The Department of Justice filed a complaint in the U.S. District Court for the Central District of California seeking a permanent injunction against VivaCeuticals Inc., doing business as Regeneca Worldwide, and its CEO Matthew A. Nicosia, to prevent violations of the Federal Food, Drug and Cosmetic Act (FDCA). Defendants have agreed to cease all operations as part of a settlement with the Department.
According to the complaint, which was filed by the Department of Justice's Consumer Protection Branch, 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 alleges that the defendants violated the FDCA by manufacturing and distributing a product called RegeneSlim Appetite Control (RegeneSlim), 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 government's enforcement action resulted from a series of U.S. Food and Drug Administration (FDA) inspections of the defendants' manufacturing facility that found recurring FDCA violations of the same nature as those alleged in the complaint, and which the defendants failed to correct 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.”
In conjunction with the filing of the complaint, 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 judicial approval.
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.
For more information about the Consumer Protection Branch and its enforcement efforts, visit its website at http://www.justice.gov/civil/consumer-protection-branch.
Company Failed to Follow Good Manufacturing Practices and Distributed Dietary Supplements Containing the Unsafe Food Additive “DMAA”
Civil Division Topic: Consumer ProtectionUpdated January 18, 2017
Central District of California DOJ/ 17-087 / January 18, 2017