Recently, there have been two significant changes to the de minimis rule regarding imports into the United States.
These are: the removal of the FDA review exemption for low-value shipments, and the complete repeal of the de minimis rule that had previously allowed duty-free importation of goods valued under USD 800.
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The de minimis rule itself is being fully repealed, meaning low-value shipments (under USD 800) will no longer be exempt from customs duties or taxes.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.
For any inquiries, please contact CBP or FDA
Due to the changes in the de minimis rule, delays in shipments and an increase in various procedures required of recipients are expected in the future.
Additionally, please note that further changes to the de minimis rule may be introduced going forward.
For details about these recent changes or future updates, we recommend contacting U.S. Customs and Border Protection (CBP) or the U.S. Food and Drug Administration (FDA) directly.