FDA Seeks First-of-Its-Kind Penalty for Firm Substituting Ingredients without Changing Labels

November 28, 2011

The agency also notes it’s the first time it has taken legal action against a dietary supplement manufacturer of this size for failing to comply with dietary supplement current Good Manufacturing Practices.

On November 23, FDA filed a permanent injunction against a dietary supplement company the agency says substituted ingredients and products, without making the appropriate corresponding changes to product labels.

The agency also notes it’s the first time it has taken legal action against a dietary supplement manufacturer of this size for failing to comply with dietary supplement current Good Manufacturing Practices (GMPs), which would ban these violations FDA deems as adulteration and misbranding of final products. (As of 2010, the company was responsible for meeting the cGMP requirements for firms with 20 or fewer employees.)

The permanent injunction seeks to stop the defendants from making and distributing more than 400 products. The defendants are named as ATF Fitness Products Inc., Manufacturing ATF Dedicated Excellence Inc., and their owner and operator James G. Vercellotti of Oakmont, PA. The firms manufacture and distribute more than 400 dietary supplements, including vitamins and minerals, under the brand names “Sci-Fit,” “Nature’s Science,” and “For Store Only.”