The lawsuit was filed on behalf of two Florida defendants representing a class of plaintiffs who bought products from the defendants, two companies called IQ Formulations LLC and Europa Sports Products Inc.
Status of DMBA at heart of case
The companies sold two weight loss products that contained methylpentane citrate, otherwise known as AMP citrate or DMBA. The ingredient, which other formulators have claimed but have not proven comes from an orchid species, is a stimulant that is chemically related to amphetamine.
DMBA came to FDA’s attention in the period immediately after its high profile action against DMAA, a related ingredient. DMAA had been implicated in several deaths of otherwise healthy young people, and FDA moved to have it removed from the market. There was some disagreement about the precise safety profile of DMAA, but FDA decided to err on the side of caution.
And there was also disagreement about the chemical provenance of the ingredient. Proponents claimed the ingredient came from geranium. FDA disagreed, and in any case ruled that products containing the ingredient were adulterated by definition as it should have had a New Dietary Ingredient Notification on file and did not.
That is the situation that DMBA finds itself in. The ingredient has never been the subject of an FDA enforcement action based on its safety. But the agency did issue 14 warning letters in 2015 to companies selling the ingredient based on the fact that there were no NDI Notifications on file for DMBA.
FDA has only rarely based warning letters solely on missing NDI Notifications. Usually if a company has a problem with an ingredient like this in one of its formulations, that shows up as a line item in a warning letter that mentions other issues as well. As the NDI Notification procedure is a way to vet the safety of new ingredients, the 2015 warning letter blitz could be seen as FDA signaling its unease about the basic safety of the ingredient without calling its safety into question directly as it did with DMAA.
The court dismissed the Florida case on a lack of ‘standing.’ In other words, the defendants were unable to show actual harm or that, “a likelihood that a court ruling in [the plaintiff’s] favor would remedy [his] injury.”
The class action suit in Florida hinged on how the plaintiffs were allegedly harmed by not knowing that DMBA occupied this regulatory limbo. The defendants alleged that if they had known of the presence of the illegal ingredient, they would not have purchased the products. There was no allegation that they were harmed by the products themselves nor that they had even consumed them.
Correct decision could stem flow of private enforcement actions
Legal experts contacted by NutraIngredients-USA welcomed the decision as a roadblock in the way of a rising tide of attempts to privately enforce the Food, Drug and Cosmetic Act via various state consumer protection statutes.
“I think it’s good holding,” said Ivan Wasserman, who heads the Washington, DC office of the law firm Amin Talati Upadhye.
“In layman’s terms standing is meant to ensure that the plaintiff is sufficiently motivated to prosecute the case because he or she has been injured and the court’s remedy will be sufficient,” Wasserman said.
“As I understand it they were not alleging that the products weren’t effective. The plaintiffs were alleging that if they had known about the NDI issue they would not have purchased the product. It seems the court found that speculative at best,” he said.
“It has been this way for a while, that plaintiffs’ lawyers have tried to step into the shoes of FDA to regulate these issues,” said Justin Prochnow, a shareholder in the firm Greenberg Traurig.
“I think it’s not because they think the American public is so aggrieved but because they think it is a great way to make money,” he said.
In this case, Prochnow said the court rightly declined to go forward with the action because few, if any, consumers could reasonably be expected to have made a purchase decision based on an ingredient’s NDI status.
“I think for the average consumer, 90%, and that’s probably being generous, have no idea what an NDI is,” he said.