US Senators examine youth vaping epidemic, call for more enforcement over illegal products

Kirstin Garriss
Wed, June 12, 2024 

There are new efforts underway to get e-cigarettes out of the hands of middle and high school students. More than two million teens are currently using e-cigarettes, according to the 2023 National Youth Tobacco Survey.

Josephine Shapiro from Seattle, Washington said she’s one of them.

“My first vape that I ever tried was a blueberry ice vape and I was 13 at the time,” she said.

Shapiro is now a senior at Lincoln High School. She said initially she didn’t think vaping was bad because some flavors tasted like candy.

“It’s like that motion, the flavor, the taste, that’s what you’re craving,” said Shapiro. “And so the constant rush or the flavor is what you want, you know, so it’s like, you’re hitting it maybe I don’t know 100 times a day.”

Now after years of vaping, she’s trying to quit.

“It’s really hard because it’s everywhere and like honestly, I haven’t been clean for more than two months since I decided to quit,” said Shapiro.

Wednesday, she shared her struggles with nicotine products directly with Congress during a Senate hearing about youth vaping.

“I was already addicted, and little did I know it was about to get worse,” said Shapiro during the hearing.

She wants lawmakers to ban all flavored tobacco products.

“My friends have started with vapes, the flavored tobacco product, and transformed into cigarettes and transformed into other drugs because it’s a gateway,” she said.

Tony Abboud with the Vaping Technology Association told Congress he agrees that teens shouldn’t be using these products.

“We don’t want any kids doing this. That’s why we raised the age to 21 and we advocated for that and that’s why we’ve made this product illegal,” said Abboud. “That’s why we’ve worked hard doing the other things making more commonsense regulations to ensure these products don’t get into their hands.”

Abboud believes Congress should consider tougher restrictions for marketing.

“We can get to those concerns, we can get to access restrictions and do things that doesn’t’ require removing all the products that adults are using,” he said.

This week, the U.S. Food and Drug Administration (FDA) and the Justice Department announced a new task force to target illegal sales and distribution of e-cigarettes. The task force will include officials from the US Marshals Service, the US Postal Inspection Service, the Federal Trade Commission, and the Bureau of Alcohol, Tobacco, Firearms and Explosives (ATF).

But both Democrats and Republicans slammed these agencies for what they call years of inaction on the issue.

“The FDA and the Justice Department have the tools to prevent this epidemic. They have failed to use them,” said Sen. Dick Durbin, D – Illinois.

“The FDA’s refusal to follow congressional intent and implement the Tobacco Control Act has led to disastrous consequences for public health and American jobs,” said Sen. Thom Tillis, R – North Carolina.

Now FDA officials say it’s stepping up enforcement over illegal products.

“We participated in a landmark joint operation with Customs and Border Protection resulting in the seizure of $18 million worth of unauthorized e-cigs,” said Brian King, director of the FDA’s Center for Tobacco Products.

King said the agency is also asking Congress for more support to help address a backlog in tobacco product application approvals.

“We seek authorization for FDA to collect user fees from e-cigarette manufacturers, all of whom are paying no fees, to increase collections by $114 million to account for increased workload,” said King.

With graduation on the horizon, Shapiro said she’ll continue her quitting journey.

“I want to be a doctor; I want to be successful. I want to live a full life without nicotine products,” said Shapiro.

Recently, the FDA said it has also issued more than 1,100 warnings to several distributors, manufacturers, and retailers for illegally selling unauthorized tobacco products like e-cigarettes.

‘What the hell are you waiting for?’ Senators grill FDA, DOJ about lack of action on youth vaping epidemic

Jen Christensen
Wed, June 12, 2024



Republicans and Democrats on the US Senate Judiciary Committee showed rare agreement Wednesday as they took to task the US Food and Drug Administration and the US Department of Justice for what they described as inaction on the country’s youth vaping epidemic.

Nearly three years ago, a federal court ruled that the FDA was violating the Tobacco Control Act by allowing e-cigarette products that did not have FDA pre-authorization to stay on the market.

An FDA official testified Wednesday that the topic was a “top priority,” but the agency has missed the September 2021 deadline that the court set to for the agency to complete its review of e-cigarette makers’ applications to sell their products.

Since that time, one study found, an estimated 2.1 million children have used e-cigarettes regularly, and the majority use flavored products.

“After the court-ordered deadline passed on September 9, 2021, the FDA could have ordered every single unauthorized e-cigarette off the market, and that’s what it should have done,” Sen. Dick Durbin, D-Illinois, told Dr. Brian King, director of the FDA’s Center for Tobacco Products, at Wednesday’s hearing. “Instead, thousands of unauthorized e-cigarettes flooded the market.”

In fact, Durbin said, his staffers found vapes in flavors like Red Bull, strawberry, dragonfruit and watermelon bubble gum at a shop just a mile from FDA headquarters.

“Not a single one of these products has been authorized by the FDA. None of them. These illegal products, clearly designed for kids by their flavors, are being sold” even in the shadow of FDA headquarters, he said.

Placing one of the products in front of him, Durbin asked how the FDA could let such sales happen.

“The volume of those applications and the volume of the market requires us to prioritize our enforcement efforts,” King testified.

Sen. Marsha Blackburn, R-Tennessee, also told the representatives from the FDA and the Department of Justice that she was displeased.

“I think it’s disappointing to hear you kind of talk in circles about what you are planning to do, but you haven’t established a plan, and you’re not certain what your way forward is going to be,” she said.

King said the FDA has received 27 million applications for e-cigarette products. But unlike with companies that make drugs and medical devices, which pay user fees that fund the agency’s work, the FDA is not allowed to collect fees from e-cigarette makers. King asked the Senate committee for the authority to fund this increased workload.

“The rapidly evolving tobacco product landscape presents an unprecedented time and resource challenge that no other center at FDA has ever faced,” King said.

Since June, the FDA has authorized only 23 e-cigarette products – none of them flavored – and has denied many more. Hundreds of thousands of additional applications are still pending.

From 2020 to 2023, there was a 1,500% increase in flavored tobacco products sold in the US, said Sen. John Cornyn, R-Texas. He also brought in flavored vape products that his staffers bought, including watermelon bubble gum, apple melon berry and one called Tyson Heavyweight.

“Dr. King, those are clearly designed for consumption by children, correct?” Cornyn asked.

“I can’t speak to the intent of the manufacturer, but I can say that flavors do appeal to kids. Ninety percent of youth who use e-cigarettes use flavored varieties,” King testified.

About 10% of high school-age adolescents and nearly 5% of middle school students use e-cigarettes, according to the US Centers for Disease Control and Prevention. Over the past five years, there has been a 60% decline in the number of middle and high school students using e-cigarettes, King said. But when they do vape, teens and young adults are much more likely to use flavored e-cigarettes than adults.

“More work is definitely needed,” he testified.

Enforcement of the law is the other challenge, the FDA and DOJ said at the hearing. The FDA has conducted thousands of inspections of e-cigarette manufacturers and distributors resulting in nearly 900 warning letters, King said. More than 500 warning letters have gone to retail stores, King said, but if the letters are ignored that’s as far as the FDA can go, so it must rely on the DOJ and other agencies. It was only this week that the FDA and several law enforcement agencies announced that they were creating a task force that will use the criminal and civil tools available to fight the illegal sale and distribution of e-cigarettes.

“What in the hell have you been waiting for?” Durbin asked Arun Rao, deputy assistant attorney general for the Civil Division’s Consumer Protection Branch in the Department of Justice.

“Senator, we have been acting on a number of fronts,” Rao replied. He said the Justice Department has been working with the US Marshals Service and the FDA on seizures of illegal products, but he admitted that “many manufactures have exploited the premarket authorization process.”

Rao testified that many manufacturers whose products have been denied FDA authorization make minimal alterations and resubmit for approval. Some overseas e-cigarette makers will also misrepresent shipments in an effort to slip past regulators, and some stores make their own products.

“Taken together, these factors have made illegal e-cigarettes all too accessible,” Rao said.

Many products come from China, but that country has banned flavored e-cigarettes, and the products are not sold in Chinese stores – a point that wasn’t lost on the committee.

“You can’t sell them in China, but you can sell them in the United States and essentially victimize and addict our children to these nicotine delivery devices,” Cornyn said.

Nicotine is highly addictive and hurts kids, testified Dr. Susan Walley, immediate past chair of the American Academy of Pediatrics’ Section on Nicotine and Tobacco Prevention and Treatment. Nicotine can permanently hurt a teen’s developing brain, studies show, impairing working memory and attention.

Flavored products are too tempting and easy to access, said Walley, who brought with her a flavored e-cigarette product called OMG Blow Pop that she said she purchased within walking distance of a school.

“Simply put, this is unacceptable,” she said. “We need the federal government to get these illegal products off the market.”

Even representatives of the vaping industry testified that they were unhappy with the FDA’s authorization process.

“This is a hot mess right now,” said Tony Abboud, executive director of the Vapor Technology Association. He complained that there was no clear pathway through the approval process and said that without one, “we are going to persist in having an illicit market.”

A high school senior, Josie Shapiro of Seattle, told the committee that vaping products are too easy to access. She said she started vaping after several friends did.

“They thought vapes were harmless because of the fun flavors and colorful packaging,” Shapiro testified.

Shapiro said she has tried to quit several times, but vaping has taken over her and her friends’ lives.

“I’ve felt completely out of control, helpless and alone,” she said. “I couldn’t spend quality time with my friends without thinking about when we were going to get our next hit.”


‘You’re failing!’: the federal government is having a reckoning over youth vaping, as senators tear into FDA and DOJ

Eva Roytburg
Wed, June 12, 2024 


Millions of American youth are hooked on nicotine—and politicians tore into top public health officials during a contentious hearing Wednesday on the meteoric rise of illegal e-cigarettes.

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

“While these two agencies sit on their hands, during both the Trump and Biden administrations, e-cigarette companies addicted a new generation of children to nicotine, erasing the hard work so many of us did to convince them not to smoke tobacco cigarettes, and ultimately save their lives,” Judiciary Chairman Dick Durbin (D-IL) said during his opening remarks.

Frustration was a bipartisan emotion during the hearing, where senators yelled, pointed, and cursed in their questioning. Much of the anger pointed toward a flood of illegal disposable vapes from China, which come in flavors and colors attractive to youth.

Twice as many high school and middle school students are using e-cigarettes than adults, Durbin said during the hearing. The disposable vapes, which come in flavors like blueberry ice and watermelon bubble gum, don’t fulfill their marketed promise of helping existing smokers cease, but rather pull in a new crowd of vapers, he added.

Key to Durbin’s ire was a missed deadline. The FDA was required to complete a review of every product on its docket by September 9, 2021, via a court order from the District Court of Maryland. After the deadline passed, the FDA could have ordered every unauthorized e-cigarette off the market, but it didn’t.

“Instead, these unauthorized e-cigarettes flooded the market, designed to and effectively addicting millions of young Americans,” Durbin said.
‘How is that allowed to happen?’

In the last three years, 2.1 million children have picked up vaping, according to a study by the NIH. As proof, Durbin trotted out an enlarged photograph of a selection of vapes at a smoke shop less than a mile away from the FDA’s Maryland headquarters.

““These illegal products, clearly designed for children by their flavors, are being sold in the shadow of FDA’s building,” Durbin said. “How is that allowed to happen?”

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

FDA approval for tobacco products is extraordinarily rare – the agency has only approved one-thousandth of one percent of all e-cigarette applications it has received, and none 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 such as Juul, are being sold illegally, he said.

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

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

Rao replied that the executive branch is signaling aggressive enforcement, but Durbin cut him off.

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

Rao said that the department stood ready to fine unlawful tobacco companies and had begun seizing illicit products—but Durbin cut him off again.

“You’re failing!” Durbin said, pointing to the photograph of the Maryland smoke shop’s disposable vape selection. “Within a mile of the FDA, there’s evidence of your failures.”

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

“The effect that nicotine had on my mind 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 the FDA’s 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 U.S. Postal Inspection Service.

Tillis called the creation of the task force a “political stunt,” and said that the exclusion of Customs and Border Protection makes it “crystal clear” that the FDA is not serious about enforcing laws against e-cigarettes. (The state he represents, North Carolina, is the U.S.’ largest tobacco producer.)

The criticism comes amid a war that King has almost single-handedly been battling against an influx of illegal flavored disposable vapes.

Of the youth who currently use e-cigarettes, 90% use flavored products, with popular brands such as Elf Bar and Esco Bar dominating the market, according to 2023 FDA data.

Beyond teens, disposable vapes have also dominated the young adult market. One-third of British 18-to-24-year-olds adults are hooked on nicotine, with research suggesting that the disposable vapes created a market among young people who wouldn’t have otherwise smoked.

The FDA has attempted to impose import bans on these products; however, vape companies maneuver around the orders with ease. For example, Shenzhen iMiracle, the privately owned Chinese company that manufactures fan-favorite Elf Bar, simply changed the name of the product when regulators cracked down. Now, you can purchase “EB Create” products in flavors such as orange creamsicle and watermelon ice.

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

To date, the FDA has issued a number of warning letters to domestic manufacturers of vapes, in addition to the import bans. However, the inclusion of the U.S. Postal Inspection Service in the new task force signals that the federal government is ready to take a stronger stance against illegal vape imports.
Juul Labs comes back to market

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

It has 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 that Juul “lacked sufficient evidence” and had “conflicting data” that its products were appropriate for the protection of public health.

Juul has continuously argued that its products help smokers quit cigarettes, 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 “administratively stayed” the ban, meaning that it suspended, but did not rescind the order.

That meant Juul was back on the shelves, but the damage to the company was already done. Its valuation plummeted, and the company laid off hundreds of employees to avoid bankruptcy.

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

Senator John Cornyn (R-Texas) said that it amazed him that U.S. vaping companies – such as Juul – faced “kafkaesque” bureaucracy, navigating complex litigation and changing regulation.

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

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

This story was originally featured on Fortune.com