Pharmaceutical

Dietary supplement maker shut down by DOJ for violations

dietary supplements pills probiotics Dietary supplement maker shut down by DOJ for violationsVitaCeuticals Inc., doing business as Regeneca Worldwide in Irvine, California, has agreed to cease operations under an agreement with the U.S. Department of Justice (DOJ). According to the consent decree, the company cannot resume manufacturing of drugs or dietary supplements until the Food and Drug Administration (FDA) deems its manufacturing practices are in compliance with the law.

The lawsuit, filed in the U.S. District Court for the Central District of California, claimed the company was producing dietary supplements that did not meet the FDA’s current Good Manufacturing Practices (cGMP) based on several violations identified during a 2014 inspection of the company’s manufacturing plant.

Federal prosecutors also alleged VitaCeuticals and its CEO, Matthew A.Nicosia, were manufacturing and distributing a product called RegeneSlim Appetite Control that contained a dangerous ingredient, 1,3 diemthylamylamin, or DMAA, which is in violation of the Federal Food, Drug & Cosmetic Act. Prosecutors also claimed that the company falsely claimed RegeneSlim was a cure, mitigation, treatment or prevention of a disease, rendering it an unapproved and misbranded drug.

The action against VitaCeuticals and Nicosia was part of a sweep of civil cases waged against dietary supplement manufacturers.

“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. “The Department of Justice will continue to work closely with the FDA to prevent dietary supplement manufacturers from jeopardizing public health.”

Source: DOJ