Four new class actions filed in California by El Segundo, CA-based Kirtland & Packard LLP this week target Labrada Nutrition (Stim-Force); Vital Pharmaceuticals (Anarchy Covalex); S.A.N Nutrition Corp (Launch); and Dorian Yates Nutrition (Noxpump) - none of whom have been sent warning letters by the FDA - contrary to the wording in the complaints.
An FDA spokesman confirmed that letters had not been sent to the firms above.
But he added: "If there are other dietary supplement manufacturers marketing products containing DMAA who have not submitted evidence of their safety to FDA, their products would also be considered adulterated.
"FDA urges them to take immediate action to bring their products into compliance with FDA regulations and ensure that they are safe for consumption."
Complaints quote liberally from FDA warning letters -which are not legally binding
The new actions - which quote liberally from last week's FDA warning letters - allege Stim-Force, Noxpump, Anarchy Covalex and Launch contain DMAA (1,3-Dimethylamylamine) in a synthetic form that is “illegal and dangerous”.
They come hot on the heels of complaints against SEI Pharmaceuticals, Isatori Global Technologies, Nutrex Research, Gaspari Nutrition, Musclemeds Performance Technologies, SNI, Exclusive Supplements, Fahrhenheit Group, Muscle Warfare and USP Labs, who were warned by the FDA that failure to cease distribution of supplements containing DMAA could result in enforcement action “without further notice”.
Attorney: ‘I expect firms are going to be more willing than ever to fight back instead of opting for a quick settlement’
However, being 'first to file' may not necessarily work in Kirtland’s favor, Greenberg Traurig shareholder Justin Prochnow told NutraIngredients-USA.
“It seems fairly obvious that these cases were filed in a rush to be the ‘first to file’ so that they can be the lead cases.
“So often, the cases that are rushed to be filed ahead of everyone else are put together without enough time for proper investigation of the facts and circumstances and are based on one media statement, or, as appears to be the case in this situation, a warning letter issued by the FDA.
“These cases will need to be proven by the plaintiffs and they will not be able to just rely on the FDA's opinion in a warning letter."
He added: “I expect that companies in the food, beverage and supplement industries have had enough of the onslaught of litigation and are going to be more willing than ever to fight back instead of opting for a quick settlement."
Company reactions
S.A.N. Nutrition Corp declined to comment, while Dorian Yates Nutrition and Vital Pharmaceuticals were unavailable for comment as this article went to press.
However, Dr Kyle Workman, chief operation officer at Labrada Nutrition, said Stim-Force - which was launched last year - had only been on the market for "two or three months" before it was discontinued.
But he said he was not surprised plaintiff's lawyers were now seeking to target every company that had sold products containing DMAA.
Legal uncertainty
Meanwhile, the debate over the source, regulatory status and safety of DMAA rages on, with the American Herbal Products Association (AHPA) arguing that “if DMAA exists in geranium through the plant's own synthesis processes, human-synthesized DMAA is also a lawful dietary ingredient."
Fans of DMAA supplements have been discussing their options in the online forum at Bodybuilding.com (which has temporarily stopped selling Jack3d et al).
One member asks if it’s worth stocking up now and is told: “You should stock up if you want, they're just going to replace it with something else in the ingredients other than DMAA. [But] don't stock up in plans to sell it for profit though…”
What are the other supplement firms saying?
Most of the recipients of FDA 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 year due to technical issues with an ingredient (not DMAA), while Exclusive Supplements says its Biorhythm SSIN product is not a big seller.
USP Labs is not returning calls, but is understood to be preparing to defend Jack3d and OxyElite Pro strongly.
GNC, meanwhile, says there is "no basis" for the FDA's crackdown.
Click here for more updates on DMAA.