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SANTA ANA, California – The Department of Justice yesterday filed a consent decree in United States District Court that seeks a permanent injunction against the Irvine-based VivaCeuticals Inc. (doing business as Regeneca Worldwide) and its chief executive officer, Matthew A. Nicosia, to prevent violations of the Federal Food, Drug and Cosmetic Act (FDCA). As part of the settlement with the Justice Department, the defendants have agreed to cease all operations.
According to a civil complaint filed in late 2015, the defendants violated the FDCA by failing to manufacture dietary supplements in accordance with the FDA’s current good manufacturing practice (CGMP) regulations. The complaint also alleged that the defendants violated the FDCA by manufacturing and distributing a product called RegeneSlim Appetite Control, which contained the unsafe food additive 1, 3 dimethylamylamine (DMAA), and failing to disclose the presence of DMAA in RegeneSlim’s labeling. The complaint further alleges 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 defendants agreed to settle the litigation through a consent decree that would permanently prohibit them from committing violations of the FDCA. 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 the defendants’ manufacturing practices have come into compliance with the law. The proposed decree is currently awaiting approval by United States District Judge Josephine L. Staton.
The government’s enforcement action resulted from a series of inspections by the United States Food and Drug Administration of the defendants’ manufacturing facility that found recurring FDCA violations of the same nature as those alleged in the complaint. The defendants failed to correct these violations, despite FDA warnings.
“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.”
“This case involves unsafe supplements, some of which contained DMAA, which can cause serious health problems, including the possibility of a heart attack,” said United States Attorney Eileen M. Decker. “This company has a lengthy history of distributing drugs and dietary supplements in violation of the FDCA, but this settlement will ensure that this practice comes to an end.”
This matter was handled by Trial Attorneys Clint Narver and Monica Groat of the Civil Division’s Consumer Protection Branch, with assistance from Claudia Zuckerman of the FDA’s Office of the Chief Counsel.