Quick answer: The FDA does not approve dietary supplements before they are imported, but the importer is responsible for making sure the product is safe and correctly labeled. In practice, a US buyer importing from China should check five things before the first order: the factory's FDA facility registration, prior notice for each shipment, the importer's foreign supplier verification (FSVP) duties, US-compliant labels, and who acts as importer of record under the shipping terms (EXW, FOB or DDP).
This guide is general information for buyers, not legal advice. Rules change, so confirm the current requirements with the FDA, your customs broker or a regulatory advisor before you ship.
What the FDA expects from an importer
According to the FDA's guidance on importing food products, dietary supplements are regulated as foods, and the importer is responsible for making sure the product is safe, sanitary and labeled according to US requirements. The FDA does not pre-approve imports, and it may detain shipments that appear non-compliant.
| Requirement | What it means for a buyer |
|---|---|
| Facility registration | The facilities that make, pack or store the product must be registered with the FDA. See the FDA's food facility registration page. |
| Prior notice | The FDA must receive prior notice of each incoming food shipment, usually filed by your customs broker. |
| Foreign supplier verification (FSVP) | The US owner or consignee of the goods is normally the FSVP importer and must have a verification program for the supplier. Dietary supplements have modified requirements in some cases. See the FSVP at a glance page. |
| Labels | The label must follow US rules, including the Supplement Facts panel. See the FDA's Dietary Supplement Labeling Guide. |
| Manufacturing practice | Dietary supplements must be made under current good manufacturing practice. See the FDA's cGMP small entity compliance guide. |
Who does what under EXW, FOB and DDP
The shipping term decides who handles customs. Agree on it in writing before you pay a deposit.
| Term | Seller (factory) | Buyer |
|---|---|---|
| EXW (ex works) | Hands the goods over at the factory | Arranges export clearance, freight, US import clearance and duties |
| FOB (free on board) | Delivers to the port and clears export | Arranges ocean or air freight, US import clearance and duties |
| DDP (delivered duty paid) | Arranges freight, import clearance and duties to your address | Receives the goods |
Even under DDP, confirm in writing who is the importer of record and who is named as the FSVP importer at entry, because the FDA's rule defines the FSVP importer as the US owner or consignee, or the US agent of the foreign owner if there is none. For a deeper comparison, read our guide to DDP vs FOB for supplement buyers.
Documents to ask your manufacturer for
Ask for these before you place the order, not after the goods are on the water:
- Ingredient specification for every ingredient, with the amounts per serving.
- Certificate of analysis (COA) for the finished batch, and the testing items it covers.
- Facility certificates and, if the supplier claims FDA registration, the registration number, so you can check it.
- Label artwork proof in a format your regulatory advisor can review.
- Commercial invoice and packing list that match the product name, quantity and value on the label and the order.
- Allergen and vegan statements where your product makes such claims.
Our group holds NSF/ANSI 455-2 GMP, FSSC 22000, ISO, HACCP, BRCGS and Halal certificates, and we can discuss which documents your project needs in the quotation. See how to verify a Chinese supplement manufacturer before you order and our factory audit and export checklist.
Common mistakes new importers make
- Choosing the shipping term last. The term changes who pays duties and who files the paperwork, so it changes your real cost.
- Approving a label that has not been reviewed for the US. Check the Supplement Facts panel, the ingredient names, the serving size and your claims before printing.
- Mismatched documents. If the invoice, the packing list and the label describe the product differently, the shipment can be delayed.
- Not asking who the FSVP importer is. This should be settled before the shipment leaves China.
- Planning the launch without the clearance time. Add time for freight and customs to the production schedule. See our guide to the launch timeline by format.
A practical checklist before your first order
| Step | Done? |
|---|---|
| Confirm the factory's FDA facility registration and cGMP practice | |
| Decide the shipping term (EXW, FOB or DDP) and who is importer of record | |
| Hire a customs broker and ask who files prior notice | |
| Name your FSVP importer and plan your supplier verification | |
| Review the label artwork with a regulatory advisor | |
| Collect the COA, specifications, invoice and packing list |
Importing supplements from China: questions
Does the FDA approve dietary supplements before they are imported?
No. The FDA does not pre-approve imports, but it can detain shipments that do not comply. The importer is responsible for safety and correct labeling.
Do I need a customs broker?
Most small brands use one. A broker files the customs entry and usually the prior notice, and can tell you what the current requirements are.
What is the minimum order for a first shipment?
At NuCoreBio, the minimum is 500 bottles for gummies, capsules, powders and tablets, so a small first shipment is possible. See how to start from a low MOQ.
Can the factory handle the shipping for me?
We ship EXW from our factories in Guangzhou or Haikou, FOB, or DDP to your address. The terms that fit your project are confirmed in the quotation.
Start your US launch
Send your product, target market and first-order quantity. We will confirm the minimum, the timeline and the documents you will receive.
Request a quote or read about our private label supplement manufacturer services.
Sources
- Importing Food Products into the United States, FDA
- Registration of Food Facilities and Other Submissions, FDA
- Final Rule on Foreign Supplier Verification Programs (FSVP) at a Glance, FDA
- Dietary Supplement Labeling Guide, FDA
- Small Entity Compliance Guide: cGMP for Dietary Supplements, FDA
This guide is general information and not legal advice. Requirements change; confirm the current rules with the FDA, your customs broker or a regulatory advisor.