- For Immediate Release:
The U.S. Food and Drug Administration (FDA) today announced an immediate review of new clinical trials that involve sending American citizens’ living cells to China and other hostile countries for genetic engineering and subsequent infusion back into U.S. patients – sometimes without their knowledge or consent.
This action by the FDA follows mounting evidence that some of these trials failed to inform participants about the international transfer and manipulation of their biological material and may have exposed Americans’ sensitive genetic data to misuse by foreign governments including adversaries.
This practice was made possible by a data security rule finalized under the Biden Administration in December 2024 and implemented in April 2025 by the U.S. Department of Justice. While the rule imposed export controls to limit sensitive data transfers to countries of concern, the Biden Administration specifically requested and approved a sweeping exemption that allowed U.S. companies to send trial participants’ biological samples — including DNA — for processing overseas as part of FDA-regulated clinical trials. This exemption applied even in cases involving companies partially owned or controlled by the Chinese Communist Party.
“The previous administration turned a blind eye and allowed American DNA to be sent abroad — often without the knowledge or understanding of trial participants,” said FDA Commissioner Dr. Marty Makary. “The integrity of our biomedical research enterprise is paramount. We are taking action to protect patients, restore public trust, and safeguard U.S. biomedical leadership.”
The FDA is actively reviewing all relevant clinical trials that relied on this exemption and will require companies to demonstrate full transparency, ethical consent, and domestic handling of sensitive biological materials. New trials that cannot meet these standards will not proceed.
The agency is also working closely with the National Institutes of Health (NIH) to ensure that no federally funded research is compromised by these practices. Additional enforcement and policy measures could be forthcoming.
This action is part of a broader national effort to implement Executive Orders 14117 and 14292, which direct the federal government to prevent the exploitation of sensitive biological data by foreign adversaries and ensure research funding flows only to secure, transparent, and U.S.-compliant institutions.
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Boilerplate
The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, radiation-emitting electronic products, and for regulating tobacco products.
