FDA Takes Legal Action Against Dietary Supplement Maker In Pennsylvania

Editor's Choice
Main Category: Regulatory Affairs / Drug Approvals
Also Included In: Litigation / Medical Malpractice;  Complementary Medicine / Alternative Medicine
Article Date: 28 Nov 2011 - 0:00 PST


The FDA has for the first time taken legal action against a dietary supplement manufacturer and owner, which has substituted ingredients and products and failed to note the changes on the final product labels. The U.S. Department of Justice, which filed the permanent injunction for the FDA, could prohibit the defendant from producing and distributing over 400 products for violating the Federal Food, Drug and Cosmetic Act.

It is the first time that the FDA is carrying out legal proceedings against a dietary supplement manufacturer of this size because of its failure to comply with the dietary supplement current Good Manufacturing Practice (cGMP) regulations, which require manufacturers to ensure quality in their dietary supplements by controlling all aspects of their processes and procedures. In 2007, the cGMPs came into effect for dietary supplements in a stepped process based on company size. The company did not meet the relevant cGMP requirements after 2010, when the its compliance date became effective.

Manufacturing ATF Dedicated Excellence, Inc. (MADE) produces over 400 dietary supplements, which include vitamins and minerals under the brands "Sci-Fit," "Nature's Science" and "For Store Only." MADE is the exclusive manufacturer of dietary supplements for ATF Fitness Products Inc. (ATF) which distributes the products all across the U.S.

The FDA has therefore requested a permanent injunction against ATF Fitness Products Inc. (ATF), Manufacturing ATF Dedicated Excellence, Inc. (MADE), and the owner and operator of both companies, Mr. James G. Vercellotti of Oakmont, Pa.

Dara Corrigan, associate commissioner for regulatory affairs commented:

"Dietary supplements have a significant role in the public's health. Today's injunction reinforces our commitment to ensuring that these supplements meet the cGMP requirements the law establishes."

On the 23rd November 2011, the government filed a complaint in the U.S. District Court for the Western District of Pennsylvania, raising allegations that in addition to "adulterating" and "misbranding" their final products, the manufacturer and owner of the companies did not report serious adverse events in connection to their products. One incident included an individual who consumed one of the products, which led to a spike in blood pressure, hospitalization and subsequently a mild heart attack.

Warning Letter, March 11, 2004
Warning Letter, November 19, 2004
Seizure, January 12, 2006

Written by Petra Rattue
Copyright: Medical News Today
Not to be reproduced without permission of Medical News Today

• Additional
• References
• Citations