All de minimis-eligible imports regulated by the U.S. Food and Drug Administration now must be submitted to the agency for review during the entry process, according to a July 9 Customs and Border Protection bulletin.
The change means FDA-regulated shipments are subject to the same entry requirements regardless of quantity and value, per the bulletin. Previous exemptions allowing sub-$800 products in five categories to be released by customs without FDA review have been rescinded. Affected categories are:
- Cosmetics
- Dinnerware (including eating and/or cooking utensils)
- Radiation emitting, non-medical devices, including microwaves, televisions and CD players
- Biological samples for laboratory testing
- Food, excluding ackees, puffer fish, raw clams, raw oysters, raw mussels and foods packed in air tight containers intended to be stored at room temperature
Impacted products now must include all required FDA data elements for an Entry Type 86 filing, which is a streamlined entry process for de minimis shipments, per an update from freight forwarder Cole International on the rule change. Logistics provider Coppersmith said importers should ensure FDA product codes, intended use and manufacturer information are all submitted correctly.
"Compliance delays can lead to holds, refusals, or enforcement action, especially for repeat offenders," according to Coppersmith.
CBP said in its bulletin that the change was enabled by technological capabilities that "have advanced significantly."
"This allows FDA to review all electronically transmitted FDA-regulated products offered for import, regardless of shipment quantity and value, to facilitate legitimate trade and prevent the importation of violative products," the agency's bulletin said.
The Trump administration has upped customs enforcement efforts against low-value imports in a bid to reduce the amount of contraband entering the U.S. The de minimis exemption, which allows imports of less than $800 to arrive duty and tax free, has already been eliminated for China and Hong Kong imports. The exemption is slated to end entirely on July 1, 2027.
