Life After “De Minimis”: What Importers of Cosmetics, Food, and Supplements Must Know
Introduction
The elimination of de minimis import rules 2025 marks a turning point for global trade. The change rescinds previous rules allowing sub-$800. Shipments that once bypassed duties and simplified entry now require full customs clearance and compliance.
For businesses importing cosmetics, dietary supplements, and food products, this shift directly impacts supply chain costs, timelines, and regulatory obligations. At Cosmereg, we help companies adapt to evolving cosmetic import regulations and ensure their products meet market requirements without delays.
What Changed with De Minimis Import Rules 2025
Previously, shipments under a set threshold could enter without duties or extensive documentation. With the removal of this rule:
- Every shipment, regardless of value, requires customs clearance
- Duties and broker fees apply even to small parcels
- Regulatory authorities now review all imports, increasing compliance risks
This is especially relevant for brands shipping cosmetics and supplements in small quantities, as their models often relied on frequent low-value shipments.
Key Implications for Cosmetics, Food, and Supplements
Higher Costs
All importers must now account for duties, customs filing fees, and broker charges—costs that directly affect margins.
Stricter Oversight
Authorities may inspect products more frequently, checking for compliance with cosmetic import regulations, ingredient lists, safety data, and proper labeling.
Documentation Burden
Detailed records, from supplier certifications to safety assessments, must be maintained and presented on request.
How Cosmetic Import Regulations Are Impacted
For cosmetics brands, the removal of de minimis brings increased attention to:
- Labeling compliance (INCI names, claims, allergen statements)
- Safety substantiation for ingredients and finished products
- Classification of borderline products (e.g., sunscreens, acne creams)
Even small sample shipments for testing or marketing now require full customs clearance under de minimis import rules 2025.
Food and Dietary Supplement Requirements After De Minimis
Full FDA Entry Review
Every shipment of food or dietary supplements must now undergo FDA entry procedures. Importers must submit Prior Notice before arrival; failure can lead to refusal, delays, or destruction of goods.
Foreign Supplier Verification Program (FSVP)
Importers must comply with FSVP requirements under FSMA:
- Verify suppliers follow preventive controls and GMP.
- Maintain records of audits, hazard analyses, and certifications.
- Appoint a qualified U.S. agent or FSVP importer.
Labeling Requirements
Food and supplement labels must meet strict U.S. standards:
- Correct Nutrition Facts or Supplement Facts panels.
- Allergen labeling in compliance with FALCPA.
- Claims (health, structure/function, nutrient content) must be truthful and substantiated.
Product Safety Documentation
- Certificates of Analysis (COAs) for raw materials and finished goods.
- Test results for microbiology, heavy metals, and contaminants.
- Batch/lot traceability to manage recalls.
Facility Registration
All foreign facilities must maintain active FDA Food Facility Registration (renewed every two years). Shipments from unregistered sites will be refused.
Tariff Classification and Duties
Supplements and foods must be declared under the correct HTS codes. Misclassification may cause penalties or delays.
Importer Recordkeeping
Importers must keep invoices, shipping documents, FSVP files, and test reports, typically for two years, and provide them during FDA inspections.
Practical Strategies to Adapt
- Consolidate Shipments – reduce frequency of small parcels.
- Review Labels Thoroughly – ensure all claims and warnings meet cosmetic import regulations and food/supplement labeling standards.
- Strengthen Supplier Oversight – request GMP, safety data, and compliance certifications.
- Plan for Extra Costs – adjust pricing and logistics budgets.
- Build Internal Compliance Systems – streamline documentation, traceability, and regulatory checks.
Conclusion
The end of de minimis import rules 2025 reshapes how cosmetics, food, and supplements enter global markets. While costs and compliance requirements rise, businesses that consolidate shipments, improve documentation, and align with cosmetic import regulations and FDA food/supplement rules can minimize risks and remain competitive.
At Cosmereg, we guide companies through these regulatory changes, ensuring smooth product entry, timely compliance, and sustainable growth. Contact us for a consultation.
