Illegal vaping is flooding the market and the government is scrambling

In particular, the senators blamed the Food and Drug Administration (FDA) and the Department of Justice (DOJ) for failing to enforce the Tobacco Control Act, which authorizes federal agencies to management of tobacco products.

“While these two agencies sit hand in hand, under the Trump and Biden administrations, e-cigarette companies have addicted a new generation of children to nicotine, undoing the hard work that many of us have put in. work to persuade them not to smoke cigarettes, and ultimately save their lives,” said Judiciary Chairman Dick Durbin (D-IL) in his opening remarks.

Frustration was a bipartisan emotion during the hearing, where senators shouted, criticized and cursed during questioning. Much of the anger is directed at the influx of illegal disposable vapes from China, which come in a variety of flavors and colors. attractive to young people.

Durbin said during the hearing that twice as many high school and middle school students are using e-cigarettes as adults. The disposable vapes, which come in flavors like blueberry ice and watermelon bubble gum, don’t deliver on the market promise of helping current smokers quit, he added. That attracts a large number of new vapers.

The key to Durbin’s anger is missing deadlines. The FDA is required to complete a review of every product in its file by September 9, 2021, through a court order from the District Court of Maryland. After the deadline passed, the FDA could have taken all illegal e-cigarettes off the market, but they did not.

“Instead, these illegal e-cigarettes are flooding the market, designed to effectively addict and addict millions of young Americans,” Durbin said.

“Why was that allowed to happen?”

According to an NIH study, in the past three years, 2.1 million children have used vaping. As evidence, Durbin presented an enlarged photo of a selection of vapes at a smoke shop less than a mile from the FDA’s Maryland headquarters.

“These illegal products, clearly designed for children by their flavor, are being sold in the shadow of the FDA building,” Durbin said. “Why was that allowed to happen?”

Brian King, director of the FDA’s Center for Tobacco Products, blames the lack of enforcement on the large backlog of applications that tobacco products have submitted for FDA approval—27 million applications, as of this week.

Senator Thom Tillis (R.N.C.) said during the hearing that FDA approval of tobacco products is extremely rare – the agency only approves 1/1001% of all applications e-cigarettes they received and received no approvals for two years. There are only 23 FDA-approved vape products that are legal, he said: all the others, including established giants like Juul, are being sold illegally.

However, these products are thriving in the market, which prompted a lively exchange between Deputy Assistant Attorney General Arun Rao, representing the justice department, and Durbin.

“Mr. Rao, these tobacco company lawyers beat you to death, to the point where you don’t enforce the law as written?” “You call this an urgent need,” Durbin growled. “What is urgent about waiting three years and doing nothing?”

Rao replied that law enforcement was signaling aggressive enforcement, but Durbin interrupted him.

“I’m sorry, I object to the signal,” Durbin said. “Do something!”

Rao said the department was ready to fine illegal tobacco companies and had begun seizing illegal products – but Durbin interrupted again.

“You are failing!” Durbin said, pointing to a photo of the Maryland smoke shop’s collection of disposable vapes. “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 nicotine addiction on her. She started vaping when she was 14 years old.

“The effects of nicotine on my mind were intense and scary,” she said. “I felt completely helpless, out of control and alone.”

New special forces

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 rapid 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 stunt” and said the exclusion of Customs and Border Protection makes it “clear” that the FDA is not serious about enforcing laws against Electronic cigarettes. (The state he represents, North Carolina, is the largest tobacco producer in the United States.)

The criticism comes as King fights almost single-handedly against a wave of illegal flavored disposable vapes.

According to 2023 FDA data, among youth currently using e-cigarettes, 90% use flavored products, with popular brands like Elf Bar and Esco Bar dominating the market.

In addition to teenagers, disposable vapes have also dominated the youth market. A third of adults in the UK are aged 18 to 24 addicted to nicotinewith research showing that disposable vaping has created a market among young people who would otherwise not smoke.

The FDA attempted to impose an import ban on these products; however, vape companies fulfill orders with ease. For example, Shenzhen iMiracle, the private Chinese company that makes the fan-favorite Elf Bar, simply changed the product’s name when regulators cracked down. You can now buy “EB Create” products in flavors like orange sorbet and watermelon ice.

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

To date, the FDA has grant several warning letters to domestic vape manufacturers, in addition to an import ban. However, the inclusion of the U.S. Postal Inspection Service in the new task force signals that the federal government is willing to take a stronger stance on illegal vape imports.

Juul Labs returns to the market

The government’s announcement comes just days after the FDA rescinded its marketing ban on Juul Labs.

It’s been nearly two years since the federal health agency Order Juul e-cigarettes and vaping products on the market. At the time, the FDA said Juul “lacks sufficient evidence” and has “conflicting data” that its products are appropriate to protect public health.

Juul has consistently argued that its products help smokers quit, even though some public health organizations, such as the American Lung Association, been in dispute for a long time their effectiveness.

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

That means Juul is back on store shelves, but the damage to the company has already been done. Its value plummeted and the company laid off hundreds of employees avoid bankruptcy.

The FDA will now subject Juul products back to scientific review, a kind of purgatory where thousands of e-cigarettes and vapes await approval.

Sen. John Cornyn (R-Texas) says he is surprised that US vaping companies — such as Juul — face “kafkaesque” bureaucracy, having to deal with complex litigation complexity and regulatory changes.

“Meanwhile, these Chinese vapes make $3 billion a year by advertising directly to American citizens. Is that accurate?” Cornyn asked, King affirmed it.

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