Teen vaping hits a decade-low. Could Supreme Court review of flavored vapes reverse this?
The FDA says flavored vapes pose a greater risk of hooking a new generation on nicotine than the potential benefit of helping conventional smokers switch.
WASHINGTON −Six years after teen vaping was declared an epidemic, the use of e-cigarettes by young people has declined to its lowest level in a decade.
“That’s a big deal,” Health and Human Services Secretary Xavier Becerra said in September when announcing usage had dropped to 6% among middle and high school students.
Now the Supreme Court will hear oral arguments on Monday about whether one of the moves that contributed to that decline – the federal government’s blocking of millions of e-cigarette products with flavors like “Jimmy the Juice Man Peachy Strawberry,” “Killer Kustard,” and “Iced Pineapple Express” – was correctly handled.
Makers of flavored e-liquids argue the Food and Drug Administration improperly changed the rules midstream on how the products would be evaluated.
“FDA’s regulatory regime has been anything but reasonable,” a group of businesses and trade associations representing the industry told the court.
The FDA contends the manufacturers failed to show their products were more likely to help existing smokers switch to vaping than to hook another generation of Americans on nicotine.
“That common-sense determination was not arbitrary and capricious,” Solicitor General Elizabeth Prelogar wrote in a filing.
But if the justices disagree and direct the FDA to reconsider the products, the manufacturers could find a friendlier regulatory environment under the incoming Trump administration.
In a recent social media post, President-elect Donald Trump said he “saved” flavored vaping during his first administration and will do it again after he returns to the White House in January.
E-cigarettes are nicotine product of choice for teens
E-cigarettes, which were developed in China, began appearing in the U.S. market in the mid-2000s. The battery-operated devices heat a liquid containing nicotine into aerosol that the user inhales.
While vaping produces fewer toxic chemicals than traditional cigarettes, it’s still not safe.
Nicotine, in addition to being highly addictive, can harm brain development. The aerosol can also contain cancer-causing chemicals, heavy metals and ultrafine particles that are damaging when inhaled deeply.
By 2015, e-cigarettes had taken over traditional cigarettes as the nicotine product of choice about U.S. high school students, according to the Center for Disease Control and Prevention’s National Youth Tobacco Survey.
When the surgeon general, in 2018, declared teen vaping an epidemic, one in five high school students reported having used e-cigarettes. Usage was increasing faster than for any previous substance.
“I thought I was just enjoying the flavors, but soon my 14-year-old brain craved the nicotine more and more,” Josephine Shapiro, a high school senior from Seattle, Washington, testified before a Senate committee in June. “I’ve tried to quite vaping over and over again, but it is really hard.”
At the same hearing, the head of the leading vapor industry trade association, said youth vaping in the U.S. is “dramatically resolved.”
FDA first sued for not moving fast enough
In 2019, Trump signed legislation raising the federal minimum age for sale of tobacco products from 18 to 21 years.
But he also weakened a plan to crack down on flavored e-cigarettes, allowing exceptions that benefited manufactures, retailers and adults.
Public health groups had already sued the FDA for not moving fast enough to review the products after the agency, in 2016, finalized rules for regulating them under the 2009 Family Smoking Prevention and Tobacco Control Act.
That led to a court-imposed deadline of September 2020 for companies to submit marketing applications.
The FDA has since approved fewer than three dozen e-cigarette products, most of them tobacco flavored which, the government said, is of low interest to young people.
Because it’s rejected more than a million products flavored to taste like fruit, candy or desserts, companies claim the FDA has imposed a de facto ban on those versions and isn't properly evaluating their products.
Most appeals courts have sided with FDA
Seven federal appeals courts rejected that argument. But the New Orleans-based 5th U.S. Circuit Court of Appeals – arguably the most conservative federal appeals court – sided with two companies, Triton Distribution and Vapetasia LLC.
The court said the FDA sent manufacturers "on a wild goose chase."
After the companies "spent untold millions" to comply with the approval process, the appeals court said, the FDA "imposed new testing requirements without any notice."
The court also faulted the FDA for dismissing out-of-hand companies’ strategies to keep their products away from minors because, the agency said, such efforts haven’t proven to be effective.
The government says the appeals court misread both the record and the regulatory rules agencies must follow.
The FDA contends it correctly applied the Tobacco Control Act, which says the agency must consider both the “likelihood that existing users of tobacco products will stop using such products” and the “likelihood that those who do not use tobacco products will start using such products.”
The companies didn’t show, the FDA says, that their products are better than tobacco-flavored e-cigarettes in helping smokers switch without attracting new tobacco users.
Case is `the whole banana' for e-cigarette industry
The Supreme Court’s conservative majority has not been hesitant to rein in agencies’ regulatory authority. But Marc Scheineson, a former associate FDA commissioner now at Alston & Bird where he’s helped small tobacco companies deal with the agency, said he’s not sure how the justices will rule.
“The court hasn't been a great supporter of FDA, but tobacco and industry isn't favored either normally,” he said of the high stakes. “To the industry, this is the whole banana, so to speak.”
Public health groups worry that if the Supreme Court sides against the FDA, that will reverse the progress made in taking vaping products off the market and will make it easier to approve new ones.
But if the FDA, under the Trump administration, takes a different approach to reviewing the products, Dennis Henigan of the Campaign for Tobacco-Free Kids, said there are legal guardrails the FDA can’t overrun without finding themselves back in court.
“We will be prepared to enforce those guardrails,” Hennigan said, “just as we were in the first Trump administration.”