On June 18, 2025, the U.S. Food and Drug Administration (FDA) issued a policy update affecting the design and approval of certain clinical trials. The agency announced that new trials involving the export of U.S. participants’ cells or genetic material to laboratories in countries designated as “countries of concern” will no longer be permitted.

This action aligns with a broader federal policy framework initiated under Executive Order (EO) 14117, Preventing Access to Americans’ Bulk Sensitive Personal Data and United States Government-Related Data by Countries of Concern. Issued in early 2024, EO 14117 directed the Department of Justice (DOJ) and the Department of Homeland Security (DHS) to address national security risks associated with foreign access to sensitive U.S. data. In January 2025, the DOJ published a final rule (28 CFR Part 202) outlining how certain data-related transactions may be subject to restrictions or additional compliance requirements.

Scope of the Update

The DOJ rule introduced the concept of “restricted transactions” defined as data transactions involving U.S. persons that:

• Include covered data (such as health, genomic, or biometric data) and
• May involve access by a foreign person or entity associated with a country of concern.

Initially, several transaction types were exempted, including FDA-regulated clinical trials. The FDA’s June 18 announcement narrows this exemption by stating that trials involving the export of human cells or genetic material for laboratory analysis in a country of concern will not be approved.

Countries of Concern

According to the DOJ’s final rule, the designated countries of concern are:

• China (including Hong Kong and Macau)
• Cuba
• Iran
• North Korea
• Russia
• Venezuela

These countries were selected based on national security and foreign policy assessments related to the use and potential misuse of sensitive personal data.

Enforcement Continues Through FDA Oversight

To date, the FDA’s clinical trial review and approval process remains the primary mechanism for enforcement. Neither the FDA nor U.S. Customs and Border Protection has indicated any additional procedures, such as shipment monitoring, to detect or block relevant exports.

Sponsors are required to provide accurate information about data flows in their Investigational New Drug (IND) or Investigational Device Exemption (IDE) applications. In the absence of new border enforcement measures, compliance relies primarily on trial design transparency and regulatory submissions.

Considerations for Sponsors and Research Partners

The policy update may affect trials that engage labs in countries of concern. Sponsors may want to:

• Reevaluate trial protocols and data-sharing workflows,
• Review agreements with CROs and third-party vendors for cellular or genetic data,
• Determine whether cross-border transfers now fall under the DOJ’s restricted transaction framework and
• Stay informed about forthcoming guidance from the FDA, DOJ, or DHS.

Summary

The FDA’s June 18 announcement signals a shift in how clinical trials involving biological materials and international labs are assessed. Anchored in evolving national data security priorities, the update highlights the importance of transparent and carefully designed data exports. Sponsors involved in clinical research should review their practices and agreements to align with these policy expectations.

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