Will the market or FDA deliver the final blow for DMAA?
I was reminded of this scene after considering the future of DMAA. Many of the people I speak to, from lawyers to industry observers to regulators, predict that the end is nigh for the controversial ingredient, but who will deliver the final blow – the market, the FDA, or someone else?
Blow after blow
Yet another study was published this week that concluded that DMAA is not a constituent of geranium. On the regulatory side, agencies around the world, from Sweden to New Zealand, are warning against, or banning, the ingredient.
In the US, FDA took a clear position on this when it issued warning letters to 10 manufacturers and distributors of supplements containing DMAA. Let’s not forget the class actions against manufacturers and retailers.
The market is now responding to all this: After defending the ingredient earlier this year, GNC reported in July that it was making a concerted effort to move away from DMAA.
Its bricks and mortar retailing competitor, Vitamin Shoppe, has also said that the DMAA issue is behind them and that most manufacturers have reformulated to remove DMAA from their products.
So are the market forces enough to finish DMAA?
One company, USPlabs, shows no signs of throwing in the towel, and is continuing to fund studies to support the safety and natural credentials of the ingredient. I don’t pretend to know USPlabs’ strategy, but for the moment they are maintaining their position that DMAA is from geranium (albeit grown under special conditions in a very special part of China), and that the ingredient is safe.
If it is found in nature – and that’s a pretty big ‘if’ from where I’m sitting, considering the other studies that have failed to find it – then that doesn’t get away from the issue of whether the ingredient used in dietary supplements is synthetic.
And with that we move down the route of NDIs. FDA is making no sign of moving away from its stance that “a synthetic copy of a constituent or extract of an herb or other botanical is not a dietary ingredient, and such ingredients must be approved for use in supplements,” – just look at the recent recall of sexual health supplements including Eroxil, Erosyn and Fertalin.
If it goes the NDI route, I doubt the odds will be very favorable for a positive opinion. Indeed, Ed Wyszumiala, from NSF International, told me he thinks that FDA will ban the ingredient through the NDI route.
The lawyer’s view
Marc Ullman, partner at Ullman, Shapiro & Ullman says: “This ingredient has a limited lifespan.
“For retailers, there are safety questions, and FDA has raised questions on the legality of it. If you sell products with this ingredient in there, then you are creating a huge exposure for liability.”
“FDA has made the allegations, it has warned the company. USPlabs has responded, and said it disagrees, and that pushes the burden back to FDA. Where from here? Does FDA start an enforcement action, with seizures and an injunction, and take this to court?”
If it goes to court then it does look like FDA has the better argument, with multiple reports from well-respected analytical groups concluding that DMAA is not found in geranium. The agency also has 42 adverse event reports linked to the ingredient.
As the ingredient wobbles on its feet and DMAA critics say, “Finish him!” it seems that the final blow will have to be regulatory, after numerous haymakers from the market.
One industry source told me: “I think DMAA makes a great test case. Assuming that it's not safe and demonstrated as such and then removed then the system would have worked.”