Personal Injury Blog

FDA Takes Action against Dietary Supplement Maker for Health and Safety Violations

December 3rd, 2011
health and safety violations

health and safety violations

Scant federal scrutiny over the herbal and dietary supplement manufacturing industry is something that has concerned San Diego defective product attorneys.  For the first time, the Food and Drug Administration has taken legal action against a manufacturer for substituting ingredients in its supplements, and failing to mention the change in its labels, which is causing potential health and safety violations.

The company, Pennsylvania-based Manufacturing ATF Dedicated Excellence Inc. produces more than 400 dietary nutritional supplements under the brands For Store Only, Nature Science and Sc-Fit.  This company substituted ingredients in these products, and failed to mention the change in ingredients on its labeling.

The company along with ATF Fitness Products Inc,. the company that distributes all products produced by Manufacturing ATF Dedicated Excellence Inc. is now the target of a permanent injunction by the Food and Drug Administration.  The owner and operator of both companies is also mentioned in the injunction.  The injunction has been filed by the US Department of Justice on behalf of the Food and Drug Administration for violating in the Federal Food, Drug and Cosmetic Act.

The injunction was filed in November in the US District Court for the Western District of Pennsylvania.  According to the complaint, the manufacturer and owner of these 2 companies failed to report serious adverse events related to the use of their products.  In one incident, a person who consumed these products fell severely ill.  He suffered a spike in blood pressure and had a heart attack.

This is the first time that the agency has taken any legal action against a supplement manufacturer for violation of the current Good Manufacturing Practice regulations.  These regulations require that manufacturers ensure that their products are of high quality by monitoring and controlling all aspects of production.

The failure of the Food and Drug Administration to crack down on nutritional product manufacturers is worrisome to San Diego personal injury attorneys.  The thriving nutrition supplement industry is a billion-dollar one, and manufacturers have little trouble promoting products that promise the moon and more.  Unfortunately, the industry is not sufficiently regulated, and the Food and Drug Administration has limited authority to take action against companies that engage in spurious production practices.

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