Debate on e-cigarettes lights up 10 years after FDA tobacco law

Calls grow for agency, Congress to do more after spike in teen use

Florida Rep. Donna E. Shalala says Congress must update the 2009 law that gave the FDA the authority to regulate tobacco products. (Tom Williams/CQ Roll Call file photo)
Florida Rep. Donna E. Shalala says Congress must update the 2009 law that gave the FDA the authority to regulate tobacco products. (Tom Williams/CQ Roll Call file photo)
Posted June 19, 2019 at 8:00am

A decade after Congress gave the Food and Drug Administration the authority to regulate tobacco products, there is a growing sense that the law should be revisited to address a product that lawmakers barely knew about in June 2009: electronic cigarettes.

The tension lies in how to balance e-cigarettes’ potential benefits with their clear risks. While e-cigarettes may offer a less harmful alternative for adults who smoke combustible cigarettes, they can appeal to young people who never would have smoked.

[High school e-cigarette use is exploding and reversing prevention gains]

Industry critics want to ban the flavored varieties of liquid nicotine that fuel e-cigarettes and attract nonsmokers. On the other hand, those who view e-cigarettes, or vaping, as a safer alternative to cigarettes fear FDA rules would effectively ban the products and drive millions to traditional tobacco.

Driven by the popularity of the sleek device by Juul Labs, which uses liquid nicotine pods with flavors such as mango and cucumber, e-cigarette use among high school students reached record levels in 2018 — offsetting the decline in cigarette smoking that occurred in the past two decades.


The FDA’s e-cigarette policies still face uncertainty. Although the Obama administration set a 2018 deadline for companies to apply to the agency for permission to sell the devices, the Trump administration initially delayed those reviews until 2022 and then, alarmed by teen use, changed the date to 2021. And after a recent court ruling in favor of plaintiffs challenging that timeline, the FDA may have to act more swiftly than that.

As a result, the law’s second decade starts with some of the most robust discourse on tobacco use in years, with some lawmakers including Senate Majority Leader Mitch McConnell of Kentucky calling for raising the federal purchasing age to 21. It would be hard to debate that simple change without examining the FDA’s e-cigarette problem more broadly.

[McConnell introduces bill making the legal smoking age 21]

Rep. Donna E. Shalala, who was the Health and Human Services secretary during the Clinton administration, said Congress should update the law. With the popularity of cigarette smoking falling, the Florida Democrat sees e-cigarettes as a way for the industry to target young users.

“That’s why laws have to be improved,” she said. “Because the industry is going to find a way to build their pipeline, and to do that, they have to go after kids.”

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FDA’s approach

Mitch Zeller, who has led the FDA’s Center for Tobacco Products since 2013, said the agency made strides in carrying out the law by creating public education campaigns and conducting enforcement, including 1 million retail inspections on age requirements.

The agency also launched a massive study of 46,000 individuals to assess their tobacco product use and health over time. Zeller said it already shows that exclusive e-cigarette use exposes an individual to fewer toxins than cigarette smoking, but those who use both are exposed to even higher levels than expected.

Frustration over how the FDA is handling e-cigarettes is overshadowing some of its successes, though.

The law “gives FDA the tools precisely that it needed to ensure that if a product like an e-cigarette came along, that it had the ability to evaluate the product,” said Matthew L. Myers, president of the Campaign for Tobacco-Free Kids advocacy group.

The problem is that the FDA is unwilling to make difficult decisions involving e-cigarettes, he said.

After e-cigarette use among high schoolers shot up 78 percent in one year, the public’s concern prompted the agency to reconsider its actions.

Earlier this year, the FDA declared that flavored e-cigarettes other than mint and menthol could only be sold in locations that were off limits to people below the smoking age, and flavored e-cigarette varieties would have to submit their applications a year earlier, in 2021.

To some, the FDA’s reversal was too little, too late.

House Energy and Commerce Chairman Frank Pallone Jr. said the law saved lives, but he is frustrated by the agency.

“This delay has allowed certain e-cigarette products to remain on the market without first undergoing review of their public health impact,” the New Jersey Democrat said. “This delay has allowed e-cigarette products to proliferate.”

Others, such as former agency lawyer Coleen Klasmeier, said the FDA needed time to figure out its strategy.

“For all of the work that Congress invested in enacting the legislation, that pales in comparison to the work it takes to actually make the statute achieve these extraordinarily ambitious public health goals,” she said.

Still, the fact remains that e-cigarettes are widely available. Consumers have no verified information about what’s in them, their health effects or whether they help you quit smoking.

Former House Energy and Commerce Chairman Henry A. Waxman, who co-authored the law, said Congress didn’t anticipate that the FDA would let vaping products stay on the market for so long without agency review.

“We shouldn’t allow vape products at all unless the science indicates they are safe and effective,” the California Democrat said.

The e-cigarette industry is equally frustrated.

“If FDA doesn’t relent on what they’re requiring, it will wipe out this sector,” said former associate FDA commissioner Marc Scheineson, an Alston & Bird partner who advises smaller tobacco companies.

To Zeller, all the FDA’s decisions, including the deadline changes, have struck the “public health balancing act” between preventing new tobacco users and ensuring smokers can switch to e-cigarettes.

“It all goes back to the standard that Congress wrote into the law,” he said.

Congressional outlook

The chance of Congress amending the law is higher this session than at any other point in the past decade.

Before lawmakers act, a court could force the FDA’s hand. In March 2018, a coalition of public health groups sued the FDA over its 2017 decision to delay the e-cigarette regulation deadlines.

Last month, a judge ruled that the delay was illegal and asked the parties to offer remedies. The health groups asked for the deadlines to take effect this year. The FDA countered that any new deadline shouldn’t be earlier than 10 months from now. The judge could soon decide how to move forward.

Congress could debate tobacco legislation against that backdrop.

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Lawmakers from both parties agree that Congress should raise the national tobacco purchasing age to 21, joining 15 states and Washington, D.C.

Industry giants such as Altria and Juul also support raising the age, they say, because it would counter youth tobacco use — though people who don’t trust the industry say the companies hope lawmakers stop there and don’t impose further restrictions.

As part of that debate, many Democrats and some Republicans want to essentially ban e-cigarette flavors the same way they’re forbidden for combustible cigarettes.

A bill by Shalala and Pallone would do that, as well as ban online sales of any tobacco product, including e-cigarettes. Sens. Lisa Murkowski, an Alaska Republican, and Richard J. Durbin, an Illinois Democrat, also have a bill to restrict flavors, and New Hampshire Democratic Sen. Jeanne Shaheen introduced a bill to impose a fee on e-cigarette makers.

McConnell’s bill would simply raise the age.

Some critics say the industry has ulterior motives for supporting the age change. When Arkansas enacted an age increase this year, it included language banning localities from creating stricter limits. Tobacco-control advocates also see McConnell’s bill as an opportunity for the industry to influence state laws.

Democrats will likely insist on a far-reaching debate.

“The hard truth is that simply raising the legal age for purchase to 21 is not enough,” Pallone said.

But Shalala is optimistic that the parties will compromise.

“We will pass something significant and we will take another step in public health,” she said. “You can just feel it. The parents are alarmed, the schools are alarmed, and they’re all speaking to their members of Congress.”

Correction, June 20, 12:50 p.m. | A previous version of this story mischaracterized a provision in a tobacco bill by Rep. Robert B. Aderholt.