Bio-Botanica, Inc./Nature’s Answer, Inc. – FDA Warning Letter, May 18, 2021

This FDA Warning Letter, CMS# 613479, addresses the product Coral Calcium, labeled as a dietary supplement, due to the inclusion of cesium chloride as a dietary ingredient. The FDA states that cesium chloride is a "new dietary ingredient" under section 413(d) of the Act because it was not marketed in the U.S. before October 15, 1994, and there's no evidence of its presence in the food supply as an unaltered food article.

Consequently, the product is deemed adulterated under sections 402(f) and 413(a) of the Act because a new dietary ingredient notification was not submitted as required by section 413(a)(2) and 21 CFR 190.6. The introduction of such products into interstate commerce is prohibited under sections 301(a) and (v).

Furthermore, the FDA asserts there is no safety evidence establishing that cesium chloride is reasonably expected to be safe as a dietary ingredient. Animal research indicates it can cause irregular heartbeats, and human reports show serious heart problems, linking it to lower potassium levels. Therefore, even with a notification, the product would be adulterated under sections 402(f) and 413(a), and specifically 402(f)(1)(B) due to lack of reasonable assurance of safety.

The letter requires a