The Justice Department announced today that the U.S. District Court for the Eastern District of New York has entered a consent decree of permanent injunction against Applied Polymer Systems dba APS Pharmaco (APS) and its president, Nuka Reddy, all of Lindenhurst, New York, to prevent the distribution of adulterated dietary supplements.
According to a complaint filed July 21, the defendants violated the Federal Food, Drug, and Cosmetic Act (FDCA) by manufacturing and distributing dietary supplements that were adulterated. Under the FDCA, dietary supplement manufacturers are required to have systems in place to ensure that their products meet specifications for identity, purity, strength and composition. The government’s actions resulted from a series of inspections of APS’ manufacturing facility beginning in 2012, which revealed, among other things, that APS failed to perform identity tests or examinations for certain dietary ingredients before using them in their products.
In conjunction with the filing of the complaint, the defendants agreed to settle the litigation and be bound by a consent decree of permanent injunction that prohibits them from committing violations of the FDCA. The consent decree requires the dietary supplement manufacturer to cease all operations and requires that if they wish to resume manufacturing dietary supplements in the future, the FDA first must determine that APS’ manufacturing practices have come into compliance with the law. The consent decree also requires a recall of all products sold since Jan. 1, 2014. The consent decree was filed with the complaint and was docketed on July 23.
The FDA referred this matter to the Department of Justice. The Consumer Protection Branch of the Justice Department’s Civil Division, together with the U.S. Attorney’s Office for the Eastern District of New York, brought this case on behalf of the United States.