Millions of American youth are hooked on nicotine and politicians lashed out at top public health officials during a contentious hearing Wednesday over the soaring rise of illegal e-cigarettes.
Specifically, 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 sit on their hands, under both the Trump and Biden administrations, e-cigarette companies have gotten a new generation of kids addicted to nicotine, undoing the hard work many of us have done to convince them not to smoke cigarettes. cigarettes, and will ultimately save their lives,” said Judiciary Chairman Dick Durbin (D-Ill.) during his opening remarks.
Frustration was a bipartisan emotion during the hearing, with senators shouting, pointing and cursing during questioning. Much of the anger has been fueled by a flood of illegal disposable e-cigarettes from China, whose flavors and colors appeal to young people.
Durbin said during the hearing that twice as many high school and middle school students use e-cigarettes as adults. Disposable vapes in flavors such as blueberry ice cream and watermelon bubblegum don’t deliver on their market promise of helping existing smokers quit smoking, but rather attract a new crowd of vapers, he added.
The key to Durbin’s anger was the missed deadline. The FDA was required to complete its review of each product on its list by September 9, 2021, based on a ruling from the District Court of Maryland. After the deadline, the FDA could have banned the sale of every unauthorized e-cigarette, but did not.
“Instead, the market has been flooded with unauthorized e-cigarettes designed to effectively addict millions of young Americans,” Durbin said.
– How could this happen?
Over the past three years, 2.1 million children have started vaping, according to a National Institutes of Health study. As evidence, Durbin presented an enlarged photograph of a set of vapes at a tobacco store less than a mile from the FDA’s headquarters in Maryland.
“These illegal products, clearly designed to appeal to children, are being sold in the shadow of the FDA building,” Durbin said. “How is this possible?”
Brian King, director of the FDA’s Center for Tobacco Products, blamed a lack of enforcement for the huge backlog of applications tobacco products have submitted for FDA approval – 27 million applications as of this week.
FDA approval of tobacco products is extremely rare: The agency has approved only one-thousandth of one percent of all e-cigarette applications it receives, and none in two years, Sen. Thom Tillis (R-N.C.) said during the hearing. . Only 23 vaping products are considered FDA-approved and legal: All other products, including established giants like Juul, are sold illegally, he said.
But the products are booming in the marketplace, prompting a heated debate between Deputy Assistant Attorney General Arun Rao of the Justice Department and Durbin.
“Mr. Rao, are these tobacco company lawyers beating you to death, to the point that you are not enforcing the law as it is written?” Durbin chuckled. “You call it urgent. What’s so urgent about waiting three years and doing nothing?”
Rao responded that the executive branch was signaling aggressive enforcement, but Durbin interrupted.
“Sorry, I’m against signals,” Durbin said. “Do something!”
Rao said the department was ready to fine illegal tobacco companies and began confiscating illegal products, but Durbin interrupted him again.
“You’re failing!” Durbin said, pointing to a photo of a selection of disposable vapes at a Maryland smoke shop. “There is evidence of your failures a mile away from the FDA.”
High school student Josie Shapiro also spoke at the hearing, speaking about the impact of nicotine addiction on her. She started smoking cigarettes when she was 14 years old.
“The effect of nicotine on my mind was strong and frightening,” she said. “I felt completely helpless, out of control and alone.”
New task force
The hearing comes during a busy week for FDA tobacco regulators. Monday agency announced interagency task force to combat the rapid growth of illegal e-cigarettes.
The task force will include four other federal agencies, 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 Customs and Border Protection exception makes it “crystal clear” that the FDA is not serious about enforcing laws against e-cigarettes. (The state he represents, North Carolina, is the largest tobacco producer in the United States.)
The criticism comes as King has waged an almost single-handed war against the influx of illegal flavored disposable vapes.
Of the youth 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.
Apart from teens, disposable vapes also dominate the youth market. A third of British adults aged 18 to 24 are addicted to nicotine, with research showing disposable vapes have created a market among young people who would not otherwise smoke.
The FDA has attempted to impose import bans on these products; however, vape companies easily circumvent the orders. For example, Shenzhen iMiracle, the privately held Chinese company that makes the fan-favorite Elf Bar, simply changed the name of the product when regulators cracked down. You can now purchase EB Create products in flavors like Orange Cream and Watermelon Ice Cream.
Last year, Shenzhen iMiracle earned between $3.5 billion and $4 billion from EB Create, Elf Bar, Lost Mary and other e-cigarettes, while regular sellers retained 30% of their profits from the brand.
Currently, the FDA has published a number of warning letters to domestic vape manufacturers, in addition to import bans. However, the inclusion of the U.S. Postal Inspection Service on the new task force signals that the federal government is ready to take a tougher stance on illegal vaping imports.
Juul Labs returns to the market
The government’s announcement comes just days after the FDA lifted its marketing ban on Juul Labs.
It’s been nearly two years since the federal health agency ordered e-cigarettes and Juul vaping products to be removed from the market. At the time, the FDA said Juul had “insufficient evidence” and “conflicting data” that its products were appropriate to protect public health.
Juul has consistently claimed that its products help smokers quit, although some public health organizations, such as the American Lung Association, claim that its products help smokers quit. argued for a long time their effectiveness.
Two weeks after the marketing ban, in July 2022, the FDA “administratively suspended” the ban, meaning it suspended but did not rescind the order.
This meant that Juul was back on the shelves, but the damage to the company was already done. Its value plummeted and the company laid off hundreds of employees to avoid bankruptcy.
Now the FDA will return Juul products to scientific review, a purgatory of sorts where thousands of e-cigarettes and vapes await approval.
Sen. John Cornyn (R-Texas) said he was struck by how U.S. vaping companies such as Juul faced “Kafkaesque” bureaucracies as they navigate complex litigation and regulatory changes.
“Meanwhile, these Chinese vapes make $3 billion a year by advertising directly to American citizens. That’s for sure?” Cornyn asked, and King confirmed.
Cornyn said he looks forward to working with Durbin on upcoming legislation aimed at eliminating the “outrageous” status quo.