How Vaping Snuck Up On Regulators

Jim Zarroli

November 15, 2019 / 12:29 pm

caption: Even as the popularity of e-cigarettes exploded — with unknown health risks — the federal government was slow to regulate vaping companies.

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.