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In Brief

Lithia mineral water pegged as new drug; FDA warns Parrillo on unverified CofAs; Takeda markets Tylenol in Japan; CSPI sues J&J/McNeil over Splenda health claims; Harkin reports on pending health care cuts; more news In Brief.

An FDA warning letter to Lithia Mineral Water Inc. says claims for the firm’s water make it a new drug. The July 20 letter details improper claims on Lithia’s website that say the water can lower cholesterol, help autistic children and “heal the brain.” Austell, Ga.-based Lithia also ran afoul of FDA’s stance on misbranded liquid dietary supplements, given that Lithia is labeled as a supplement but marketed as a conventional food Also see "FDA Should Not Judge A Liquid Supplement By Its Packaging - Stakeholders" - Pink Sheet, 8 February, 2010.. The agency notes that Lithia contains “actively charged ionic colloidal silver” and asks the company for evidence that the ingredient is generally recognized as safe. FDA in 1999 published a final rule establishing that all OTC drug products containing colloidal silver are misbranded Also see "Colloidal Silver Ingredients Not Safe, Effective In OTCs - FDA Final Rule" - Pink Sheet, 23 August, 1999..

Firms must confirm suppliers’ tests to verify the reliability of certificates of analysis before they can rely on CofAs to...

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