FDA Tries To Shut Dietary Supplement Maker

FDA Tries To Shut Dietary Supplement Maker

November 29th, 2011 // 1:37 pm @

On the eve of the Thanksgiving holiday in the US, the FDA waded into the controversy over dietary supplement makers by filing a permanent injunction against a manufacturer, ATF Fitness Products and two related entities, for substituting ingredients and products without noting any changes on final product labeling.

The move would stop ATF and its owner from making and distributing more than 400 products that allegedly violate the Federal Food, Drug, and Cosmetic Act. This is the first time the FDA has taken such legal action against a dietary supplement manufacturer of this size for failing to comply with Good Manufacturing Practice regulations for dietary supplements, which went into effect in 2007 (back story).

Those rules require dietary supplement makers to conduct tests to confirm the identity of all ingredients used in their products, but ATF and its related entities were not in compliance. An outside consultant identified 76 GMP deviations that were deemed ’significant’ during an early 2010 review, and many of these were subsequently cited by the FDA in an inspection last spring.In fact, ATF has a history of violations. The FDA issued warning letters back in 2004, leading to seizures.

Meanwhile, the FDA also charges that ATF never filed or investigated serious adverse event reports. In one case, an individual who took ‘Kreation Powder’ last year reported a spike in blood pressure, hospitalization and a mild heart attack, according to the complaint filed in federal court by the FDA (you can read that right here). Among the various vitamin and mineral brands made and sold by ATF are ‘Sci-Fit,’ ‘Nature’s Science’ and ‘For Store Only.’

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