FDA WARNING_LETTER - American Nutriceuticals LLC - October 13, 2020

The FDA issued a Warning Letter to Mr. Kravitz and Mr. Coury regarding their dietary supplement, pH Balancer Plus, which contains cesium chloride. The letter states that cesium chloride is a "new dietary ingredient" under section 413(d) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 350b(d)].

The product is deemed adulterated under sections 402(f) and 413(a) of the Act [21 U.S.C. §§ 342(f) and 350b(a)] because a new dietary ingredient notification was not submitted to the FDA at least 75 days before its introduction into interstate commerce, as required by section 413(a)(2) and 21 CFR 190.6. The FDA states there is no information demonstrating cesium chloride was lawfully marketed as a dietary ingredient before October 15, 1994, or present in the food supply in an unchemically altered form.

Furthermore, the FDA concludes 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 heart problems in humans, linking it to lower potassium levels. Therefore, even with a notification, products containing cesium chloride would be adulterated under sections