By Elaine Watson Nutra Ingredients USA
They’ve had the sword of Damocles hanging over their heads for months. So when 10 firms selling DMAA supplements were finally told to put up or shut up by the FDA last week, it looked like the game might finally be up for the controversial stimulant.
Most of the companies that have received warning letters have yet to issue official statements, although several say they are reformulating (Fahrenheit Nutrition's LeanEfx, Muscle Warfare's Napalm, Isatori's PWR). MuscleMeds says it dropped Code Red last fall due to technical issues with an ingredient (not DMAA). Exclusive Supplements is still deciding what to do but says its Biorhythm SSIN product is not a significant seller. USP Labs is not returning calls, but is understood to be preparing to defend Jack3d and OxyElite Pro strongly. ***, meanwhile, says there is "no basis" for the FDA's crackdown.
But it now seems clear this crackdown marks the beginning, not the end, of a debate many observers claim should have taken place six years ago - when these products first hit the market.
Dude, it’s [a synthesized copy of an extract of] geranium…
To consumers, the terms of this debate must seem bewildering, with the future of Jack3d et al appearing to depend as much on arcane technical arguments about guidance documents and geranium chemistry as on whether they are actually safe.
Meanwhile, to journalists, the fact we still don’t know where an ingredient used in some of the nation’s top-selling supplements is actually coming from is certainly odd.
Not so long ago, brand owners were still insisting the DMAA in their products was from geranium - they certainly listed it as such on their labels - although the sheer quantity of raw material apparently needed to produce even small quantities of DMAA made this explanation pretty unconvincing.
Today, their line (and their labeling) seems to have changed to ‘yes, the DMAA in these supplements is synthetic, but it’s still a lawful dietary ingredient because we’re synthesizing something that exists naturally in geranium and has been in the food supply for years’ (and does not require an NDI notification).
Or as the lean finely textured beef lobby might say, ‘Dude its geranium…’
…Or is it?
The American Herbal Products Association, meanwhile, did little to clear up the confusion last summer when it issued two press releases on DMAA within 24 hours.
The first said it was not aware of any “appropriate scientific evidence” to support the contention DMAA was in geranium oil.
The second said new - unpublished - research suggested it might be.
In a statement issued this week, its tense remains conditional: “If DMAA exists in geranium through the plant's own synthesis processes, human-synthesized DMAA is also a lawful dietary ingredient…”
United Natural Products Alliance (UNPA) executive director Loren Israelsen acknowledges: “It is unusual, given the size of this category of supplements, to have that as an open question this far down the road.
“But that’s where we are now. We’re told additional data will be in the public domain soon.”
‘The wording grants FDA the broadest range of options’
Meanwhile, to confuse matters further, the FDA also appears to be keeping its options open and will not clarify exactly on what basis it concludes that “synthetically produced DMAA is not a dietary ingredient”.
As Israelsen observes, this “artfully crafted” statement could be read in two ways.
On the one hand, it could mean the FDA thinks DMAA does not meet the legal definition of a dietary ingredient because it’s a novel substance first commercialised by a drug company that does not exist in geranium. Case closed. Goodbye DMAA.
On the other, it could mean the FDA accepts DMAA could be in geranium, but is cracking down on it regardless because it does not consider synthetic botanical constituents to be dietary ingredients, says Israelsen.
This interpretation - which most commentators seem to be going with - would offer some wiggle room, as it’s an argument articulated in a draft guidance document on new dietary ingredients (NDIs) that is not legally binding.
If the FDA can be persuaded that synthetic botanical constituents are lawful dietary ingredients - and that DMAA fits this description - it may still insist on an NDI notification if the amounts historically consumed in food differ materially from those consumed in supplements, says Israelsen.
“Has it been transformed such that it’s chemically altered [triggering an NDI requirement]? We don’t know.
‘We should not use DMAA as a case study with respect to resolution of the NDI guidance’
As for safety, while the FDA refers to “concerning” adverse event reports about DMAA, it does not state categorically that DMAA - taken as directed - is unsafe or that safety fears even prompted its crackdown. Instead, it cites a failure to submit NDIs.
Says Israelsen: “The wording grants FDA the broadest range of options.”
The important thing now, he says, is to wait and see what the firms targeted actually have to say, and to try to ensure that the debate about the NDI draft guidance does not turn into a debate about DMAA.
“We should not use DMAA as a case study with respect to resolution of the NDI guidance… This will just muddy the waters.”
So what happens now?
Confused? I certainly am. And I’ve been writing about this all year.
At this stage the only thing I can predict with any confidence is that, however this pans out, a lot of lawyers will be laughing all the way to the bank.