DE MINIMIS ENDS FOR FDA REGULATED SHIPMENTS
In a recent Bulletin, U.S. Customs and Border Protection announced that all prior de minimis exemption guidance notifications for FDA-regulated products have been rescinded as of July 9, 2025. This operational shift leverages significant technological enhancements within both the trade and FDA systems to uphold rigorous health, safety, and security standards across the supply network. Importers must continue to satisfy Prior Notice requirements under 21 CFR 1.277(b) for all food and feed entries unless specifically exempted.
“Effective immediately, all FDA-regulated products must be submitted to the FDA for review. All prior communications exempting certain low-value FDA-regulated products are rescinded.”
U.S. Customs and Border Patrol | CSMS # 65581188
Since 1994, items such as cosmetics, dinnerware, radiation-emitting non-medical devices, biological samples for laboratory testing, and most foods valued under the $800 de minimis threshold could be released by CBP without an FDA entry (most commonly via a Type 86 entry). Those exemptions are now retired.
LEARN MORE ABOUT IMPORTING FDA-REGULATED PRODUCTS: FDA IMPORT BASICS
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