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Illegal vapes are flooding the market and the government is scrambling

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Millions of young Americans are addicted to nicotine — and politicians attacked top public health officials during a contentious hearing Wednesday on the rapid rise of illegal e-cigarettes.

In particular, the senators blamed the Food and Drug Administration (FDA) and the Department of Justice (DOJ) for not enforcing the Tobacco Control Act, which allows federal agencies to regulate tobacco products.

“While these two agencies have been sitting on their hands, during the Trump and Biden administrations, e-cigarette companies have addicted a new generation of kids to nicotine, erasing the hard work many of us have done to convince them not to smoke tobacco cigarettes,” said Judiciary Chairman Dick Durbin (D). of Illinois) during his opening remarks: “Ultimately saving their lives.”

Frustration was a bipartisan sentiment during the hearing, as senators shouted, pointed, and cursed during their questioning. Much of the anger has pointed to the flood of illegal disposable e-cigarettes from China, which come in flavors and colors attractive to young people.

Twice as many high school and middle school students use e-cigarettes as adults, Durbin said during the hearing. He added that disposable e-cigarettes, which come in flavors like raspberry ice and watermelon gum, are not fulfilling their marketed promise of helping current smokers quit smoking, but they are attracting a new crowd of e-cigarettes.

The reason Durbin was angry was the missed deadline. The FDA was required to complete a review of each product on its docket by September 9, 2021, under a court order from a Maryland district court. After the deadline passed, the FDA could have ordered the withdrawal of every unapproved e-cigarette from the market, but it did not.

“Instead, these unauthorized e-cigarettes have flooded the market, designed to effectively addict millions of young Americans,” Durbin said.

“How could this be allowed to happen?”

In the past three years, 2.1 million children have used e-cigarettes, according to a study by the National Institutes of Health. As evidence, Durbin provided a zoomed-in photo of a selection of e-cigarettes at a smoke shop less than a mile from FDA headquarters in Maryland.

“These illegal products, clearly designed for children based on their flavors, are being sold in the shadow of the FDA building,” Durbin said. “How could this be allowed to happen?”

Brian King, director of the FDA's Center for Tobacco Products, blamed the lack of enforcement on 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 has received, and it has not approved any in two years, said Sen. Thom Tillis (RN). C.) During the hearing. . He said only 23 vaping products are considered FDA-approved and legal: all others, including giants like Juul, are sold illegally.

However, these products are thriving in the market, a point that led to a heated argument between Deputy Assistant Attorney General Arun Rao, representing the Department of Justice, and Durbin.

“Mr. Rao, are the tobacco company's lawyers beating you to death, so much so that you don't apply the law as it is written?” Durbin crept in. “You call this an urgent need. What's the point in waiting three years and doing nothing?

Rao responded that the executive was referring to strict enforcement, but Durbin interrupted him.

“I'm sorry, I'm against signals,” Durbin said. “Do something!”

Rao said the administration was prepared to fine illegal tobacco companies and had begun confiscating illicit products, but Durbin cut him off again.

“you are a loser!” Durbin said, pointing to a photo of a disposable e-cigarette kit at a Maryland smoke shop. “A mile away from the FDA, there is evidence of your failures.”

High school student Josie Shapiro also spoke during the hearing, testifying about the effects of nicotine addiction on her. She started vaping when she was 14 years old.

“The effect of nicotine on my brain 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 tobacco regulators at the Food and Drug Administration. On Monday, the agency Announce Multi-agency task force to combat the spike in 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 CBP's exclusion makes it “absolutely 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 amid a war King is waging almost alone against the influx of illegal flavored disposable e-cigarettes.

Among young people 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 teens, disposable e-cigarettes have also dominated the young adult market. A third of British adults aged 18 to 24 are addicted to nicotine, and research suggests disposable e-cigarettes have created a market among young people who wouldn't smoke otherwise.

The Food and Drug Administration attempted to impose an import ban on these products; However, vape companies easily manipulate orders. For example, Shenzhen iMiracle, the privately owned Chinese company that makes the fan-favorite Elf Bar, simply changed the name of the product when regulators cracked down. Now, you can purchase EB Create products in flavors like Orange Creamsicle and Watermelon Snow.

Shenzhen iMiracle generated about $3.5 billion to $4 billion last year from EB Create, Elf Bar, Lost Mary and other e-cigarette products, while brick-and-mortar sellers kept 30% of their profits from the brand.

To date, the US Food and Drug Administration (FDA). Issued A number of warning letters to local manufacturers of e-cigarettes, in addition to an import ban. However, the inclusion of the U.S. Postal Inspection Service in the new task force indicates that the federal government is ready to take a stronger stance against illegal e-cigarette imports.

Juul Labs is back in the market

The government's announcement comes just days after the US Food and Drug Administration lifted its marketing ban on Juul Labs.

It's been nearly two years since a federal health agency ordered Juul's 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 to protect public health.

JUUL has consistently argued that its products help smokers quit cigarettes, although many public health organizations, such as the American Lung Association, It has long been disputed Its effectiveness.

Two weeks after the marketing ban, in July of 2022, the FDA “administratively suspended” the ban, meaning it suspended the order, but did not rescind it.

This meant that Juul was back on the shelves, but the damage to the company had already been done. Its value fell, and the company laid off hundreds of employees Avoid bankruptcy.

The US Food and Drug Administration (FDA) will now send Juul products back for scientific review, a type of disinfectant as thousands of e-cigarettes and vapes await approval.

Sen. John Cornyn (R-Texas) said he was astounded that US e-cigarette companies — like Juul — face a “Kafkaesque” bureaucracy, dealing with complex lawsuits and regulatory changes.

Meanwhile, these Chinese e-cigarettes generate $3 billion a year from advertising directly to American citizens. Is that accurate?” Cornyn asked, which King confirmed.

Cornyn said he looks forward to working with Durbin on upcoming legislation to address the “outrageous” status quo.

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