Supplement export documentation that clears customs the first time

Most destination markets ask for six manufacturer-side documents: a Certificate of Free Sale from FDA or Health Canada (apostilled or legalised where required), a GMP attestation letter, an ISO 17025 Certificate of Analysis, a commercial invoice with the correct HS classification, a certificate of origin, and labels formatted for the destination market. Some regions add Halal, Kosher, or Vegan certification on top. We prepare the full pack during the production run.

The core pack: a Certificate of Free Sale from the FDA or Health Canada, a GMP attestation letter backed by the facility registration or Site Licence, an ISO 17025 Certificate of Analysis for the batch, a commercial invoice with the correct HS tariff code, a packing list, and a certificate of origin. Some destinations add apostille or consular legalisation of the CFS, Halal certification, or an ingredient breakdown letter. Your importer confirms the exact list for your market; every document named here is one we prepare as part of the run.

Yes. Supplements made in the US or Canada ship legally to most markets once the manufacturer-side documentation pack is in place and the importer has filed whatever registration the destination requires. Before committing to a production run, have your in-country agent confirm that no ingredient in your formula is restricted in the destination, and whether the market requires product registration before sale (China general trade, Saudi Arabia, Brazil, and Mexico all do). We produce the manufacturer documents; your agent handles the filings.

No. We are honest about this on purpose. In-country supplement registration is technical, market-specific, and almost always faster and cheaper through a local regulatory agent who already has relationships with the authority. We provide the manufacturer-side documentation your local agent will need to assemble the dossier: Certificate of Free Sale, GMP attestation, finished-product specifications, COAs, ingredient breakdown letters, label artwork. If you do not already have a local agent, we are happy to introduce you to one we have worked with on a previous shipment.

You do. It is treated as a pass-through cost. The apostille fee through the relevant Secretary of State or Global Affairs Canada is modest. Consular legalisation (required by some Gulf and Latin American countries) varies by embassy and usually runs a few hundred dollars per document plus a courier charge. We arrange the process and bill it at cost.

Standard terms are EXW (you arrange pickup at the manufacturing facility) or FCA. We can quote FOB at a US or Canadian port for an additional handling fee. CIF and DDP are out of scope, because those terms involve insurance and destination clearance that your freight forwarder is better positioned to handle.

Not in-house. We design and print labels in English for most destinations, and in bilingual English/French for Canada (which is a Canadian legal requirement, not an export requirement). When your destination needs Spanish, Portuguese, Arabic, or any other language on the principal display panel, we hand over editable source files so your in-country agent or a local printer can produce the destination-compliant label. Working with a local translator avoids the mistakes that come from translating a regulated product label from afar.

Usually yes. We use ISO 17025 accredited third-party labs, which is the standard most customs authorities and regulatory bodies recognise. If your destination market requires testing at a specific lab inside the country (for example, certain SFDA-approved labs in Saudi Arabia), the importer arranges that after the shipment arrives. We do not pay for or schedule that in-country testing.

Yes. We will quote the manufacturing run, the documentation pack, and the optional Halal or Kosher coordination separately. Pricing on the documentation does not depend on which country you ship to. It depends on which documents you need. Once you have an importer, they will tell you which documents their customs authority asks for; we adjust the pack from a standard checklist.

That review sits with your local agent or importer. We will flag obvious cases during formulation (for example, a vinpocetine product is a non-starter in the EU, certain melatonin doses are restricted in the UK), but we are not regulatory specialists for every market and we will not pretend to be. The reliable filter is your in-country agent reviewing your formula sheet before you commit to manufacturing.

Most documents are ready within 5 to 10 business days after the production run completes and the third-party lab releases the COA. The Certificate of Free Sale from FDA or Health Canada typically takes another 2 to 6 weeks depending on backlog and whether legalisation is required. We start the CFS request early in the production cycle so it lands close to when the product ships.

Yes, through cross-border e-commerce (CBEC). Several of our partner CMOs ship North American-made supplements into Chinese bonded warehouses (Hangzhou, Zhengzhou, Ningbo) on a regular cadence, where they fulfil to consumers via Tmall Global, JD Worldwide, Kaola, or Douyin Global. CBEC keeps the product outside the NMPA "Blue Hat" health-food registration that general-trade retail requires, so the documentation lane is the manufacturer-side pack we already produce. Your CBEC platform partner handles the bonded-warehouse import and the in-store listing.

Only if you want the product on bricks-and-mortar shelves in mainland China through general-trade import. Blue Hat takes 12 to 24 months, costs tens of thousands of dollars, and is filed by a Chinese regulatory agent on behalf of an in-country licensee. For cross-border e-commerce (Tmall Global and similar), Blue Hat is not required, which is why CBEC is the default channel almost every foreign supplement brand uses to enter China. We are happy to introduce you to a Chinese agent if you are committed to a full general-trade play, but we do not file Blue Hat ourselves.