A federal judge has ordered Regeneca Worldwide, a California dietary supplement distributor, to stop selling its products that were found to contain harmful ingredients including 1,3-dimethylamylamine (DMAA).
Regeneca was first served a warning letter in August 2012 by the FDA for marketing a dietary supplement containing DMAA. After assuring corrective action, the Company continued to distribute a DMAA-containing dietary supplement.
District Judge Staton for the Central District of California entered a consent decree of permanent injunction between the United States and VivaCeuticals, Inc. (doing business as Regeneca Worldwide). The complaint was filed on behalf of the Food and Drug Administration (FDA) against Regeneca Worldwide for illegally distributing unapproved new drugs and adulterated and misbranded dietary supplements.
This consent decree prohibits Regeneca from marketing unapproved new drugs, and adulterated and misbranded dietary supplements. The Company must hire good manufacturing practices and labeling experts, implement procedures to comply with good manufacturing practice and labeling requirements, and receive written permission from the FDA in order to resume operations. Regeneca is also required to destroy all remaining inventory.
DMAA, an amphetamine derivative, has been commonly used in sports supplements. It has claimed uses in aiding body building, enhancing athletic performance, and aiding weight loss. DMAA was previously approved as a nasal decongestant but no medical use of DMAA is acknowledged today.
DMAA constricts blood vessels an arteries, leading to increased blood pressure and cardiovascular problems such as shortness of breath, arrhythmias, chest tightening, heart attack, as well as seizures, and other neuropsychological conditions.
For more information visit FDA.gov.