Supplement maker Nutrex Research has hit back at allegations made in two class action lawsuits filed in the wake of the FDA crackdown on controversial pre-workout stimulant DMAA (1,3-Dimethylamylamine).
Nutrex Research is one of 10 firms to receive a warning letter from the Food and Drug Administration (FDA) in April raising concerns about the safety and legal status of supplements containing DMAA and has now been targeted in three class action lawsuits by plaintiffs in California and Illinois.
In complaints filed in California on March 2 and April 30 on behalf of plaintiffs Stephen Rush and Jason McKenna by law firms Wasserman, Comden, Casselman & Esensten LLP and Kirtland & Packard LLP respectively, Nutrex was accused of selling supplements containing DMAA in a synthetic form that is “illegal and dangerous”.
Nutrex denies the allegations describing DMAA
In responses dated June 27 and July 2 respectively, Nutrex denied all the allegations and called for the complaints to be dismissed without prejudice.
It said: “Nutrex admits that it received a letter from the FDA concerning DMAA and asserts that the letter speaks for itself as to its contents. Nutrex denies all the remaining allegations...
“The complaint fails to state facts sufficient to constitute a cause of action upon which relief may be granted…”
Nutrex expressly denies that plaintiff and class have been injured …
It added: “Nutrex denies the allegations describing DMAA… Nutrex expressly denies that Plaintiff and the Putative Class have been injured as a result of any violations of law by Nutrex.
"Plaintiff’s cause of action based on fraud is barred because Nutrex lacked any intent to deceive plaintiff or other purchasers.
“Plaintiff’s action is not proper for class action certification as plaintiff’s claims are not typical of the claims of the purported class action members.”
Finally, it noted: “Nutrex’s products are not required to be all-natural and Nutrex does not promise consumers that they are such.”
Third class action lawsuit also targets Vitamin Shoppe
It has yet to respond to a third class action complaint filed on behalf of plaintiff Rochelle Ibarolla by law firm Oliver Law Group against Nutrex Research and Vitamin Shoppe on June 18 in Illinois.
This complaint alleges that Nutrex products “contain a number of dangerous stimulants scientifically proven to have an array of harmful side effects”.
It adds: “Many Nutrex products contain the dangerous and illegal synthetic compound DMAA, which was originally developed as a nasal decongestant but is now used by some as a ‘party pill’.
“Side effects of DMAA include headache, nausea, and stroke – facts that Nutrex and its retailers, such as Vitamin Shoppe, neglect to disclose to their customers.”
Is DMAA in geranium or not?
Nutrex has recently reformulated Hemo Rage, Lipo 6 and its other DMAA-containing supplements but reserves the right to use DMAA again in future "if the uncertainty... over the status of this ingredient gets resolved”.
In a letter to the FDA sent in early May, Keller and Heckman attorney Frederick A. Stearns - representing Nutrex - defended both the safety and legal status of its DMAA-containing supplements.
He said: “A close examination of the Ping, et al. study [a 1996 paper dismissed by one leading chemist as 'scientifically indefensible'] shows its original conclusions [that DMAA is a natural constituent of geranium] were correct.”
He then quoted from a September 2011 memo from consultancy Cantox, which claimed supplement maker USP Labs had fresh data from ”two independent and highly respected analytical chemistry laboratories" that “corroborates the original data published by Ping et al, and further demonstrates the occurrence of DMAA in the geranium plant, Pelargonium graveolens, and its edible oil”.
Assuming the new data does prove DMAA is in geranium, firms using nature identical synthetic copies of it in their supplements are not breaking the law, said Stearns.
USPLabs has not responded to requests for comment about a study published in the Journal of Analytical Toxicology on June 25 alleging that DMAA is not detectable in plant material and oil from geranium (Pelargonium graveolens).
FDA: Still assessing situation…
The FDA meanwhile, has not issued any further information since sending out the warning letters in April.
A spokesman told NutraIngredients-USA that officials were “still in the process of assessing each firm’s response to the warning letter it received”.
But he added: “Retailers should take steps to ensure that the products they sell are legal. If a retailer is selling a product that doesn’t meet FDA’s requirements, FDA can take action at the retail level, such as seizing products.”
Click here to read the latest developments on DMAA.