How is the FDA declaration (Prior Notice for pharmaceuticals, etc.) handled for shipments to the U.S.?

For shipments to the United States, the FDA declaration process is handled by the carrier (DHL, FedEx, UPS, etc.) acting as your customs broker. You do not need to file a declaration directly with the FDA yourself.

Responsibility and Workflow for U.S. Customs Clearance

• The Carrier's Role

  Using their internal customs brokerage department, the carrier handles the Prior Notice (PN) filing and the submission of required information to the FDA based on the commercial invoice and documents prepared by us.




• The Consignee's (Your) Role

  During the clearance process, the FDA may request additional details, such as the 'Purpose of Import' or a 'Physician's Prescription.' In such cases, please provide the requested information promptly following the instructions from the carrier.




• Our Role

  To ensure a smooth FDA declaration, we prepare and attach accurate customs documentation that clearly specifies the active ingredients and the intended use of the products.

Practical Considerations

• Prior Notice (PN): While a PN number is mandatory for importing pharmaceuticals or supplements into the U.S., this is typically processed automatically within the carrier's logistics system.

• Risk of Import Refusal: If the FDA determines that a shipment exceeds personal importation limits (in terms of quantity or specific ingredients), there is a risk that the package may be returned or destroyed. We strongly recommend verifying local U.S. regulations regarding your specific items before placing an order.