The U.S. Food and Drug Administration (FDA) today announced an immediate halt to new clinical trials that were shipping American citizens’ living cells, including precious DNA, to foreign labs in hostile countries like China for genetic engineering. Even more alarming, some patients were reportedly unaware their biological material was being sent overseas and manipulated.
The bombshell decision comes amidst mounting evidence that these trials, greenlit by a controversial exemption under the previous administration, failed to properly inform participants about the international transfer and manipulation of their sensitive genetic data.
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This alarming practice, made possible by a data security rule finalized in late 2024, has potentially exposed Americans’ most personal information to misuse by adversarial foreign governments.
“The previous administration turned a blind eye and allowed American DNA to be sent abroad — often without the knowledge or understanding of trial participants,” declared a resolute 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 now-scrapped exemption, implemented in April 2025 by the U.S. Department of Justice, specifically allowed U.S. companies to send trial participants’ biological samples — including DNA — for overseas processing as part of FDA-regulated clinical trials. Shockingly, this loophole even extended to companies partially owned or controlled by the Chinese Communist Party.
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The FDA is now launching a sweeping review of all clinical trials that exploited this exemption. Companies will now be forced to demonstrate “full transparency, ethical consent, and domestic handling of sensitive biological materials.” Any new trials failing to meet these stringent new standards will be immediately blocked.
This decisive action by the FDA is part of a larger, coordinated national effort to implement Executive Orders 14117 and 14292, which aim to prevent foreign adversaries from exploiting sensitive biological data and ensure that crucial research funding only supports secure and transparent U.S.-compliant institutions. Additional enforcement and policy measures are expected to follow as the government tightens its grip on the flow of America’s most valuable biological assets.
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