Spiral strand of DNA / Envato Market
by Worthy News Washington D.C. Bureau Staff
(Worthy News) – The U.S. Food and Drug Administration (FDA) announced last Thursday it has suspended authorization for all new clinical trials involving the transfer of Americans’ living cells or genetic material to China and other adversarial nations for genetic engineering, following mounting evidence of serious ethical and security breaches.
The FDA said some trials failed to inform participants that their biological material–including DNA–was being exported abroad for manipulation and reinfusion, potentially exposing Americans’ sensitive genetic data to misuse by foreign governments, including the Chinese Communist Party (CCP).
“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 suspension comes amid scrutiny of a 2024 Biden administration policy that, despite imposing export controls on sensitive data transfers to hostile nations, included a sweeping exemption. This loophole, requested and approved by the administration, allowed U.S. companies to send biological samples–including DNA–to foreign labs, even those partially owned or controlled by the CCP, for use in FDA-regulated trials.
The FDA said it is conducting an immediate review of existing clinical trials that relied on this exemption. Moving forward, companies will need to prove full transparency, secure domestic handling of biological materials, and ethical consent from participants. New trials failing to meet these requirements will be blocked.
The agency is coordinating with the National Institutes of Health (NIH) to ensure federally funded research is not compromised. Additional enforcement and policy measures are expected in the coming weeks.
National security experts have raised alarm over the potential for foreign powers to exploit Americans’ genetic data. Dr. Robert G. Darling, a former biological weapons expert with the U.S. Army Medical Research Institute, warned that China could use such data in efforts to develop “designer” biological weapons capable of targeting specific ethnic groups. “This is truly one of the nightmarish scenarios,” he said.
The FDA’s action aligns with directives in Executive Orders 14117 and 14292, including President Trump’s recent order aimed at preventing dangerous gain-of-function research and protecting U.S. biosafety and biosecurity.
While China denies developing biological weapons, U.S. intelligence and State Department reports continue to cite concerns about dual-use military-civilian biological research in China, including ethnic-targeted biological weapons described in official Chinese military writings.
As the FDA’s investigation unfolds, officials said the focus remains on restoring public trust and ensuring U.S. biomedical research does not inadvertently aid adversaries.
The agency did not disclose which specific trials or companies are under review.
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