All FDA-regulated products, regardless of shipment size or declared value, must now be submitted to the FDA for review. Previously, certain products falling under the $800 de minimis threshold were exempt from PGA filing requirements; these must now also be reported to the FDA. All prior communications exempting low-value FDA-regulated products from review are rescinded.
CBP and FDA have noted that advances in the technological capabilities of both the trade and the FDA, now make it possible to review all electronically transmitted FDA-regulated entries offered for import. This measure is intended to better facilitate legitimate trade and prevent the importation of violative products.
As a reminder, Prior Notice (PN) requirements remain in effect for all food and feed shipments, regardless of value or quantity, unless otherwise exempt under 21 CFR 1.277(b).
Please refer to the CSMS message for the full text and linked resources on FDA regulations and de minimis requirements: CSMS# 65581188