Inspections, Compliance, Enforcement, and Criminal Investigations
Lithia Mineral Water, Inc. 7/20/12
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
Atlanta District Office
60 Eighth Street N.E.
Atlanta, GA 30309
July 20, 2012
Ian S. Simpson, CEO
Lithia Mineral Water, Inc.
2910 Veterans Memorial Highway SW
Austell, GA 30168
Dear Mr. Simpson:
On October 18-25, 2011, the U. S. Food and Drug Administration (FDA) conducted an inspection of your water processing facility located at 2910 Veterans Memorial Highway SW in Austell, GA and reviewed the labeling of your mineral water product “Lithia,” which is identified as a dietary supplement on the principal display panel of the product label. As a result of our review of your website at the Internet address http://lithiamineralwater.com in June 2012, we have determined that your “Lithia” product is being promoted for conditions that cause it to be a drug as defined by section 201(g)(1)(B) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. 321(g)(1)(B)] because it is intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease.
Examples of some of the claims observed on your website include:
- “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.”
In addition, when scientific publications are used commercially by the seller of a product to promote the product to consumers, such publications may become evidence of the product's intended use. For example, your website cites a 1990 article from an unspecified journal to support the following claim about treatment of fibromyalgia and other diseases:
- “Lithium (found naturally in LITHIA) is a trace mineral micronutrient… [I]t is possible (research evidence*) that deficiencies in Lithium and other essential micronutrient minerals may cause a multitude of behavior symptoms and diseases such as fibromyalgia, dementia, and Alzheimer’s. A research study showed that Lithium therapy dramatically reduced the symptoms of fibromyalgia in a case study of four woman who suffered from this debilitating ailment.
* Nov 1, 1990 ... Lithium carbonate augmentation therapy in fibromyalgia. M A Tyber”
Your website also contains disease claims in the form of personal testimonials, including:
- “I have watched the effects of the LITHIA WATER FOR SEVERAL YEARS. Besides using it in my family, I do not hesitate to say that it is a water of real merit and especially adapted to … rheumatism and its kindred disorders.”
- “I work with autistic children and I’m suggesting to their parents that LITHIA may help their child.”
Your “Lithia” product is not generally recognized as safe and effective for the above referenced uses and, therefore, the product is a “new drug” as defined by section 201(p) of the Act [21 U.S.C. 321(p)]. New drugs may not be legally marketed in the U.S. without prior approval from FDA as described in section 505(a) of the Act [21 U.S.C. 355(a)]. FDA approves a new drug on the basis of scientific data submitted by a drug sponsor to demonstrate that the drug is safe and effective. Further, your product is offered for conditions that are not amenable to self-diagnosis and treatment by individuals who are not medical practitioners; therefore, adequate directions cannot be written so that a layperson can use these drugs safely for their intended uses. Therefore, this product is misbranded within the meaning of section 502(f)(1) of the Act [21 U.S.C. 352(f)(1)], in that the labeling fails to bear adequate directions for use. The introduction of a misbranded drug into interstate commerce is a violation of section 301(a) of the Act [21 U.S.C. 331(a)].
This letter is not intended to be an all-inclusive list of violations in connection with your product and its labeling. You are responsible for ensuring that your firm is operating in compliance with all requirements of the Act and applicable FDA regulations, such as the food additive regulations (21 CFR Parts 170-180), the regulations for processing and bottling of bottled drinking water (21 CFR Part 129), and the standards for bottled water (21 CFR 165.110). You should take prompt action to correct all of the violations noted in this letter and prevent their future recurrence. Failure to do so may result in FDA taking regulatory action against your firm, such as seizure or injunction, without further notice.
Although you characterize your “Lithia” product as a “dietary supplement” on the principal display panel of the product label, numerous other statements in your product labeling describing “Lithia” as “water” or “mineral water,” the use of a Nutrition Facts panel on the product label, and the serving size, appearance, and packaging of the product, as well as the intended goods and services declaration (“Lithia water; Mineral water”) in the trademark application for the use of the mark "Lithia, Since 1888" (see U.S. Patent and Trademark Office documents posted on the Internet at http://tdr.uspto.gov/search.action?sn=85006189# ) all establish that your “Lithia” product is represented for use as a conventional food: namely, the beverage “bottled water” or “mineral water” (see 21 CFR 165.110(a)). Therefore, “Lithia” does not meet the definition of a dietary supplement and may not be marketed as such. See section 201(ff)(2)(B) of the Act (21 U.S.C. 321(ff)(2)(B)). We also note that, under the Act, any substance added to a conventional food, such as your “Lithia” product, must be used in accordance with a food additive regulation approving the substance for such use, unless the substance is the subject of a prior sanction or is generally recognized as safe (GRAS) among qualified experts for its use in foods (21 CFR 170.30(g)). The addition of a substance that is not the subject of a prior sanction, is not GRAS for its intended use, and is not used in accordance with a food additive regulation causes the food to which the substance is added to be adulterated under section 402(a)(2)(C) of the Act (21 U.S.C. 342(a)(2)(C)). Adulterated foods cannot be legally marketed in the United States.
The label for your “Lithia” product states that “actively charged ionic colloidal silver 2 PB” is added to the product. Please clarify whether “actively charged ionic colloidal silver 2 PB” indicates that silver ion (Ag+) or elemental silver (Ag) is present in your finished product. In addition, please provide the concentration of silver in the final product as intended to be consumed, and describe the intended functional effect of the “actively charged ionic colloidal silver” in the finished product. “Actively charged ionic colloidal silver” is not approved as a food additive or prior sanctioned for use in mineral water, and the basis on which you may have concluded that it is GRAS for such use is not clear. Please provide your basis for concluding that “actively charged ionic colloidal silver” is GRAS for use in mineral water, including supporting data or other documentation.
Please respond to this office in writing within fifteen (15) working days from your receipt of this letter. In your response, identify the steps you have taken or will take to correct the above noted violations and prevent similar violations in the future. Include any documentation necessary to show that correction has been achieved. If you are unable to complete the corrective actions within fifteen (15) working days, state the reason for the delay and the time within which you will complete the corrections. Please include in your response the information requested above regarding “actively charged ionic colloidal silver 2 PB,” along with any supporting data or other documentation.
Your written response should be sent to the U.S. Food and Drug Administration, Attn: Lakisha N. Morton, Compliance Officer, at the address noted in the letterhead. If you have any questions, please contact Mrs. Morton at 404-253-1285.
John R. Gridley