A DMAA scandal timeline

Forthane

In the late 1940s, drug maker Eli Lilly developed Forthane, a nasal decongestant featuring the vasoconstrictor methylhexaneamine (MHA), aka 1,3 dimethylamylamine (DMAA)—a synthetically-derived chemical similar in structure to ephedrine and amphetamine. The chemical is a vasoconstrictor with stimulant properties. The drug was first marketed in 1951, but quickly faded into obscurity and its patent later expired without renewal.

Ping

In 1996, a study (Ping, et al.) surfaced out of China in the Journal of Guizhou Institute of Technology which found that MHA—curiously mislabeled "hexaneamide" in the study—was a natural component of Pelargonium graveolens (geranium) oil, at a level of .66 percent. To date, the Ping study is the only existing published report linking MHA to geranium, though that may be about to change.

Geranimine

Nearly a decade after the Ping study, in 2005, Patrick Arnold—the infamous chemist behind androstenedione and Major League Baseball's BALCO scandal, and an apparent whiz at digging up defunct drug patents—trademarked MHA as Geranimine, selling it as a dietary ingredient in sports nutrition supplements through his company Proviant Technologies. Since then, the chemical has become common in pre-workout supplements for its stimulant effect.

WADA

DMAA/MHA received some national coverage in 2006 when the Washington Post interviewed leading anti-doping chemist Don Catlin of the Catlin Consortium. Catlin had studied the chemical and its vasoconstrictor effects and concluded that it was an unsafe stimulant and should be banned from the sports world. The World Anti-Doping Agency (WADA) didn't catch on, however, until 2009, when it placed the chemical on its 2010 banned substances list. Since its prohibition, DMAA/MHA has been the focus of dozens of doping scandals worldwide, affecting athletes of all disciplines from countries as diverse as Jamaica, England, Portugal, South Africa, South Korea, Greece, India and Australia. In fact, because of the ingredient's ubiquity in supplements worldwide, WADA's penalty for its use is more lenient than is typical.

"Sunrise"

In November 2009, New Zealand's government placed DMAA on its restricted substances list in response to a growing party pill epidemic. New Zealand's Ministry of Health tallied a number of adverse events related to recreational use of DMAA pills featuring such monikers as "Sunrise" and "Hummer." Later, in December 2010, the New Zealand Medical Journal reported the case of a man suffering a cerebral hemorrhage after taking two DMAA pills along with alcohol and caffeine.

AHPA

In the summer of 2011, the American Herbal Products Association (AHPA) added some clarity to the issue of nomenclature, prohibiting member companies from labeling DMAA or MHA as geranium on product labels as of January 3, 2012. The decree is a step forward, especially since professional athletes may be in the dark as to which name syncs up with the term on WADA's prohibited list. AHPA waffled a bit on recognizing DMAA as a natural ingredient, however, both ignoring and referencing the Ping study in separate press releases. Whether or not DMAA is natural is currently a point of contention, and will have an impact on FDA's stance going forward.

The lawsuits

A series of class action lawsuits leveled against DMAA supplement sellers also hit in 2011, with consumers taking issue with product labeling and safety. First, in May, a New Jersey man sued VPX, claiming the company fraudulently marketed its Redline Ultra Hardcore product as containing apple geranium leaves, though it actually contained a non-plant-derived synthetic ingredient, 1,3-dimethylpentylamine, another moniker for DMAA. Then, in November, Florida-based BPI was sued in a California court for selling the "dangerous, amphetamine-like ingredient" DMAA in its 1.M.R pre-workout product, among others. Curiously, 1.M.R no longer actually contains DMAA—Health Canada deemed the ingredient a drug and recalled the product in that country in June 2011—though the case is still moving forward. Most recently, in December 2011, pre-workout category leader USPlabs—with its bestseller Jack3d—was sued in a California court, with the plaintiff arguing that the company's products contain synthetic DMAA, which has no New Dietary Ingredient notification, and is therefore illegal and unsafe.

The military ban

The question of the safety of DMAA was brought into sharper focus on December 3, when the U.S. Military issued a massive recall of all DMAA-containing products from all military exchange stores worldwide. The recall is part of a U.S. Army investigation into the safety of the ingredient following the potentially-related deaths of two soldiers. The two men, both stationed in the Southwest, suffered heart attacks during training—one in the summer and one in the fall—and toxicology tests revealed traces of DMAA in their blood. The deaths put USPlabs in the hotseat, with the responsibility of proving the safety of its popular Jack3d and OxyElite Pro products, which were both subject to the recall.

USPlabs plays defense

In response to a class action suit, a military recall, and a possible ban on DMAA, USPlabs is bearing down to protect its blockbuster Jack3d from a regulatory crackdown. The shaky evidence for DMAA's natural origins provided by the Ping study isn't enough to quell the rising number of voices calling the ingredient a drug, which prompted USPlabs to hire scientific consultancy Cantox to prove DMAA's existence in geranium. On September 6, 2011, Cantox issued a statement claiming that they had gathered findings from two independent laboratories that support the conclusions of the Ping study. The findings, however, are currently awaiting publication and may not be disseminated for several months, buying USPlabs some time.

On the safety end, USPlabs has also cobbled together a series of finished product studies on OxyElite Pro and Jack3d. The Jack3d safety study is a less-than-impressive, two-week, seven-person trial which found no changes in heart rate or blood pressure among subjects taking the supplement daily. A ten-week safety study is currently awaiting publication.

The DMAA issue is coming to a head, with two tragic deaths already recorded and the 2012 Olympics fast approaching. USPlabs is right in the middle of the storm, but with a few safety studies in the bag and two geranium studies forthcoming, the company is sitting pat for the moment. But industry experts still foretell a dark end to the DMAA story sometime soon.