Lithia Mineral Water receives FDA Warning Letter

Posted on August 8, 2012 by

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The FDA reviewed http://lithiamineralwater.com in June 2012, and determined that  “Lithia” product is being promoted for conditions that cause it to be a drug. The FDA Warning Letter included the following examples:  

  • “Some of the health benefits of LITHIA™ include:
    • drinking mineral water can help … lower the level of LDL (Low Density Lipoprotein or bad cholesterol).
    • The magnesium present in LITHIA mineral water can help … lower blood pressure.
    • Mineral water are [sic] known to assist the body in combating internal infections caused by fungi and viruses.”
  • “LITHIA contains natural Lithium bicarbonate made by Mother Nature. … Numerous Scientific studies have found Lithium bicarbonate to heal the brain by stimulating the growth of new brain cells and protecting brain cells from every known neurotoxin. …  The list of health benefits goes on as to helping people with alcoholism, Alzheimer’s disease, depression, Parkinson’s disease, stroke, cluster headaches, hang overs [sic] and traumatic brain injury.”
  • “Additional studies have also reported on the neurogenesis capability of lithium to improve neurodegenerative conditions such as ALS, Alzheimer’s, spinal cord injuries and stroke.”
  • “Today, there are modern ailments that have the magnitude of silent epidemics. It is common knowledge that diseases such as Alzheimer’s, Cancer, Diabetes, Autism (ASDs), Fibromyalgia, Bipolar disorders, Immunological disorders…are increasing at an alarming rate. … Perhaps the answers for healing our growing epidemics can be found by…seeking the wisdom of the ancients who believed in the powers of mother earth’s healing spring waters, like LITHIA.”
  • “How can I avoid cancer? … Taking Chemopreventive Agents found in LITHIA may reduce your risk of cancer.” 
“Lithia” is not generally recognized as safe and effective for the above referenced uses. 
 

The Letter also discusses the Lithia label.
 
The label for “Lithia” states that “actively charged ionic colloidal silver 2 PB” is added to the product.  Apparently, FDA needs clarification whether “actively charged ionic colloidal silver 2 PB” indicates that silver ion (Ag+) or elemental silver (Ag) is present in the finished product. 
 
 “Actively charged ionic colloidal silver” is not approved as a food additive or prior sanctioned for use in mineral water. 
 
FDA needs Lithia’s basis for concluding that “actively charged ionic colloidal silver” is GRAS for use in mineral water, including supporting data or other documentation.
 _____________________________________________________© 2012 US Food Safety Corporation. No copyright claim is made for portions of this blog and linked items that are works of the United States Government, state governments or third parties.

 
Posted in: Family safety