By Fineline Cube 
The U.S. Food and Drug Administration (FDA) this week announced an immediate review of new clinical trials involving the transfer of live cells from U.S. citizens to China and other “hostile” countries for genetic engineering, followed by reinfusion into American patients. The agency noted that, in some cases, this process occurred without the informed consent of the participants. The FDA stated that this action was prompted by evidence suggesting that certain trials failed to disclose the international transfer and processing of biological samples to subjects, potentially exposing sensitive U.S. genetic data to misuse by foreign governments, including adversarial nations.
Background and Previous Regulations
In December 2024, the Biden administration introduced data security regulations to restrict the transfer of sensitive information to certain countries, enforced by the U.S. Department of Justice in April 2025. However, the administration also granted a broad exemption allowing U.S. companies to ship biological samples (including DNA) overseas for processing as part of FDA-regulated clinical trials.
FDA Commissioner’s Statement
“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.”
Current Actions and Future Measures
The FDA is now scrutinizing all trials conducted under this exemption, requiring companies to demonstrate full transparency, ethical informed consent procedures, and proper handling of sensitive biological materials. New trials failing to meet these standards will be suspended. The agency is collaborating closely with the National Institutes of Health (NIH) to ensure government-funded research remains unaffected. Additional regulatory measures may follow as the FDA strengthens oversight in this critical area.-Fineline Info & Tech