Illegal vapes are flooding the market and the government is cracking down

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

“While these two agencies sat on their hands, during the Trump and Biden administrations, e-cigarette companies addicted a new generation of kids to nicotine, erasing the hard work many of us are doing to make sure they don’t smoke, again. ultimately save their lives,” said Judiciary Chairman Dick Durbin (D-IL) during his opening remarks.

Frustration was a bipartisan feeling during the hearing, where senators shouted, pointed, and cursed at their questioning. Much of the anger was directed at the flood of disposable vapes from China, which came in flavors and colors that appealed to the youth.

High school and middle school students use twice as much tobacco as adults, Durbin said during the hearing. Disposable vapes, which come in flavors like blueberry ice and watermelon bubble gum, aren’t fulfilling their promise in the market to help existing smokers quit, but instead attract a new crowd of vapers, he added.

The key to Durbin’s upset was a missed deadline. The FDA was required to complete the review of all products on its shelf by September 9, 2021, per a court order from the District Court of Maryland. After the deadline passed, the FDA could have ordered all unapproved e-cigarettes off the market, but they didn’t.

“Instead, these unlicensed e-cigarettes are flooding the market, designed and successfully addicting millions of young Americans,” Durbin said.

‘How is that allowed?’

In the past three years, 2.1 million children have picked up vaping, according to an NIH study. As evidence, Durbin released an enlarged photo 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’s taste, are being sold under the guise of the FDA,” Durbin said. “How is that allowed?”

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

FDA approvals for tobacco products are incredibly rare – the agency has approved only one thousandth of one percent of all tobacco applications it has received, and none in two years, said Sen. Thom Tillis (RN.C.) 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 thriving on the market, a point that has caused a heated exchange of words between Deputy Assistant Attorney General Arun Rao, who represents the justice department, and Durbin.

“Mr. Rao, are these tobacco company lawyers going to beat you to death, until you keep the law as it is written?” Durbin smiled. “This calls for an urgent need. What is the urgency of waiting three years without doing anything?”

Rao responded that the executive branch was showing up to enforce the law, but Durbin cut him off.

“I’m sorry, I’m against signs,” said Durbin. “Do something!”

Rao said the department is ready to fine illegal tobacco companies and has begun seizing illegal products—but Durbin cut him off again.

“You’re failing!” Durbin said, pointing to a photo of the vape selection available at the Maryland store. “By the FDA mile, there is evidence of your failure.”

High school student Josie Shapiro also spoke during the hearing, testifying about the effects nicotine addiction had on her. He started smoking when he was 14 years old.

“The effect nicotine had on my mind was intense and terrifying,” he said. “I felt completely powerless, out of control and alone.”

A new army of work

The hearing comes amid a busy week for FDA tobacco regulators. On Monday, the agency announced 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 task force’s creation “political gerrymandering,” and said the exclusion of Customs and Border Protection made it “clear” that the FDA has no intention of enforcing regulations against e-cigarettes. (The state he represents, North Carolina, is the largest producer of tobacco in the US.)

The criticism comes amid King’s almost single-handed battle against the influx of illegal disposable flavored vapes.

Of current e-cigarette users, 90% use flavored products, with popular brands such as Elf Bar and Esco Bar dominating the market, according to FDA data for 2023.

Beyond teenagers, disposable vapes also dominate the adult market. A third of British adults aged 18 to 24 are addicted to nicotine, with research showing that disposable vapes are creating a market among young people who would not otherwise smoke.

The FDA tried to enforce an import ban on these products; however, vape companies go easy on orders. For example, Shenzhen Miracle, a private Chinese company that produces the fan-favorite Elf Bar, suddenly changed the brand name when regulators failed. Now, you can buy “EB Dala” products in flavors like orange creamsicle and watermelon ice.

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

So far, the FDA has issued a number of warning letters to domestic manufacturers of vapes, in addition to import bans. However, the addition of the US Postal Inspection Service to the new task force shows that the federal government is ready to take tough action against illegal vape imports.

Juul Labs is back on the market

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

It’s been nearly two years since the federal health agency ordered Juul’s e-cigarettes and vaping products off the market. At the time, the FDA said Juul “did not have enough evidence” and had “conflicting data” that its products were suitable to protect public health.

Juul has long argued that its products help smokers quit, even though several public health organizations, such as the American Lung Association, have long disputed their effectiveness.

Two weeks after the marketing ban, in July of 2022, the FDA “statutoryally suspended” the ban, which means that it stopped, but did not withdraw the order.

That meant 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 workers to avoid bankruptcy.

The FDA will now put Juul’s products back under scientific review, a type of purgative where thousands of electronic cigarettes and vapes are awaiting approval.

Senator John Cornyn (R-Texas) said he was surprised that hot companies in the US – such as Juul – are facing a “kafkaesque” bureaucracy, dealing with complex cases and changing regulations.

“Right now, these Chinese vapes make three billion dollars a year that they market directly to American citizens. Is that correct?” Corny asked, acknowledging the King.

Cornyn said he looks forward to working with Durbin on future legislation to fix the “outrageous” current situation.