Millions of young Americans are addicted to nicotine – and politicians sharply attacked senior public health officials during a controversial hearing on Wednesday because the number of illegal electronic cigarettes is increasing rapidly.
In particular, the senators accused the Food and Drug Administration (FDA) and the Department of Justice (DOJ) of failing to enforce the Tobacco Control Act, which authorizes federal agencies to regulate tobacco products.
“While these two agencies sat idle, e-cigarette companies during the Trump and Biden administrations addicted a new generation of children to nicotine, undoing the hard work so many of us have done to convince them to stop smoking tobacco cigarettes and ultimately save their lives,” Judiciary Committee Chairman Dick Durbin (D-IL) said in his opening remarks.
Frustration was a bipartisan sentiment during the hearing, where senators shouted, pointed fingers and cursed as they answered questions. Much of the anger was directed at a flood of illegal disposable vaporizers from China, which come in a variety of flavors and colors. attractive for young people.
Twice as many high school and middle school students as adults use e-cigarettes, Durbin said during the hearing. The disposable vaporizers, which come in flavors like blueberry ice cream and watermelon gum, don’t fulfill their sales promise of helping existing smokers quit, but rather attract new vapers, he added.
The key to Durbin’s ire was a missed deadline. The FDA was required by a Maryland District Court court order to complete a review of all products on its list by September 9, 2021. After the deadline, the FDA could have removed any unapproved e-cigarette from the market, but it did not.
“Instead, these unapproved e-cigarettes flooded the market. They were designed to, and did, addict millions of young Americans,” Durbin said.
“How can this happen?”
According to an NIH study, 2.1 million children have started vaping in the past three years. As evidence, Durbin presented a blown-up photo of a selection of e-cigarettes in a tobacco shop less than a mile from FDA headquarters in Maryland.
“These illegal products, which are clearly intended for children because of their flavors, are being sold in the shadow of the FDA building,” Durbin said. “How can this happen?”
Brian King, director of the FDA’s Center for Tobacco Products, attributed the lack of enforcement to a huge backlog of tobacco product approval applications submitted to the FDA, which reached 27 million this week.
FDA approval for tobacco products is extraordinarily rare — the agency has approved only one-thousandth of a percent of all e-cigarette applications received, and none at all 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 like Juul, are sold illegally, he said.
However, these products are very popular in the market, a point that led to a heated exchange between Deputy Attorney General Arun Rao, representing the Justice Department, and Durbin.
“Mr. Rao, are these tobacco company lawyers going to beat you to death until you stop enforcing the law as it is written?” Durbin snapped. “You call this an urgent need. What is urgent about waiting three years and doing nothing?”
Rao responded that the executive was signaling aggressive enforcement, but Durbin interrupted him.
“I’m sorry, I’m against signals,” Durbin said. “Do something!”
Rao said the agency was ready to punish illegal tobacco companies and had begun seizing illegal products – but Durbin interrupted him again.
“You are failing!” Durbin said, pointing to the photo of the Maryland tobacco shop’s selection of disposable e-cigarettes. “Within a mile of the FDA, there is evidence of your failure.”
High school student Josie Shapiro also spoke during the hearing, testifying about the effects of her nicotine addiction. She began vaping when she was 14 years old.
“The effect of nicotine on my mind was intense and frightening,” 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 regulator. On Monday announced a cross-agency task force to combat the meteoric rise of illegal e-cigarettes.
Four other federal agencies will participate 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 ploy” and said the exclusion of Customs and Border Protection shows “crystal clear” that the FDA is not serious about enforcing laws against e-cigarettes. (The state he represents, North Carolina, is the nation’s largest tobacco producer.)
The criticism comes in the wake of King’s virtually single-handed fight against the flood of illegal flavored disposable vaporizers.
Of the teens who currently use e-cigarettes, 90% use flavored products, with popular brands like Elf Bar and Esco Bar dominating the market, according to 2023 FDA data.
Beyond teenagers, disposable vaporizers also dominate the young adult market. A third of British adults aged 18 to 24 are addicted to nicotineStudies suggest that disposable vaporizers have created a market among young people who would not otherwise have smoked.
The FDA has tried to impose import bans on these products, but e-cigarette manufacturers are easily getting around these bans. For example, Shenzhen iMiracle, the privately held Chinese company that makes the popular Elf Bar, simply changed the name of the product when regulators cracked down. Now you can buy “EB Create” products in flavors like Orange Creamsicle and Watermelon Ice Cream.
Shenzhen iMiracle generated around $3.5 billion to $4 billion from EB Create, Elf Bar, Lost Mary and other e-cigarette products last year, while brick-and-mortar sellers retained 30 percent of their profits from the brand.
To date, the FDA issued a series of warning letters to domestic e-cigarette manufacturers, in addition to the import bans. However, the inclusion of the US Postal Inspection Service in the new task force signals that the federal government is willing to take stronger action against illegal e-cigarette imports.
Juul Labs returns to the market
The government’s announcement comes just days after the FDA lifted its ban on marketing Juul Labs.
Almost two years have passed since the Federal Health Authority ordered Juuls e-cigarettes and vaping products from the market. At the time, the FDA said Juul had “insufficient evidence” and “conflicting data” that its products were appropriate for protecting the public health.
Juul has consistently argued that its products help smokers quit smoking, although several public health organizations such as the American Lung Association, have argued for a long time their effectiveness.
Two weeks after the marketing ban, in July 2022, the FDA placed the ban “administratively on pause,” meaning it suspended the order but did not lift it.
This meant that Juul was back on the shelves, but the damage to the company was already done. Its valuation dropped and the company laid off hundreds of employees to Avoid bankruptcy.
The FDA will now subject Juul products to another scientific review, a kind of purgatory in which thousands of e-cigarettes and vapes await approval.
Senator John Cornyn (Republican of Texas) said he was amazed that U.S. e-cigarette companies such as Juul were faced with “Kafkaesque” bureaucracy and had to navigate complex litigation and changing regulations.
“Now these Chinese e-cigarettes are making $3 billion a year by advertising directly to American citizens. Is that true?” Cornyn asked, which King confirmed.
Cornyn said he looks forward to working with Durbin on future legislation to change the “outrageous” status quo.