
Section 321 (De Minimis) Shipments of Products Regulated by the U.S. Food and Drug Administration (FDA)
Introduction The regulatory environment for low-value imports into the United States has greatly changed. On July 9, 2025, the U.S. Customs and Border Protection (CBP), in collaboration with the Food and Drug Administration (FDA), enacted a policy change that removes the de minimis exemption of FDA-regulated products under Section 321 of the Tariff Act of 1930. In the past, importers were allowed to import eligible FDA-regulated products into the U.S.








