Bioterrorism Act of 2002

Facilities that manufacture, process, pack or hold food for US consumption must register with FDA. Prior notice must be submitted for every imported food shipment, including samples and mail or courier parcels, no more than 15 days before arrival (30 days through CBP's ACE) and at least 2 hours before arrival by road, 4 hours by air or rail, and 8 hours by water, or before mailing. Food arriving without adequate prior notice is refused or held. Records must allow tracing one step forward and back.

Prior notice applies to every imported food shipment, including small e-commerce parcels, so cross-border food sellers must file it or have their courier file it. A missing prior notice means the parcel is held or refused at the border. For example, a Canadian snack brand shipping orders by courier to US customers must ensure prior notice is submitted for each shipment before arrival, and a US 3PL receiving imported food is a registered facility that must keep records of where the food came from and went.

• De MinimisValue limit for duty-free imports

• September 11 Attacks and Supply Chain Security2001 · Border closures halt parts and cargo security tightens

• Food Safety Modernization Act (FSMA)2011 · 2011 law shifting FDA food safety to prevention
• Foreign Supplier Verification Program (FSVP)2015, compliance from 2017 · FDA rule making food importers verify foreign suppliers
• Federal Food, Drug, and Cosmetic Act (FD&C Act)1938 · Core US law on food, drugs, devices and cosmetics

1. FDA: Prior notice of imported foods fda.gov
2. FDA: Registration of food facilities fda.gov