Understanding the New FDA Policy on Section 321 (De Minimis) Shipments of FDA-Regulated Products
Background: What Is Section 321?
Under US law (19 USC. § 1321(a)(2)(C)), Section 321 provides an administrative exemption for articles valued at $800 or less imported by one person on one day. This is known as the “de minimis” exemption, and it is currently suspended.
Duty-free de minimis treatment was suspended for goods entered on or after 29 August 2025 under Executive Order 14324 (Federal Register).
CBP has since suspended the exemption indefinitely by interim final rules published on 24 June 2026: one for all modes other than the international postal network, effective 24 June 2026 (CBP interim final rule, 91 FR 37789), and one for mail, effective 24 July 2026 (CBP interim final rule, 91 FR 37801).
Shipments valued at $800 or less must now be entered using formal or informal entry procedures, and the statutory basis for the exemption is repealed with effect from 1 July 2027, as noted in those rules. The intent of Section 321 was to simplify and speed up low-value cross-border trade, particularly in e-commerce.
However, it does not exempt shipments from other US laws, including those enforced by the Food and Drug Administration (FDA). Even a very low-value shipment may be held or refused if it contains goods that violate US regulations — such as unapproved drugs, unsafe food, or mislabeled products.
Previous Exemptions for FDA-Regulated Products
Historically, FDA and US Customs & Border Protection (CBP) issued guidance allowing certain low-risk, FDA-regulated goods to enter the US under Section 321 without full FDA screening. These exemptions were set out in earlier CBP guidance.
The exempted product categories included: Cosmetics Household dinnerware and kitchen utensils Non-medical radiation-emitting devices (e.g., TVs, speakers) Biological samples Most food items (except high-risk items like ackee fruit, raw shellfish, puffer fish, and airtight canned foods) These could be cleared under de minimis value without prior FDA data submission in ACE, provided they weren’t restricted or unsafe.
However, Prior Notice for food shipments was always required, even under the exemptions.
Current Position: No De Minimis Route for FDA-Regulated Goods With the de minimis exemption suspended, shipments that previously qualified, including FDA-regulated goods, can no longer be released under the de minimis process and must be entered using informal or formal entry procedures (CBP interim final rule, 91 FR 37789).
Every FDA-regulated product imported into the US must follow standard FDA entry requirements.
Why the Change?
Risk: Even low-value shipments can include dangerous goods — e.g., counterfeit drugs or contaminated food. Technology: Advances in ACE and FDA’s import screening systems (PREDICT) now make it feasible to electronically review all shipments — large and small — without slowing commerce.
What This Means in Practice
Applies to
All FDA-regulated goods (food, dietary supplements, cosmetics, devices, etc. ) All modes of transport (air, sea, courier, postal) All shipment types, including direct-to-consumer e-commerce
No More “Disclaiming”
You cannot “disclaim” FDA filing just because a shipment is low value. If the product is subject to FDA regulation, it must be declared and reviewed.
Key Compliance Requirements (Even for Low-Value Shipments)
1. Prior Notice (PN) for Food and Feed
Required for all shipments of human and animal food, regardless of value. Submit via: FDA’s Prior Notice System Interface (PNSI) Or include PN via your customs broker’s ACE submission Exceptions are narrow (e.g., personal gifts or hand-carried food) and detailed in 21 CFR 1. 277(b). 2.
ACE Entry Filing – Use an Informal or Formal Entry CBP has suspended the Entry Type 86 test (CBP notice, 90 FR 42418), which leaves informal entry (Entry Type 11) as the main informal route for these shipments, with formal entry as an option (91 FR 37789).
If the product is FDA-regulated, the entry must include all required FDA data: FDA Product Code Intended Use Code Manufacturer’s Facility Registration (if applicable) Other info per FDA Supplemental Guide No FDA data = likely delay or refusal.
3. FDA Holds, Exams & Refusals
FDA-regulated goods in these entries are subject to FDA screening: If data is missing or non-compliant (e.g., banned ingredient, mislabeling), expect holds or detentions. Shipments can be refused or destroyed if they do not meet FDA import standards. Reminder: All imported FDA-regulated goods must comply with the same laws as US domestic goods.
4. Other Agencies Still Apply
Section 321 does not exempt you from rules from: USDA (animal & plant products) CPSC (toys, consumer goods) EPA, ATF, etc. Each agency may also apply stricter controls on low-value shipments.
Impact on Importers, Exporters, Brokers & Carriers
Importers & Online Retailers
You now need to budget for FDA compliance even on small shipments. Provide brokers or carriers with FDA product details in advance. Review your products: many previously ignored issues (e.g., unapproved supplements) will now be flagged.
Exporters & Foreign Sellers
Foreign brands selling to US consumers must now treat small shipments like commercial imports. Ensure FDA registration (e.g., food facility registration) and proper labeling.
Customs Brokers
Brokers must now treat low-value FDA entries as routine. Use informal (Type 11) or formal entries, and gather full FDA data. Update clients and internal systems to capture and file properly.
Carriers & Express Couriers
Need to enhance systems to collect and transmit FDA data. May require additional EDI from shippers. Some may limit acceptance of certain FDA-regulated items under Section 321.
Enforcement Risks
Failure to comply may lead to: Shipment holds, refusals, or destruction Financial penalties Reputational damage CBP and FDA enforcement action (e.g., for repeated undervaluation or misclassification) CBP and FDA have made it clear: the de minimis exemption was never meant to bypass safety and health laws.
Bottom Line
The “free pass” for low-value FDA-regulated imports is over. All products must comply — no matter how small the shipment. But with proper planning, the process can still be efficient. Duty-free de minimis treatment for shipments of $800 or less is currently suspended, so budget for applicable duties, taxes and fees and file an informal or formal entry.
Official Resources
FDA Import Basics FDA Supplemental Guide for ACE CBP De Minimis Policy Notice – TFTEA 2016 eCFR: 19 CFR 10.
151 Executive Order 14324 (Federal Register) CBP interim final rule: indefinite suspension of de minimis, non-postal (91 FR 37789) CBP interim final rule: indefinite suspension of de minimis, mail (91 FR 37801)
