Dietary Supplement Distributor Reprimanded for Selling DMAA-Containing Products

Regeneca Worldwide, a California dietary supplement distributor, has been ordered to stop selling their products, FDA officials announced today. The company had been distributing products that were found to contain harmful ingredients such as 1, 3-dimethylamylamylamine (DMAA).

According to the press release, a federal court judge in California approved a consent decree of permanent injunction between the United States and Regeneca Worldwide and its owner, Matthew Nicosia, that was filed by the US Department of Justice and the FDA. The complaint contended that Regeneca Worldwide had been unlawfully distributing unapproved new drugs, and adulterated and misbranded their products.

“Consumers have a right to expect safe dietary supplements,” Melinda Plaisier, the FDA’s associate commissioner for regulatory affairs, said in the press release.

The approved consent decree prohibits Regeneca from continuing to market DMAA-containing and unapproved drugs. Regeneca must also adhere to several safety practices such as hiring good manufacturing practice and labeling experts, implementing procedures to comply with manufacturing practices and labeling requirements, and receiving FDA permission to resume selling products. Additionally, the company has been ordered to destroy all remaining products.

The FDA sent the company a warning letter in 2012 for marketing a dietary supplement containing DMAA, and Regeneca agreed to correct the violations. However, the company continued to distribute supplements containing the unsafe ingredients.

Reference

Federal judge approves consent decree with California dietary supplement distributor, Regeneca Worldwide [news release]. FDA’s website. http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm540858.htm. Accessed Feb. 9, 2017.