US Customs Regulations on the Import of Masks

The US applied an FDA gate to commercial mask imports but left room for personal gifts under 100 US dollars.

Required documents

• Bill of lading (sea or air freight)
• Commercial invoice

For personal shipments sent by international express, the bill of lading was usually replaced by the express air waybill.

FDA requirements

• Masks imported into the United States for sale had to be registered and certified with the FDA — covering the manufacturer, the exporter and the product — before they could be marketed.
• Products contacting the mouth required FDA registration not only for the product itself but also for the producing factory, so problems could be traced back to the source.
• Personal gifts — marked on the description as unsolicited gifts with a declared value under US$100 — could be exempted from FDA control.

What this meant in practice

FDA registration takes time and money. In 2020, mask factories that had never registered with the FDA could not clear commercial volumes into the US market; only factories already exporting masks to the US could supply importable product. For individuals, shipments of fewer than 1,000 masks with a value under US$100 were generally released without FDA control. At the then-current Chinese market prices — about RMB 1 per ordinary disposable mask, RMB 2 per disposable medical mask, and around RMB 20 per N95 mask — that exemption covered roughly 700 disposable masks.

Declare honestly

Under-declaring the value on the commercial invoice risks being identified by customs as tax evasion. Declare the true value of the masks. The United States exempted medical products such as masks from customs duty on many China origins at that time, but honest, conservative invoice values kept the shipment safe.

Use a forwarder

Domestic international freight forwarders (much cheaper than retail express counters, which sometimes refused mask shipments outright) prepared the business invoice with the correct product name, value and piece count, so the shipment cleared without detention.