USPLabs has maintained radio silence ever since receiving a warning letter from the Food and Drug Administration (FDA) raising concerns about the regulatory status and safety of DMAA in late April.
However, the lawsuit is one of the strongest indications yet that it does not plan to roll over and accept the FDA's interpretation of the legal status of the controversial stimulant.
USPLabs is working on reformulated products as a back up option
Speaking to NutraIngredients-USA this morning, Peter Hutt, a senior counsel in the Washington, DC law firm of Covington & Burling, confirmed that USPLabs had written to the FDA strongly defending its products Jack3d and OxyElite Pro.
He added: "In the view of the company, DMAA is documented with three separate analytical studies as being present in geranium and by law there is no requirement that DMAA in supplements be natural and no requirement for submitting an NDI."
As for safety, he added: "There are seven clinical safety studies submitted and discussed and also toxicology reports confirming its represents no significant risk."
However, USPLabs has been working on reformulated versions of Jack3d and OxyElite Pro should the FDA fail to be persuaded by its arguments, he said.
Defendant 'falsely charges Plaintiff with selling the equivalent of rat poison'
Meanwhile, in a complaint filed in Dallas, Texas, on May 23 against MMRNV LLC (doing business as Max Muscle Sports Nutrition, Reno, Nevada) and owner Philip J. Tracy, USPLabs said a recent interview Tracy had conducted with local TV station KRNV had damaged its reputation and harmed its business.
Tracy, who is the owner of Max Muscle Reno, a dietary supplement retail outlet that no longer sells Jack3d, but “does, however, sell other dietary supplements that directly compete with Jack3d”, conducted an interview with KRNV, through its news broadcast, News4, said USPLabs.
Interview prompted ‘additional inflammatory and derogatory statements’
During this interview, parts of which were published on the website my4news.com, Tracy described Jack3d as “an amphetamine-like compound” that “speeds up your heart rate”.
He also said: "When you are working out your heart is pumping. If you take a product that constricts your blood, you're actually causing damage to your body and possibly death.
"It's a derivative of rat poisoning and has a lot of side effects."
The interview was subsequently republished on several other news sites, which in turn prompted “additional inflammatory and derogatory statements to be published on Defendant Max Muscle Reno’s website and Facebook page”, claimed USPLabs.
USPLabs has ‘suffered economic loss attributable to Defendant’s disparaging statements’
It added: “The statements were made in the context of direct references to the ‘manufacturer’ of Jack3d, and USPlabs is the only manufacturer of this product.
“USPlabs has suffered economic loss attributable to Defendant’s disparaging statements.”
Meanwhile, Jack3d “continues to be marketed and sold through retail stores and online retailers, which are competitors of Defendants”, noted USPLabs.
“As a franchise of a national chain of Max Muscle retail stores, Defendants are well aware of these business relationships.
“Defendants made the false and disparaging statements… about Jack3d with the intent to harm Plaintiff USPlabs by interfering with Plaintiff’s business relationships with current purchasers of Jack3d.”
Comments 'impugn USPLabs' honesty, integrity, and business reputation'
Tracy’s “false and disparaging statements” interfered with USPLabs’ current and prospective relationships with potential purchasers of Jack3d, claimed USPLabs, which is represented by legal firm The Brewer Law Group.
His statements were also defamatory, claimed USPLabs: “Defendants’ statements are defamation per se in that they impugn Plaintiff’s honesty, integrity, and business reputation, and expose Plaintiff to public hatred and financial injury.
“Further, one of the statements falsely charges Plaintiff with selling the equivalent of rat poison for human consumption, which would be a crime.”
Tracy did not respond to requests for comment before this article went to press, while Hutt declined to comment on the case, which is being handled for USPLabs by The Brewer Law Group in Dallas.
FDA: Still evaluating responses to warning letters
All 10 recipients of the April FDA warning letters on DMAA have now written back , an FDA spokesman told NutraIngredients-USA.
“Each of the companies has responded to the warning letter it received and FDA is in the process of evaluating the responses.”
But he added: “Because the matter is still open, FDA cannot offer additional information at this time.”
Asked whether the FDA planned to seize DMAA-containing supplements from stores or warehouses, he said: “FDA cannot offer comment on any future actions it may be considering.”
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