Major changes to U.S. customs rules are now in effect, and shippers are already feeling the impact. With the removal of the de minimis exemption and the introduction of new tariff requirements, every shipment into the U.S. now needs either informal or formal clearance. Add to that the FDA’s tighter grip on regulated goods, and it’s clear the paperwork bar has been raised higher than ever.
FDA scrutiny now universal—and non-negotiable
On 9 July 2025, the FDA officially scrapped the low-value shipper loophole. All FDA-regulated imports must now undergo a full review, regardless of their value, Reuters reports.
This change covers a wide range of products, including:
- Food (HTS Chapters 7–23 and 25): Must carry prior notice numbers, English labelling, and manufacturer details.
- Cosmetics (HTS Chapters 33, 3401, 9616): Require complete manufacturer information and compliant labelling.
- Dinnerware (HTS Numbers 3924, 4199, 4823, 6911, 6912, 7010, 7013, 7323, 7418, 7615, 7907, 8007, 8208, 8210, 8211, 8215, 8309, 9617): Must clearly state manufacturer and country of origin.
- Radiation-emitting electronics: May require FDA Form 2877.
- Biological samples (HTS Chapter 30): Invoices must specify intended use, with additional documentation required if linked to pharmaceuticals or vaccines.
CustomsCity highlights how abrupt this change was, effective immediately with no transition period. All FDA-regulated imports must now comply with the same formal entry requirements.
For sellers, that means even small beauty products, snacks, and gadgets—if FDA-regulated—now face the full customs ramp. No shortcuts.
The end of de minimis: every parcel matters
On 29 August 2025, the U.S. officially eliminated the de minimis duty-free threshold of $800 for all countries. That milestone marked the end of years of lower-barrier imports of low-value goods.
DHL highlight the scope of this change, citing that almost 1.4 billion packages entered the U.S. duty-free last year under the previous rule. Now, every shipment requires duty assessment and customs entry.
According to U.S. Customs and Border Protection, carriers had clear compliance timelines. But the impact has been immediate. Notably, postal traffic into the U.S. dropped by more than 80% as carriers scrambled to adjust, according to AP News.
Why this matters for shippers
These changes aren’t siloed; they reinforce one another. With de minimis gone, every package is subject to clearance (and the greater scrutiny that comes with that), duties, and potentially tariffs. That means incomplete or vague paperwork is now a guaranteed source of delay.
According to FedEx, the top four reasons for shipment delays at U.S. customs are:
- Insufficient product descriptions: Authorities require full details—e.g. “Men’s long-sleeve T-shirt, 80% cotton / 20% polyester”—not simply “clothing.”
- Missing importer number: A receiver’s Tax ID or importer ID is required for formal entries (shipments valued over $2,500).
- Incomplete product composition: Without a full material breakdown, duties may be misapplied and clearance delayed.
- Lack of manufacturer details: A Manufacturer Identification (MID) code or full business name and address is mandatory for formal entry and FDA-regulated items.
Why this matters now more than ever
Previously, low-value parcels often cleared customs with minimal data. That era is over. Every shipment now requires clearance, and even minor errors—like a vague description—can stall orders and frustrate customers.
For sellers, this means:
- Accuracy first: Descriptions, HS codes, and materials must be complete and in English.
- Full transparency: Manufacturer and importer information must be included wherever applicable.
- Plan for costs: Tariffs and duties now apply across all shipments.
- No shortcuts: Every shipment requires customs entry, regardless of value.
The bottom line
The U.S. remains a prime market, but entry is no longer frictionless. The removal of de minimis, the arrival of tariffs, and the FDA's universal oversight mean shippers must rethink their approach to documentation and compliance.
Nevertheless, it's a challenge faced equally by everyone. Those who adapt quickly - tightening paperwork, improving product data, and working closely with logistics partners - will keep parcels moving and customers happy. Those who don't may find themselves caught in customs limbo.

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