Legal Docket: Vaping on trial

NICK EICHER, HOST: If you didn’t know this song, I’d be surprised if you didn’t know of it.

Smokin’ in the Boys’ Room was a hit in 1973, undoubtedly the biggest song Brownsville Station ever did.

SOUND: But everybody knows that smokin’ ain’t allowed in school.

The rock band Motley Crüe covered it in 1985 and gave it a heavy metal edge.

It was something of an anthem of teenage rebellion, when lighting up in the school bathroom was practically a teenage cliché.

Today, school administrators have replaced “No Smoking” signs with vaping detectors and hallway monitors. Different era, same problem: Teens craving nicotine—only now it’s fruit-flavored vapes.

Today, we’ll talk about two Supreme Court cases on e-cigarettes—products said to be designed to help adult smokers quit, but accused of sparking a teen vaping epidemic

It’s Monday, January 27 and you’re listening to The World and Everything in It from listener-supported WORLD Radio. Good morning! I’m Nick Eicher.

JENNY ROUGH, HOST: And I’m Jenny Rough. Time now for Legal Docket.

Vaping may not be allowed in the boys’ room, but that just makes it more enticing.

JOSEPH: Well, I know it’s a thing. I know that kids are doing it. They’re doing it all over the place, including bathrooms at schools. It’s like an epidemic.

Jim Joseph is a father of three teens. When he visited his daughter’s high school in Reston, Virginia, he was startled to find a faculty member stationed near the restroom.

JOSEPH: And I saw a woman sitting at a desk outside of the bathrooms. And I asked her, “What are you doing out here?” She said, “I’m monitoring the bathroom.” This is high school kids and they’ve got a monitor out there just in case kids are in there too long, or she sees something or smells something, she runs in there and checks on them. They’ve had to staff up for this. It’s crazy.

But kids tend to find a way around it. Jennifer Cannon lives in New Jersey and distinctly remembers the day her daughter came home from school.

CANNON: She said, “Yeah, I was in the bathroom today, and I came out of the stall, and this girl, ‘cause the kids would go to the bathroom to sneak and vape, said, ‘Hey, do you hit nic?’” And my daughter said, “Who’s Nick?” … My daughter, literally, it didn’t occur to her that she wanted to hit her vape, as the kids say.

Believe it or not, back in the 1970s, some kids didn’t even have to sneak.

SISTARE: I’m old enough that, in school, we had a smoking court in high school.

Billy Sistare attended high school in North Carolina, a leading tobacco exporter. Smoking court was where you smoked … not where you got in trouble for smoking.

SISTAIRE: You could actually go outside and smoke in the smoking court. Most of the schools back then had smoking courts.

Sistare picked up the habit.

SISTAIRE: I started smoking probably when I was 14. My mom smoked, and I just started kind of stealing some of hers.

By his 50s, he smoked a pack-and-a-half a day. Real cigarettes. Paper, filter, tobacco, fire.

Three years ago, he wanted to quit.

SISTAIRE: So I started trying to vape to wean myself off of it.

It worked. Today, he vapes about one e-cigarette a week. That’s the equivalent of about a pack of conventional cigarettes a week. And he’s lost his taste for tobacco. He prefers other flavors.

SISTAIRE: Blue razz-ice and blueberry, a lot of blueberry flavors are my go-to thing.

EICHER: Now, that’s the crux of these two Supreme Court cases we’re covering today: Companies claim flavored vapes help adults quit smoking by providing an alternative to real cigarettes. But the Food and Drug Administration worries the sweet flavors get a new generation hooked on nicotine.

A federal law called the Family Smoking Prevention and Tobacco Control Act requires any new tobacco product to get FDA approval first. The FDA weighs whether the benefits outweigh the risks—especially the risk of teen addiction.

ROUGH:In the first case, two companies asked the FDA for permission to sell fruit, candy, and dessert-flavored vaping products.

The FDA said no. Its rationale was that the companies hadn’t shown enough scientific evidence that the benefits of helping adults quit outweigh the risk of tempting teens.

The companies sued and in the Fifth Circuit Court of Appeals, they won. The Fifth Circuit said the FDA sent the companies on what it called a “wild goose chase”: Hinting at one set of requirements, then changing course. To the court, that’s arbitrary and capricious, to use the legal term of art. Agencies are prohibited by law from acting in an arbitrary and capricious manner.

The FDA appealed to the Supreme Court, where Deputy Solicitor General Curtis Gannon argued there was no flip-flopping.

He said the agency has always required good science.

GANNON: An applicant must show the marketing of its product would be appropriate for the protection of the public health. … Respondents’ nicotine solutions for e-cigarettes are flavored to taste like fruit, candy, or various desserts.

EICHER: Flavors like Pink Lemonade, Chewy Clouds Sour Grape, and Killer Kustard, “custard” with a “K.” Marketing.

Justice Clarence Thomas asked government lawyer Gannon about the switching standards.

THOMAS: Well, in fairness to Respondents, I think their argument is that the guidance were actually a moving target, that either they weren’t clear, or you changed the guidance as time went on.

GANNON: That is their argument, Justice Thomas, but I think that the key point is that they knew from the statute that they needed to be making this comparison about what the benefits were with respect to existing smokers and weighing that against the potential costs with respect to non-smokers and attracting youth.

Justice Ketanji Brown Jackson wanted clarity on the FDA’s analysis of the pros and cons of the flavored e-liquids.

JACKSON: So the statute plainly requires the agency to evaluate benefits and harms. So can you just speak for a moment about why flavored e-cigarettes are more harmful than unflavored from the government's perspective?

GANNON: Flavors are attracting youth into smoking when they are non-users. Congress said that we need to evaluate the likelihood that non-users are going to start using tobacco products. The concern would be that they're getting addicted to nicotine at a time when nicotine is dangerous to their developing brains and may be, you know, sentencing them to a long life of needing to satisfy that addiction.

ROUGH: Attorney Eric Heyer argued for the two companies. He tried to hammer home the point that the FDA kept changing its position.

HEYER: Before, FDA said, quote, no specific studies are required for an application. After, FDA denied applications for over one million products and over 250 applicants because they lacked a randomized control trial, a longitudinal cohort study, or some "other evidence." FDA’s denial orders suffer from multiple flaws.

But Justice Elena Kagan thought the FDA adequately warned the applicants from the get-go to think hard about flavors, and the companies simply could not convince the agency they were necessary.

I’ve condensed this exchange between Justice Kagan and corporate lawyer Heyer.

KAGAN: Everybody basically knows that flavors are particularly dangerous in terms of kids starting the use of smoking products.

HEYER: I respectfully dispute the fact that everybody knows this and everybody knows that.

KAGAN: Well, you that that, I mean, FDA has been completely upfront about this. Blueberry vapes are very appealing to 16-year-olds, not to 40-year-olds.

HEYER: I respectfully disagree, your Honor.

KAGAN: No, I'm not saying that you don't have a point of view on that question. I mean, there’s just not a lot of mystery here about what the FDA was doing.

HEYER: Well—

KAGAN: 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.

EICHER: Justice Sonia Sotomayor followed up on that. She pointed to the statute’s language to show it plainly lays out what’s required.

SOTOMAYOR: this is the statute speaking. This is not them. This is not a policy. This is not a guideline. Tell us that your product is going to help adults stop smoking cigarettes and show us that youth is not going to start.

EYER: Often the quitting journey is to move away from tobacco or menthol flavors because they don't want to be reminded of the combustible cigarettes. They want to move to these other options to be quit and to stay quit.

ROUGH: Nine in 10 adults who smoke picked up the habit in their teens. But even if the Court validates the FDA’s process here, the companies can always reapply.

The corporation involved in this case is Triton Distribution. It’s based in Texas. That’s within the Fifth Circuit. So when Triton initially appealed the FDA’s denial, it did so in the right venue. In the legal context, this means simply that it filed its appeal in the right place.

And the question of venue brings us to a second vaping case.

EICHER: Now this one is a little different. It involves RJ Reynolds Vapor Company. Because Reynolds is headquartered in North Carolina—it can’t file in the more favorable Fifth Circuit. The applicable law is particular about “venue.” It says if you want to appeal an FDA denial, you have to do it either in the D.C. Circuit or in the circuit where the company resides.

So RJ Reynolds Vapor convinced a couple of its Texas and Mississippi retailers to join its appeal. That would put it in the Fifth Circuit.

ROUGH: The FDA is fighting that move, arguing non-applicant retailers don’t have the right to challenge the denials. Yet the law does say that “any person adversely affected” by an FDA denial has a right to appeal.

Vivek Suri represented the FDA in this case and gave a masterful presentation, I noticed he didn’t even bring notes to the lectern. But the justices seemed suspicious of his argument that the retailers don’t belong; that the manufacturer is just riding their coattails. Here’s Justice Brett Kavanaugh.

KAVANAUGH: I mean, the retailer is losing money. And financial injury certainly sounds like adverse effect under any, as you would say, ordinary understanding of the term

And that’s this week’s Legal Docket.

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