Feds Force Misbranded Dietary Supplement Off the Market

By Paul Gaita 01/25/17

The makers of RegeneSlim are shutting their doors as part of a lawsuit settlement. 

Pile of pills and bottle of supplements.

A Nevada-based dietary supplement manufacturer has been ordered to cease operations by the Department of Justice (DOJ), which claims the company's product contains a stimulant that can pose a serious health risk.

In the consent decree, Regeneca Worldwide (also known as VivaCeuticals) and its CEO, Matthew A. Nicosia, are alleged to have violated the Federal Food, Drug and Cosmetic Act (FDCA) by manufacturing and distributing a product called RegeneSlim Appetite Control which contained dimethylamylamine (DMAA), while failing to acknowledge the presence of the additive in the product's packaging.

The DOJ also alleged that the defendants further violated FDCA regulations by marketing the product as a cure or treatment for disease.

Regeneca Worldwide agreed to settle the litigation by adhering to the consent decree and stopping all operations. If the company seeks to revive its business in the future, it must prove to the Food and Drug Administration (FDA) that its manufacturing processes are in compliance with the law. The proposed settlement is currently awaiting judicial approval.

Regeneca's problems with the federal government stem back to 2012, when the FDA sent a warning letter to CEO Nicosia telling him to cease distribution of RegeneSlim products containing DMAA. In 2014, the company voluntarily recalled RegeneSlim after it was determined that DMAA was present.

But inspections of Regeneca's operations revealed recurring violations of the FDCA, despite previous warnings issued by the FDA. In November 2015, the Consumer Protection Branch of the DOJ filed a complaint, which prompted the proposed consent decree.

In a statement issued by the DOJ on January 18, Principal Deputy Assistant Attorney General Benjamin C. Mizer said, "When dietary supplement manufacturers place unsafe and undisclosed ingredients in their products and disregard CGMP (current good manufacturing practices) regulations, they put the public health at risk. The Department of Justice will continue to work closely with the FDA to prevent dietary supplement manufacturers from jeopardizing public health."

DMAA, which is also known as methylhexanamine or geranium extract, has been marketed as a "natural stimulant" in some dietary supplements. The additive is considered by the FDA to be a health risk to consumers, especially in combination with caffeine and other ingredients. DMAA may cause elevated blood pressure, and the adverse effects attributed to DMAA include shortness of breath, arrhythmia, heart attack, seizures, neurological or psychological problems and even death.

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Paul Gaita lives in Los Angeles. He has contributed to the Los Angeles Times, Variety, LA Weekly, Amazon.com and The Los Angeles Beat, among many other publications and websites.