Concerns have emerged regarding China's dual-use research capabilities, which may involve the development of biological weapons and the potential misuse of sensitive genetic data pertaining to Americans.

Experts have warned that the transfer of genetic data could empower China to create targeted biological weapons aimed at specific ethnic groups, a concern underscored by military writings from the People's Liberation Army.

In response to these concerns, the FDA has halted a Biden-era program that permitted the transfer of Americans' DNA samples to China for genetic engineering, citing issues related to informed consent and the risk of misuse by foreign governments.

The FDA is currently reviewing DNA transfers under two executive orders, including a recent directive aimed at restricting dangerous gain-of-function research that poses risks to American lives and national security.

This decision follows a policy enacted in December 2024 by the Biden administration, which allowed U.S. companies to send DNA samples overseas under a broad exemption for FDA-regulated clinical trials, even involving firms partially controlled by the Chinese Communist Party.

FDA Commissioner Marty Makary has emphasized the importance of protecting patients and restoring public trust in U.S. biomedical research, criticizing the previous administration for facilitating the transfer of American DNA abroad without sufficient oversight.

To further safeguard federally funded research from these transfers, the FDA is collaborating with the National Institutes of Health, and additional policy measures may soon be introduced.

Recent arrests of two Chinese nationals for smuggling biological materials into the U.S. have intensified concerns regarding the safety and security implications of genetic data transfers.