The FDA's nicotine stain: Juul isn't only culprit in teen e-cigarette smoking epidemic

By | September 23, 2018

The epidemic of e-cigarette use among America’s teenagers is associated with a four-letter word: Juul. The wildly popular maker of flavored e-cigarettes has become as cool for a teenager to hold as an iPhone. But the advocacy groups and medical associations that have been campaigning against tobacco and nicotine products for years believe the FDA should be held equally accountable.

Although the FDA’s recent crackdown on the sale of e-cigarettesused by as many as 3 million teenagers, according to government data recently leaked to the press — has received praise, watchdog groups say this step is long overdue and still not nearly enough to reverse a public health crisis that has gotten out of control due to years of inaction by health regulators in both the Obama and Trump administrations.

A multidecade effort to reduce the rate of teens smoking traditional cigarettes has had dramatic success, with the rate of teen smokers declining from more than 36 percent in 1996 to under 10 percent, and the millions of teens now addicted to nicotine through e-cigarette use leaves advocates, like the Campaign for Tobacco-Free Kids, frustrated. “I’m not very happy with either the FDA or Juul,” said Matt Myers, president of the antismoking nonprofit. “What I want is the government to do its job,” he said. “The FDA pointing the finger at Juul is not enough.”

Statements from major medical groups echo this view.

“For years, the American Lung Association has been sounding the alarm that FDA has been extremely slow to use its authority to protect children from e-cigarettes,” the group said in a statement after the FDA’s crackdown was announced. “It is long past time for FDA to consider using its authority and time for them to take meaningful action.”

The American Academy of Pediatrics went further, saying it outright rejects the FDA’s new plan — which gives the five leading e-cigarette manufacturers 60 days to submit plans as to how they will address youth use of their products — as meaningful action, describing the crackdown as one more “delay.”

The national assistant vice president of advocacy for the American Lung Association, Erika Sward, agrees, summing up the FDA’s plan as “one more delay. … One more instance where FDA makes a major announcement without any action to back it up.”

“FDA for years has repeatedly missed opportunities to keep tobacco products out of the hands of our children,” said the American Cancer Society.

“The time for action is before a product such as Juul is in every high school in the United States, not after,” said the Truth Initiative, a group dedicated to preventing youth tobacco use.

In March several of these groups, including the Campaign for Tobacco-Free Kids, the American Academy of Pediatrics, American Cancer Society Cancer Action Network, American Heart Association, American Lung Association, Campaign for Tobacco-Free Kids and Truth Initiative, filed suit against the FDA for delaying regulation on e-cigarette products. Several individual pediatricians also joined the case.

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On Sept. 12, the day FDA Commissioner Scott Gottleib announced the crackdown, shares of cigarette makers went up. The market concluded it was a sign that traditional smoking would benefit, a theory that seems debatable given that two of the five leading e-cigarette products — Vuse from British American Tobacco‘s Reynolds company, and MarkTen from Altria — are manufactured by U.S. tobacco companies.

The ALA’s Sward took another view of the move in tobacco stocks: “They know this is even more inaction from FDA.”

Recognizing a problem is one thing, and many of these groups give the FDA credit for highlighting some of the issues central to the teen e-cigarette epidemic. Myers said it was “a clear call to action” about the need for change and identified use of flavors, product marketing, online sales with too few protections, irresponsible retailers and manufacturers willing to sell to irresponsible retailers as all part of the problem. “That’s a good agenda,” Myers said, but he added that the FDA letter said the e-cigarette manufacturers were instructed to present a plan that “may” include each of these components but didn’t say it must include all of them. “It means we’ll get fluff back,” Myers said.

In fact, there is no way to know if the FDA will share the company’s responses with the public, and it remains unclear how exactly the FDA will judge the responses in terms of adequacy in meeting FDA goals. “Will the FDA show anyone the responses, or will we just have to trust them at their word if they choose not to take further action,” Sward said. “The FDA is not transparent when it comes to these issues, and keeping these responses in a locked file draw will not satisfy us.”

The history of regulation of cigarettes has shown that it is naïve to think for-profit companies will voluntarily take sufficient action. “Companies have ripped their tactics right out of the Big Tobacco playbook,” Sward said, and a big reason for that is that the FDA continues to let them.

“It’s too early to know if this is real oversight or just a fig leaf. FDA unlawfully delayed its review of existing products by years,” said Jeff Dubner, senior counsel at executive branch watchdog Democracy Forward, which along with many of these other groups remains in litigation against the FDA. … Until Commissioner [Scott] Gottlieb … proves that this … announcement has teeth, it’s hard to credit this tough-on-vaping posture.”

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There is one overriding legal reason why so many anti-tobacco product advocates remain critical of the FDA. The regulator still will not use the statutory authority that Congress gave it in 2009 under the Family Smoking Prevention and Tobacco Control Act to regulate manufacturing, distribution and marketing of tobacco products, which was extended in 2016 to e-cigarettes under what is known as the deeming regulation. In fact, even with the latest crackdown, the FDA still has not moved up the deadline for submission of e-cigarette product premarket authorizations for products on the market before August 2016, which it delayed from August 2018 to 2022.

“The No. 1 need is for every product on the market before August 2016 to go through premarket review,” Sward said. E-cigarette products that came on market before the Deeming Rule took effect in 2016 were grandfathered and allowed to stay on the market, but Sward said the FDA is not enforcing the rule for any e-cigarette products, including two Juul flavored products that came on the market after the cutoff.

“The reality of what we do know is that in the absence of meaningful regulation, e-cigarettes have produced products of incredibly wide variability and consistency, and they have marketed them in ways often to make them appealing to kids,” said Myers of the Campaign for Tobacco-Free Kids. “There are over 7,000 flavors being used in e-cigarettes … without any scientific study. When you think about consequences of the FDA not setting ground rules and not requiring manufacturers to produce sound science about products, it has an impact both for smokers who want to quit and those concerned about adolescents. Both suffer.”

That’s a point often lost in the current debate over teen use of these products: e-cigarettes were designed for smoking cessation, and that remains a goal that many of these advocacy groups still support, but there is barely any science on which to base a belief that e-cigarettes are more likely to result in a smoker quitting than a teenager moving on to traditional cigarettes.

Myers said government research shows that as many as one-quarter of all teens who use e-cigarettes may end up as smokers. The one study from the U.K. that has been cited most widely as proof that e-cigarettes do work as a smoking cessation device, including by the U.S. Congress, was deemed to be irrelevant to the U.S. marketplace by major medical groups, including the American Medical Association and American Academy of Pediatrics.

“The industry has been using the same argument since 2009 and 2010, and there is no more scientific evidence behind it, or only a little more behind it today,” Sward said, adding that “the Obama administration has a lot of responsibility for this laying at its feet as well.” In 2015, when a measure went to the White House to ban all new flavored e-cigarette products unless the manufacturers could provide a public health benefit, it was stripped out, a decision that Sward summed up as a complete “lack of political will” to take on corporations.

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There is one belief that these groups do pin their hopes on, and it is not related to any of the concrete steps outlined by the FDA this month. It’s more personal. “I think the jury is out on whether this is just another delay, but I truly believe Gottlieb doesn’t want to be known as the person who allowed e-cigarettes to addict another generation of kids,” Myers said. “I don’t doubt that, but I’m not sure if he is prepared to take the actions needed. He hasn’t done it yet.”

In response to its critics, an FDA spokesman pointed to many of the steps outlined by the regulator and referred to Gottlieb’s statement that “the FDA won’t tolerate a whole generation of young people becoming addicted to nicotine.”

The FDA’s crackdown includes 1,300 warnings, letters and fines aimed at retailers illegally selling e-cigarettes to minors, “revisiting” its deadline for the compliance policy on premarket applications from flavored e-cigarette makers, stepping up enforcement actions, investigating unlawful marketing and sales of products on e-cigarette manufacturer websites and developing an “overall policy roadmap,” to address youth use.

Of the crackdown in retail sales, Myers was not hopeful, saying that it is “the smallest part of the problem. It’s easy to run stings.”

Gottlieb’s statement acknowledged FDA inaction. “I’ve spent a lot of time considering whether there were different choices we could have made last summer that would have lessened, or avoided, the epidemic of youth use that I believe is before us. … what if we hadn’t extended the compliance dates for filing applications for e-cigs on the market when the deeming rule went into effect?”

He concluded it would not have made a difference.

The FDA commissioner also implied that the advocacy groups may yet get their wish and see the FDA take significant regulatory action, and referenced the data on the increase in teen use already leaked to the press: “If as we expect, preliminary data that’s in our possession and will be finalized and released in the coming months confirm our present observations that the youth use of e-cigs is rising very sharply; we’ll swiftly change course.”

Critics aren’t hopeful that the plans submitted by the e-cigarette makers will do much good. “It is just naive,” Myers said. “To have not learned from history, to think we can count on the unregulated marketplace to prioritize public health.”

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