Regeneca Shutting Down

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Regeneca Worldwide has been ordered to cease operations by the Department of Justice, which filed a consent decree of permanent injunction against the company and its CEO, Matthew Nicosia, alleging that they violated the Federal Food, Drug and Cosmetic Act (FDCA) by manufacturing and distributing RegeneSlim Appetite Control, which contained the additive dimethylamylamine (DMAA), and failing to disclose the presence of DMAA on product packaging. The DOJ complaint filed in November 2015 also alleged that Nicosia and Regeneca Worldwide violated the FDCA by marketing RegeneSlim as a cure, mitigation, treatment or prevention of disease.

DMAA, also known as methylhexanamine or geranium extract, is a stimulant considered by the FDA to be a health risk to consumers, especially if combined with caffeine and other ingredients. In 2012, the FDA sent Nicosia a warning letter telling him to stop selling RegeneSlim products containing DMAA. The company recalled RegeneSlim in 2014. However, inspections of Regeneca's manufacturing operations uncovered repeated violations of the FDCA and in November 2015, the Department of Justice filed the complaint that prompted the consent decree.

Regeneca agreed to adhere to the consent decree and shut down its operations to settle the litigation. If it seeks to reopen in the future, the company must prove to the FDA that its manufacturing processes are in compliance with the law. The settlement is pending judicial approval.