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Despite the passage of the Rubio-led Uyghur Forced Labor Prevention Act (UFLPA) in 2021, a recent report has revealed that two Xinjiang-based pharmaceutical entities continue to exploit American laws for profit. To uphold the UFLPA, the U.S. Food and Drug Administration (FDA) and U.S. Department of Homeland Security (DHS) must swiftly add Xinjiang Nuziline Bio-Pharmaceutical Co. and SEL Biochem Xinjiang Co. to the UFLPA Entity List and remove them from the FDA’s Registered Drug Establishments Site. This would prevent the companies from distributing pharmaceuticals tainted with forced labor throughout the United States.
U.S. Senator Marco Rubio (R-FL) sent a letter to FDA Commissioner Robert Califf and DHS Secretary Alejandro Mayorkas demanding they uphold their responsibility of ensuring that all goods imported to the U.S. are not made with slave labor and ban these companies from doing business in the U.S.
The full text of the letter is below.
Dear Commissioner Califf and Secretary Mayorkas:
I write with regard to recent reports identifying two pharmaceutical producers based in the Xinjiang Uyghur Autonomous Region (XUAR) of the People’s Republic of China (PRC) that are permitted by the U.S. Food and Drug Administration (FDA) to distribute their products in the U.S. This is in clear violation of current law which prohibits imports from the region due to the Chinese Communist Party’s (CCP) egregious human rights abuses, including genocide, forced abortions, and forced sterilizations. Aside from the significant national security and public health risks associated from sourcing and distributing pharmaceuticals and active pharmaceutical ingredients (APIs) from the PRC, banning companies likely engaging in forced human labor and human rights abuses from doing business in the United States is a foundational tenet of promoting freedom and democracy, and is the reason for the enactment of the Uyghur Forced Labor Prevention Act in 2021. I urge you to rectify this dangerous transgression of the law and immediately ban all distribution of products from these companies in the United States. I also urge you to conduct a thorough review of all companies currently authorized by the FDA to distribute pharmaceuticals or APIs in the U.S., and assess whether additional companies should be prohibited from distribution under current laws and regulations.
The Uyghur Forced Labor Prevention Act ensured that the CCP is held accountable for its use of slave labor and that products made using forced labor would no longer be distributed in any American supply chain. The U.S. has the responsibility of ensuring pharmaceutical and API products are made ethically before distributing to consumers. However, recent analysis by the Centers for Advanced Defense Studies exposed that the FDA currently allows at least two pharmaceutical producers, Xinjiang Nuziline Bio-Pharmaceutical Co. and SEL Biochem Xinjiang Co. to import APIs and drug products into the U.S. Both of these companies are linked to slave labor in Xinjiang and are not listed on the UFLPA Entity List. By including these companies on the FDA’s Registered Drug Establishments Site, they are able to legally import into the United States, despite being prohibited under current law.
I am concerned that the FDA and the U.S. Department of Homeland Security (DHS) has not conducted sufficient oversight into the pharmaceutical and API producers allowed to conduct business in the U.S., nor made sufficient efforts to uphold U.S. law. The Uyghur Forced Labor Prevention Act assures the American people that the products they purchase were made without slave labor. It is clear that the lack of oversight by the FDA has not made this true. The FDA and DHS have a responsibility to rectify this dangerous error and uphold the law. Therefore, I demand both departments and the Forced Labor Enforcement Task Force to immediately place Xinjiang Nuziline Bio-Pharmaceutical Co. and SEL Biochem Xinjiang Co. on the UFLPA Entity List. I also ask that the FDA and DHS complete a thorough review of every company authorized to distribute pharmaceuticals and API in the United States to ensure compliance with the Uyghur Forced Labor Prevention Act. I ask that you provide a formal response outlining the FDA and DHS’s commitment to complete these actions.
Thank you for your attention to this important matter. I look forward to your prompt response.
Sincerely,