FDA WARNING_LETTER - The Mineral Store, Inc./Elemental Research, Inc. - October 09, 2020

The FDA issued a Warning Letter to Elemental Research, Inc. regarding their product, Cesium Plus, labeled as a dietary supplement containing cesium chloride. The FDA determined that cesium chloride is a "new dietary ingredient" not marketed in the U.S. before October 15, 1994, and not present in the food supply in an unchemically altered form.

Consequently, Cesium Plus is deemed adulterated under sections 402(f) and 413(a) of the Federal Food, Drug, and Cosmetic Act because the required new dietary ingredient notification was not submitted. Furthermore, the FDA stated there is no evidence establishing the safety of cesium chloride as a dietary ingredient, citing animal research showing irregular heartbeats and human reports of serious heart problems, linked to lower potassium levels. Therefore, even with a notification, products containing cesium chloride would be adulterated under section 402(f)(1)(B) due to a lack of reasonable assurance of safety.

The FDA requires Elemental Research, Inc. to immediately cease distribution of Cesium Plus and any other products containing cesium chloride. Failure to comply could result in enforcement actions, including product seizure and injunctions. The company must respond within fifteen working days, outlining corrective actions and preventative measures, or provide reasoning and supporting information if they believe no violation exists.