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Cotton demands FDA investigate Chinese drug ingredients in weight loss drugs

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FIRST ON FOX: A Senate Republican is asking the Food and Drug Administration (FDA) to investigate whether illegal Chinese ingredients are in U.S. weight-loss drugs.

Sen. Tom Cotton, R-Ark., called on FDA Commissioner Martin Makary to investigate how unregulated and illegal Chinese active pharmaceutical ingredients have penetrated the U.S. supply chain and whether they are finding their way into popular weight-loss drugs.

“China’s access to America’s pharmaceutical supply chain presents national security risks as well as significant health risks to American patients,” Cotton wrote in a letter to Makary first obtained by Fox News Digital.

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Sen. Tom Cotton, R-Ark., called on FDA Commissioner Martin Makary to investigate how widely illegal and unregulated Chinese pharmaceutical ingredients are in the U.S. and how common they are in weight-loss drugs that are not FDA-regulated. (Bill Clark/CQ Polling, Inc. via Getty Images)

Cotton’s concern follows recent reports from the FDA and Customs and Border Protection (CBP) that between September 2023 and January 2025, authorities seized 195 shipments of illegal active pharmaceutical ingredients.

He noted that the ingredients “are likely used in compound weight loss drugs” entering the U.S. market. About 60 of these shipments came from China and Hong Kong.

“It is estimated that by January 2026, up to 1.5 million American patients may be using unregulated compounded weight loss medications from Chinese manufacturers that may contain potentially dangerous ingredients,” Cotton said. he wrote.

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person stands on scales holding GLP1 injection

Americans are turning to risky, unregulated sellers for GLP-1 weight loss drugs. (iStock)

The ingredients are typically used in compounded versions of GLP-1 weight loss drugs marketed as alternatives to FDA-approved drugs, such as Ozempic and Wegovy.

Earlier this month, the Department of Health and Human Services announced that it would refer telehealth company Hims & Hers to the Department of Justice for “possible violations of the Federal Food, Drug, and Cosmetic Act” for its planned sale of a compounded weight-loss drug that has not been approved by the FDA.

Makary similarly said the FDA “will take decisive action to restrict GLP-1 active pharmaceutical ingredients (APIs) intended for use in non-FDA-approved compounded drugs that are mass-marketed as alternatives to FDA-approved drugs by companies, including Hims & Hers and other compounding pharmacies.”

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The company announced last week that it would remove the weight-loss pill, billed as a cheaper alternative to Wegovy, from the market following mounting pressure from federal agencies.

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Cotton acknowledged the move and called for similar investigations to continue.

“I encourage further investigation into other entities that are exposing American patients to dangerous, unregulated Chinese APIs,” Cotton wrote.

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