In a CSMS message posted July 9, 2025, U.S. Customs and Border Protection (CBP) announced that, effective immediately, all shipments of products regulated by the U.S. Food and Drug Administration (FDA) must be subject to FDA-review upon importation.

Imported goods are subject not only to U.S. customs laws, but also to any applicable requirements and review by partner government agencies (PGA), including the FDA, the Center for Disease Control, the Animal and Plant Health Inspection Service, Food Safety and Inspection Service, the Consumer Product Safety Commission and others that regulate imports and enforce compliance with certain health and safety regulations.  PGAs collaborate with CBP to oversee and inspect imports, ensuring that imports meet certain product specifications and requirements.  Importers of such goods are required to assign PGA Message Sets to the entry, which effectively alert the target agency of the importation.  PGAs help review entry submissions and determine whether imports are admissible.  Goods found to be in violation of PGA requirements can be subject to penalties, import refusals, and seizure by CBP.

In the past, the FDA has treated certain categories of products—cosmetics, dinnerware, radiation emitting non-medical devices, biological samples for laboratory testing, and most food items—as exempt from the PGA requirement when the shipment qualifies for de minimis treatment under Section 321 of the Tariff Act of 1930.  CBP’s Section 321 de minimis program allows duty-free entry for certain shipments imported by one person on one day not exceeding $800 in aggregate fair retail value.  (The Trump administration recently curtailed the program by excluding products of China and Hong Kong from de minimis benefits.)  Under previous guidance, CBP and PGAs could clear de minimis shipments entered through Entry Type 86 without PGA data.

In the July 9 CSMS, CBP explained that, with technological advancements, the FDA now has the capability to review and screen all electronically transmitted FDA-related imports, regardless of shipment quantity and value, and emphasized that even small shipments can pose health and safety risks. Under the new guidance, de minimis shipments can still be processed through Entry Type 86, but PGA data must be declared—opening up the shipment for PGA review.  

This will have a potentially significant impact on academic medical centers and start-up biotechnology and pharmaceutical companies performing basic research or proof of concept studies, where importation of small biological samples for testing must now go through the FDA review and approval process. (For more information on FDA data requirements for imports, see the FDA supplemental guide here.)

In a recently published Corporate Counsel article, “Conducting Investigations and Discovery in China, Part II: Navigating Judicial and Regulator Expectations in Cross-Border Reviews,” Crowell’s John E. Davis and the Zhong Lun Law Firm’s Gary Gao (Jun Gao) further delve into legal and practical challenges in conducting discovery and investigations in China, including strategies for effectively reviewing information under restricted conditions for cross-border transfer and use in the U.S., as well as key considerations in managing Court and regulator expectations to ensure a smooth and compliant process.

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To read the first article in this series, click here.

Last weekend, both the Trump administration and the European Commission made announcements concerning the ongoing EU-US tariff dispute. This alert keeps you up to date with the latest developments.

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The Trump administration continues to raise the stakes for importers and other actors in the international trade space. Bloomberg Law reports that the Department of Justice has tasked its MIMF (Market Integrity and Major Frauds) Unit with investigating fraud schemes by companies dodging U.S. tariffs. The MIMF Unit is already well-versed in financial fraud investigations, is set to grow significantly with the addition of prosecutors previously assigned to consumer protection matters, and now is shifting resources to tariff evasion cases.

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On this 4thof July, Britain was also celebrating. The first country to secure a trade deal with the Trump Administration, the U.K. can indeed celebrate the so-called Special Relationship.

But what exactly is in the deal?

For starters it’s not a free trade agreement in the traditional sense. Rather, it’s more like a starter pack, with both sides making certain commitments, while leaving most of the details to be worked out later. But understanding what’s been agreed so far, and what’s still yet to come will help transatlantic companies position themselves in this new normal.

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On July 7, 2025, President Trump issued an Executive Order extending the suspension of reciprocal tariffs to August 1, 2025. The suspension was initially set to expire on July 9, 2025. The suspension does not affect the 10% reciprocal tariff rate on China, which is in effect until August 12, 2025.

The country-specific reciprocal tariffs implemented under the International Emergency Economic Powers Act (IEEPA) were first announced on April 2 under EO 14257. Soon after, Trump implemented a 90-day suspension on the reciprocal tariffs (excluding tariffs on China) and imposed a 10% baseline tariff rate on all imports from all trading partners listed in Annex 1 of EO 14257, except China.

A Fact Sheet published by the White House summarizing the new EO noted that some of the reciprocal tariffs that will take effect August 1 will be modified from the tariff rates originally announced in April. Trump has sent letters to over a dozen countries notifying them of revised tariff rates, and additional letters and revised rates may be announced in the coming weeks. For some countries, including Cambodia, Bosnia and Herzegovina, and Myanmar, the revised reciprocal tariff rate is lower than the rate initially announced in April. In other cases, such as Malaysia, Korea, and Japan, the revised reciprocal tariff rate is the same or slightly higher.

Cases challenging the legality of the reciprocal tariffs under IEEPA are currently pending before the Court of Appeals for the Federal Circuit and the Court of Appeals for the District of Columbia Circuit. These appeals follow decisions at lower courts (the Court of International Trade and the District Court for the District of Columbia) that ruled that Trump’s use of IEEPA to impose reciprocal tariffs was illegal and outside the scope of presidential authority. These decisions are currently stayed, pending the results of the appeals. Oral arguments for the case before the Federal Circuit are scheduled to take place on July 31, 2025.

As part of the tax and spending provisions included in the “Megabill” signed by Trump into law on July 4, 2025 are provisions that eliminate the de minimis exemption under Section 321 of the Tariff Act of 1930. The de minimis exemption currently allows shipments not exceeding $800 to enter the U.S. duty-free, excluding shipments coming from China and Hong Kong. The tax and spending law officially eliminates the de minimis entry privilege for commercial shipments from all countries, with an effective date of July 1, 2027. In addition to its repeal of de minimis, the law imposes a new civil penalty for misuse of the de minimis entry process.  Violators of Section 321 of the Tariff Act of 1930 will be fined a civil penalty up to $5,000 for the first violation and up to $10,000 for each subsequent violation.  The effective date for the new penalty provision is August  3, 2025 (30 days after the law’s enactment).

On July 3, 2025, the U.S. House of Representatives voted 218-214 to pass President Trump’s domestic tax and spending bill, which passed in the Senate earlier last week in a narrow 51-50 vote. The House approved an initial version of the Megabill in May. An earlier version of the Megabill drafted in the Senate did not eliminate de minimis, but the version that ultimately passed in the House and Senate did.

Litigation challenging Trump’s previous elimination of the de minimis exemption for shipments coming from China is currently pending before the Court of International Trade (CIT). In Axle of Dearborn, Inc. v. Department of Commerce, auto parts importer Detroit Axle is arguing that Trump’s removal of the de minimis exemption for Chinese shipments was in violation of the Administrative Procedure Act (APA) and any changes to de minimis should have undergone a formal rule-making process. The CIT has scheduled oral arguments for the case to take place on July 10, 2025, where the CIT will consider Detroit Axle’s motion for a preliminary injunction against the enforcement of the de minimis removal. If de minimis treatment for Chinese shipments is reinstated as an outcome of this CIT case, the reinstatement would be temporary, given the enactment of the tax and spending law and the end to de minimis treatment for all countries in July 2027.

Crowell & Moring LLP continues to monitor this and other developments in the customs space and their impact on business and industry going forward.

Reflecting the administration’s continued focus on transnational cartels, on June 25, 2025, FinCEN identified three Mexican financial institutions as “primary money laundering concerns,” and imposed restrictions on U.S. financial institutions from engaging in transactions with these entities.

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On June 23, 2025, the Ninth Circuit issued a long-awaited decision in Island Industries Inc. v. Sigma Corp. affirming a $26M False Claims Act (“FCA”) judgment against the defendant importer.  Sigma had appealed the judgment after a jury found the company violated the FCA by failing to pay customs duties owed to U.S. Customs and Border Protection (“CBP”).  The Ninth Circuit’s decision addresses an important jurisdictional issue and illustrates the significant financial exposure importers can face under the FCA at a time of increased tariffs and enforcement by the government.

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The current version of SNAP-R will be decommissioned on June 30, 2025, and a new SNAP-R site and URL (https://snapr.bis.gov/) is taking its place. All current users should migrate their SNAP-R accounts from the decommissioned site to the new platform for continued access. Each user’s account must be migrated individually, and it is recommended that users complete this process as soon as possible.

SNAP-R is a platform administered by the Bureau of Industry and Security (BIS) within the Department of Commerce. It is an electronic licensing system that allows users to submit and manage export and reexport license applications, commodity classification requests, and license exception agricultural commodity (AGR) notifications. Users can also track the status of applications and communicate with BIS licensing officers regarding supporting documentation.

For instructions on how to migrate your legacy SNAP-R account to the new platform before the end of June, the BIS user guide is linked here. For troubleshooting and additional questions, you can contact the SNAP-R Helpdesk at snapr@bis.doc.gov.