FDA Halts Trials That Send Americans’ Cells to China, Other ‘Hostile Countries’

Regulatory officials said they just learned about an exception to a security rule that was finalized under the previous administration.

Food and Drug Administration Commissioner Dr. Marty Makary in Washington, in a file photograph. Alex Wroblewski/AFP via Getty Images

The U.S. Food and Drug Administration (FDA) on June 18 announced a halt to clinical trials that involve sending cells from Americans to “hostile countries” until they can confirm that the Americans have granted informed consent.

FDA officials said that a security rule finalized in late 2024 under the previous administration, and implemented in April, limits exports of sensitive data to China and other countries of concern, but that the rule contains an exemption for companies sending biological samples such as DNA for processing overseas as part of trials regulated by the agency.