Back in February, the US Food and Drug Administration, or FDA, announced that it had won its battle against VivaCeuticals Inc. Owned by Matthew A. Nicosia, and doing business as Regeneca Worldwide, the company stood accused of knowingly hawking weight loss supplements and other health products that were tainted with an amphetamine derivative.
A full month later, the company is finally announcing a recall of all Regeneca products.
Included in this recall are:
All production codes are covered in this recall.
In the press release announcing the recall the company admitted that the recall was the result of the Consent Degree. It also says that it is no longer doing business in the US.
If you have any Regeneca products on hand, even if they’re not on the above list, you are, of course urged not to use them. You can, the company says, return them to your place of purchase for what the company calls “a possible exchange”. There is no word on what kind of exchange you will be offered, in light of the company’s withdrawal from the US marketplace.
The fisticuffs between Regeneca and the FDA goes back to 2012, when the agency fired off an official warning to Matthew Nicosia about his RegeneSlim product. Although the weight loss supplement was clearly labeled as containing 1,3-dimethylpentylamine HCL, the FDA informed Nicosia that his supplement was still “adulterated” because that particular ingredient was not officially recognized as an allowed dietary supplement ingredient. Nicosia was told to immediately stop distributing RegeneSlim or face a possible court injunction and, potentially, even a raid and seizure of his business.
The FDA alleges that Regeneca promised to address the problems with its products but simply continued to distribute tainted supplements. Eventually the FDA sought an injunction against the company.
The consent degree announced last month would have required Regeneca to destroy all its existing inventory and then hire experts in labeling and good manufacturing practices to put the company onto a path of FDA compliance. Regeneca would have then needed to repetition the FDA for permission to resume distributing its supplements.
Instead, Nicosia apparently chose to close up shop.
Photo Credit: Screenshot of archived Regeneca.com captured March 14, 2017 by Lisa Barger.