FDA WARNING_LETTER - Lithia Mineral Water, Inc. - October 25, 2011

On October 18-25, 2011, the FDA inspected Lithia Mineral Water, Inc.'s facility. A subsequent review of their website in June 2012 revealed that their "Lithia" product, labeled as a dietary supplement, was promoted for disease treatment, cure, mitigation, or prevention, classifying it as an unapproved new drug under section 201(g)(1)(B) of the Act. Examples of claims included lowering LDL, blood pressure, combating infections, healing the brain, and helping with Alzheimer's, depression, and cancer. The product is not generally recognized as safe and effective for these uses, making it a "new drug" under section 201(p) and requiring FDA approval per section 505(a).

Furthermore, the product is misbranded under section 502(f)(1) because it addresses conditions not amenable to self-diagnosis, lacking adequate directions for layperson use. The letter also states that "Lithia" is represented as a conventional food (bottled/mineral water) and not a dietary supplement, violating section 201(ff)(2)(B). The addition of "actively charged ionic colloidal silver 2 PB" to the product raises concerns, as it is not an approved food additive, prior sanctioned, or clearly GRAS, potentially adulterating the product under section 402(a)(2)(C).