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 identify dietary supplement components, FDA warns Parrillo Performance in a...

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