FDA issues warning letters to companies selling dietary supplements containing cesium chloride

The U.S. Food and Drug Administration today posted five warning letters issued to companies marketing dietary supplements containing cesium chloride. In a February 2020 public health alert, the FDA warned consumers and health care professionals to avoid using dietary supplements containing cesium salts, primarily cesium chloride. In July 2018, the FDA alerted health care professionals of significant safety risks associated with cesium chloride in compounded drugs. Cesium chloride is sometimes 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. Therefore, firms must provide certain safety-related information about the ingredient to the FDA before including it in a dietary supplement. Companies marketing these products have not met this requirement, and as a result, their products cannot be legally marketed.

The warning letters were issued to:

• American Nutriceuticals, LLC
• Complete H2O Minerals, Inc.
• Daily Manufacturing, Inc.
• Elemental Research, Inc. and The Mineral Store, Inc.
• Essence-of-Life, LLC

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. We take very seriously our role to protect the public from dangerous dietary supplements."

Steven Tave, Director of the Office of Dietary Supplement Programs in the FDA's Center for Food Safety and Applied Nutrition

If consumers believe that a product might have caused a reaction or illness, they should immediately stop using the product, contact their health care provider, and submit a complaint to the FDA using MedWatch or the Safety Reporting Portal.

The FDA has requested responses from the companies within 15 working days stating how they will correct the violations. Failure to correct the violations promptly - or provide reasoning and supporting information as to why the products are not in violation of the law - may result in legal action, including product seizure and/or injunction.