The U.S. Food and Drug Administration (FDA) just announced that it is planning on shutting down a Pennsylvania dietary supplement maker. This is, said the agency, the first permanent injunction of its kind and that this move affects over 400 products.
The FDA said it took legal action against ATF Fitness Products Inc. (ATF); Manufacturing ATF Dedicated Excellence, Inc. (MADE); and James G. Vercellotti of Oakmont, Pennsylvania, the owner and operator of both companies. The action was taken because the supplement maker and owner substituted ingredients and products without noting the changes on final product labels.
MADE makes more than 400 dietary supplements, including vitamins and minerals, under a number of brands such as “Sci-Fit,” “Nature’s Science,” and “For Store Only.” ATF purchases dietary supplements made exclusively by MADE, distributing them throughout the United States.
The permanent injunction, which was filed on behalf of the FDA by the U.S. Department of Justice (DOJ), would stop the defendants from making and distributing more than 400 products that violate the Federal Food, Drug, and Cosmetic Act.
This is the first time FDA has taken legal action against a dietary supplement manufacturer of this size for its failure to comply with the dietary supplement current Good Manufacturing Practice (cGMP) regulations.
The cGMPs for dietary supplements was put into effect in 2007 in a so-called “stepped process” that is derived by company size. Based on the stepped process, this company’s compliance date went into effect in 2010; the firm did not meet relevant cGMP requirements after that date, as it was mandated.
cGMP regulations require manufacturers ensure quality in their dietary supplements by controlling all process and procedure aspects.
“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 cGMP requirements the law establishes,” Corrigan added.
The government’s complaint—filed on November 23, 2011, 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 neglected to report serious adverse events associated with their products.
Specifically, in one case, an individual who consumed one of the products reported experiencing a spike in blood pressure, required hospitalization, and suffered a subsequent mild heart attack.