On Friday, February 13th, United States Senator Tom Cotton sent a letter to the Food and Drug Administration (FDA) Director Martin Makary, requesting an investigation into how illegal and unregulated pharmaceutical ingredients from China are infiltrating the U.S. supply chain. Cotton warned that potentially 1.5 million American patients are using unregulated complex weight loss drugs.
In his letter, Cotton expressed his deep concerns about the infiltration of illegal active pharmaceutical ingredients (API) from China into the U.S. supply chain. These ingredients are the core effective components in medications.
“Cotton wrote, “Allowing China to infiltrate the U.S. drug supply chain not only threatens national security but also poses significant health risks to American patients.”
The letter cited the latest analysis from the FDA and the U.S. Customs and Border Protection (CBP), indicating that the scale of infiltration of illegal active pharmaceutical ingredients from China has reached alarming levels.
“Between September 2023 and January 2025, a total of 195 batches of illegal active pharmaceutical ingredients entered the U.S. market, likely to be used in manufacturing complex weight loss drugs,” Cotton wrote. “Of these shipments, approximately 60 batches were confirmed to originate from China and Hong Kong. It is estimated that as of January 2026, there could be as many as 1.5 million patients in the U.S. using these unregulated weight loss drugs, potentially containing hazardous substances from Chinese manufacturers.”
He urged the FDA to further investigate the prevalence of these illegal and unregulated Chinese active pharmaceutical ingredients in the U.S. and the extent to which they have infiltrated into unregulated weight loss drugs.
American consumers have turned to complex weight loss drugs primarily to address high obesity rates and the high cost and persistent shortages of branded drugs such as Ozempic and Wegovy. However, these complex drugs that mimic the effects of popular weight loss drugs conceal significant risks due to the opacity of ingredient regulation.
Previously, the federal government has begun efforts to clean up the American weight loss drug market.
On February 6th, the Department of Health and Human Services (HHS) transferred the large drug selling platform Hims & Hers to the Department of Justice (DOJ) for investigation, accusing it of planning to sell unapproved complex weight loss drugs, potentially violating federal laws.
Under pressure, the company announced last week that it would withdraw related products from the market.
Subsequently, FDA Director Martin Makary also pledged to take “decisive actions” to restrict the use of these widely used and unapproved active pharmaceutical ingredients.