The cases will be watched closely, as they appear to be based - in part - on one of the most hotly disputed claims in the FDA’s draft guidance on new dietary ingredients (NDIs): that synthetic copies of botanical constituents are not dietary ingredients permitted for use in supplements.
Warning letters - and the NDI guidance - are not the same as the law
They also reflect a growing trend in which plaintiff’s lawyers are building cases by trawling through FDA warning letters - which like the NDI draft guidance - only reflect the FDA’s opinion/current thinking, and are not legally binding, Colorado-based attorney Justin Prochnow told NutraIngredients-USA.
However, this does not make them any less costly to deal with, he pointed out.
The new lawsuits (see box) follow DMAA-related class actions vs GNC, Cellucor Sports Nutrition, Woodbolt Distribution, BPI Sports and USP Labs (which was sued in December 2011 and February 2012 by two different firms).
While plaintiffs dwell on the regulatory status of DMAA, they also allege it is unsafe, citing passages from the FDA warning letters plus references to the safety probe by the US military into DMAA following the deaths of two soldiers found to have it in their blood.
All plaintiffs seek damages and a jury trial.
Synthetic botanicals: Maybe they do want to have that fight?
Should the FDA end up making its case in court - for example if it seizes supplements and is challenged in court, officials might prefer to home in on safety, said Prochnow.
However, the FDA might well want to take a stand on the synthetic botanical constituent issue, he said. “Maybe they do want to have that fight?”
That said, the fact that the FDA had attacked DMAA on several angles - no NDI notification, safety concerns, and its claim that synthetically-produced DMAA is not a dietary ingredient - suggested it didn’t want to put all its eggs in one basket, he said.
Will the FDA up the ante with a seizure?
A lot will depend on how the firms respond to the warning letters and whether the FDA decides to up the ante by seizing supplements, he said.
“If they do take a stand on the synthetic botanicals issue, there will be a lot of people willing to jump in on the other side. The industry has fought very hard on this issue.”
It is clear that FDA has decided to take on DMAA
As for the warning letters, the fact the FDA had spelled out that firms risked seizures/injunctions suggested it meant business, he said.
“It is clear that FDA has decided to take on DMAA.”
Finally, the fact that the letters contained a reminder that all NDIs are subject to notification requirements also suggested the agency was “not prepared to put everything on hold” while it mulled over comments about its guidance, he said.
Can new data corroborate Ping study?
The future of DMAA seems to hang on whether new research is published proving, beyond a doubt, that DMAA is found naturally in geranium, as supplement makers insist.
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".
However, two new studies allegedly corroborating Ping’s findings are expected to be published soon, said American Herbal Products Association (AHPA) president Michael McGuffin, referencing a statement released by Cantox Health Sciences International last year.
He added: “In AHPA's view, if DMAA exists in geranium through the plant's own synthesis processes, human-synthesized DMAA is also a lawful dietary ingredient."
The firms targeted in the lawsuits were still formulating their official responses as this article went to press.
Click here to see GNC's reaction to the FDA crackdown and background on DMAA.
Click here to see AHPA’s reaction.
Click here to get reaction from the CRN, NPA, ABC and analytical testing experts plus a list of the products and firms targeted.
Click here to see the NutraIngredients-USA DMAA timeline.
Click here for analysis of how the NDI issue relates to the debate.
Click here for an analysis of the legal status of DMAA.