Government agencies populated with scientists people are pleased to call “experts” are often thought to be above the ordinary give-and-take of politics and, especially, immune to the clarion calls of activists and pressure of public opinion. Scientific experts, or “the science-based community,” is supposed to be driven by data and evidence, not the naked pressure of agenda driven interests. As we will see in the case of the Food and Drug Administration’s relationship to e-cigarette regulation, these assumptions about the impartiality of scientists don’t always hold water.
The FDA is readying a new action plan to be announced soon concerning e-cigarettes. Nobody knows what the agency will do. But it really shouldn’t be so complicated.
E-cigarettes are not entirely safe and they should not be used by kids.
At the same time, combustible cigarettes are around 95 percent more dangerous than e-cigarettes. Many adults who have not been able to quit smoking using other methods have now completely quit with the help of a wide variety of these far-less harmful non-combustible alternatives.
The FDA must finally formulate sensible, science-based policies to achieve two key goals:
1) Enforce existing rules that ban the sale of e-cigarettes to minors.
2) Support adult smokers who attempt to quit with e-cigarettes, as recommended by the American Cancer Society.
The FDA says that because of “news reports,” public opinion, and data about youth use that the agency hasn’t released, it is threatening to take draconian steps to make e-cigarettes less appealing and harder to get for adult smokers. The Washington Post reported on Thursday that the agency plans to remove e-cigarette pods and flavored e-cigarettes from most outlets until a manufacturer applies for and receives approval for each product. The agency is also warning that it may ban sales everywhere except in vape shops.
This posture represents a dramatic and surprising reversal from July 2017, when the agency announced a new “comprehensive regulatory plan” for tobacco products, including e-cigarettes, which embraced the idea of tobacco harm reduction.
Commissioner Scott Gottleib, M.D., stated that the plan required “demonstrating a greater awareness that nicotine—while highly addictive—is delivered through products that represent a continuum of risk and is most harmful when delivered through smoke particles in combustible cigarettes.” In other words, we should be more concerned about the smoke delivery system than we are about nicotine itself.
As part of that plan, the FDA extended the application deadline in order to give the agency time to first issue “foundational rules to make the product review process more efficient, predictable, and transparent for manufacturers.” Although the FDA has failed to establish those rules, it is now threatening to undo the extension by fiat.
Commissioner Gottlieb spoke clearly last year, explaining that, “Unless we change course, 5.6 million young people alive today will die prematurely later in life from tobacco use.” As the FDA has stated, cigarette smoking is by far the leading cause of tobacco-related disease.
Gottlieb continued, “Envisioning a world where cigarettes would no longer create or sustain addiction, and where adults who still need or want nicotine could get it from alternative and less harmful sources, needs to be the cornerstone of our efforts—and we believe it’s vital that we pursue this common ground.”
But in the last two months, under intense pressure from activists, the FDA has abandoned that common ground. Instead, it is pitting the proper goal of preventing youth use against the other proper goal of helping adult smokers quit. These goals are not and cannot be seen as mutually exclusive.
The news reports and the public opinion the FDA is largely relying upon to justify this about-face have been generated by pressure groups who want non-medicinal nicotine products off the market entirely.
Sound science isn’t an obstacle for those hell-bent on removing e-cigarettes from the market. Consider the latest creepy video from a group known as “The Truth,” featuring puppets, which at once seems to target kids, journalists, and politicians alike. The text under the video states that vaping “…MAKES YOU 4X MORE LIKELY TO START SMOKING CIGARETTES.”
Actually, the latest study, by Rand, concludes otherwise: “EC use among youth is prospectively associated with progression toward greater cigarette use.” Are kids who engage in risky behaviors such as vaping also more likely to start smoking? Absolutely. Does vaping “make” or cause youth to start smoking? That’s not what the evidence says.
The Truth knows better than to confuse association with causation…at least accidentally.
Can’t we agree that kids absolutely shouldn’t use e-cigarettes without intentionally misleading kids by exaggerating the risks? Meanwhile, reporters were the real puppets, repeating unsupported assertions without scrutiny. This, in turn, has led to distorted public opinion. And as the FDA now concedes, that opinion contributed to its threatened reversal on e-cigarettes.
But it’s not too late. In its new plan, the FDA should implement this rational common ground by taking the following three steps:
1) Focus on the bad actors. The FDA should act swiftly and forcefully, as it has the authority to do, against any retailer caught selling an e-cigarette to a minor. In an October 31st announcement, the agency properly acknowledged it must do more, including preventing youth access through social sources.
2) The FDA must work constructively with the industry it regulates. Reports indicate it has begun doing so, to prevent youth initiation, while at the same time permitting recreational nicotine products not only to remain on the market but to be developed to appeal to adult smokers. To do so, it should announce long-promised product standards which would allow the private sector to develop and then market lower-risk nicotine products to attract even more adult smokers. Those standards should distinguish between sweet flavors which adults also enjoy and the marketing of those flavors. There’s no need, for example, to label sweet flavored e-cigarettes “gummy bear.”
3) Make good on the promise to change misconceptions about nicotine, which, while addictive, is not the major cause of tobacco-related disease. Everyone should have a right to accurate information about the risks of vaping, including the risks as compared to smoking, as Public Health England has donewith much success.
What should FDA not do?
1) Remove e-cigarettes from any outlet, such as convenience stores and gas stations, where adults regularly purchase the e-cigarettes that made them non-smokers. Vape shops offer valuable quit-smoking advice and are generally among the most responsible vendors. But convenience stores are, well, convenient. Quitting is hard enough as it is. We should want lower-risk products to be available to adult smokers in the same places they have been buying their cigarettes for decades.
Further, collective punishment of entire classes of retailers punishes the responsible vendors who are necessary to implement widespread harm reduction.
2) Allow either side to erode common ground. Just as the FDA shouldn’t be lenient with those who sell or give e-cigarettes to kids, it shouldn’t allow false assertions about the risks of e-cigarettes to stand unchallenged. Misleading statements influence policy-making, even if only by distorting public opinion. Worse, campaigns which exaggerate the risks of e-cigarettes harm public health by giving adult smokers all they need not to try quitting: another excuse.
3) Fall prey to the notion that the FDA has in its power the ability prevent every last youth from every trying an e-cigarette. Commissioner Gottlieb said in September: “It’s now clear to me, that in closing the on-ramp to kids, we’re going to have to narrow the off-ramp for adults who want to migrate off combustible tobacco and onto e-cigs.”
Completely preventing youth from experimenting with risky products is impossible. It was impossible in the days of prohibition and it is even more impossible today. Products which appeal to youth also appeal to adult smokers. And products which don’t appeal to youth, won’t appeal to many adult smokers. This is why stores like Walgreens are permitted to offer fruit flavored nicotine gum, even without a prescription. Kids generally don’t buy it. Neither do most smokers.
Design appeal, a variety of flavors, and availability are all necessary components to effectively implement tobacco harm reduction for adult smokers. What’s not necessary is allowing kids to buy or use them.
When giving the FDA authority to regulate recreational lower-risk nicotine products, Congress believed the FDA could be sophisticated enough to at once prevent youth use while helping adults quit smoking. Sadly, to date, the FDA has accomplished little on either front. These failures don’t justify a misplaced “crackdown” on e-cigarettes and responsible sellers. They require an intensive focus on stopping the bad actors.
If the FDA doesn’t get it right— this month—President Trump should ask Gottlieb, in an exit interview, why the agency couldn’t achieve a central promise of the Trump presidency: improve our lives not with more regulation, but with less of it, wisely implemented.
This could very well be another case where the common sense instincts of an elected politician trump the scientific instincts of scientists trying to apply them within a political context. Scientific and political expertise, after all, is not the same thing.
Originally published here