Millions of American youth are hooked on nicotine—and politicians tore into top public health officials during a contentious hearing Wednesday on the meteoric rise of illegal e-cigarettes.
Particularly, the senators blamed the Food and Drug Administration (FDA) and the Department of Justice (DOJ) for not enforcing the Tobacco Control Act, which authorizes federal agencies to regulate tobacco products.
“While these two agencies sit on their hands, during both the Trump and Biden administrations, e-cigarette companies addicted a new generation of children to nicotine, erasing the hard work so many of us did to convince them not to smoke tobacco cigarettes, and ultimately save their lives,” Judiciary Chairman Dick Durbin (D-IL) said during his opening remarks.
Frustration was a bipartisan emotion during the hearing, where senators yelled, pointed, and cursed in their questioning. Much of the anger pointed toward a flood of illegal disposable vapes from China, which come in flavors and colors attractive to youth.
Twice as many high school and middle school students are using e-cigarettes than adults, Durbin said during the hearing. The disposable vapes, which come in flavors like blueberry ice and watermelon bubble gum, don’t fulfill their marketed promise of helping existing smokers cease, but rather pull in a new crowd of vapers, he added.
Key to Durbin’s ire was a missed deadline. The FDA was required to complete a review of every product on its docket by September 9, 2021, via a court order from the District Court of Maryland. After the deadline passed, the FDA could have ordered every unauthorized e-cigarette off the market, but it didn’t.
“Instead, these unauthorized e-cigarettes flooded the market, designed to and effectively addicting millions of young Americans,” Durbin said.
‘How is that allowed to happen?’
In the last three years, 2.1 million children have picked up vaping, according to a study by the NIH. As proof, Durbin trotted out an enlarged photograph of a selection of vapes at a smoke shop less than a mile away from the FDA’s Maryland headquarters.
““These illegal products, clearly designed for children by their flavors, are being sold in the shadow of FDA’s building,” Durbin said. “How is that allowed to happen?”
Brian King, the director of the FDA’s Center for Tobacco Products, blamed the lack of enforcement on a massive backlog of applications that tobacco products have submitted for FDA approval—27 million applications, as of this week.
FDA approval for tobacco products is extraordinarily rare – the agency has only approved one-thousandth of one percent of all e-cigarette applications it has received, and none in two years, Sen. Thom Tillis (R-N.C.) said during the hearing. Only 23 vape products are considered FDA approved and legal: all other products, including established giants such as Juul, are being sold illegally, he said.
However, these products are thriving in the market, a point which prompted a heated exchange between Deputy Assistant Attorney General Arun Rao, representing the justice department, and Durbin.
“Mr. Rao, are these tobacco company lawyers beating you to death, to the point where you don’t enforce the law as it is written?” Durbin snarked. “You call this an urgent need. What is urgent about waiting three years and doing nothing?”
Rao replied that the executive branch is signaling aggressive enforcement, but Durbin cut him off.
“I’m sorry, I’m against signals,” Durbin said. “Do something!”
Rao said that the department stood ready to fine unlawful tobacco companies and had begun seizing illicit products—but Durbin cut him off again.
“You’re failing!” Durbin said, pointing to the photograph of the Maryland smoke shop’s disposable vape selection. “Within a mile of the FDA, there’s evidence of your failures.”
High school student Josie Shapiro also spoke during the hearing, testifying about the effects nicotine addiction had on her. She started vaping when she was 14 years old.
“The effect that nicotine had on my mind was intense and scary,” she said. “I felt completely helpless, out of control and alone.”
New task force
The hearing comes during a busy week for the FDA’s tobacco regulators. On Monday, the agency announced a multi-agency task force to combat the meteoric rise of illegal e-cigarettes.
Four other federal agencies will be involved in the task force, including the Federal Trade Commission (FTC) and the U.S. Postal Inspection Service.
Tillis called the creation of the task force a “political stunt,” and said that the exclusion of Customs and Border Protection makes it “crystal clear” that the FDA is not serious about enforcing laws against e-cigarettes. (The state he represents, North Carolina, is the U.S.’ largest tobacco producer.)
The criticism comes amid a war that King has almost single-handedly been battling against an influx of illegal flavored disposable vapes.
Of the youth who currently use e-cigarettes, 90% use flavored products, with popular brands such as Elf Bar and Esco Bar dominating the market, according to 2023 FDA data.
Beyond teens, disposable vapes have also dominated the young adult market. One-third of British 18-to-24-year-olds adults are hooked on nicotine, with research suggesting that the disposable vapes created a market among young people who wouldn’t have otherwise smoked.
The FDA has attempted to impose import bans on these products; however, vape companies maneuver around the orders with ease. For example, Shenzhen iMiracle, the privately owned Chinese company that manufactures fan-favorite Elf Bar, simply changed the name of the product when regulators cracked down. Now, you can purchase “EB Create” products in flavors such as orange creamsicle and watermelon ice.
Shenzhen iMiracle generated around $3.5 to $4 billion last year from EB Create, Elf Bar, Lost Mary, and other e-cigarette products, while brick-and-mortar sellers retained 30% of their profits from the brand.
To date, the FDA has issued a number of warning letters to domestic manufacturers of vapes, in addition to the import bans. However, the inclusion of the U.S. Postal Inspection Service in the new task force signals that the federal government is ready to take a stronger stance against illegal vape imports.
Juul Labs comes back to market
The government’s announcement comes only a few days after the FDA rescinded its marketing ban on Juul Labs.
It has been nearly two years since the federal health agency ordered Juul’s e-cigarettes and vaping products off the market. At the time, the FDA said that Juul “lacked sufficient evidence” and had “conflicting data” that its products were appropriate for the protection of public health.
Juul has continuously argued that its products help smokers quit cigarettes, though several public health organizations, such as the American Lung Association, have long disputed their effectiveness.
Two weeks after the marketing ban, in July of 2022, the FDA “administratively stayed” the ban, meaning that it suspended, but did not rescind the order.
That meant Juul was back on the shelves, but the damage to the company was already done. Its valuation plummeted, and the company laid off hundreds of employees to avoid bankruptcy.
The FDA will now place Juul products back under scientific review, a kind of purgatory where thousands of e-cigarettes and vapes await approval.
Senator John Cornyn (R-Texas) said that it amazed him that U.S. vaping companies – such as Juul – faced “kafkaesque” bureaucracy, navigating complex litigation and changing regulation.
“Meanwhile, these Chinese vapes make $3 billion a year advertising directly to American citizens. Is that accurate?” Cornyn asked, which King affirmed.
Cornyn said he looked forward to working with Durbin on upcoming legislation to address the “outrageous” status quo.
