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Regulatory News In Brief

FTC/Garden of Life case continues; FDA deems ForMor in violation of GMPs; Kanebo faulted for pharmaceutical GMP failures; CytoSport settles litigation over Muscle Milk labeling; USPlabs’ carb claim canned in NAD review; FDA extends comment time on FSMA tracking pilots.

The Federal Trade Commission fails to convince a federal court that Garden of Life LLC violated an injunction through its supplement marketing as the U.S. Court of Appeals for the Eleventh Circuit affirms a lower court’s denial of an FTC motion regarding an alleged violation Also see "In Brief" - Pink Sheet, 18 June, 2012.. The appellate court’s April 15 decision supports a district court’s finding that the West Palm Beach, Fla., subsidiary of Atrium Innovations Inc.had competent and reliable scientific evidence in the form of a clinical pharmacologist’s expertise to back claims for the OceansKids supplement. However, the appeals court sided with FTC regarding misrepresentations of scientific evidence for GOL’s Grow Bone System calcium supplement, and remanded the question to the lower court to review. The company had claimed the product was associated with a 2.8% increase in bone mineral density in six months when data showed it was over a 12-month period.

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