Millions of young Americans are addicted to nicotine — and politicians criticized top public health officials during a contentious hearing Wednesday on the meteoric rise of illegal e-cigarettes.
The senators notably criticized 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 stand idly by, under the Trump and Biden administrations, e-cigarette makers have addicted a new generation of children to nicotine, erasing the hard work many of us have done to convince them not to smoke tobacco cigarettes, and ultimately save their lives,” said Judiciary Chairman Dick Durbin (D-IL) during his opening remarks.
Frustration was a bipartisan emotion at the hearing, where senators shouted, pointed and cursed during their questions. Much of the anger was directed at a flood of illegal disposable vapes from China, which come in flavors and colors. attractive to young people.
Twice as many high school and college students use e-cigarettes as adults, Durbin said at the hearing. Disposable vapes, which come in flavors like blueberry ice cream and watermelon bubble gum, are not fulfilling their marketing promise of helping existing smokers quit, but are instead attracting a new crowd of vapers , he added.
The key to Durbin’s anger was the failure to meet a deadline. The FDA was required to complete a review of each product on its docket by September 9, 2021, via an order from the District Court of Maryland. Once the deadline passed, the FDA could have banned the sale of all unauthorized e-cigarettes, but it did not do so.
“Instead, these unauthorized e-cigarettes have flooded the market, designed to addict millions of young Americans,” Durbin said.
“How is this allowed to happen?” »
Over the past three years, 2.1 million kids have started vaping, according to an NIH study. As proof, Durbin showed an enlarged photograph of a selection of vapes at a smoke shop less than a mile from FDA headquarters in Maryland.
“These illegal products, clearly designed for children in their flavors, are being sold in the shadow of the FDA building,” Durbin said. “How is this allowed? »
Brian King, director of the FDA’s Tobacco Products Center, blamed the lack of enforcement for the massive backlog of applications that tobacco products have submitted for FDA approval — 27 million applications this week.
FDA approval for tobacco products is extremely rare: The agency has approved only one-thousandth of one percent of all e-cigarette applications it has received, and none in two years, a Sen. Thom Tillis (R-N.C.) said during the hearing. . Only 23 vape products are considered approved and legal by the FDA: all other products, including established giants such as Juul, are sold illegally, he said.
However, these products are thriving in the market, a point that sparked a heated exchange between Deputy Deputy 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 won’t enforce the law as it’s written? Durbin sneered. “You call that an urgent need. Is there any urgency in waiting three years without doing anything?
Rao responded that the executive branch was signaling aggressive enforcement, but Durbin interrupted.
“I’m sorry, I’m against signals,” Durbin said. “Do something!”
Rao said the department was ready to fine illegal tobacco companies and had begun seizing illicit products, but Durbin interrupted him again.
“You fail!” said Durbin, pointing to the photo of the Maryland tobacco store’s selection of disposable vapes. “Within a mile of the FDA there is evidence of your failures.”
High school student Josie Shapiro also spoke at the hearing, testifying about the effects of her nicotine addiction. She started vaping when she was 14 years old.
“The effect that nicotine had on my mind was intense and frightening,” she said. “I felt completely helpless, out of control and alone.”
New working group
The hearing comes during a busy week for FDA tobacco regulators. Monday, the agency announcement 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 US Postal Inspection Service.
Tillis called the creation of the task force a “political stunt” and said the exclusion of Customs and Border Protection “clearly” shows that the FDA is not serious about enforcing laws against cigarettes electronic. (The state he represents, North Carolina, is the largest tobacco producer in the United States.)
The criticism comes amid a war in which King is almost single-handedly fighting an influx of illegal flavored disposable vapes.
Among young people currently using 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 teenagers, disposable vapes have also dominated the young adult market. A third of UK adults aged 18 to 24 are addicted to nicotineresearch suggesting that disposable vapes have created a market among young people who otherwise would not have smoked.
The FDA has attempted to impose import bans on these products; however, vaping companies easily circumvent the orders. For example, Shenzhen iMiracle, the private Chinese company that makes the fan-favorite Elf bar, simply changed the product name when regulators took action. Now you can buy “EB Create” products in flavors like Orange Cream Ice Cream and Watermelon Ice Cream.
Shenzhen iMiracle generated around $3.5 billion to $4 billion last year from EB Create, Elf Bar, Lost Mary and other e-cigarette products, while physical sellers kept 30% of their profits from the brand.
To date, the FDA has issued a number of warning letters to domestic vape manufacturers, in addition to import bans. However, the inclusion of the United States Postal Inspection Service in the new task force indicates that the federal government is prepared to take a tougher stance against illegal vape imports.
Juul Labs returns to the market
The government’s announcement comes just days after the FDA reversed its marketing ban on Juul Labs.
It’s been almost two years since the federal health agency ordered Juul e-cigarettes and vaping products off the market. At the time, the FDA said Juul “lacked sufficient evidence” and had “conflicting data” that its products were appropriate for protecting public health.
Juul has always claimed that its products help smokers quit, although several public health organizations, such as the American Lung Association, have long disputed their effectiveness.
Two weeks after the marketing ban, in July 2022, the FDA “administratively suspended” the ban, meaning it suspended, but did not revoke the order.
That meant Juul was back on shelves, but the damage to the company was already done. Its valuation fell and the company laid off hundreds of employees to avoid bankruptcy.
The FDA will now put Juul products back under scientific review, a sort of purgatory where thousands of e-cigarettes and vapes await approval.
Senator John Cornyn (R-Texas) said he was surprised that US vaping companies – such as Juul – were facing “Kafkaesque” bureaucracy, complex litigation and regulatory changes.
“Meanwhile, these Chinese vapes make $3 billion a year advertising directly to American citizens. Is it correct ? Cornyn asked, which King confirmed.
Cornyn said he looked forward to working with Durbin on upcoming legislation to address the “outrageous” status quo.
