This has been a major debate for well over a year, and has major implications for the nutritional supplement industry – for reasons that go beyond DMAA-containing products. We’ll get into that below.
Before we begin, a few disclaimers:
- This site is not run by USPLabs, nor are we affiliated with them in any manner. We are a Jack3d fan site that was originally created to dispel some myths about this awesome product, and find good deals.
- That said, we are going to be a bit biased. That is why we are linking to the original study if you’d just like to read that. We’ll also host it here in case it gets removed though.
- As an FYI, it is December of 2012 now, but the study below was released in August of 2012. This is not breaking news, but we figured it should be discussed here.
The Latest Research
“DMAA, which is used in some nutritional supplements, has led some to question whether it is actually a constituent of the geranium plant and its oils. A validated method for quantification of DMAA in geranium plants has been established in the present investigation and has confirmed the presence of 1,3-DMAA and 1,4-DMAA in the plant tissue and essential oil.”
This study was done by Intertek-AAC Labs, who is based in Champaign, IL. They used a very reliable form of chromatography-electrospray mass spectrometry (LC-ESI/MS/MS) to determine this. The specific genus of geranium was Pelargonium graveolens, a Chinese variety.
Further statistical analysis and re-testing shows that the results were R&R – repeatable and reproducible, a necessary cornerstone in quality analysis.
End of story: DMAA is a naturally occurring substance that comes from Chinese geranium. This makes it acceptable for use as a dietary supplement, as discussed below.
Why the Conflicting Research?
So perhaps you’ve seen other studies claiming the opposite. How is that possible?
It’s best to read the response on this page at DMAAResearch.com, but the major bullet points are here:
- The studies claiming DMAA was not found did not use Chinese geraniums. Each plant is different, and not all species behave the same. Specifically, the best one is from the Rongjiang region of the Guizhou province. Even within China, the plants differ.
- Improper detection methods. The studies claiming against DMAA being in geranium used GC/MS analysis, but the geranium plant’s spectrum is too complex for this form of measurement.
There are other matters that are discussed on the link above, but these are the two most important points.
Why is this Important?
According to the DSHEA act of 1994, the FDA requires an NDI, or New Dietary Ingredient, to be filed if a new ingredient is created that has not been present in the food supply.
However, in April of 2012, they sent warning letters to USPLabs and other makers of DMAA-containing products, stating (now incorrectly) that “Synthetically produced dimethylamylamine is not a vitamin, mineral, amino acid, herb or other botanical.”
The warning letter also mentions that “We [the FDA] also remind you that the new dietary ingredient notification requirement applies to all dietary supplements that contain new dietary ingredients that have not been present in the food supply as articles used for food in a form in which the food has not been chemically altered.”
Since various geraniums have long been found to contain 1,3 Dimethylamylamine, and have been in the food supply, the supplement industry seemingly did nothing wrong by including it in their products. It is a naturally-occurring substance.
So it looks like the FDA seems to have mistaken a critical component in their warnings – The fact that DMAA has natural origins, which negates the premise of their letters.
While the DMAA used in some supplements may be synthetically created, this is okay per current guidelines. After all, the Vitamin C in your multivitamin is not necessarily naturally found – it can legally be synthetically generated in a lab, so long as cGMP (common Good Manufacturing Practices) are followed. DMAA is NO different, since it is naturally-derived.
So here’s the hypothetical: If DMAA can be found in nature, yet the FDA were to say that it cannot be used in dietary supplements… then what is that to say for ALL of the supplements out there that use synthetically-derived ingredients (that are originally naturally found in nature – like your vitamin C)??
The implications of such a decision like this could devastate an entire industry, and create a massive price increase in just about everything you eat and drink. We hope to have this whole matter clarified.
The DSHEA also states that it is the FDA’s job to determine if a supplement is dangerous or not. Much research has been done on this, and DMAA has been determined to be safe when used properly.
DMAA is, however, a stimulant, and when used improperly or by people with pre-existing conditions who have not been approved by a doctor, it can lead to side effects. The same goes for caffeine – another naturally occurring stimulant. Caffeine is 100% legal, yet it can also cause immense problems when taken improperly.
The most severe case of DMAA abuse occurred when an individual used over 30 times the recommended dose! (this person was also not using a USPLabs-based product). But had that been caffeine, he may have ended up dead! This is why everyone must follow label directions – whether it’s from USPLabs or their competitor. All labels must be followed to a tee, and a doctor’s approval must be granted first!
So, as the law stands now, once an ingredient is naturally derived or an NDI is created for it, and it is used as a supplement, the FDA must then show that it is harmful.
As an ironic side note, prescription drugs end up killing 106,000 every year, a number that’s likely gone up since this research was done in 2000.