Dietary supplement maker Regeneca Worldwide is conducting a voluntary nationwide recall of its RegeneSlim appetite control dietary supplement after an analysis by the Food and Drug Administration (FDA) confirmed the presence of the illegal ingredient DMAA.
DMAA, an amphetamine derivative, also known as 1,3-dimethylamylamine, methylhexanamine, or geranium extract, is a commonly used stimulant ingredient in pre-workout and weight-loss dietary supplements. The FDA has previously warned that DMAA is potentially dangerous to health.
It can narrow blood vessels and arteries, causing a rise in blood pressure or other cardiovascular problems, including shortness of breath, arrhythmias, tightening in the chest, and heart attack. In addition, it can adversely interact with medications the supplement user may be taking.
In 2013 the FDA said that supplements containing DMAA are illegal and the agency is doing “everything within its authority” to remove these products from the market.
For many years DMAA was an approved drug for nasal decongestion
For many years DMAA was an approved drug for nasal decongestion, but approval was withdrawn in 1983 and the FDA says DMAA currently has no recognized medical use.
In the United States and Puerto Rico, RegeneSlim is available through a direct sales force and it is sold online, according to the FDA. The recalled RegeneSlim is from lot numbers EX0616R15814 and 11414RE5516. To date, the FDA says, there have been no reports of illnesses. Regeneca is a division of VivaCeuticals, Inc., Las Vegas, Nevada.
Consumers who have RegeneSlim from affected lots should stop using the product and return it to the place of purchase for exchange. For questions to Regeneca, call 1.949.281.2600 from 9 a.m. to 6 p.m. Pacific Time.
Any user who experiences problems that may be linked to RegeneSlim use should contact a physician or health care provider.
The FDA encourages consumers and health care providers to report adverse reactions or quality problems with RegeneSlim through the MedWatch Adverse Event Reporting program: www.fda.gov/medwatch/report.htm.