July 25, 2012

Claim That DMAA Is Made From Flowers Doesn’t Smell So Sweet

Arlington, TX—Despite marketing claims that 1,3-dimethylamylamine (DMAA) is a natural supplement derived from geranium plants, a new study found it indistinguishable from synthetic versions of the compound.

“Eight different commercial geranium extracts of different geographical origins (China and the Middle East) were examined for the presence of DMAA by high-performance liquid chromatography coupled with mass spectrometry (HPLC-MS). No DMAA was detected in any of the eight geranium products with a limit of detection of 10 parts per billion (w/w),” the authors write in an early release article from the journal Drug Testing and Analysis.

DMAA, also known as 1-3 dimethylpentylamine or methylhexaneamine, is not regulated as a drug by the FDA because supplement manufacturers claimed it was a natural component of the geranium plant.

In April, the FDA sent warning letters to 10 manufacturers of the following products: Biorhythm SSIN Juice, LeanEfx, Spirodex, PWR, Napalm, Code Red, Hemo Rage Black, Lipo-6 Black Ultra Concentrate, Lipo-6 Black, Lipo-6 Black Hers Ultra Concentrate, Lipo-6 Black Hers, MethylHex 4, 2, Nitric Blast, Oxy Elite Pro, and Jack 3D.

FDA said it had received 42 adverse event reports on products containing DMAA, alleging that the supplement caused cardiac disorders, nervous system disorders, psychiatric disorders, and death.

Dimethylamylamine, also known as 1,3-dimethylamylamine, methylhexanamine, or geranium extract, is marketed as a natural stimulant, the FDA warning letters said, but no evidence has been presented to indicate that DMAA is safe. The Dietary Supplement Health and Education Act of 1994 (DSHEA) requires manufacturers, marketers, and distributors of dietary supplements to prove that they are marketing a safe product.

DMAA can narrow blood vessels and arteries, which can elevate blood pressure and potentially lead to cardiovascular events ranging in seriousness from shortness of breath and tightening in the chest to heart attack, according to the FDA letters.

Controversy about the supplements was fueled last year after two soldiers died of heart attacks during fitness training, and 1,3-dimethylamylamine was found in their toxicology reports. A number of class action lawsuits also have been filed.

Daniel W. Armstrong, who holds the Robert A. Welch Chair in Chemistry at the University of Texas Arlington, and colleagues sought to resolve any dispute about the origin of DMAA in supplement products. They analyzed two synthetic DMAA compounds obtained from different commercial sources, the DMAA concentration as well as components in 13 supplements obtained from three different retail sources, and eight geranium extracts from different regions of China and the Middle East.

Armstrong said that in supplements with significant added amounts of synthetic pharmacological compounds, “information should be clearly labeled, including their effects and possible side effects, so that consumers can make an informed choice.”

U.S. Pharmacist Social Connect