FDA has 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 US 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 Dec 2024 and implemented in Apr 2025 by the 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 US 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 
CCP.
fda.gov/news-events/pr