TL;DR
Short answer: Import compliance is a document game: facility registration, Prior Notice, the batch COA and origin statements all travel with the goods. Duty is HS-code specific, so confirm the code and the rate before you set your landed cost. DDP hands freight, duty and clearance to the supplier for a single landed price, and a 200-bottle trial on DDP is the cheapest import education available.
United States
Dietary supplements enter under food rules: the producing facility needs current FDA facility registration; shipments need FDA Prior Notice filed before arrival; labels follow the Supplement Facts format. Registration numbers are verified under NDA in our process before production.
European Union
Supplements are regulated as food supplements: permitted vitamin/mineral forms and maximum levels vary by member state, so confirm the formula is permitted in your target country before you print labels — not after.
Other markets (RU, Middle East, LatAm)
Each market has its own registration or notification step. If a market allows it, DDP routing with a supplier who has shipped there before is the pragmatic first move — ask for market references, not promises.
Every shipment is classified under an HS code, and duty follows that code plus origin and current tariff schedules. Because rates change and classifications can be contested at the border, treat any quoted "average supplement duty" with suspicion. The practical checklist: ask your supplier for the HS code on the proforma invoice, have your broker confirm the rate into your market, and add it into your landed-cost math before you set retail price.
Landing cost, stated simply
Landed cost = product + freight + duty + clearance + last-mile. If you cannot get the supplier to state every line, you cannot trust the "cheap" price — the cheapest FOB quote in the world loses to a transparent DDP quote every time.
| Incoterm | You handle | Supplier handles | Best for |
|---|---|---|---|
| EXW | Everything after the factory gate | Production and handover | Buyers with an established freight network |
| FOB | Ocean freight onward, import, clearance | Delivery to the port, export | Mid-volume buyers with a broker |
| DDP | Receive at door (duty may be included or split per quote) | Freight, duty, clearance, delivery | First orders, trials, FBA direct — one landed price |
Terms vary by quote and market — always confirm which duties and fees are inside a DDP price before you compare it with FOB.
If a supplier cannot produce this file set for a trial order, they will not produce it for a 5,000-unit order either — the paperwork is the product.
Do I need a US FDA registration to import supplements?
Two registrations are in play: the manufacturing facility must hold FDA facility registration (and comply with cGMP), and if you import, the US-side responsibilities follow the buyer/importer role. Verify your manufacturer’s registration before you sign — it is disclosed under mutual NDA in our process.
What is FDA Prior Notice?
For food and dietary supplements entering the US, importers must file Prior Notice with FDA before arrival so the shipment can be reviewed at the border. Your customs broker or DDP freight partner handles the filing with the shipment documentation.
How are duties calculated for supplements?
Duty depends on the HS code classification of the product, its origin and the current tariff schedules — there is no single "supplement rate." Ask for the HS code used on your invoice and have your broker confirm the rate for your market before you price the landing cost.
What documents must ship with my consignment?
At minimum: commercial invoice, packing list, the batch COA, and market-specific paperwork such as FDA Prior Notice confirmation or EU food-supplement declarations. A DDP shipment should land with all of this handled — confirm it in writing.
What is the difference between DDP and EXW/FOB for a first order?
Under EXW or FOB the import risk and customs process sit on you. Under DDP the supplier owns freight, duty and clearance through to delivery — one landed price, less surprise. For a first 200-bottle trial, DDP removes most of the logistics learning curve.
Can you ship direct to Amazon FBA?
Yes — private-label orders can be labeled, barcoded (FNSKU) and shipped direct to US or EU FBA fulfillment centers, with customs clearance handled on the route. See the Amazon launch checklist for the file set that should travel with the shipment.
Send an RFQ with your market and volume — receive tiered pricing plus a clear freight and DDP answer for your destination, not a vague promise.