A month after Regeneca Worldwide, a division of VivaCeuticals Inc., was ordered by a federal court to stop selling dietary supplements because they contained a dangerous ingredient, the company announced it was issuing a nationwide recall of its entire line of herbal and dietary supplements.
The recall affects all lots of the company’s brand name products, which include RegeneSlim, RegenErect, RegeneArouse, RegeneBlend, RegeneBoost, RegeneBlast and RegeneFit. The supplements were sold nationwide online through the company’s websites, and through a direct sales force within the U.S. and Puerto Rico for both consumption and retail sales.
Due to the consent decree entered by the federal court for the Central District of California, the company has stopped doing business in the U.S.
Last month, U.S. District Judge Josephine L. Staton entered the consent decree of permanent injunction based on a complaint filed by the U.S. Department of Justice on behalf of the Food and Drug Administration (FDA), that alleged Regeneca Worldwide was unlawfully distributing unapproved new drugs, and adulterated and misbranded dietary supplements.
Laboratory analysis determined that some of the products contained 1,3-dimethylamylamine, or DMAA, an amphetamine derivative 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 it is no longer recognized as having any medical benefit. In fact, it can cause harm to consumers.
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 other neurological and psychological conditions.
In August 2012, the FDA warned Regeneca to stop marketing dietary supplements containing DMAA, and while the company assured the agency that it was correcting the violations, it continued to distribute dietary supplements containing DMAA.
Consumers who have purchased Regeneca products affected by this recall are advised to stop using them immediately and return it to the place of purchase for a possible exchange. Any adverse events related to use of these dietary supplements should be reported to the FDA MedWatch Adverse Event Reporting Program at www.FDA.gov/MedWatch/Report.htm.