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Important Changes to the U.S. De Minimis Rule and FDA Import Requirements
The United States has recently implemented significant changes to its customs regulations that directly affect personal imports and e-commerce shipments. In particular, two major updates stand out: the removal of the FDA review exemption for low-value shipments and the full repeal of the de minimis rule that previously allowed goods under USD 800 to enter duty-free.
Removal of the FDA review exemption (announced on July 9, 2025)
This exemption has been removed. Even if a shipment’s value is under USD 800, it must go through FDA review if it includes FDA-regulated products.
Full repeal of the de minimis rule (effective from August 29, 2025)
The de minimis rule itself is being fully repealed, meaning low-value shipments (under USD 800) will no longer be exempt from customs duties or taxes.
While some of these changes already apply to specific categories or countries (like shipments from China), they will take effect worldwide from August 29, 2025.
Due to the changes in the de minimis rule, delays in delivery and an increase in various procedures required by recipients are expected in the future.
For details about these changes, please contact the U.S. Customs and Border Protection (CBP) or the Food and Drug Administration (FDA).