South Korean Exporters Face Rising FDA Shipment Delays
Exporters of food and medical products face increased documentation scrutiny and higher rejection rates at U.S. customs.
Updated on Oct. 25, 2026 in International Trade
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FDA refusals of South Korean food, pharmaceutical, and medical device shipments reached 284 cases in the first half of 2025. This 8 percent year-over-year increase reflects mounting non-tariff regulatory barriers for exporters.
Why it matters
Rising customs rejections complicate market access and operational predictability for international distributors. These barriers often manifest as stringent documentation demands and sudden reclassifications that can halt supply chains.
FDA shipment rejections hit 284 cases in the first half of 2025, an 8 percent increase from the 263 cases recorded in the first half of 2024. Industry inquiries regarding these non-tariff barriers remain elevated after 154 were logged between May 2023 and April 2024.
The players
U.S. Food and Drug Administration
The federal agency responsible for protecting public health through the regulation of food, drugs, and medical devices.
The details
Entering the U.S. market requires strict adherence to safety and compliance reviews, where shipments are frequently stalled by granular documentation requests. Regulators are increasingly scrutinizing Harmonized System codes, forcing exporters to navigate reclassifications that delay final clearance. Operations are further pressured by the prospect of stricter origin verification, particularly for goods incorporating Chinese raw materials.
Timeline
2019: FDA refusal cases totaled 222.
May 2023 - April 2024: A response center logged 154 inquiries regarding trade barriers.
2023: Total FDA refusal cases reached a peak of 318.
May 2024: A non-tariff barrier response center for marine products launched operations.
January - June 2025: FDA refusal cases reached 284.
Market Landscape
The increasing use of granular Harmonized System reclassifications mirrors a broader trend toward utilizing technical compliance as a non-tariff barrier to trade. This shift forces exporters to move beyond standard tariff planning to manage rigorous, real-time customs oversight.
Exporters should prioritize audit-ready documentation and verify the origin of all raw materials to mitigate the risk of sudden shipment holds. Operators should also monitor for upcoming changes in labeling mandates that could trigger further non-tariff scrutiny.
The takeaway
Operational resilience in the U.S. market now depends on proactive compliance with increasingly complex customs and labeling protocols. Management teams should track the frequency of origin-related document requests to identify potential bottlenecks before they result in official shipment rejections.
Further reading
For broader context on navigating complex customs requirements, review our latest International Trade coverage.
Source note: This article includes information reported by Pulse.
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