Understanding the New FDA Policy on Section 321 (De Minimis) Shipments of FDA-Regulated Products
Background: What Is Section 321?
Under U.S. law (19 U.S.C. § 1321(a)(2)(C)), Section 321 allows low-value shipments — currently those valued at $800 or less per person per day — to enter the U.S. duty- and tax-free, without formal customs entry procedures. This is known as the “de minimis” threshold.
The intent of Section 321 is to simplify and speed up low-value cross-border trade, particularly in e-commerce. However, it does not exempt shipments from other U.S. laws, including those enforced by the Food and Drug Administration (FDA).
Even a $50 shipment may be held or refused if it contains goods that violate U.S. regulations — such as unapproved drugs, unsafe food, or mislabeled products.
Previous Exemptions for FDA-Regulated Products
Historically, FDA and U.S. Customs & Border Protection (CBP) issued guidance allowing certain low-risk, FDA-regulated goods to enter the U.S. under Section 321 without full FDA screening. These exemptions were outlined in:
CSMS #94-001260 (1994)
CSMS #17-000388 (2017)
CSMS #52257745, #53697179 (Operational updates)
These 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.
New July 2025 Policy: All FDA Shipments Now Require Review
In July 2025, CBP and FDA issued CSMS #65581188, a significant change:
Effective immediately, all FDA-regulated products must be submitted for FDA review — regardless of value or quantity.
This policy rescinds all previous exemptions for de minimis shipments of FDA-regulated goods. Every FDA-regulated product imported into the U.S. must now 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 Entry Type 86
Entry Type 86 allows low-value (under $800) shipments to be filed electronically.
If the product is FDA-regulated, Entry Type 86 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 will now actively screen all FDA-regulated de minimis shipments:
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 U.S. 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 U.S. 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 Entry Type 86 or standard 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 status under $800 still applies, and tools like Entry Type 86 can speed up compliant shipments.
