In a CSMS message posted July 9, 2025, U.S. Customs and Border Protection (CBP) announced that, effective immediately, all shipments of products regulated by the U.S. Food and Drug Administration (FDA) must be subject to FDA-review upon importation.

Imported goods are subject not only to U.S. customs laws, but also to any applicable requirements and review by partner government agencies (PGA), including the FDA, the Center for Disease Control, the Animal and Plant Health Inspection Service, Food Safety and Inspection Service, the Consumer Product Safety Commission and others that regulate imports and enforce compliance with certain health and safety regulations.  PGAs collaborate with CBP to oversee and inspect imports, ensuring that imports meet certain product specifications and requirements.  Importers of such goods are required to assign PGA Message Sets to the entry, which effectively alert the target agency of the importation.  PGAs help review entry submissions and determine whether imports are admissible.  Goods found to be in violation of PGA requirements can be subject to penalties, import refusals, and seizure by CBP.

In the past, the FDA has treated certain categories of products—cosmetics, dinnerware, radiation emitting non-medical devices, biological samples for laboratory testing, and most food items—as exempt from the PGA requirement when the shipment qualifies for de minimis treatment under Section 321 of the Tariff Act of 1930.  CBP’s Section 321 de minimis program allows duty-free entry for certain shipments imported by one person on one day not exceeding $800 in aggregate fair retail value.  (The Trump administration recently curtailed the program by excluding products of China and Hong Kong from de minimis benefits.)  Under previous guidance, CBP and PGAs could clear de minimis shipments entered through Entry Type 86 without PGA data.

In the July 9 CSMS, CBP explained that, with technological advancements, the FDA now has the capability to review and screen all electronically transmitted FDA-related imports, regardless of shipment quantity and value, and emphasized that even small shipments can pose health and safety risks. Under the new guidance, de minimis shipments can still be processed through Entry Type 86, but PGA data must be declared—opening up the shipment for PGA review.  

This will have a potentially significant impact on academic medical centers and start-up biotechnology and pharmaceutical companies performing basic research or proof of concept studies, where importation of small biological samples for testing must now go through the FDA review and approval process. (For more information on FDA data requirements for imports, see the FDA supplemental guide here.)