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 Triceutical Inc. and its president, Liqun Zhang, of Farmingdale, New York, to prevent the distribution of adulterated dietary supplements.
According to a complaint filed last month, 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 Triceutical’s manufacturing facility in Farmingdale, which revealed, among other things, that Triceutical failed to ensure that components, dietary supplements, packaging and labels were not mixed up, contaminated or deteriorated.
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 the defendants wish to resume manufacturing dietary supplements in the future, the FDA first must determine that Triceutical’s manufacturing practices have come into compliance with the law. The consent decree was filed with the complaint in June and docketed yesterday.
Triceutical was the manufacturer of Joint King dietary supplement, which was found to contain high levels of Vitamin D. A consumer of Joint King experienced headache, confusion and kidney failure resulting in hospitalization due to Vitamin D toxicity.
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, filed this case on behalf of the United States.