WASHINGTON — They aren’t the type of words that usually show up in Supreme Court briefs, but on Tuesday, they will be there just the same: Cobra Sexual Energy.
The court is set to hear oral arguments in Nutraceutical Corp. v. Lambert, the latest flash point in a five-year spat between unsatisfied California men and Nutraceutical Corp., a supplement company that sells a dietary supplement called “Cobra Sexual Energy” that contains a mix of horny goat weed, yohimbe, and potency wood, and that the company boasts will help with “animal magnetism.”
The justices will focus more on the “class action” status of the case than the eyebrow-raising merits of the lawsuit. But the case points to the limited role of the Food and Drug Administration in policing the supplement industry. Dietary supplements, which include everything from vitamin C tablets to workout stimulants, are used by 75 percent of Americans, according to a recent survey from an industry trade group, the Council for Responsible Nutrition.
Because the FDA has limited power to police the industry, consumers are increasingly turning to class-action lawsuits to hold manufacturers accountable.
“FDA-regulated industries have seen an enormous amount of class action litigation over the last 10 years,” Anthony Anscombe, a partner at the law firm Steptoe & Johnson, who focuses on class-action defense, told STAT.
The class-action case the Supreme Court will weigh Tuesday began in California, in 2013. Troy Lambert, who’s from Long Beach, is the named plaintiff. The crux of his lawsuit argues that Nutraceutical Corp. ran afoul of California’s unfair competition laws by misleading consumers.
Among the plaintiffs’ complaints: “that Defendants’ conduct is immoral, unscrupulous, and offends public policy by seeking to profit from male vulnerability to false or deceptive virility or aphrodisiac claims.”
For Lambert, it all started with an otherwise ordinary trip to the Rite Aid convenience store in Long Beach. He wasn’t in the market for a sexual enhancer, but the photo of a cobra emblazoned on Cobra Sexual Energy’s bright red box caught his eye, according to the complaint.
The product’s promises are thin. The box proclaims consumers will “Perform Your Best With Animal Magnetism,” but that’s as explicit as the product’s label gets. Lambert hoped the pills would help him have sex for longer.
He saw no effect, even after he polished off the first bottle of 60 capsules. Nonetheless, he kept up hope the product would build up in his system over time. So he bought it a handful more times over the next couple of months, shelling out between $16 and $18 each time and keeping the purchases a secret from his wife.
Lambert’s lawsuit is seeking $210,000, most of which would be split among the men who took the product.
Nutraceutical contends that its claims about the product were “non-actionable puffery.”
“They are suggestive hyperbole that are inherently subjective, non-quantifiable, and ‘so exaggerated as to preclude reliance by consumers,’” Nutraceutical writes in a court filing.
It’s not clear how many people tried Cobra Sexual Energy. But Nutraceutical is well-established in the dietary supplement market. The company has more than 50 product lines — most of which have nothing to do with sex — and the company had over $230 million in net sales in 2016, according to the company’s most recent financial filings.
Target, Rite Aid, and CVS all sold Cobra Sexual Energy back in 2012. And while the product has been pulled from the shelves at all three chains, it is still available online — as is a female version packaged in a bubble gum pink box.
Nutraceutical declined to comment for this story. But Daniel Fabricant, who heads a dietary supplement lobbying association, the Natural Products Association, called the Cobra Sexual Energy lawsuit “a shakedown.”
“The plaintiff bar looks at the product and says, ‘OK, this is a reputable manufacturer, they’re going to settle,’” Fabricant said. “Well, these guys decided not to settle.”
Fabricant said the lawsuit is on flimsy ground.
“They don’t have data to show that the public was misled by the claim and furthermore they don’t have any data that shows there was any sort of public health harm. So I’m a bit confused as to what exactly we’re protecting consumers from,” Fabricant told STAT.
The case highlights a unique fact of U.S. food and drug law: The FDA has jurisdiction over every prescription drug sold here, as well as some authority to oversee over-the-counter products like Tylenol or hydrocortisone cream. The agency has less authority over vitamins or dietary supplements.
Under a 1994 law called the Dietary Supplement Health and Education Act, the FDA can’t review dietary supplements before they hit the market to ensure they are safe and actually do what they say they will, like it can for new drugs. Instead, the FDA begins monitoring supplements’ safety after they’re on the market and the agency reviews substantiation for claims “as resources permit.”
The FDA can only swiftly step in when supplements actually contain FDA-approved drugs. Sexual enhancers are the worst offenders, according to a recent study published in the Journal of the American Medical Association. In the past year, FDA has alerted consumers to avoid products like “XXXPlosion Ultra,” “Rhino 69 Extreme 50000” and “Best Leopard Miracle of Honey,” all of which included the active ingredient used in the drugs Viagra and Cialis.
And that has some advocates pushing for Congress to expand the FDA’s regulatory authority. They say the agency doesn’t have the resources to adequately monitor the market, and that unsafe and deceptive products often slip through the cracks.
They say Congress should beef up what the agency can and can’t do.
“People being misled is extremely common,” Dr. Peter Lurie, head of the Center for Science in the Public Interest, told STAT. “In the commonsense understanding of whether or not people are induced to have higher hopes than they ought to, I think that’s as common as snow in Alaska.”
Lurie, who previously served as associate commissioner for public health strategy and analysis at the FDA, places part of the blame on Congress for “shackling the FDA with a statute that doesn’t give it the authority that it needs to police this marketplace.” His organization, CSPI, files class-action lawsuits on behalf of consumers.
“The agency itself is hopelessly underfunded in the dietary supplement area,” he added. “The size and the nimbleness of the dietary supplement market is such that it’s very difficult for their staff to stay on top of this.”
The dietary supplement industry, on the other hand, says the FDA already has the authority to pull products off the market if they are unsafe. Fabricant saw the agency do just that when he led FDA’s office of dietary supplements as it forced workout enhancers Jack3d and OxyElite Pro off the market in 2013.
The FDA did not respond to request for comment.
In the void, however, class-action lawsuits have become an increasingly popular tool for regulating the market.
Industry groups have said increase in class actions is the byproduct of money-hungry class-action attorneys.
“It’s been one of the biggest burdens for the natural products industry for the past 25 years,” Fabricant said.
Anscombe acknowledged that the expectation of a payout is one of the motivating factors for filing these cases.
“If Plaintiffs did not see money to be won, they wouldn’t bring lawsuits,” he wrote in an email to STAT.
The Supreme Court isn’t likely to solve these hot-button FDA issues — it is actually weighing an issue related to the cases’ “class action” status.
The case was dealt a major setback in 2015 when the district court decertified the class in the case, effectively killing the class action. Lambert’s attorney appealed this decision but missed a key deadline. The Court of Appeals for the 9th Circuit nonetheless gave Lambert and his attorney a pass. On Tuesday, the Supreme Court will decide whether the 9th Circuit got that decision to extend the deadline right.
“Neither side has much interest in the larger question, sure. But each side has a strong interest in winning this dispute,” Dan Epps, associate professor of law at Washington University and co-host of the Supreme Court podcast “First Mondays,” said. “So each side is highly motivated to fight tooth and nail over every point, and here there ended up being this interesting question about equitable extensions for appeal deadlines.”
The justices, then, won’t have to weigh the merits of the complaint — giving them the chance to sidestep something of an age-old dilemma. As Lambert’s brief before the appeals court described it, after all, “the fraudulent sale of fake, snake oil, ‘herbal’ aphrodisiacs is an ancient problem.”