Bio-Botanica/Nature’s Answer Cesium Chloride Product Adulterated: FDA

FDA says Bio-Botanica/Nature’s Answer’s Coral Calcium, that contains cesium chloride as a dietary ingredient and is labeled as a dietary supplement, is adulterated because cesium chloride is a new dietary ingredient. A 5/5 Warning Letter says there is no information demonstrating that cesium chloride was lawfully marketed as a dietary ingredient in the U.S. before the 1994 date in the Federal Food, Drug, and Cosmetic Act and no history of use or other evidence of safety establishing that cesium chloride will reasonably be expected to be safe when used as a dietary ingredient.

The letter says research in animals has shown that cesium chloride can cause heart arrhythmias and says there have been reports of humans experiencing serious heart problems after taking cesium chloride.

The company was told to respond with specific steps being taken to address the violations cited in the letter with documentation of each step and a timetable for completing the work.