More than 400 dietary supplement products would be banned from the marketplace under an injunction being sought by the U.S. Food and Drug Administration (FDA).
Named in the action are ATF Fitness Products Inc. (ATF), Manufacturing ATF Dedicated Excellence, Inc. (MADE), and James G. Vercellotti of Oakmont, Pa., owner and operator of both companies.
The companies make more than 400 dietary supplements, including vitamins and minerals, under the brands “Sci-Fit,” “Nature’s Science” and “For Store Only.” ATF purchases dietary supplements exclusively from Vercellootti's companies and distributes them throughout the United States.
It's the first time FDA has taken legal action against a supplement manufacturer of this size.
The agency said the companies substituted ingredients and products without noting the changes on the final product labels. That would be a violation of the Federal Food, Drug, and Cosmetic Act.
“Dietary supplements have a significant role in the public’s health,” said Dara Corrigan, associate commissioner for regulatory affairs. “Today’s injunction reinforces our commitment to ensuring that these supplements meet the ... requirements the law establishes.”
The government's complaint, filed in the U.S. District Court for the Western District of Pennsylvania, alleges that in addition to “adulterating” and “misbranding” their final products, the manufacturer and its owner failed to report serious adverse events associated with their products.
In one case an individual who consumed one of the products reported experiencing a spike in blood pressure, hospitalization and a subsequent mild heart attack.
Val Gutka (Mon, 28 Nov 2011 10:08:11 +0000): It's all about the Benjamen's & placating the guys with the $$ to fill the pockets of law makers.