FDA WARNING_LETTER - Complete H2O Minerals Corporation - October 09, 2020

This FDA Warning Letter, dated October 9, 2020, addresses the product Ultimate Cesium Concentrate, labeled as a dietary supplement containing "cesium chloride." The FDA identifies cesium chloride as a "new dietary ingredient" not marketed in the U.S. before October 15, 1994.

The product is deemed adulterated under sections 402(f) and 413(a) of the Federal Food, Drug, and Cosmetic Act because no new dietary ingredient notification was submitted to the FDA, as required for ingredients not previously in the food supply or lacking a history of safe use. Furthermore, the FDA states there is no evidence establishing cesium chloride's safety as a dietary ingredient, citing animal research showing irregular heartbeats and human reports of serious heart problems, linked to lower potassium levels.

The letter mandates prompt corrective action, including immediately ceasing distribution of Ultimate Cesium Concentrate and any other products containing cesium chloride. Failure to comply could lead to enforcement actions such as product seizure and injunctions. The recipient must respond within fifteen working days, detailing corrective steps, preventative measures, and supporting documentation, or provide reasons for delay.