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. 

Comments

On the DMAA issue, and nutrition/dietary supplement issues in general, I wanted to be sure you are aware of newhope360.com, the umbrella website for New Hope Natural Media’s publications.

Connor Link at Nutrition Business Journal, has been covering the DMAA story from the start and has another iteration in the works this week so stay tuned to newhope360.com!

Here are some of his recent articles on DMAA:

http://newhope360.com/blog/meet-dmaas-replacement-dendrobium-extract
http://newhope360.com/regulation-and-legislation/dmaa-forcing-fdas-hand-ndis
http://newhope360.com/blog/financial-impact-dmaa-crackdown

Thanks for your time & attention— I always enjoy your work!

  • Wena
  • May 29, 2012
  • 8:28 pm

It sounds like a cosmetic-branding of Chinese traditional medicine, if they are referencing a Chinese article that sounds like it has links to herbal medicine.

  • julie
  • May 31, 2012
  • 5:27 pm

Maybe I’m remembering wrong, O-chem was long ago, but I seem to remember geraniums producing some sort of “natural” pesticide. In some cases, natural is more dangerous than synthetic, and I think this was one of them.

Supplements are tough. I have some friends who take them, who try to convince me, but I want nothing to do with them. Except for melatonin, and not very often. They really need some regulation. Maybe not the full on process for pharmaceuticals, but at least some GMP, and proof of efficacy (or at least no harm).

  • Christine
  • June 1, 2012
  • 7:00 am

In Canada, supplements are regulated. The system is not perfect, but new products (i.e., those who haven’t already been on the market for many years) must meet Health Canada’s safety and efficacy standards to receive a license before they are sold.

Applicants would have to demonstrate that DMAA can be taken safely – and if so, relevant risk statements would be required on the labels.

Of course, once the product receives its license, there is very little control over how the product is marketed. So while Health Canada may approve a certain claim (i.e., one that falls in line with the available evidence) and that’s the one that can appear on the product label, the product’s website can be very different. Like I said, the system is not perfect, but it’s a step in the right direction.

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