How Vaping Snuck Up On Regulators

Nov 15, 2019
Originally published on November 15, 2019 7:34 pm

When President Obama signed the Family Smoking Prevention and Tobacco Control Act in 2009, it gave government regulators an important new weapon in its battle against Big Tobacco.

For the first time, the Food and Drug Administration had the power to regulate the manufacturing, distribution and marketing of tobacco products, including the new and then-largely unknown practice of vaping.

Ten years later, e-cigarettes have become dramatically more popular, yet government officials have still not begun regulating the hundreds of vaping products now on the market.

"Today, nearly a decade after these products were first introduced, not a single e-cigarette has been reviewed for safety purposes, for addiction purposes, for youth abuse purposes or for efficacy in helping smokers quit," says Matthew Myers, president of the Campaign for Tobacco-Free Kids.

Some 10.8 million Americans had started vaping as of last year, including more than 25% of high school students, according to a government study. The surge has been driven to a great degree by the immense success of Juul, by far the most popular vaping product.

Physicians say a growing number of young people have become addicted to the nicotine in e-cigarettes.

"We're seeing kids that are using four pods a day, and this is the equivalent of four packs of cigarettes a day. I mean, it is an astounding amount of nicotine that is being delivered in these products," says Dr. Karen Wilson of the American Academy of Pediatrics.

Yan Dichev started using a kind of e-cigarette called box mods six years ago, as a high school sophomore in Georgia. They contained little to no nicotine, and he figured they were safe.

When he got to college in California, everyone was using Juul, which has significantly more nicotine.

"It was something cool in college to have," he says. "Especially at, like, parties. If you're out drinking, instead of smoking a cigarette, you smoked a Juul."

Today he uses Juul products every day, and figures he's pretty much addicted.

"I kind of have to hit it. So if I don't hit it, then I get kind of cranky. So I go and hit it and it just gets me back to feeling like myself and feeling normal," Dichev says.

What's taken regulators so long?

The passage of the Tobacco Control Act required the FDA to build an entire new regulatory infrastructure from scratch, and it faced numerous lawsuits from a tobacco industry determined to delay the process. Regulators didn't have a lot of time to focus on the new vaping products, Wilson says.

"I think they were still trying to grapple with the impact of the Tobacco Control Act on the ... tobacco industry, let alone trying to figure out how to manage this new business that was popping up," she says.

The Obama administration was probably too cautious about taking on Big Tobacco, adds Democratic Sen. Sherrod Brown of Ohio, who wrote often to regulators urging them to act faster.

"I can't count the number of times I've heard government officials who care about public health at FDA say, 'Well, if we do this, we're going to get sued by the tobacco companies,' " Brown says.

"And our answer is, 'No matter what you do, they're going to sue you, because they're going to use some of the most expensive law firms in the country to fight these rules and regulations,' " he says.

By 2016, the government was ready to begin regulating e-cigarettes. But the Trump administration decided to delay the review process until 2022. A federal judge overturned that decision and ordered the agency to move up implementation to next year, but industry groups are appealing the ruling.

Scott Gottlieb, who headed the FDA when the decision was made, says some evidence exists that e-cigarettes may help smokers quit, and rushing to regulate too quickly may mean some beneficial products don't get on the market.

"We know e-cigarettes aren't safe, but we viewed them as less harmful than combusting tobacco. Because after all it's not the nicotine that causes all the death and disease from tobacco use. It's the combustion. It's lighting tobacco on fire," he says.

Gottlieb says the immense success of one product has greatly complicated the regulatory process.

"Really what drove this was a single product, it was Juul, and what we didn't envision was the spike in the popularity, explosive popularity of that single product," he says.

Juul Labs has taken steps to address the criticism, promising to stop advertising in the U.S., and refrain from selling the fruit-flavored products that appeal to teenagers. It also says it will no longer lobby the Trump administration over a recent proposal to bar flavored e-cigarettes altogether.

Meanwhile, concerns about the health effects of vaping have mushroomed, following the deaths of 42 people. The Centers for Disease Control and Prevention has linked most of the deaths to a Vitamin E acetate often used as an additive to THC, the active ingredient in marijuana.

And vaping by teenagers hit a record high this year.

Copyright 2020 NPR. To see more, visit https://www.npr.org.

AILSA CHANG, HOST:

More and more people are getting sick after vaping. At least 42 people have died, thousands more have been injured, and as the outbreak grows, so do questions about the federal government's role in regulating e-cigarettes. NPR's Jim Zarroli reports.

JIM ZARROLI, BYLINE: As a high school sophomore, Yan Dichev started using a vaping product called a box mod. He liked the clouds of smoke it produced.

YAN DICHEV: Me and my friends would just sit in my car and we would just - we call it hot boxing. We would just blow a lot of smoke into the car and then open the windows, and we thought it was really cool to watch the smoke go out.

ZARROLI: That was six years ago. By the time he got to college, a nicotine-laced vaping product called Juul had come along.

DICHEV: It was something cool in college to have, especially at, like, parties. If you're out drinking instead of smoking a cigarette, you smoke the Juul.

ZARROLI: Juul was marketed as a way to help smokers transition away from cigarettes, but lots of nonsmokers, especially kids, also took it up, and an industry that didn't exist a decade ago now has some 10 million users. One reason vaping has gotten such a foothold so quickly is the government's slowness to regulate it. In 2009 President Obama signed something called the Family Smoking Prevention and Tobacco Control Act.

(SOUNDBITE OF ARCHIVED RECORDING)

PRESIDENT BARACK OBAMA: The decades-long effort to protect our children from the harmful effects of tobacco has emerged victorious. Today change has come to Washington.

ZARROLI: The law meant that the Food and Drug Administration now had the power to regulate tobacco products, including e-cigarettes, but doing so took far longer than expected. There were numerous lawsuits from Big Tobacco determined to slow-walk the regulatory process. Karen Wilson of the American Academy of Pediatrics says regulators didn't really have time to focus on vaping.

KAREN WILSON: I think they were still trying to grapple with the impact of the Tobacco Control Act on the industry - you know, the tobacco industry - let alone trying to figure out how to manage this new business that was popping up.

ZARROLI: Some members of Congress complained about the inaction. Democratic Senator Sherrod Brown of Ohio told NPR that the Obama administration was probably too cautious about taking on Big Tobacco, and that included the new vaping companies.

SHERROD BROWN: The more these regulations and rules are slow-walked, the more young people become addicted. Public officials allowing this slow walk ultimately results in terrible public health problems.

ZARROLI: By 2016 the FDA had finally come up with a rule to regulate e-cigarettes, but the Trump administration decided to delay its implementation until 2022. Scott Gottlieb, who headed the FDA then, argues that there's some evidence e-cigarettes can help smokers quit.

SCOTT GOTTLIEB: We know e-cigarettes aren't safe, but we viewed them as less harmful than combusting tobacco because after all, it's not the nicotine that causes all the death and disease from tobacco use. It's the combustion. It's lighting tobacco on fire.

ZARROLI: Gottlieb says rushing to regulate e-cigarettes too quickly can mean getting in the way of products that may legitimately help people quit smoking. A federal judge has ordered the agency to speed up the review process, but that decision is being appealed. That means long after the Tobacco Control Act became law, the FDA is still not reviewing hundreds of vaping products to determine whether they're safe. Matthew Myers is president of the Campaign for Tobacco-Free Kids.

MATTHEW MYERS: Today, nearly a decade after these products were first introduced, not a single e-cigarette has been reviewed for safety purposes, for addiction purposes, for youth abuse purposes or for efficacy in helping smokers quit.

ZARROLI: And more and more people take up vaping every year. One government survey said 25% of high school students had vaped in the preceding month, and 42 people have died this year after vaping. They had ingested a Vitamin E acetate often used as an additive to THC, the active ingredient in marijuana. Scott Gottlieb says the effort to regulate vaping has become harder because of the immense success of Juul.

GOTTLIEB: Really, what drove this was a single product. It was Juul. And what we didn't envision was the spike in the popularity - the explosive popularity of that single product.

ZARROLI: Partly because of Juul, vaping by teenagers hit a record high this year. Juul has tried to address the criticism. For example, it no longer advertises in the U.S., and it stopped selling the fruit-flavored products that appealed to teenagers. Still, Karen Wilson of the American Academy of Pediatrics says many teens have become hardcore nicotine addicts.

WILSON: We're seeing kids that are using four pods a day, and this is equivalent of four packs of cigarettes a day. I mean, it is an astounding amount of nicotine that is being delivered in these products.

ZARROLI: Among them is Yan Dichev. He's now a college senior, and he uses Juul every day.

DICHEV: I kind of have to hit it, so if I don't hit it, then I get kind of cranky. So I go and hit it, and it just gets me back to feeling like myself and feeling normal.

ZARROLI: He figures he'll try to quit after he graduates, but in the meantime, he says, he's pretty much addicted.

Jim Zarroli, NPR News, New York. Transcript provided by NPR, Copyright NPR.