The U.S. Food and Drug Administration has halted new clinical trials that involve exporting Americans’ living cells to China and other foreign adversaries for genetic engineering.
In a June 18 statement, the FDA announced a sweeping review of such trials following what the agency called “mounting evidence” that some participants were never informed their biological material would be manipulated overseas and potentially infused back into them after foreign genetic engineering, in some cases, allegedly without their knowledge or consent.
The announcement marked a major policy reversal for the federal government and comes in response to growing national security concerns about the misuse of American genetic data by foreign governments, particularly the Chinese Communist Party (CCP).
For years, federal oversight of where and how American DNA could be processed was limited, and loopholes allowed sensitive biological material to be exported overseas with little transparency.
“China has amassed the largest genomic holdings of anywhere in the world,” Anna Puglisi, director of biotechnology programs at Georgetown’s Center for Security and Emerging Technology, told the U.S. Senate during a hearing on national security in 2021.
According to the FDA presser, the now-halted practice was made possible by a Biden-era exemption to a 2024 data security rule that otherwise restricted sensitive data transfers to hostile countries.
The exemption, finalized in April 2025, allowed American firms conducting FDA-regulated clinical trials to send trial participants’ biological samples — including DNA — abroad for processing, even when those samples were handled by entities partially owned or controlled by the 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 press release said the FDA will now require all companies using this exemption to prove they obtained full informed consent and handled samples ethically and securely. Trials that cannot meet these standards will be barred from proceeding.
The FDA is also coordinating with the National Institutes of Health (NIH) to ensure federally funded research has not been compromised. Further enforcement actions and policy measures may follow.
This review is said to align with Executive Orders 14117 and 14292, issued by President Donald Trump. These orders direct federal agencies to limit foreign access to sensitive biological data and restrict federal funding to secure, U.S.-compliant institutions.
The FDA’s announcement also appears to validate concerns long voiced by lawmakers. In 2019, Senator Chuck Grassley (R-Iowa) and then-Senator Marco Rubio (R-Fla.) — now Secretary of State — sent a letter to HHS and the Centers for Medicare and Medicaid Services (CMS) warning of potential U.S. taxpayer funding flowing to genomics firms tied to the Chinese government.
The October 2019 letter asked whether “CMS may be providing payments for genetic testing or analysis to U.S. entities that have domestic partnerships with WuXi, BGI, and other genomics companies with ties to the Chinese government.” Grassley and Rubio cited concerns that Medicare and Medicaid providers were contracting with companies affiliated with Huawei, which U.S. intelligence agencies have described as a state-directed actor used to steal trade secrets and conduct espionage.
Rubio, long an outspoken critic of Beijing’s use of biotechnology for surveillance and repression, introduced the Stopping Genetic Monitoring by China Act in 2023, while still in the Senate. The bill aimed to prohibit the export of U.S. genetic technology to China and called attention to alleged CCP abuses of genetic data in Xinjiang and Tibet.
Ultimately, the bill failed to pass.
In Tuesday’s FDA statement, officials did not name specific companies under scrutiny but made clear that partnerships involving foreign-owned or foreign-operated facilities would face heightened scrutiny going forward.