FDA orders dietary supplement distributor to stop selling products

United States District Judge Josephine L. Staton for the Central District of California issued a consent decree of permanent injunction with Regeneca Worldwide, a division of VivaCeuticals Inc., for unlawfully distributing unapproved new drugs and adulterated and misbranded dietary supplements, according to a press release issued by the FDA.

The distributor’s products were found to contain unsafe ingredients including 1, 3-dimethylamylamine – an amphetamine derivative often claimed to be a body-building aid, an athletic performance enhancer and a weight-loss aid, yet has no recognized medical use. Use of dimethylamylamine narrows blood vessels and arteries, potentially causing several cardiovascular issues including elevated BP, shortness of breath, arrhythmias, tightening in the chest and myocardial infarction, in addition to seizures and other neurological and psychological conditions, according to the FDA.

“Consumers have a right to expect safe dietary supplements,” Melinda Plaisier, associate commissioner for regulatory affairs at the FDA, said in the release. “When a company continues to defraud and deceive consumers, risking public health, we will take action to protect the American public.”

The FDA sent a warning letter to Regeneca in August 2012 for marketing RegeneSlim, a dietary supplement containing dimethylamylamine, which was then recalled in August 2014. However, Regeneca continued to distribute a supplement made with dimethylamylamine even though it asserted that it would correct such violations, according to the FDA.

The consent decree requires that all of Regeneca’s products be destroyed. The company must hire manufacturing practice and labeling experts and fulfill labeling requirements, as well as obtain written FDA permission before it can resume operations, according to the FDA.

For more information:

http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm540858.htm

Disclosure: Healio Internal Medicine was not able to confirm relevant financial disclosures at the time of publication.