FDA links illegal DMAA to MI, arrhythmias
The FDA took aim at DMAA again, warning that the amphetamine derivative poses cardiovascular risks, including the potential for arrhythmias and MI. “Dietary supplements containing DMAA are illegal and FDA is doing everything within its authority to remove these products from the market,” according to the agency.
DMAA (1,3-dimethylamylamine, methylhexanamine) is sometimes described as a geranium extract that has been added to some dietary supplements and marketed as a “natural” stimulant. It has been used in sports supplements in the U.S. that purport to provide help with body-building, athletic performance and losing weight.
“FDA is not aware of any reliable science indicating that DMAA exists naturally in plants,” the agency warned.
Ingesting DMAA can elevate blood pressure and lead to cardiovascular problems; DMAA combined with caffeine or other ingredients may increase risks. As of April 11, FDA had received 86 reports from consumers and physicians of adverse events involving products containing DMAA, including psychiatric disorders, heart problems, nervous system disorders and death.
In 2012, the FDA sent warning letters to 10 companies that manufactured or distributed dietary supplements containing DMAA, informing them that marketing products with DMAA is illegal. It ordered them to remove products with DMAA from the market and reformulate their supplements without DMAA. Most companies agreed to stop marketing the supplements, according to the FDA, which is following up with manufacturers ensure they are complying with its warning.
“While FDA is working to get these products off the market, consumers should not buy or use any dietary supplement product containing DMAA,” it advised.
Product labels listing DMAA should include one of the following as an ingredient:
- 1,3-DMAA
- 1,3-Dimethylamylamine
- 1,3-Dimethylpentylamine
- 2-Amino-4-methylhexane
- 2-Hexanamine
- 4-Methyl-2-hexanamine
- 4-Methyl-2-hexylamine
- 4-methyl- (9CI)
- Dimethylamylamine
- Geranamine
- Methylhexanamine
- Methylhexanenamine