Krishnamoorthi Sends Letters to Chinese Biotech Firms Regarding Illicit and Potentially Dangerous Counterfeit GLP-1 Manufacturing Threatening U.S. Drug Supply

WASHINGTON — Congressman Raja Krishnamoorthi today announced that he has sent formal letters to three People’s Republic of China–based biotechnology companies demanding detailed information about their manufacturing, labeling, and export of glucagon-like peptide-1 (GLP-1) drugs and associated active pharmaceutical ingredients (APIs) that may be entering the U.S. drug supply unlawfully and without appropriate safety oversight.

“For millions of Americans relying on GLP-1 medications, safety is not optional,” said Congressman Krishnamoorthi. “Illicit manufacturing practices and the shipment of unregulated injectable drugs into the United States may not only be illegal—they are potentially dangerous, exposing patients to unstudied health risks and undermining the safeguards that exist to protect public health. PRC-based manufacturers do not, and should not, enjoy an exemption from accountability.”

The letters were sent to Chinese Peptide Company, Hubei JXBio Biotech, and Fujian Genohope Biotech amid growing concern that PRC-manufactured GLP-1 products and APIs are being used to make compounded injectable weight-loss drugs falsely marketed as substitutes for FDA-approved medications such as Ozempic and Wegovy.

In the letters, Ranking Member Krishnamoorthi cited hundreds of reports received by the FDA of adverse events linked to illicit compounded GLP-1s, warning that the true scope of harm remains understudied and may be significantly underreported. He also referenced a recent FBI warning that fraudulent compounded weight-loss drugs have been associated with gastrointestinal disorders, nervous system disorders, cardiac disorders, psychiatric disorders, and death.

Although the FDA declared an end to the semaglutide shortage earlier this year, Krishnamoorthi warned that PRC-manufactured GLP-1s and related APIs continue to proliferate in the U.S. supply chain, often through mislabeling or other practices designed to evade regulatory scrutiny, increasing the risk that unsafe or improperly tested products reach American patients.

Across all three letters, Ranking Member Krishnamoorthi posed the same questions and requested the production of documents, asking each company to respond to the following:

1. Please provide a full list detailing all semaglutide and tirzepatide products and associated APIs you manufacture, sell, and ship to customers in the U.S.
2. Please provide a comprehensive list of retailers in the U.S. that you supply (including any retailers supplied by your customers).
3. Please describe your business relationship(s) with U.S.-based compounding companies and other U.S.-based customers.
4. Please describe your company’s practices used for labeling semaglutide and tirzepatide products and associated API that are imported into the U.S.
   1. Have you ever labeled any of your semaglutide and tirzepatide products “for research use only,” “not for human use,” “animal-grade,” or any other sort of similar labels that might indicate the product is not intended for human consumption?
   2. If yes, how many instances are you aware of such labeling?
   3. Please provide a full list of orders from the past 12 months that contain semaglutide or tirzepatide products and/or associated APIs that were labeled with any of the aforementioned labels.
5. Please describe any agreements made with U.S.-based compounding companies regarding labeling of semaglutide and tirzepatide shipped into the U.S.
6. Please describe the manufacturer safety assurance procedures your company uses to monitor any and all facilities where semaglutide and tirzepatide and associated APIs are manufactured.
7. Please describe the safety and quality testing procedures your company uses for all manufactured semaglutide and tirzepatide products and associated APIs.
8. Please produce your company’s drug manufacturing license in the PRC.
9. Please produce your company’s registration, if applicable, with the U.S. FDA.
   1. In the preceding 36 months, how many times has the U.S. FDA inspected your facilities?
   2. Please provide any U.S. FDA-issued Form 483s or U.S. FDA warning letters your company has received.
10. Please describe any subsidies, funding, or other benefits your company receives from any government entity in the PRC.

Krishnamoorthi requested that each company respond fully and produce all responsive documents by January 31, 2026, emphasizing Congress’s obligation to protect Americans from unsafe, unregulated, and potentially dangerous pharmaceutical products entering the United States.

The letter to Chinese Peptide Company is available here.

The letter to Hubei JXBio Biotech is available here.

The letter to Fujian Genohope Biotech is available here.