FDA Sends Warning Letters To Dietary Supplement Manufacturers Over Presence of Cesium Chloride

A number of dietary supplement manufacturers are illegally selling products containing cesium chloride, according to a warning issued by federal health regulators, who warn the products may pose serious safety risks for consumers.

The FDA issued a press release this week, announcing it has sent warning letters to American Nutriceuticals, LLC; Complete H2O Minerals, Inc; Daily Manufacturing, Inc.; Elemental Research, Inc.; The Mineral Store, Inc.; and Essence-of-Life, LLC, over the presence of cesium chloride in some of their dietary supplement products.

Cesium chloride is a mineral salt often promoted as an alternative treatment for cancer. However, no cesium chloride containing products have been approved by the FDA to treat cancer or any other disease. Cesium chloride is a new dietary ingredient that has not previously been present in the food supply in a non-chemically altered form. According to the FDA, it is subject to a 75-day premarket notification to establish its safety in dietary supplements.

The companies selling the products must provide certain safety related information about the ingredient to the FDA before including it in a dietary supplement. However, companies marketing these products have not met this requirement and as a result their products cannot be legally marketed, the letters warn.

In February 2020, the FDA issued a public health alert warning consumers and healthcare providers to avoid using dietary supplements containing cesium salts, primarily cesium chloride.

Cesium chloride is associated with a lower blood level of potassium, which is a mineral that is essential to normal heart function. Using products containing cesium chloride may lead to heart problems.

“The FDA will continue to take action against dietary supplements that contain cesium chloride because of significant safety concerns—including heart toxicity and potential death—associated with this ingredient,” said Steven Tave, Director of the Office of Dietary Supplement Programs in the FDA’s Center for Food Safety and Applied Nutrition. “We take very seriously our role to protect the public from dangerous dietary supplements.”

The FDA requested a response from the companies within 15 working days to explain how they will correct the violations. Failure to correct the violations may result in legal action, including product seizure and or injunction.

Consumers who have experienced a reaction or illness related to using the product should contact their doctor and issue a complaint to the FDA’s MedWatch Adverse Event Reporting program.