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FDA Refuses to Ban Heart-Toxic Dietary Supplements Containing Cesium, Endangering Patients and Ignoring Agency’s Own Expert Assessment

Statement of Dr. Michael Carome, Director, Public Citizen’s Health Research Group

Note: Today, the U.S. Food and Drug Administration (FDA) partially denied and partially granted Public Citizen’s July 2018 petition calling on the agency to ban all dietary supplements containing heart-toxic cesium chloride (or any other cesium salt supplement) – which have been promoted as an alternative treatment to cancer. The agency granted our request to warn consumers and health care professionals about the harms that can result from taking any dietary supplements containing cesium chloride or other cesium salts, and it issued a public health alert today. However, the agency denied our request to require that all such dietary supplements be removed from the market. Public Citizen sued the FDA in September 2019 for failing to respond to the petition; this was the FDA’s response.

By denying our request to remove dietary supplements containing cesium chloride (or any other cesium salt) from the market, the FDA has ignored its obligation to protect public health. It also has allowed consumers to continue to be exposed to life-threatening dietary supplements that have been promoted without basis to vulnerable cancer patients.

The FDA’s indefensible action endangers consumers and cannot be reconciled with the assessment of cesium chloride by the agency’s own experts in the Center for Drug Evaluation and Research (CDER). Nor can it be reconciled with the agency’s decision to advise consumers and health care professionals today not to use or recommend dietary supplements containing cesium salts because of potentially fatal safety risks.

In 2016, CDER reviewers evaluating scientific evidence regarding the use of cesium chloride in pharmacy compounding concluded that this substance is “not safe for human use” and “has not been shown to be efficacious for the prevention or treatment of any form of cancer.” Cesium taken orally can cause potentially fatal heart rhythm abnormalities, seizures, fainting and death.

As a result, in 2018, the FDA took action to prohibit the use of cesium chloride in pharmacy compounding but failed to ban its use as a dietary supplement. In responding to our July 2018 petition, the FDA reaffirmed that cesium salts, such as cesium chloride, are too dangerous to use.

The agency’s flimsy rationale for its partial denial of our petition was that only a small number of cesium salt supplements are on the market and that undertaking the rulemaking would not be an efficient regulatory mechanism. However, given the research that FDA experts have already taken to evaluate cesium chloride, the burden of pursuing regulatory action would be minimal and would save lives.