There’s an old joke in mathematics that involves a complicated proof that seems to prove one plus one equals zero. It’s the kind of thing professors assign to their students as a rite of passage. It’s also an apt description for the way the U.S. Food and Drug Administration feels about approving flavored vaping products.
Years ago, the agency issued a series of guidelines explaining how companies could get nicotine vapes approved to sell in the U.S. The rules were long, complex, and expensive, often amounting to millions of dollars to bring a vape to market. But brands had no choice. They commissioned studies, paid fees, and followed procedure, all to get products that millions of Americans were already using legally approved for continued sale.
. . . without warning, the FDA denied the vape businesses’ applications—millions of them—claiming it needed more information. Clearly, something didn’t add up. One plus one equaled zero.
Then, without warning, the FDA denied the vape businesses’ applications—millions of them—claiming it needed more information. Clearly, something didn’t add up. One plus one equaled zero.
Frustrated, the companies fought back—and mostly lost. Luckily, an ingenious legal strategy engineered by the businesses behind the brands Vapetasia and Triton has proven successful so far. Their case is now before the U.S. Supreme Court, which will decide the fate of America’s vaping industry next month. And while traditional court watchers don’t believe they’ve got a shot at winning, the companies remain optimistic.
All Part of the Plan
As the FDA began issuing denials, Vapetasia CEO Chris Finch started planning. He knew the next step was to sue the FDA, but he also knew it would take money, manpower, and risk. He needed a way to even the scales. Finch realized that partnering with fellow vaping company Triton could help on every front.
Taking a page from Sun-Tzu’s The Art of War, Finch’s team picked the battleground most conducive to their victory. By merging with Triton, the company relocated to Texas, which put its appeal before the most conservative court in the nation—the Fifth Circuit. Known for its business-friendly politics and weariness of government intervention, the Fifth Circuit was the best chance for victory.
Then something unexpected happened: The FDA handed down approvals for six vaping products made by Vuse Alto, a subsidiary of RJ Reynolds. Vuse’s applications lacked the same information as the other vape companies, specifically “behavioral studies” or data that proves the products won’t entice young people to start smoking. Finch nearly went apoplectic.
As the FDA began issuing denials, Vapetasia CEO Chris Finch started planning. He knew the next step was to sue the FDA, but he also knew it would take money, manpower, and risk.
“We worked on our case to the best of our ability. And then while we’re waiting to take our case in and ask for a stay [an order that would halt enforcement of the FDA’s decision,] Vuse gets approved,” he said. “The second Vuse gets approved, we march straight in there. F-ck that. You just approved a product that’s lacking the same thing that you just denied millions of applications for? Absolutely not. That’s not okay. So we went in, and we got to stay immediately. It wound up working out and we were granted a stay, and we started the process from there.”
With their business interests protected, the team kept working on their legal strategy. While nearly every lawsuit brought against the FDA floundered in appellate courts, the Fifth Circuit sided with Vapetasia and Triton. In an en banc ruling signed by 10 out of the circuit’s 16 appellate judges, the court strongly rebuked the federal agency for issuing denials after companies followed their guidelines explicitly.
The judgment itself is a riotous read. Consider this zinger: “Then, months after receiving hundreds of thousands of applications predicated on its instructions, FDA turned around, pretended it never gave anyone any instructions about anything, imposed new testing requirements without any notice, and denied all one million flavored e-cigarette applications for failing to predict the agency’s volte face. Worse, after telling manufacturers that their marketing plans were ‘critical’ to their applications, FDA candidly admitted that it did not read a single word of the one million plans.”
That’s about as close to “shut the hell up” as legalese gets.
The End Has No End
After losing in the Fifth, the FDA appealed to the Supreme Court. Some saw it as a bold move, considering the court’s 6-3 Republican supermajority. But the presentation seemed to veer off course quickly.
Many of the justices, even the conservatives, seemed to express sympathy with the FDA. Some questioned why vape companies couldn’t simply spend millions more dollars, do behavioral studies, and re-apply. Others pointed out that because the agency used weasel words when providing guidance (noting that applicant “could provide” behavioral studies but “didn’t expect” them to be necessary), it was well within its rights to deny applications that failed to include such information.
“The hearing was not the best for us,” Finch admits. “We were really hoping the justices would be a little bit more educated on our case with their questions, and they really weren’t, which threw us for a little bit of a loop. Nothing really went as planned. But at the end of the day, Supreme Court cases are decided on briefs, not oral arguments.”
Instead of losing, however, he believes SCOTUS will send the case back down to the Fifth Circuit, affirming its earlier ruling.
“I feel good about it because I feel like I’m on the right side of things,” he said. “If I was to take a guess at what was going to happen, I’d think we will probably get remanded back, and the Fifth Circuit’s opinions will be upheld. I say that because about a week before our hearing in the Supreme Court, we were notified by them that we were on a short list due to the administration change of cases that they deemed could be thrown out because of the new administration’s stances.”
The second Vuse gets approved, we march straight in there. F-ck that. You just approved a product that’s lacking the same thing that you just denied millions of applications for? Absolutely not. That’s not okay.
The stakes are high. If Vapetasia and Triton win, we’ll be in for an influx of American-made flavored vaping products. If they lose, we might be stuck with the (technically illegal) Chinese knockoffs. But more than that, it would be a victory for common sense.
“I just want people to know that there are people out there that care about their businesses and that are fighting to keep them alive,” Finch said. “Obviously I don’t really like going through this process. There was so many times where I just wanted to give up. It just took two guys that were crazy enough to even attempt this and go through it. I don’t fault anybody else for not doing this. This was ridiculous. It was insane. And to subject yourself to something like this… I don’t recommend it.”
“But we started it, and we had to see it through the end. That’s just who we are to our core,” he added. “It’s just the path that we chose to take. I want to keep this thing alive. It’s important to me, and I think it’s important to the benefit of public health as a whole.”
