FDA WARNING_LETTER - Daily Manufacturing Company - October 13, 2020

The FDA issued a Warning Letter to Mr. Daily regarding his product, Cal II Supreme, labeled as a dietary supplement. The product's labeling declares cesium chloride as a dietary ingredient.

The FDA determined that cesium chloride is a "new dietary ingredient" under section 413(d) of the Federal Food, Drug, and Cosmetic Act (the Act) because there is no information demonstrating it was lawfully marketed as a dietary ingredient in the U.S. before October 15, 1994, or present in the food supply as an unchemically altered food article.

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

Furthermore, the FDA states that even if a notification had been submitted, dietary supplements containing cesium chloride would be adulterated under sections 402(f) and 413(a) of the Act. This is due to a lack of safety evidence; animal research shows cesium chloride can cause irregular heartbeats, and human reports indicate serious heart problems and lower blood potassium levels. Therefore, the product is adulterated under section 4