On Monday, the Supreme Court held an outwardly normal oral argument in a high-stakes case about vaping. The bottom line is that the justices seem likely to reject attempts to undermine the Food and Drug Administration’s authority over nicotine vapes.
The case is important not only for what it means for the relationship between the FDA and tobacco companies, but for what it indicates about the future of American law. The question before the court on Monday has come up several times before various lower court judges. And every time, lower courts have ruled in favor of the FDA — except once. That one exit decision, authored by Judge Andy Oldham, a Trump appointee who is considered a strong candidate for the Supreme Court in the incoming administration, should be an opening.
So, while the current panel of justices seems likely to follow existing law and uphold the FDA, Monday’s case at all suggests that the courts are friendlier to efforts to subvert agencies like the FDA if President-elect Donald Trump can fill them in. may be High Court seat.
known as litigation FDA vs. wages and white lion investmentOne stems from a 2009 law that gives the FDA authority to regulate tobacco and other nicotine products. Because the FDA took so long to begin enforcing this law against vaping, many flavored vaping products are now widely available, but the FDA has now begun the process of pulling those products from the market.
According to the 2009 Act, the FDA is supposed to All vaping products are prohibited Unless they are “suitable for protecting public health”. Specifically, the FDA must weigh whether a particular vaping product may cause existing cigarette smokers to “discontinue using such product,” causing new vapers to pick up the habit and become addicted to nicotine.
Armed with this statutory mandate, the FDA approved some tobacco- and menthol-flavored vaping products, while rejecting fruit, candy, or dessert-flavored products. The idea is that vapes that taste like cigarettes might appeal to adult smokers, while vapes that taste like cherry or cinnamon candy might appeal more to teenagers who aren’t yet addicted to nicotine.
white lion Two vaping companies are involved that make products with flavors like “Chewy Clouds Sour Grape,” “Killer Kustard,” and “Suicide Bunny Mother’s Milk and Cookies.” The FDA has rejected these companies’ requests to approve these teen-friendly products.
Both Oldham and the tobacco companies behind the lawsuit argued that the FDA engaged in “regulatory switchbacks” when it allegedly asked vaping companies to submit one type of evidence in their applications for approval of flavored vapes, then rejected those applications for failing to provide a different type. did Evidence But only Justices Clarence Thomas and Samuel Alito were openly present for the argument.
There is a minor aspect to the case that may cause some judges to rule against the FDA on too narrow a basis. But, for the most part, white lion Courts (including judges like Oldham) who can decide which vaping products are legal under the 2009 law, not the FDA, are likely to end up with a perfectly normal decision.
FDA vs. wages and white lion investment Not a hard case
The FDA took a long time to develop its regulation of flavored vapes. The legislation to regulate tobacco products is only 15 years old, and it wasn’t until 2016 that the FDA actually finalized regulations governing vaping. Vaping companies must seek FDA approval for their products by September 9, 2020, or those products will be immediately removed from the market. Companies that met the deadline received an additional grace period to allow them to sell their vapes while the FDA considered their application.
The result is that, while the FDA has actually come close to denying many of these applications (and the FDA says it has denied more than 1 million different vaping product sales applications), there are already plenty of companies selling flavored vapes in the US. . Those companies filed lawsuits once the FDA rejected their applications.
But, with one exception, every court has declined to consider those cases. Eight federal appeals courts heard these vaping cases and rejected seven of them in unanimous opinions. Only the United States Court of Appeals for the Fifth Circuit, the most right-wing of the federal circuit, bought the vaping companies’ arguments. This is part of a pattern in the Fifth Circuit. The Court’s justices — especially Oldham — have consistently handed down decisions that curtail federal agencies’ ability to act, often relying on arguments that have no support in actual law.
It was pretty clear during Monday white lion Oral argument that the argument against the FDA is weak and imprecise. Oldham’s primary argument against the FDA was that the agency had changed its requirements for product approval. Oldham claims the agency first told vaping companies they didn’t need to do two specific types of testing — “randomized controlled trials and longitudinal cohort studies” — and then rejected applications to sell certain vapes because they didn’t include those types of studies.
But it didn’t happen. What the FDA actually said was that companies could submit this type of research, but it would “consider other evidence” that suggests a particular vaping product may be beneficial to public health.
Indeed, many justices were surprised by the suggestion that the FDA had changed its position during the lengthy approval process. “I don’t really see what’s surprising here, or what’s changed here,” Justice Elena Kagan told Eric Hare, a lawyer for the vaping companies. Justice Sonia Sotomayor said she was “perplexed” trying to understand how the FDA changed its position.
Meanwhile, several Republicans on the court also appeared skeptical of Oldham and the vaping company’s arguments. Justice Brett Kavanaugh, for example, expressed confusion about why the case was in federal court in the first place. As he noted, vaping companies want a court order to force the FDA to reconsider their applications. But, as Kavanaugh points out, companies are already allowed to reapply for approval in the event of a denial. So, what exactly, he asked, is the legal issue that needs to be decided by the courts?
Similarly, Justice Amy Coney Barrett criticized Oldham’s conclusion that the FDA’s vague statements should be construed against the agency, at one point asking Hare how the rule might work if it were widely applied.
There is a side issue in this case that could cause headaches for the FDA. In their applications, vaping companies were supposed to outline what safeguards they have in place — such as requiring ID checks at vapes retailers — to prevent young people from buying nicotine products. The FDA admits that it hasn’t even bothered to evaluate these categories of applications by many vaping companies, and the government doesn’t really defend its inaction on these categories of applications.
Instead, the government claims its error was harmless, as the applications would have been denied anyway because the FDA had already denied other applications offering similar protections against youth vaping.
Some of the justices suggested that the case should be sent back to the FDA to give it a chance to fully evaluate these applications. But that suggestion seemed to lose steam as the argument progressed. Even Justice Neil Gorsuch, who often votes on the right side of the court, at one point seemed to agree with the government that it was “clear” the FDA would deny the applications again if the case were sent back to them.
That said, if any part of the case is sent back to the FDA, the agency will take up the question of flavored vapes under a new Trump administration — and Hare was quite honest about what his clients hope they get a new one. Results from the Republican-run FDA.
But, as Kavanaugh points out, nothing prevents vaping companies from reapplying for approval under the Trump administration. So, if Trump and his underlings are determined to legalize flavored vapes, they’ll likely have a chance to do so regardless of what the courts do. white lion.
In any event, it seems highly unlikely that the Court will sign off on Oldham’s approach, or issue a sweeping decision striking down the FDA. For now, at least, some of the most extreme elements within the Supreme Court’s moderate and judiciary appear to be seeing daylight.
