FDA’s anti-vape regs do more harm than good.
Two weeks ago, Scott Gottlieb, M.D., left his post as commissioner of the federal Food and Drug Administration (FDA) after a two-year stint.
Dr. Gottlieb left behind an odd legacy: an Ahab-like war on flavored vape juices that no one saw coming and that has left most sensible observers confused.
That war is based on an imagined ‘epidemic’ of teen vaping. And some people, including Gottlieb, view that ‘epidemic’ as a ‘gateway drug’ to deadly teen smoking.
Each of these premises is either false or unproved.
As a result, Gottlieb’s policy prescriptions are very likely misguided. Indeed, as I’ll try to show, they are far more likely to do harm than good.
Let’s hope his successor steers a more sensible course.
Vaping Saves Lives
Remarkably, the national smoking rate has been declining at the very same time that vaping rates have soared. Coincidence?
More importantly, by all accounts vaping is about 95 percent safer than smoking.
So if vaping is massively safer than smoking, and helping to reduce smoking, why on earth would we want to discourage it?
Vaping is by far the single most successful smoking-cessation technology ever invented, almost twice as effective as other nicotine replacement therapies, according to a major new study in the New England Journal of Medicine.
Vape juice usually, but not always, contains nicotine. Consumers can choose how much nicotine they want, if any.
When consumed in moderate amounts, nicotine is harmless. A far greater danger is tobacco smoke, with its 7,000 harmful and cancer-causing chemicals. To the extent that vaping diverts people from smoking—and it does—it saves lives.
And it can save many more, if we let it. A study published in the British Medical Journal last year estimates that between 1.6 and 19.5 million American lives could be saved over ten years if most cigarette smokers switched to vaping, with the most likely outcome being 6.6 million lives saved.
A Parting Shot
In one of his final acts as commissioner, Gottlieb on March 13 took his one-man war on flavored vape juices to a new level, declaring his agency’s intention, at a date to be determined (but presumably soon), to pull flavored vape juices (which, by the way, is basically all of them) from the shelves of any retail establishment where minors are allowed to be present.
Ominously, he further threatened that if this latest move fails to curb the alleged ‘epidemic’ of teen vaping, then his agency will simply pull flavored vape products from the market altogether. Sigh.
To be sure, teen nicotine addiction is a bad thing. It can harm young, developing brains. That’s why every state already bans vape sales to minors.
But Gottlieb’s prohibitionist approach is unlikely to work and will almost certainly be counterproductive.
What Hath Gottlieb Wrought?
Under FDA’s proposed ‘separate facilities’ requirement, gas stations and convenience stores won’t be able to sell flavored e-liquids unless they establish a separate room or out-building devoted solely to these products, thereby stigmatizing them relative to cigarettes.
This requirement is onerous. Realistically, most retail locations other than vape shops will not be able to comply with it, and will simply stop offering flavored e-juices. Meanwhile, cigarettes will remain available. Thus life-saving alternatives will disappear from the very locations where the vast majority of adult smokers are most likely to encounter them. The result is predictable. The playing field will incline toward combustible forms of nicotine—the opposite of the desired outcome!
The Curious Mint Exemption
Oddly, the Gottlieb Rule’s crackdown on flavored e-juices exempts three flavors: tobacco, menthol, and mint. Why? Well, FDA claims kids don’t care for these ‘traditional’ cigarette flavors, so maybe keeping them around might actually help adult smokers migrate to vaping.
But that’s not right. Kids actually do like tobacco, menthol, and mint. In fact, more than 80 percent of young vapers use those flavors.
And mint has never been a traditional cigarette flavor. So why give it special treatment? Well, perhaps because mint-flavored vape pods are the main revenue source of Juul, the nation’s largest vape products manufacturer. In fact, mint pods represent more than 70 percent of Juul’s sales.
Perhaps we shouldn’t be surprised, then, that Juul strongly supports Gottlieb’s Rule, as does Altria, maker of best-selling Marlboro cigarettes, which recently bought a 35 percent stake in Juul. Could Juul-Altria’s support be part of a cronyist quid pro quo?
Not an Epidemic
Is teen vaping an ‘epidemic’? The evidence suggests not.
While the National Tobacco Youth Survey does show a rise in youth vaping in 2018, this data is critically incomplete. FDA has leaked only the bits of the survey that favor Gottlieb’s preferred narrative. The full 2018 results won’t be published for months. Importantly, the leaked data does not tell us what percentage of young vapers are current or ex-smokers. Until we know that, we can’t know whether the recent rise is an epidemic—or a public-health victory.
The information we do have tells us 60 percent of non-smoking teen vapers only do so five or fewer times a month, rather than on a daily basis. In other words, they’re weekend experimenters, not addicts. We also know that in 2017 only one in five teen vapers vaped daily, and half of those did not smoke. So we can deduce that out of 14.9 million U.S. high schoolers, a mere 184,000 (1.24 percent) are vapers who also smoke to some extent.
So much for Dr. Gottlieb’s ‘epidemic.’
Not a Gateway Drug
Is vaping a gateway drug to smoking? Doubtful. The authors of an important 2015 Yale study found ‘no evidence supporting the claim that e-cigarettes increase smoking (i.e., gateway effects or renormalization of smoking).’
To be sure, a 2017 meta-analysis did claim a 23.2 percent probability that a vaper will go on to become a cigarette smoker. But that figure, even if accurate, must be put in perspective. As health policy expert David Hogberg points out: ‘At that rate, it would take over ten years, based on current high-school enrollment trends, before the number of high-school seniors taking up cigarettes due to vaping reached even half the number of people who would be saved by e-cigarettes.’
Warning: Bad Policy Is Addictive
Beyond its false premises, the tragedy of Gottlieb’s Rule is its likely consequences. Consider.
- In 2017 Lancaster County, Nebraska, mounted an aggressive campaign to curb sales of vape products to minors. Underage vape sales plummeted by 75 percent in one year. But at the same time, sales of tobacco products to minors increased by 26 percent. Coincidence?
- The aforementioned 2015 Yale study found that state-level bans on underage vape purchases led to ‘a statistically significant 1.0 percentage point increase in recent cigarette smoking rates among 12 to 17 year olds.’ Tragically, that regression largely reversed the preceding, seven-year downward trend in teen smoking.
In sum, the Gottlieb Rule, if implemented, is likely to make it harder for adult smokers (and teens) to quit, while suspiciously steering teens (and adults) toward the vape products of one company, Juul.
And it probably won’t even stop kids from vaping. Data from FDA’s own Population Assessment of Tobacco and Health (PATH) survey reveals that 90 percent of teens obtain their vape products, not through direct purchase, but rather from friends, many of whom, presumably, obtain them from an adult.
A Better Strategy
So what should we do instead? Here’s a five-part suggestion:
First, continue to ban sales, to children under 18, of products that contain nicotine, and enforce the ban, as at present, with fines and undercover compliance checks.
Second, and this is critical, keep non-combustible smoking-cessation products, including vapes, on the same shelves as tobacco products, so adult consumers can choose healthier options conveniently without stigma.
Third, tax combustibles more heavily than safer nicotine-delivery systems.
Fourth, speed up FDA’s approval and ‘safer than smoking’ certification of heat-not-burn devices and other promising noncombustible alternatives to cigarettes.
Fifth, intensify scientific research on the health effects of non-combustibles, to help consumers make informed choices.
Vaping saves lives. It can save more lives, if we let it.
Instead of pursuing prohibition, FDA should help informed consumers make healthy choices for themselves, in freedom.
Let’s hope Dr. Gottlieb’s successor agrees.
Dean Clancy, a former senior Republican official in Congress and the White House, writes on U.S. health reform, budget, and constitutional issues. Follow him at deanclancy.com or on twitter @deanclancy.