by Marion Nestle
May 29 2012

The latest battle in the supplement wars: FDA v. DMAA

Welcome to the largely unregulated universe of dietary supplement marketing, in this case of DMAA, a.k.a. 1,3-dimethylamylamine, methylhexanamine, or geranium extract (from which it is supposedly isolated).
DMAA is supposed to stimulate athletic performance.
In April, the FDA sent letters warning ten DMAA distributors that it considered their products adulterated because:
  • DMAA does not naturally come from a food.
  • Most of it is produced synthetically
  • It might not be safe.
The FDA received 42 complaints of adverse events associated with taking DMAA supplements.  Although the reports do not prove that DMAA caused the problems, these are serious: cardiac disorders, nervous system disorders, psychiatric disorders, and death.The FDA says:

dimethylamylamine narrows the blood vessels and arteries, which increases cardiovascular resistance and frequently leads to elevated blood pressure. This rise in blood pressure may increase the work of the heart such that it could precipitate a cardiovascular event, which could range from shortness of breath to tightening of the chest and/or a possible myocardial infarction (heart attack).

One FDA warning letter went to a company called Muscle Warfare for its DMAA supplement “Napalm” which “produces intense sensations of power, drive, energy, focus, motivation, and awareness.  Enormous strength, speed and endurance increases may result.”

Here’s how the company says Napalm works:

Upon ingestion, energy is almost instantly kicked in with Air Strike while core body heat is dramatically supported. This extra body heat may then dramatically support the release of heat shock proteins, during your workout by way of our patent pending Thermobraic Heat Shock Protein Deployment System via Myobolic-SERMS/1&2….Muscle Pumps are fueled via a remarkable creatine free, Plasma Scorch Muscle Engorgement Agent….

Just pure power and dry hard size. Anabolism is kicked in by your ultra-intense workout coupled with our powerful mTOR pathways inducing Vaso-Anabolic Branched Chain Amino Acid Blend. Further hormonal anabolic support is induced by our patent pending NMDA™ hormonal support agent. NMDA™ specifically targets growth hormone, testosterone, IGF-1 and IGF-2 release and has been scientifically shown to provide dramatic support!

As I keep saying, you can’t make this stuff up.

The supplement industry, ever eager to find an athletic supplement that everyone will want to take has reacted with outrage to the FDA’s warning letters (see NutraIntredients-USA.com for a series of articles on DMAA).

Since Congress passed the Dietary Supplement Health and Education Act (DSHEA) in 1994, the supplement industry has gotten a virtually free pass on regulation and its less scrupulous members push the limits of marketing to the point where the FDA has no choice but to act.

DMAA supplement marketers now argue that if DMAA comes from geraniums, synthetic DMAA should be legal. 

I had no idea people were eating geraniums, but never mind.  The flowers may not contain DMAA anyway.

According to NutraIngredients, most DMAA is synthetic (hence: not natural):

There is only one study repeatedly referenced to show that DMAA is a naturally occurring constituent of geranium oil (Ping, Z.; Jun, Q. & Qing, L. (1996), ‘A Study on the Chemical Constituents of Geranium Oil, Journal of Guizhou Institute of Technology 25 (1): 82–85) – which analytical testing experts contacted by NutraIngredients-USA say is “not scientifically defensible“.

The supplement industry views the warning letters as signs that the FDA is going to start giving its products greater scrutiny.

That would be a step in the right direction, but maybe the FDA won’t have to.  The warning letters elicited a flood of  class action lawsuits against DMAA.

If the FDA won’t or can’t act, lawyers will take up the burden of regulating potentially unsafe and misleadingly marketed supplements.

Update, June 29:  Oops.  Investigators fail to find DMAA in geranium extracts or oils. 

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