VivaCeuticals Inc., doing business as Regeneca Worldwide, and its owner Matthew A. Nicosia, a distributor of dietary supplements, have been ordered by a federal court to stop selling its products because they were found to contain dangerous ingredients including 1, 3-dimethylamylamine (DMAA).
U.S. District Judge Josephine L. Staton for the Central District of California entered a consent decree of permanent injunction against the parties based on a complaint, filed by the U.S. Department of Justice on behalf of the Food and Drug Administration (FDA), that Regeneca Worldwide was unlawfully distributing unapproved new drugs, and adulterated and misbranded dietary supplements.
DMAA is an amphetamine derivative that has been widely used in sports supplements sold in the U.S. It is often promoted as a “natural” supplement for bodybuilding, athletic performance, and weight loss. DMAA was at one time an approved drug for nasal decongestion, but the drug is no longer recognized as having any medical benefit.
DMAA narrows blood vessels and arteries, which can cause blood pressure to elevate and may lead to cardiovascular problems including shortness of breath, arrhythmias, tightening in the chest, and heart attacks. It may also cause seizures and other neurological and psychological conditions.
In August 2012, the FDA sent Regeneca a warning letter over its marketing of dietary supplements containing DMAA. Despite the company’s assurances that it was correcting the violations, it continued to distribute dietary supplements containing DMAA.
Under the consent decree, Regeneca is prohibited from marketing unapproved new drugs and adulterated and misbranded dietary supplements. Before the company can resume operations, it must hire good manufacturing practice and labeling experts, implement procedures to comply with good manufacturing practice and labeling requirements, and receive written permission from the FDA. The decree also requires Regeneca to destroy all remaining products.
“Consumers have a right to expect safe dietary supplements,” said Melinda Plaisier, the FDA’s associate commissioner for regulatory affairs. “When a company continues to defraud and deceive consumers, risking public health, we will take action to protect the American public.”
Source: FDA News Release