Bio-Botanica, Inc./Nature’s Answer, Inc. Warning Letter Details

Summary

Bio-Botanica, Inc./Nature's Answer, Inc. was cited for marketing Coral Calcium, a dietary supplement containing cesium chloride, without meeting regulatory requirements for new dietary ingredients. The company failed to demonstrate that cesium chloride was either present in the food supply before October 15, 1994, or that it had submitted the required safety documentation to FDA at least 75 days before marketing the product. Because cesium chloride lacked pre-1994 market history and the company provided no safety evidence to FDA, the product was deemed adulterated under federal law.