FDA v. Wages and White Lion Investments, which the Supreme Court will hear on the first Monday in December, is a significant case in its own right. It involves the Food and Drug Administration’s long-delayed attempt to regulate flavored nicotine vapes and to prevent children from becoming addicted to nicotine because they are enticed by vapes with fruit or candy flavors.
But the case is also significant for another reason. Seven federal appeals courts unanimously rejected legal challenges to the FDA’s decision not to authorize certain flavored vapes and e-cigarettes. Only one outlier court, the United States Court of Appeals for the Fifth Circuit, took a position that is unusually favorable to tobacco companies, which led us to this Supreme Court case.
The Fifth Circuit is the most right-wing appeals court in the federal system — and is notorious for its contrarian decisions. Post 2024 election, it is a particularly important court to watch, as it is also considered a breeding ground for potential Trump nominees to the Supreme Court.
One of its judges, Andrew Oldham, is the author of the Fifth Circuit’s decision in White Lion. Oldham is widely considered a strong contender for a Supreme Court nomination if an opening arises in the incoming Trump administration, especially if his former boss, Justice Samuel Alito, retires.
In his White Lion opinion, Oldham claims that the FDA botched its decision to effectively pull several fruit- and candy-flavored nicotine vapes from the market, and must run through its decision process again. If it were to do so, the agency could reach a different result on flavored vapes: It will have new leadership in the Trump administration.
There are two things to know about Oldham’s opinion. One, it appears to have been written not just to sabotage the FDA’s regulation of vaping but to drastically undercut the federal government’s ability to perform all sorts of routine and uncontroversial actions. If the Supreme Court accepted his arguments, they’d greatly undermine the federal government’s ability to regulate businesses and communicate with the public.
Two, Oldham’s opinion is very sloppy: It takes significant liberties with the law and is riddled with very basic factual errors. In fact, shortly after it was handed down, one of the tobacco companies that prevailed in Oldham’s court filed a brief motion pointing out one of these factual errors and asking the court to “amend, modify, or otherwise clarify” Oldham’s opinion to remove this misstatement of fact (the court refused to do so).
All of that means White Lion is significant for three reasons. It is likely to reveal whether the Supreme Court will allow judges to sabotage attempts to regulate tobacco that are authorized by federal law. It shines a light on a prominent Trump judge who may soon become one of the most powerful people in the United States. And it places the justices in the awkward position of reviewing some truly shoddy work by someone who could soon become one of their colleagues.
Though the Supreme Court is very conservative, with a 6-3 Republican supermajority, it is likely that even this Court will reverse Oldham’s White Lion decision. Neither the Fifth Circuit, nor Oldham in particular, have a particularly strong record when their decisions are reviewed by the Supreme Court. Additionally, seven federal appeals courts other than the Fifth Circuit have considered the same legal question presented in White Lion, and every single judge that heard those cases rejected Oldham’s reasoning.
Still, it’s important to remember that this is the same Supreme Court that recently held that Trump is allowed to use the powers of the presidency to commit crimes, so there’s no guarantee that a majority of the justices will follow existing law in White Lion, no matter how clear that law may be.
So what are the rules governing flavored vapes?
White Lion arises out of the FDA’s effort to rein in youth vaping long after, as Trump’s own FDA commissioner said in 2019, the US saw an “epidemic-level rise in youth e-cigarette use.”
Congress did not pass a law permitting the FDA to regulate tobacco until 2009, and the FDA didn’t finalize its regulations allowing it to regulate vapes until 2016. Those regulations, moreover, only gradually rolled out enforcement of the new restrictions on vapes, and litigation delayed matters even further.
In the end, companies that wished to sell vaping products were required to seek FDA approval of those products by September 9, 2020, or else those products were to be removed from the market. Companies that met this application deadline were given an additional grace period when they could still market their product in the US while the FDA considered their application.
The result is that flavored vapes are now everywhere, and the FDA is stuck playing catch up. The White Lion case involves the FDA’s decision not to allow two companies to sell vapes with flavors that seem designed to appeal to children and teens, such as “Chewy Clouds Sour Grape,” “Killer Kustard,” and “Suicide Bunny Mother’s Milk and Cookies.”
Despite the law’s slow rollout, it imposes strict regulations on “new” tobacco products, which it defines as any such product “that was not commercially marketed in the United States as of February 15, 2007,” or any modification to a tobacco product marketed after this date. Flavored vapes count as such a “new” product.
Under the law, the FDA “shall deny an application” seeking to market such a product unless it determines that permitting a particular vape to remain on the market is “appropriate for the protection of the public health.” To make this determination, the FDA must weigh whether permitting a particular vaping device to be sold would cause more existing smokers to “stop using such products” than it would cause “those who do not use tobacco products” to “start using such products.”
Armed with this statutory mandate, the FDA has approved vaping products that it believes are likely to convert tobacco smokers into vapers, on the theory that vaping is less dangerous than smoking. But it has rejected products that it believes are likely to encourage people who do not currently use nicotine — and especially children and teens who do not vape — to take up the habit.
Specifically, the FDA approved several vaping products that taste similar to cigarettes, believing that adult smokers may prefer these less-dangerous products over smoking. Most of the FDA-approved flavored vapes are tobacco flavored, but the FDA also recently approved a handful of menthol-flavored vapes as well (menthol is a common flavor in cigarettes).
At the same time, the FDA has thus far rejected applications to market fruit-flavored, candy-flavored, or other sweet-tasting vapes, pointing to data showing that these products are especially likely to appeal to children and teens.
All of this said, the FDA has not issued a blanket rule forbidding fruit-flavored vapes or approving tobacco-flavored ones. Instead, anyone who wishes to sell a vaping product in the United States must submit an individualized application to the FDA, which must lay out the evidence that their product is likely to convert adult smokers into vapers without encouraging new people to take up vaping.
So it is at least theoretically possible that someone could develop a cherry-flavored vape that is unusually unattractive to teens and earn FDA approval.
So how did Andy Oldham wind up getting involved?
After the FDA started denying applications to sell flavored vapes, lawsuits abounded. For the moment, however, every single judge who does not sit in the Fifth Circuit rejected Oldham’s arguments that the FDA broke the law when it denied these applications. (The one possible exception is the Eleventh Circuit, which ruled in favor of a vaping company in Bidi Vapor v. FDA (2022). Bidi Vapor, however, was a narrow opinion that turned on facts specific to that case.)
Oldham and his court, meanwhile, claim to have found five separate legal flaws in the FDA’s decision to reject flavored vapes that every other judge this issue came before missed.
Oldham devotes the bulk of his opinion to a single argument: He claims that the FDA broke the law because it told vaping companies to submit one kind of evidence when they applied for FDA approval of their products, and then the FDA did a “regulatory switcheroo” and denied those applications for failing to present a different kind of evidence. However, in reaching this conclusion, Oldham misstates the law and makes factual errors that undermine the entire premise of his opinion.
Oldham’s primary argument, for example, is that the FDA engaged in a “switcheroo” because it previously told vaping companies that it “does not expect that applicants will have to conduct long-term studies to support an application,” then later decided to impose “two requirements—randomized controlled trials and longitudinal cohort studies.” (A “longitudinal cohort study” is one that follows a large group of test subjects over a long time.)
But this claim is obviously false. Here’s what the FDA actually said when it denied the applications at issue in White Lion:
In light of the known risks to youth of marketing flavored [vaping products], robust and reliable evidence is needed regarding the magnitude of the potential benefit to adult smokers. This evidence could have been provided using a randomized controlled trial and/or longitudinal cohort study that demonstrated the benefit of your flavored [vaping] products over an appropriate comparator tobacco-flavored [product]. Alternatively, FDA would consider other evidence but only if it reliably and robustly evaluated the impact of the new flavored vs. Tobacco-flavored products on adult smokers’ switching or cigarette reduction over time.
The FDA, in other words, very clearly did not say that applicants must submit “randomized controlled trials and longitudinal cohort studies,” as Oldham claims. It said that applicants “could have provided” these kinds of studies. But the FDA also “would consider other evidence.”
Elsewhere in his opinion, Oldham tries to impose a new legal obligation on federal agencies that would severely undermine their ability to function and communicate with the public.
During the period between 2016, when the FDA issued its initial rule announcing that it would regulate vapes, and when the agency actually started to grant or deny applications to sell certain vaping products, the agency also released several nonbinding “guidance” documents. These documents provided vaping companies with some information on the agency’s thinking on the product approval process, and offered them advice on how to assemble a successful application.
These sorts of guidance documents do not have the force of law, but agencies of all kinds frequently release them to advise the public about the agency’s internal thinking, and to help companies anticipate what sort of actions could get them in trouble with the federal government.
Oldham claims that the vaping companies should prevail because these documents “could be read in good faith” to support those companies’ position, even though these documents are nonbinding and the agency itself rejects the companies’ interpretation of these documents. As Oldham writes, “for FDA to prevail, not only must its understanding of the [guidance documents] be reasonable, but the manufacturers’ understanding of those [documents] also must be unreasonable.”
Oldham, in other words, would permit regulated businesses to comb through every nonbinding statement an agency has ever made, looking for phrases that could plausibly be interpreted to undermine the agency, and then insist that such a contested interpretation of a nonbinding document must bind the agency.
As the Justice Department points out in its brief, Oldham’s rule would create a perverse incentive for agencies that would hurt regulated businesses in the long run. Right now, agencies routinely release guidance documents in order to “furnish private parties with useful advice about how the agency interprets the law and how it plans to exercise its discretion.” But if those documents can be weaponized against the agency in the way Oldham suggests, that “discourages agencies from providing guidance in the first place—an outcome that, in the long run, harms rather than helps regulated parties.”
If you want to read a more comprehensive catalog of Oldham’s many missteps, I encourage you to read the Justice Department’s brief. It exposes an opinion riddled with errors of all kinds, many of which are obvious to anyone familiar with the facts of this case.
The poorly reasoned White Lion opinion is typical of Oldham’s work
Everyone, including federal judges, has bad days at the office. So if White Lion were an isolated example of Oldham releasing a shoddy opinion, it could probably be overlooked.
But White Lion is by no means an isolated case. It is, in fact, quite typical of Oldham’s work.
Shortly before the election, for example, Oldham handed down an opinion in Republican National Committee v. Wetzel, which claims that an 1872 law setting the date when federal elections take place forbids states from counting mailed ballots that arrive after Election Day — and that somehow no one noticed this fact for the last 152 years.
Ordinarily, after mentioning a judge’s opinion, I would attempt to summarize its reasoning, but it is hard to even say what Oldham’s argument is. As I wrote shortly after the decision was handed down, he appears to have simply made up some of his conclusions — and he cites no legal authority whatsoever to support key contentions.
Or take Oldham’s opinion in NetChoice v. Paxton (2022), where Oldham upheld a state law that would have placed the Texas government in charge of content moderation at the major social media outlets. This law is obviously unconstitutional — the First Amendment does not permit the government to seize control of the media’s editorial decisions — and the Supreme Court rejected Oldham’s approach in a 6-3 decision.
Oldham also joined two opinions threatening the continued existence of two entire federal agencies, the Federal Housing Finance Agency and the Consumer Financial Protection Bureau. If the Supreme Court had adopted Oldham’s position in either case, it would have so severely disrupted the US housing market that it could have triggered the worst economic catastrophe since the Great Depression. Fortunately, the justices rejected Oldham’s position in each case, and by a lopsided margin.
At least on the surface, Oldham appears conventionally qualified for the Supreme Court. He graduated from Harvard Law School, clerked for Alito, and is a sitting US Court of Appeals judge. But his record on the bench reveals someone who is reckless with power, often not even really bothering to explain the reasoning behind his opinions.
Nevertheless, by all outward signs, he is a strong contender for the high Court in the incoming Trump administration. Among other things, the Federalist Society, which played an enormous role in selecting Trump’s judicial nominees during his first term, just made Oldham the opening speaker at its annual lawyers convention. That’s a plum speaking gig for any judge campaigning for higher office.
If he does achieve such office, Oldham’s uniquely careless approach to legal analysis could shape US law for a very long time. Oldham is in his mid-40s, so he could potentially serve on the Supreme Court for several decades if appointed.
