FDA Cracks Down on DNA Export to Hostile Countries
On Wednesday, the Food and Drug Administration (FDA) declared a new initiative aimed at restricting the export of DNA from the US to countries deemed hostile, including China.
Historically, the FDA permitted the outsourcing of genetic manipulation studies involving American cells to labs in these countries. Sometimes, this practice allowed for the re-importation of these cells back into the US without the participants in the clinical trials being informed, according to the agency’s statement.
Last year, the US started implementing stricter export controls on sensitive genetic data aimed at curtailing its flow to adversarial nations. These regulations, finalized in December 2024 and put into effect in April, highlighted gaps in the pharmaceutical sector and other clinical studies where biological materials, such as live cells, could still be sent to China. FDA representatives noted that these exemptions even extended to businesses with links to the Chinese Communist Party.
“The previous administration provided little oversight, allowing American DNA to be sent abroad frequently without the full awareness of test participants,” Dr. Marty McCurry, an FDA committee member, commented.
Prior to these changes, advancements in cell therapy, especially those involving live cells for disease treatment, posed the risk of exposing Americans’ genetic information to countries seen as threats. There are approximately 8,000 active cell therapies and around 1,000 gene therapy trials currently in progress, according to clinical data.
In light of recent shifts, the US government has intensified scrutiny on the potential transfer of American genetic information to China’s military, a concern that amplified after the Covid-19 pandemic began in Wuhan. BGI Group, based in Shenzhen and known as the world’s largest genomic sequencing firm, has faced scrutiny; several of its affiliates have been blacklisted due to their connections to “venue surveillance” and their involvement in potentially funneling genetic data into military applications.
Biosecurity experts have raised alarms, theorizing about the risks of specific genetic attacks against certain ethnic groups by the Chinese military. Yet, other scholars argue that these ideas remain speculative and not grounded in established fact.
