Cesium chloride is declared as a dietary ingredient on the labeling of some dietary supplements. Under existing law, a “new dietary ingredient” is a dietary ingredient that was not marketed in the United States before October 15, 1994. The FDA is not aware of any information demonstrating that cesium chloride was lawfully marketed as a dietary ingredient in the United States before this date. As a result, cesium chloride is a new dietary ingredient, and dietary supplements that contain cesium chloride must, among other requirements, satisfy one of the following:
- Cesium chloride, and all other new dietary ingredients in the product, must have been present in the food supply as an article used in food in a form in which the food has not been chemically altered; or
- There must be a history of use or other evidence of safety establishing that cesium chloride, when used under the conditions recommended or suggested in the product labeling, will reasonably be expected to be safe; and at least 75 days before the product is introduced or delivered for introduction into interstate commerce, the manufacturer or distributor must notify the FDA of the basis on which the manufacturer or distributor has concluded that a dietary supplement containing cesium chloride will reasonably be expected to be safe.
Because neither of these conditions has been met by those marketing products that contain cesium chloride as a dietary ingredient, these products are deemed to be adulterated.
Cesium chloride is sometimes promoted as an alternative treatment for cancer, but it has never been proven to be safe and effective to treat cancer or for any other use. On February 5, 2020, the FDA warned consumers to avoid using dietary supplements containing cesium salts, including cesium chloride, due to significant safety concerns.
On October 9, 2020, the FDA issued warning letters to the following companies whose dietary supplement labeling lists cesium chloride as a dietary ingredient:
- American Nutriceuticals, LLC
- Complete H2O Minerals, Inc.
- Daily Manufacturing, Inc.
- Elemental Research, Inc. and The Mineral Store, Inc.
- Essence-of-Life, L.L.C.
The agency will continue to update this page in the event additional actions are taken related to cesium chloride.
For More Information:
- Constituent Update
- Press Release
- Public Health Alert Concerning Dietary Supplements Containing Cesium Salts