FDA WARNING_LETTER - Essense Of Life, LLC - October 13, 2020

The FDA issued a Warning Letter to Mr. McKaig regarding his product, Cesium Chloride Mineral Water, labeled as a dietary supplement. The letter, dated October 9, 2020, states that cesium chloride is a "new dietary ingredient" not marketed in the U.S. before October 15, 1994.

The product is deemed adulterated under sections 402(f) and 413(a) of the Federal Food, Drug, and Cosmetic Act because a required new dietary ingredient notification was not submitted to the FDA. Such notification is mandatory unless the ingredient was present in the food supply as an unchemically altered food article, or there is evidence of safety. The FDA states there is no information demonstrating either condition for cesium chloride.

Furthermore, the FDA asserts that there is no history of use or other evidence establishing cesium chloride's safety as a dietary ingredient. The letter cites animal research showing irregular heartbeats and reports of serious human heart problems associated with cesium chloride, noting its link to lower potassium levels essential for heart function. Therefore, even with a notification, the product would be adulterated under section 402(f)(1)(B) due to a lack of reasonable assurance of safety.

The FDA prohibits the introduction of such adulterated products into interstate commerce under sections 301(a) and (v). The letter requires prompt action to correct these violations, including ceasing