Public Citizen Sues FDA; Agency Failed to Respond to Petition for a Ban on Dietary Supplements Containing Cesium Chloride

FDA Has Long Recognized the Dangers of Cesium Chloride But Has Not Acted on Public Citizen Petition

WASHINGTON, D.C. – Public Citizen today sued the U.S. Food and Drug Administration (FDA) over its failure to respond to a petition urging the agency to ban all dietary supplements containing cesium chloride or other cesium salts from the market. The suit was filed in the U.S. District Court for the District of Columbia.

Cesium compounds have long been used in dietary supplements and pharmacy compounding despite their links to life-threatening cardiovascular events.

In 2016, FDA reviewers recognized that cesium chloride presents “serious safety concerns” and “is not safe for human use.”

On Dec. 6, 2017, Public Citizen petitioned the FDA, requesting that it take action to prevent the use of cesium chloride to produce compounded drugs. On July 23, 2018, the FDA responded, placing cesium chloride in a category of substances that may not be compounded under interim FDA guidance and issuing a health alert to medical professionals. On Sept. 5, 2019, the FDA issued a proposed rule to make permanent the ban on cesium chloride in pharmacy compounding.

Nonetheless, cesium chloride remains available in dietary supplements. Accordingly, on the same day that the FDA responded to its first petition, Public Citizen petitioned again, this time seeking a ban on cesium chloride in dietary supplements.

Now, more than a year has passed since Public Citizen submitted its petition, and the FDA still has not issued a decision on it. Such a delay violates the Administrative Procedure Act, Public Citizen said in its lawsuit.

“The FDA must protect the public from cesium-containing dietary supplements,” said Meena Aladdin, health researcher in Public Citizen’s Health Research Group. “The FDA’s failure to act exposes consumers to potentially life-threatening harm.”

Read the filing here.