A dietary supplement manufacturer that was sued more than a year ago by the U.S. Department of Justice (DOJ) as part of a sweep of civil cases against the industry has agreed to cease operations under a settlement with the government.
VivaCeuticals Inc., doing business as Regeneca Worldwide in Irvine, California, has entered a consent decree of permanent injunction with the DOJ. The company cannot resume the manufacturing of drugs or dietary supplements unless FDA determines its manufacturing practices have come into compliance with the law, according to a Jan. 18 DOJ news release.
The consent decree is awaiting judicial approval, DOJ said.
In a lawsuit filed in the U.S. District Court for the Central District of California, U.S. prosecutors alleged the company failed to produce dietary supplements in accordance with FDA’s cGMPs (current Good Manufacturing Practices). The complaint cited several cGMP violations during a 2014 inspection of the firm’s facility, including a failure to establish product specifications.
Federal prosecutors also contended the defendantswho included the company’s CEO Matthew A. Nicosiamanufactured and distributed a product (RegeneSlim Appetite Control) that contained 1, 3 dimethylamylamine (DMAA), an unsafe food additive, in violation of the Federal Food, Drug & Cosmetic Act (FDCA). In the complaint, the DOJ further alleged the defendants marketed RegeneSlim to be used as a cure, mitigation, treatment or prevention of a disease, rendering the product an unapproved and misbranded drug, since dietary supplements aren’t approved by FDA to treat diseases.
“When dietary supplement manufacturers place unsafe and undisclosed ingredients in their products and disregard CGMP regulations, they put the public health at risk," said Principal Deputy Assistant Attorney General Benjamin C. Mizer, head of the Justice Department’s Civil Division, in a statement. “The Department of Justice will continue to work closely with the FDA to prevent dietary supplement manufacturers from jeopardizing public health."
In November 2015, the DOJ announced the filing of the lawsuit as part of a nationwide sweep of civil and criminal cases against unlawful activity in the dietary supplement industry.
Regeneca Worldwide did not respond late Thursday to a request for comment.