
  • Parties to the export keep its documents for five years from the date of export (15 CFR 30.10).

How we help: Compliant Always keeps the invoices, classifications and certificates behind each declaration with the shipment and lot, dated, and answers importers' questions from that record. Ask about this

Who answers for what

WhoWhat they answer forHow we help
ExporterMeeting the importing country's laws, the certificate application and, as USPPI, the EEI.Certificates and declarations kept with each shipment, with gaps shown before it leaves.
ManufacturerBeing identified on the application, and the CGMP its facility is inspected against.Inspection reports and labels kept with the product record.
Freight forwarder or customs brokerFiling EEI as the authorised agent.The commercial documents behind the filing, in one record.
Certifying authorityThe FDA's Human Foods Program export certification team for the Certificate of Free Sale; states or associations for others.Each certificate read against what the destination asks for.

Where are the goods going?

Most of what food supplements have to meet is set where they are sold. Each guide sets out the rules on arrival, with the official source for each.

Questions businesses ask

Do I need an FDA certificate to export supplements from the US?
Not under US law. The FDA does not require export certificates, but many importing countries ask for one when a product is registered or imported. The FDA issues a Certificate of Free Sale for dietary supplements.
What is a Certificate of Free Sale for supplements?
The FDA certificate for dietary supplements, medical foods and foods for special dietary use. It is free, covers packaged and bulk finished supplements, and is requested through the CAP module of HFP eCATS.
Does the FDA charge for a Certificate of Free Sale?
No. The FDA does not charge a fee for the Certificate of Free Sale.
Does a Certificate of Free Sale mean the FDA has approved the supplement?
No. The FDA does not approve dietary supplements, and issuing the certificate does not mean it has found the products in full compliance with the FD&C Act.
Can the FDA certify that my supplement factory meets GMP?
No. The FDA inspects dietary supplement facilities for CGMP compliance but does not issue any certification of CGMP compliance, during or after inspections.
Can I get a supplement export certificate from someone other than the FDA?
Yes. The FDA says companies may obtain certificates from state or local agencies with jurisdiction over their products, or from organisations such as trade associations, where the foreign government accepts them.
Can I export a supplement containing NAC with a Certificate of Free Sale?
No. Products containing N-acetyl-L-cysteine do not meet the definition of a dietary supplement. NAC products labelled as supplements may be eligible for a different certificate, requested by a separate CAP application.
Which certificate type do I choose in the FDA application?
"Dietary Supplement" for products that bear a Supplement Facts label; "Medical Food" or "Foods for Special Dietary Use" for those categories as defined in law.
How can a foreign authority check an FDA export certificate?
Most FDA food export certificates are issued as PDFs, and anyone who receives one can verify its authenticity online through the FDA's verification portal.
Do I need to file EEI to export supplements?
Yes, through the AES, unless an exemption applies, such as $2,500 or less under one Schedule B number to one consignee, or most shipments to Canada.
How does Compliant Always help with exporting from the US?
Our team reads the rules for the routes you ship. Compliant Always shows which export documents apply to your product, keeps them with the shipment beside what the destination asks for, and watches the sources for changes. It shows what the requirements say and what your documents show; you decide.

Sources

Compliant Always is a product of Lettuce Labs LLC. It shows what requirements say and what your documents show. It is not legal advice, and you decide.

Tell us what you make, and we will show you the rules for it.

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