FDA alerts dietary supplement firms selling Cesium Chloride containing products

The US Food and Drug Administration (FDA) have issued five warning letters to firms trading in cesium chloride (CsCl) containing dietary supplements. In February 2020, the FDA alerted consumers and health care professionals to eschew the use of dietary supplements containing cesium salts, especially CsCl.

In July 2018, the FDA warned health care professionals regarding the possible safety risks linked with CsCl in compounded drugs. Cesium chloride is sometimes advocated as a substitutive treatment for cancer; however, no CsCl containing products have been authorized by the FDA to cure cancer or any other disease.

Cesium chloride is a novel dietary ingredient that was earlier not being used in the food supply in a non-chemically modified form. Hence, companies must submit certain safety-related information about the ingredient to the FDA before utilizing it in a dietary supplement. Companies marketing these products who have not completed this pre-requisite, their products cannot be legally traded.

Following are the names of those five firms which received the warning letters from the FDA:-
•    American Nutriceuticals, LLC
•    Complete H2O Minerals, Inc.
•    Daily Manufacturing, Inc.
•    Elemental Research, Inc. and The Mineral Store, Inc.
•    Essence-of-Life, LLC

Steven Tave, director of the office of dietary supplement programmes in the FDA’s Center for Food Safety and Applied Nutrition stated- “The FDA will continue to take action against dietary supplements that contain cesium chloride owing to the prominent safety issues—such as heart toxicity and potential death—linked with this ingredient. We take our responsibility to safeguard the public from dangerous dietary supplements very earnestly.”

If consumers feel that a product might have caused a reaction or sickness, they should promptly stop using the product, consult their health care provider, and file a complaint to the FDA using either MedWatch or the Safety Reporting Portal.

The FDA has appealed reciprocations from the firms within 15 working days affirming how they will rectify the breaching. Those who fail to amend the violations immediately or fail to present convincible logic and authentic evidence explaining why their products are not breaching the law may have to encounter legal action, as well as product seizure and injunction or ultimatum.

The FDA, an agency within the US Department of Health and Human Services, safeguards the public health by promising the safety, and efficiency of human and veterinary drugs, vaccines and other biological formulations for human use, and medical tools. The agency is also accountable for the safety and security of our nation’s food supply, cosmetics, dietary supplements, goods that give off electronic radiation, and for managing tobacco products.