On Monday, the Supreme Court held an ostentatiously normal oral argument in a high-stakes case about vaping. The bottom line is that the justices appear likely to reject an attempt to undermine the Food and Drug Administration’s authority over nicotine vapes.
The case is significant not because of what it means for the relationship between the FDA and tobacco companies, but what it portends about the future of American law. The question the Court considered on Monday has come before various lower court judges many times. And each time, the lower courts ruled in favor of the FDA — except once. That one outlier decision was authored by Judge Andy Oldham, a Trump appointee who is widely considered a strong candidate for the Supreme Court in the incoming administration, should an opening arise.
So, while the current panel of justices appears likely to follow existing law and back the FDA, that Monday’s case exists at all suggests the Court could grow more friendly to attempts to sabotage agencies like the FDA if President-elect Donald Trump gets to fill more seats on the high Court.
The case, known as FDA v. Wages and White Lion Investments, arises out of a 2009 law giving the FDA authority to regulate tobacco and other nicotine products. Because it took a long time for the FDA to start enforcing this law against vapes, many flavored vaping products are now widely available, but FDA has now begun the process of pulling those products from the market.
Under the 2009 law, the FDA is supposed to ban all vaping products unless they are “appropriate for the protection of the public health.” Specifically, the FDA must weigh whether a particular vaping product is likely to cause more existing cigarette smokers to “stop using such products,” than it would cause new vapers to take up the habit and become addicted to nicotine.
Armed with this statutory mandate, the FDA has approved some tobacco- and menthol-flavored vaping products, while rejecting products that are fruit, candy, or dessert-flavored. The idea is that vapes that taste similar to cigarettes are likely to appeal to adult smokers, while vapes that taste like cherries or cinnamon candy are more likely to appeal to teenagers who aren’t yet addicted to nicotine.
White Lion involves two vaping companies that make products with flavors like “Chewy Clouds Sour Grape,” “Killer Kustard,” and “Suicide Bunny Mother’s Milk and Cookies.” The FDA rejected these companies’ request to approve these teen-friendly products.
Oldham and the tobacco companies behind the case both argued that the FDA engaged in “regulatory switcheroos” when it allegedly told vaping companies to submit one kind of evidence in their applications seeking approval of flavored vapes then rejected those applications for failing to provide a different kind of evidence. But only Justices Clarence Thomas and Samuel Alito appeared open to this argument.
There is a minor side issue in the case that could give some of the justices a reason to rule against the FDA on very narrow grounds. But, for the most part, White Lion appears likely to end in a perfectly normal decision holding that the FDA, and not the courts (including judges like Oldham), gets to decide which vaping products are legal under the 2009 law.
FDA v. Wages and White Lion Investments is not a hard case
The FDA took a long time to roll out its regulations of flavored vapes. The law permitting it to regulate tobacco products at all is only 15 years old, and the FDA did not actually finalize its regulations governing vapes until 2016. Vaping companies were required to seek FDA approval of their products by September 9, 2020, or else those products would be immediately removed from the market. Companies that met the deadline received an additional grace period allowing them to sell their vapes while the FDA considered their application.
The result was that, by the time FDA actually got around to denying many of those applications (and the FDA says it has denied applications to sell over 1 million different vaping products), there were plenty of companies already selling flavored vapes in the United States. Those companies filed a flurry of lawsuits once the FDA denied their applications.
But, with one exception, every court to consider those lawsuits rejected them. Eight federal appeals courts heard these vaping cases, and seven of them rejected them in unanimous opinions. Only the United States Court of Appeals for the Fifth Circuit, the most right-wing of the federal circuits, bought the vaping companies’ arguments. This is part of a pattern in the Fifth Circuit. The court’s judges — Oldham in particular — have consistently handed down decisions undermining federal agencies’ ability to function, often relying on arguments that have no support in actual law.
It was pretty clear during Monday’s White Lion oral argument that the arguments against FDA are weak and imprecise. Oldham’s primary argument against the FDA was that the agency changed its requirements for product approval. Oldham claims the agency first told vaping companies they are not required to conduct two specific kinds of experiments — “randomized controlled trials and longitudinal cohort studies” — and then rejected applications to sell certain vapes because they did not include these kinds of studies.
But that’s not what happened. What the FDA actually said was that the companies “could have” submitted these kinds of studies, but it would also “consider other evidence” suggesting that a particular vaping product was likely to benefit the public health.
Indeed, many of the justices appeared baffled by the suggestion that FDA changed its position during the long approval process. “I’m not really seeing what the surprise is here, or what the change is here,” Justice Elena Kagan told Eric Heyer, the lawyer for the vaping companies. Justice Sonia Sotomayor said she’s “at a loss” trying to understand how the FDA switched its position.
Meanwhile, several of the Court’s Republicans also seemed skeptical of Oldham and the vaping companies’ arguments. Justice Brett Kavanaugh, for example, expressed confusion about why the case is in federal court in the first place. As he pointed out, the vaping companies seek a court order requiring the FDA to reconsider their applications. But, as Kavanaugh noted, the companies are already allowed to reapply for approval in the event of a rejection. So what, exactly, he asked, is the legal issue the courts need to decide?
Similarly, Justice Amy Coney Barrett criticized Oldham’s conclusion that ambiguous statements by the FDA must be construed against the agency, at one point asking Heyer how that rule could possibly work if applied broadly.
There is one side issue in the case that could cause a headache for the FDA. 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 really defend its non-action on these sections of the applications.
Instead, the government claims its error was harmless, because the applications would have been denied anyway because the FDA had already denied other applications proposing similar safeguards against youth vaping.
A few justices suggested that maybe the case should be sent back to the FDA to give them an opportunity to evaluate these applications in full. But that suggestion seemed to lose steam as the argument proceeded. Even Justice Neil Gorsuch, who often votes with the Court’s rightmost flank, at one point seemed to agree with the government that it is “obvious” the FDA will just deny the applications again if the case is sent back to them.
That said, if any part of this case is sent back to the FDA, the agency will take up the question of flavored vapes under a new Trump administration — and Heyer was quite honest about the fact that his clients are hoping they would get a new result from a Republican-run FDA.
But, as Kavanaugh pointed out, nothing prevents the vaping companies from reapplying for approval under the Trump administration anyway. So, if Trump and his subordinates are determined to legalize flavored vapes, they will potentially have an opportunity to do so no matter what the Court does in White Lion.
In any event, it seems very unlikely that the Court will sign onto Oldham’s approach, or hand down a broad decision disabling the FDA. For now, at least, there appears to be some daylight between the median justice on the Supreme Court, and the most extreme elements within the judiciary.
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