Dietary Supplement Manufacturer Barred from Operating for Violating cGMPs

WASHINGTON--A company that made a dietary supplement containing high levels of Vitamin D has been permanently enjoined from operating, federal authorities announced last week.

In the U.S. District Court for the Eastern District of New York, a consent decree of permanent injunction was entered against Triceutical Inc. and its president, Liqun Zhang, of Farmingdale, New York, the U.S. Justice Department said.

The government alleged in a lawsuit filed last month that Triceutical manufactured and distributed “adulterated" supplements in violation of the Federal, Food, Drug, and Cosmetic Act (FDCA). The Justice Department said Triceutical manufactured a dietary supplement (Joint King) that contained high levels of Vitamin D, leaving one consumer with confusion, a headache and kidney failure resulting in hospitalization.

“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," the Justice Department stated in a July 9 news release.

In a separate release announcing the consent decree, FDA said it issued a warning letter to Triceutical in 2012 for violating cGMPs (current Good Manufacturing Practices), including failure to test to verify the identity of dietary ingredients. 

“Follow-up inspections by FDA revealed that Triceutical failed to take adequate corrective actions to correct that violation and to ensure the manufacturing process complied with cGMP requirements," FDA stated. “Failure to follow cGMP requirements made Triceutical’s products adulterated under the Federal Food, Drug, and Cosmetic Act."

Under a consent decree that was filed with the complaint in June, Triceutical cannot resume operations unless FDA finds the company’s manufacturing practices are in compliance with the law. FDA said the company also must retain an outside auditor to determine whether the company continues to comply with cGMPs.

The company did not respond to a request for comment on the consent decree.