By Stephen Daniells Nutra Ingredients USA
The US Food and Drug Administration has filed for a permanent injunction against a Pennsylvania dietary supplement manufacturer as the agency turns the GMP compliance screw.
The injunction – the first of its kind against a dietary supplement manufacturer of this size for failure to comply with cGMP (current Good Manufacturing Practice) – would stop the defendants ATF Fitness Products Inc. from making and distributing more than 400 products for being in 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 cGMP requirements the law establishes.”
The injunction was filed by the US Department of Justice on behalf of the FDA against ATF Fitness Products Inc. (ATF), Manufacturing ATF Dedicated Excellence, Inc. (MADE), and James G. Vercellotti of Oakmont, Pa., owner and operator of both companies.
MADE reportedly manufactures over 400 dietary supplements, which are purchased by ATF for distribution throughout the US.
ATF received two warning letters in 2004, one for the labeling and/or promoting of a dietary supplement that contained androstenedione as an ingredient, and the second for “dietary supplement products that are labeled to contain materials that are sources of ephedrine alkaloids”.
This was followed by a seizure by US Marshals in 2006 of ATF’s Lipodrene dietary supplement were said to contain ephedrine alkaloids.
On November 23, 2011, the government filed a complaint in the US District Court for the Western District of Pennsylvania, alleging 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.
Indeed, 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.