On Wednesday, June 18th, the Food and Drug Administration (FDA) of the United States announced the suspension of new clinical trials that involve exporting living cells of American citizens to laboratories in hostile countries for genetic engineering purposes.
The FDA notification stated that they would immediately review the practice of sending living cells of American citizens to countries like China and other hostile nations for genetic engineering, and then bringing back the modified cells for clinical trials within the bodies of patients in the United States – sometimes without the patients’ knowledge or consent.
Increasing evidence suggests that some clinical trials have failed to inform participants that their biological materials would be transferred internationally and used for experimentation, potentially leading to the misuse of sensitive genetic data of Americans by foreign governments, including adversaries.
The Biden administration announced a data security rule in December 2024 and implemented it in April 2025. This rule limits the transmission of sensitive data to certain countries of concern, but includes a broad exemption allowing U.S. companies to send participants’ biological samples (including DNA) overseas for processing as part of FDA-regulated clinical trials. This exemption applies even to companies partly owned or controlled by the Chinese Communist Party.
FDA Director Marty Makary expressed that sending the DNA of American citizens abroad without their knowledge or understanding is unacceptable.
“We are taking action to protect patients, restore public trust, and maintain America’s leadership in the field of biomedicine,” he added.
The FDA is conducting reviews of all clinical trials that rely on this exemption, and will require companies to demonstrate full transparency, obtain ethical consent, and process sensitive biological materials domestically. New trials that do not meet these standards will not be allowed to proceed.
The FDA is also closely collaborating with the National Institutes of Health (NIH) to ensure that federally funded research is not compromised by these practices. Additional enforcement and policy measures may be implemented in the future.
This action is part of a broader effort following Executive Orders 14117 and 14292, which direct the federal government to prevent foreign entities from exploiting sensitive biological data and ensure that research funds flow only to institutions that are secure, transparent, and compliant with U.S. regulations.