Cotton to Makary: Investigate Unregulated Drug Ingredients from Communist China

FOR IMMEDIATE RELEASE
Contact: Patrick McCann (202) 224-2353
February 13, 2026

Cotton to Makary: Investigate Unregulated Drug Ingredients from Communist China

Washington, D.C. - Senator Tom Cotton (R-Arkansas) today sent a letter to FDA Commissioner Martin Makary urging further investigation into unregulated pharmaceutical ingredients flowing into our country from Communist China. Illegal, unregulated active pharmaceutical ingredients pose significant health risks to Arkansans.

In part, Senator Cotton wrote:

"Thank you for your actions to combat unsafe ingredients in our pharmaceutical supply chain. I write to reiterate concerns about active pharmaceutical ingredients (API) from unregulated Chinese entities that have made their way into our domestic supply chain. China's access to America's pharmaceutical supply chain presents national security risks as well as significant health risks to American patients."

Full text of the letter may be found here and below.

February 13, 2026

The Honorable Martin Makary, M.D., M.P.H.
Commissioner
U.S. Food and Drug Administration
10903 New Hampshire Ave.
Silver Spring, MD 20993

Dear Commissioner Makary:

Thank you for your actions to combat unsafe ingredients in our pharmaceutical supply chain. I write to reiterate concerns about active pharmaceutical ingredients (API) from unregulated Chinese entities that have made their way into our domestic supply chain. China's access to America's pharmaceutical supply chain presents national security risks as well as significant health risks to American patients.

A recent analysis from the Food and Drug Administration and U.S. Customs and Border Patrol shows that between September 2023 and January 2025, 195 illegal shipments of APIs, likely used in compounded weight loss medications, entered the U.S. market. Roughly 60 of the identified shipments originated from China and Hong Kong. It is estimated that as of January 2026, up to 1.5 million American patients could be using unregulated compounded weight loss medications that may contain potentially dangerous ingredients from Chinese manufacturers.

On February 6, 2026, the Department of Health and Human Services announced that it was referring a prevalent U.S.-based marketer of under-regulated compounded medications to the Department of Justice for potential violations of federal law. I encourage further investigations into other entities that expose American patients to dangerous, unregulated Chinese APIs.

Tom Cotton
United States Senator

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