Shipments Under USD 800: The U.S. Duty and Customs Exemption Has Ended for Cosmetics and Food
Introduction
The de minimis exemption for U.S. shipments under USD 800 has effectively ended. For many companies that exported quickly and easily through low-value shipments, 2025 became a turning point. Shipments under USD 800 are no longer covered by the “ de minimis ” exemption. In practice, this means every shipment, whatever its value, now requires a full customs entry, duty payment and an FDA compliance check. For the next step, our article on U.S. tax filing service may help.
This change matters most for manufacturers exporting cosmetics, food and dietary supplements. Success now depends not only on production quality but also on how professionally documentation, labeling and customs processes are managed.
What Did the New Rule Change?
Previously, shipments under USD 800 could enter the U.S. free of duties and formal customs entry.
Under the new rule, however:
- Every shipment requires a full entry and customs filing,
- Customs duties and processing fees apply to all shipments,
- FDA (U.S. Food and Drug Administration) and CBP (Customs and Border Protection) can now inspect even small parcels.
For manufacturers sending small batches through Amazon or Shopify, for example, this makes a more carefully planned process necessary.
Impact on Cosmetics, Food and Supplements
1. Higher Costs
For every shipment, the following now apply:
- Customs duties,
- Customs broker fees,
- Entry filing costs, charged per shipment.
Companies may therefore need to revise their export plans around the new cost structure. We cover the new tariff layer introduced in summer 2026 and its landed cost impact, alongside the end of the exemption, in our article on Amazon U.S. customs duties.
2. More Compliance and Inspection
FDA and U.S. Customs now check each product more often for:
- Ingredient safety,
- Label accuracy,
- Product classification (for example, cosmetic or drug?)
and similar criteria.
3. Document Management and Traceability
Manufacturers are now expected to prepare:
- FDA Food Facility Registration,
- FCE & SID numbers (for canned and acidified foods),
- GMP documents,
- Lab analysis reports (microbiological, heavy metals, pesticides),
- Label compliance documentation.
Cosmetics: Even Sample Shipments Now Go Through Customs
For cosmetics companies, this change especially affects manufacturers sending samples to Amazon, Etsy or directly to U.S. distributors. Even a shipment sent “for testing only” now requires a full customs entry.
Under FDA cosmetic oversight:
- INCI (International Nomenclature of Cosmetic Ingredients) names should be listed correctly,
- Claims (anti-aging, dermatologically tested, etc.) should be scientifically supported,
- Allergen declarations and warnings should be complete.
At this point, an FDA Label and Formulation Compliance Review has become an essential step for your product to enter the U.S. market smoothly.
New Requirements for Food and Supplements
From 2025 onward, companies shipping food and supplements to the U.S. should plan for the following:
FDA Prior Notice
Prior Notice must be submitted to FDA in advance for every shipment.
Without Prior Notice, products may be held at the port or refused entry.
FSVP (Foreign Supplier Verification Program)
Companies importing into the U.S.:
- the GMP and HACCP compliance of manufacturing facilities,
- laboratory test results,
- and audit reports
must be documented.
Labeling
In line with FDA standards:
- Nutrition Facts / Supplement Facts Panel,
- Allergen Declaration,
- accurate nutrient values and claims
should appear on the labels.
Recommendations for Exporters
Consolidate your shipments:
Plan bulk shipments instead of small parcels.
Have your labels reviewed:
Get a professional FDA label compliance review for the U.S. market.
Strengthen your supplier documentation:
Keep all documents across your production chain (GMP, test results, COA) ready.
Get customs and FDA support:
Have inspection, registration and filing processes handled professionally.
Conclusion
The end of the “de minimis” rule has opened a new chapter for exporters. Exporting to the U.S. now calls for more than production; it also requires expertise in regulatory, customs and labeling management.
At Export Partners, we cover:
- FDA registration and FCE/SID filing,
- label and formulation compliance review,
- U.S. customs registration and customs bond,
- and U.S. Agent representation, giving manufacturers support from a single point of contact.
Other guides in this series on the de minimis exemption
This guide is part of a series on FDA processes for exporting to the U.S. Related guides:
- MoCRA and FDA compliance for selling cosmetics on Amazon U.S.
- FDA registration, GMP and customs for vegetable oil exports
- For registration and certification support, see our FDA registration and certification service.
