The United States Supreme Court recently heard oral arguments in FDA v. Wages and White Lion Investments LLC (doing business as Triton Distribution), a pivotal case concerning the Food and Drug Administration rejecting applications to market flavored nicotine vaping devices.
The case is about much more than saving the vaping industry; it is also a landmark case for regulatory accountability related to public health and consumer choice. A decision is expected by the end of the Supreme Court’s term in June.
However, the court’s decision may not matter for the life-saving electronic nicotine-delivery systems (ENDS) market. Once President-elect Donald Trump takes office in January, Triton’s attorney Eric Heyer told the court, the FDA’s policy could change. With a new administration coming in, he explained, “The President-elect is on record saying, ‘I’m going to save flavored vapes;’ we don’t know exactly what that’s going to look like.”
As for the case brought before the court, at issue is whether the FDA acted “arbitrarily and capriciously” when denying numerous premarket tobacco product applications (PMTAs) as alleged by the manufacturers and affirmed by the U.S. Court of Appeals for the 5th Circuit, which accused the FDA of a “regulatory switcheroo.”
Elizabeth Hicks, U.S. affairs analyst for the Consumer Choice Center, stated that the case underscores the need for “fairness and transparency” in regulatory processes. “The FDA’s blanket denials have placed enormous hurdles on firms providing harm-reduction alternatives, potentially decimating an industry that millions of adult consumers rely on to transition away from smoking traditional cigarettes,” she said.
The court heard the FDA’s defense of the agency’s rejection of two companies’ PMTAs to sell flavored vape products that the agency determined pose health risks for young consumers. The justices took up the FDA’s appeal, filed after a lower court ruled that the agency had failed to follow proper legal procedures under federal law when it denied the applications to bring their nicotine-containing products to market.
In January, the full slate of 5th Circuit judges ruled 10-6 that the FDA had been “arbitrary and capricious,” violating a federal law called the Administrative Procedure Act, by denying the applications without considering the companies’ plans to prevent underage access and use. Associate Justice Clarence Thomas called the FDA guidance “a moving target” that shifted throughout the process. Also, Associate Justice Neil Gorsuch stated that applicants were not granted conditions for jury trials in administrative cases, as the court outlined in SEC v. Jarkesy. Gorsuch also wondered if the agency had failed to give applicants fair notice that the rules had changed.
Chief Justice John Roberts asked Deputy Solicitor General Curtis Gannon, the government’s lawyer, whether the government has “an obligation to tell people what they have to do to comply with your regulation.”
Gannon replied that the FDA gave these vaping businesses fair notice that their business model is “risky.” As to the evidence the companies presented, “they were barking up the right tree,” said Gannon, but “they didn’t have sufficient scientific evidence” to satisfy the statute’s requirements.
Justice Elena Kagan said that applicants know that the FDA believes flavored vapes are especially appealing to children and that they need to overcome that presumption in their PMTA submissions.
“I mean, there’s just not a lot of mystery here about what FDA was doing. You might disagree with that because you think that, in fact, the world of 40-year-olds really wants to do blueberry vaping, but you can’t say that FDA hasn’t told you all about what it’s thinking in this respect,” Kagan told Heyer.
Justice Brett Kavanaugh seemed to have sympathy for the FDA’s case. He said it was clear from the outset what the FDA’s position on issuing denial orders was: a focus on the harm to young people that flavored vape products bring. He noted that under the Tobacco Control Act, the FDA has the power to regulate tobacco products with a special focus on youth. If, after weighing the evidence, the FDA rejects an application, “It’s kind of the end of it, isn’t it?” Kavanaugh asked.
Hicks said the FDA’s rejection of Triton’s and Vapetasia’s (a co-respondent) applications demonstrates a failure to balance or even understand public health priorities and opportunities provided by less harmful nicotine products.
“While we all agree on the need to keep these products out of the hands of young people, denying adult smokers access to safer alternatives like flavored vaping devices could have dire consequences for harm-reduction efforts,” Hicks said in a press release. “Regulatory decisions should be evidence-based, not rooted in unachievable or shifting standards that are unreasonable to provide.”
Just before the hearing began, Tony Abboud, executive director of the Vapor Technology Association (VTA), said the court has the opportunity to examine and critique the farcical “wild goose chase” manufacturers have been led on over the years due to the FDA’s illegal and bad-faith actions.
“While VTA eagerly awaits the SCOTUS decision, VTA knows that a favorable ruling will not fix the systemic and ideological failures at FDA,” Abboud said. “VTA will continue to work closely with the incoming Trump administration, which can quickly and decisively end all current litigation—and all future litigation that will follow a SCOTUS decision favorable to industry—by implementing a new tobacco products standard, which establishes clear scientific guidelines for the authorization of products and a real pathway to a broad and diverse U.S. vaping industry.
“[The] Biden FDA’s illegal actions, which have deprived Americans of less harmful nicotine alternatives and are crushing an innovative industry, must be comprehensively addressed immediately through the bold and decisive leadership of President-elect Trump.”
Heyer told the justices that many small vaping companies would be forced to shut their doors without the FDA authorizing more flavors. But Kagan replied that “the difficulty with that, and the FDA, I think, has tried to document this, is that blueberry vapes are very appealing to 16-year-olds not 40-year-olds.”
There is one side issue in the case that could cause the FDA a headache. In their applications, the vaping companies were supposed to lay out what safeguards they had in place—such as requiring retail sellers of vapes to check IDs—to prevent young people from buying nicotine products.
The FDA admits it did not even bother to evaluate these sections of many vaping companies’ applications, and the government doesn’t defend its nonaction on these sections of the applications.
Instead, the government claims its error was harmless. The applications would have been denied anyway because the FDA had already denied other applications proposing similar safeguards against youth vaping.
“I guess, just to tie this up, even if … FDA had given mistaken guidance before, they’re not bound to adhere to the mistaken guidance when they now consider an application, correct?” Kavanaugh asked.
Answering for the FDA, Gannon replied, “I think when you look at the harmless error question in this case … and the court has said that it doesn’t engage in idle and useless formalities. This isn’t supposed to be an endless game of pingpong … We’re not contesting that here. We’re saying to the extent that it was an error, it was harmless because we know what FDA would do.”
The FDA has approved only 34 flavored e-cigarette varieties, all of which are tobacco or menthol-flavored. The agency maintains that it has not categorically banned flavored e-cigarette products. The court has been skeptical of the power of federal regulators overall, including by striking down the so-called Chevron doctrine that had judges deferring to agencies’ interpretation of the law.
Justice Amy Coney Barrett questioned whether the vaping companies wanted the court to take that concept a step further. “It’s almost a reverse Chevron deference, except we’re deferring to the applicant,” she said.
Heyer told Kavanaugh that a ruling reinstating the denial orders would be “punitive” for Triton and Vapetasia. The FDA, he stressed, is taking as long as three or four years to rule on applications for authorization to sell new tobacco products. His clients, Heyer said, “can’t afford to wait that out.”
Gannon urged the justices to reverse the 5th Circuit’s ruling that the FDA should have considered the companies’ marketing plans, which outlined restrictions that would have moderated the risks from e-cigarette products, such as verifying the age of purchasers through online sales. Even if the FDA made a mistake, Gannon told the justices, that error was harmless because the “agency has already concluded that the marketing restrictions wouldn’t have made any difference in keeping these products out of the hands of minors.”
Sending the case back to the FDA for it to reconsider this same issue, Gannon said, would not accomplish anything because the FDA “has already revealed what it would have done here.” Justice Neil Gorsuch appeared to agree, suggesting to Heyer that it was “pretty obvious what will happen on remand with regard to the marketing plans.”
But other justices were not necessarily convinced. Roberts observed that the court’s usual practice when the agency makes a mistake is to send the case back so that the agency can deal with it. Barrett asked Gannon whether, even if the justices had a “pretty high degree of confidence that agency would decide the marketing question the same way,” the court’s cases might nonetheless require it to send the case back to the FDA.
Gannon’s response—that it would not impose a “big burden” for the FDA to review Triton’s and Vapetasia’s applications again—prompted Barrett to observe that the harmless error question was a “pretty low-stakes” issue. Gannon resisted slightly, emphasizing a desire to avoid what he characterized as an “endless game of pingpong” between the courts and the agency.
Toward the end of Heyer’s time at the lectern, Barrett sought to distill his argument. Is your position, she queried, that the FDA’s change in position is clear and “that’s all we would need to decide for you to win?” Heyer answered that it was, but it’s not clear whether five of the justices will agree with him.
