The U.S. Food and Drug Administration (FDA) has taken legal action to stop a supplement manufacturer from making and selling more than 400 different supplement products because it has failed to comply with quality assurance regulations and did not report a heart attack associated with one of its products.
On behalf of the FDA, the U.S. Department of Justice has filed a permanent injunction in the U.S. District Court for the Western District of Pennsylvania against James G. Vercellotti of Oakmont, PA and his two companies, Manufacturing ATF Dedicated Excellence, Inc. (MADE) and ATF Fitness Products Inc. (ATF).
MADE manufactures more than 400 dietary supplement products with the brand names “Sci-Fit,” “Nature’s Science” and “For Store Only.” AFT then buys and distributes those products across the nation.
The FDA alleges that MADE failed to comply with current Good Manufacturing Practices (cGMP) regulations by “adulterating” and “misbranding” their final products.
Post-gazett.com reports that the FDA inspected MADE’s manufacturing facility in March and April and found the manufacturer did not clean and sanitize its production equipment. MADE also failed to check the uniformity of its products through sampling and testing. In some cases, it substituted ingredients listed on the label with other non-listed ingredients.
A person who took one of MADE’s products experienced high blood pressure, hospitalization and then suffered a mild heart attack. The company and its owner failed to report the incident to the FDA.
“Dietary supplements have a significant role in the public’s health,” Dara Corrigan, associate commissioner for regulatory affairs, said in a release. “Today’s injunction reinforces our commitment to ensuring that these supplements meet the cGMP requirements the law establishes.”