Recent FDA Action on Dietary Supplements Containing Cesium Chloride
October 13, 2020
On October 9, 2020, the U.S. Food and Drug Administration (FDA) issued warning letters to five dietary supplement companies whose product labeling declares cesium chloride as a dietary ingredient. The FDA considers these products to be adulterated because they are labeled as containing a new dietary ingredient, cesium chloride, and because they have not satisfied the conditions required to lawfully market a dietary supplement containing a new dietary ingredient.
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. In a February 2020 public health alert, the FDA warned consumers to avoid taking dietary supplements containing cesium salts, primarily cesium chloride.
Warning letters were sent to the following companies:
- 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 FDA has requested responses from the companies within 15 working days stating how the companies 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 injunction.
Under existing law, including the Dietary Supplement Health and Education Act of 1994, if the FDA establishes that dietary supplement products are adulterated (e.g., that the product is unsafe or lacks evidence of safety) or misbranded (e.g., that the labeling is false or misleading), the agency can then take action to remove those products from the market.
For More Information:
- Cesium Chloride in Dietary Supplements
- Press Release
- Public Health Alert Concerning Dietary Supplements Containing Cesium Salts