FDA Tightens Section 321 De Minimis Exemptions: What Importers Need to Know

Importers and shippers who rely on the Section 321 de minimis exemption for low-value shipments should take note: the U.S. Food and Drug Administration (FDA) has officially rescinded previous guidance that allowed certain FDA-regulated products to bypass full review.

What’s Changing
Under 19 U.S.C. § 1321(a)(2)(C), importers can claim a duty exemption for shipments valued at $800 or less. Previously, some FDA-regulated items could clear Customs and Border Protection (CBP) without full FDA screening. According to the new Cargo Systems Messaging Service (CSMS # 65581188), “All shipments of FDA-regulated products, regardless of quantity and value, are subject to the same regulatory requirements and may pose risks to health, safety, and security.”

This means that “Effective immediately, all FDA-regulated products must be submitted to the FDA for review.” Prior CSMS messages (#94-001260, #17-000388, #52257745, and #53697179) that allowed certain low-value items to move without FDA review are now rescinded. The agency explains that technological advances now allow them 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.”

Who’s Impacted
These updates affect any importer moving FDA-regulated goods — food, beverages, dietary supplements, cosmetics, medical devices, biological samples, and more. Small parcel express shipments that previously cleared under de minimis without FDA review now require the same level of compliance as larger shipments.

Prior Notice Requirements Remain
The FDA reminds importers that Prior Notice (PN) rules for food and feed products remain unchanged. “Prior Notice (PN) requirements must still be met on all food and feed shipments, regardless of value or quantity; unless otherwise exempt from PN requirements under 21 CFR 1.277(b).” Failing to submit an accurate PN can result in costly holds or refused entry.

What Importers Should Do Now
Future Forwarding recommends that clients take immediate steps to stay compliant:

• Review your processes for Section 321 shipments. Confirm that your customs broker and technology providers can submit full FDA data for every low-value shipment.
• Revisit Prior Notice procedures. Ensure your team knows which food or feed items require PN and that your filings are accurate and timely.
• Communicate with suppliers and shippers. Make sure your partners understand the updated requirements to avoid delays.
• Use the FDA’s resources. Familiarize yourself with the FDA Supplemental Guide for ACE, de minimis FAQs, and the official CSMS.

Stay Informed with Future Forwarding
Compliance changes like this show how quickly trade rules can evolve. Future Forwarding stays up to date on the latest regulatory shifts so our clients don’t have to worry about unexpected holds or penalties. If you have questions about how the updated Section 321 policy affects your supply chain, our team is ready to help you review your processes and keep your shipments moving smoothly.