FDA: Mineral Water is not a Supplement

ATLANTAIf a product is marketed as mineral water, it is considered a conventional food and all of its ingredients must be GRAS (generally recognized as safe), FDA said in a warning letter to Lithia Mineral Water Inc.'s CEO Ian S. Simpson. FDA took issue with how Lithia marketed its product on labels and online.

FDA inspected Lithia Mineral Water's Austell, GA, facility on Oct. 18 to 25, 2011, and found the company's Lithia mineral water product was called a supplement on the product label while resembling a functional food. FDA also reviewed the company website lithiamineralwater.com and found drug claims, according to the warning letter. FDA said the product was promoted for use in the diagnosis, cure, mitigation, treatment or prevention of disease, which violates the Federal Food, Drug and Cosmetic Act (FFDC).

Beverage or Supplement?

Lithia labels call the product a "dietary supplement," yet FDA noted other statements describe it as "water." Also, the product carries a Nutrition Facts panel, and has a serving size, appearance and packaging that suggests the product is not a supplement, but a beverage. FDA also pointed out Lithia's trademark documents also establish the product as a beverage. Because Lithia is a conventional  food, FDA said it cannot be marketed as a supplement.

And, because Lithia is a conventional food, its ingredients must be considered GRAS or be a food additive. FDA questioned the actively charged ionic colloidal silver 2 PB" that the label said is added to the product. The agency asked the company to clarify whether actively charged ionic colloidal silver 2 PB" indicates that the product contains silver ion or elemental silver. In addition, FDA requested that the company provide the concentration of silver in the product, and describe its intended effect. Actively charged ionic colloidal silver" is not approved as a food additive and has not been determined GRAS, FDA said. "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," FDA wrote.

Health Claims

FDA called out particular claims on lithiamineralwater.com that said the mineral water can help lower low-density lipoprotein (LDL) cholesterol, lower blood pressure, combat fungal and viral infections and "heal the brain by stimulating the growth of new brain cells." The website said the product helps people with "alcoholism, Alzheimers disease, depression, Parkinsons disease, stroke, cluster headaches, hangovers [sic] and traumatic brain injury." FDA also pointed to the statement, "Taking chemopreventive agents found in LITHIA may reduce your risk of cancer."

The company's website also highlighted a 1990 from an unspecified journal to support a claim about treatment of fibromyalgia and other diseases.  Personal testimonials on the website also contained disease claims related to rheumatism and autism.

FDA gave the company 15 working days to respond, identifying and documenting the steps the company will take to correct the violations and prevent similar violations in the future.

INSIDER's Take:

With previous warning letters, such as the one sent to Lazy Cakes in 2011, FDA has shown that it has a definition of what are foods and what are supplements. If a product looks like a food (or a beverage, as in this case), it must contain only ingredients that are considered GRAS or are food additives. Supplements and foods are regulated differently because consumer use is different; a consumer may drink a gallon of mineral water a day, but is unlikely to take supplements by the handful. Therefore, FDA has a higher safety barrier for foods than for supplements, and companies cannot get around those by labeling it as a supplement when it's not.

Per FFDCA, companies cannot claim supplements treat, prevent or mitigate diseases. This applies to website marketing, testimonials and even third-party research. Supplements are not drugs, and they cannot be promoted as such.