The U.S. Department of Justice announced Wednesday that an Irvine company agreed to cease operations as part of a settlement of a lawsuit alleging the firm distributed adulterated and misbranded dietary supplements in violation of federal law.
The complaint, filed last year in Santa Ana federal court, sought a permanent injunction against VivaCeuticals Inc., doing business as Regeneca Worldwide, and CEO Matthew A. Nicosia to prevent alleged violations of the Federal Food, Drug and Cosmetic Act.
According to the complaint, the defendants failed to manufacture dietary supplements in accordance with current regulations.
The complaint also alleged that the defendants illegally manufactured and distributed a product called RegeneSlim Appetite Control, which contained the unsafe food additive DMAA, and failed to disclose the presence of the amphetamine-like stimulant in RegeneSlim’s labeling.
The complaint further alleged that the defendants violated the FDCA by marketing RegeneSlim to be used in the cure, mitigation, treatment or prevention of disease, thereby causing RegeneSlim to be an unapproved new drug and a misbranded drug.
The government’s enforcement action resulted from a series of U.S. Food and Drug Administration inspections of VivaCeuticals’ manufacturing facility that found recurring violations of the same nature as those alleged in the complaint, and which the defendants failed to correct despite warnings, according to the DOJ.
“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 DOJ’s civil division.
The defendants agreed to settle the litigation through a consent decree that permanently prohibits them from committing violations of the FDCA, according to the DOJ.
The consent decree requires the defendants to cease all operations, and requires that if the defendants wish to resume manufacturing dietary supplements or drugs in the future, the FDA first must determine that their manufacturing practices have come into compliance with the law.
The decree is awaiting approval by a judge in Santa Ana federal court.
–City News Service