The Flying Circus

America’s tobacco-control policy brings to mind a sketch from Monty Python—with potentially unfunny consequences.

By George Gay

If you were told that it had been proved that people smoke tobacco for the enjoyment they derive from nicotine, which is basically harmless, but die from the result of inhaling tar, it would be rational to postulate that reducing the tar produced during smoking could have a positive health outcome. Indeed, previous attempts have been made in the U.S. and Europe to do just that while keeping the nicotine level stable or even increasing it.

What you wouldn’t suggest, I think, is lowering the amount of nicotine while retaining the tar. I mean, that would be laughable. Unless, of course, you were the U.S. Food and Drug Administration (FDA)—in which case it would make perfect sense.

This isn’t quite as straightforwardly daft as it seems, of course. The argument for lowering the tar but not the nicotine is based on the idea that because cigarettes are—according to the FDA and just about everybody else—addictive, smokers cannot stop smoking this side of death, so the only thing to do is reduce the harmful component of this habit as far as possible. The reason that this has not been made to work is that, for reasons of taste, it is not possible to reduce tar levels far enough. This is a good example of the maxim, sometimes attributed to Albert Einstein, that, in theory, theory and practice are the same, but in practice they are not.

The argument for lowering the level of nicotine, meanwhile, is based on the idea that this is the addictive component of cigarette smoke, and that reducing it to nonsatisfying levels would cause people to quit because they would no longer be getting their addictive fix. To my way of thinking, such an idea might be worth trying if it involved gradually reducing the nicotine deliveries of all cigarettes on a particular market over time, perhaps 10 years or so. But this is not what the FDA is looking at, or is being urged to undertake, as I understand it. The idea is that you go to near zero nicotine in one hit. In this case, to my mind, the idea doesn’t work even as a theory because it relies on your being able to keep two opposing ideas in your head at once, which is a trick usually confined only to artists. You must be able to believe at one and the same time that nicotine is and isn’t addictive. That is, the theory comes hard up against one of the basic tenets of rational thought: that P cannot be both Q and not Q simultaneously.

HOW DID WE GET HERE?

How has the U.S. tobacco products environment reached this strange place? I think the answer has to do with ideology. If you’ve followed the FDA since it was granted regulatory powers over tobacco products through the Family Smoking Prevention and Tobacco Control Act that was signed into law in 2009, you might have noticed that it resembles the monks in Monty Python and the Holy Grail, hooded to protect their senses from external ideas and beating themselves about the head with pieces of wood to keep on-message.

OK, some will retort that this is unfair—that, a year or so ago the FDA came up with its comprehensive plan for tobacco and nicotine regulation that places nicotine, and the issue of addiction, at the center of the agency’s tobacco regulation efforts. And they will say that the FDA has been seeking public comment. This is true, but every utterance the FDA makes seems to indicate that it has already made up its mind.

Basically, there are two arms to its plan, one of which involves lowering nicotine levels in combustible cigarettes to nonaddictive levels, the other of which involves encouraging innovation in respect to nicotine products. But the tragedy is that, in reality, the FDA, while hurrying ahead with the first arm of its plan, is dawdling or even backsliding in respect to the second.

Writing at blog.heartland.org in July 2018, Jeff Stier, senior fellow at the Consumer Choice Center and policy advisor to The Heartland Institute, said in part that last July’s extension of timelines for manufacturers to submit electronic cigarette review applications had given the FDA the chance to develop product standards and offer companies guidance on what a successful application must include. “On that front, the FDA has been eerily silent, even as the previously extended deadline looms,” he said. “Instead, it issued a second ANPRM [Advance Notice of Proposed Rulemaking], a precursor to a possible ban on certain e-cigarette flavors, as the agency seeks to better understand how flavors may appeal to youth as well as the crucial role they play in helping adult smokers quit. Instead of keeping its promise to foster harm-reducing innovation, the agency is contemplating a crushing blow to the most significant competitive threat to the cigarette industry in history.”

Like the Python monks, the FDA is wandering, hooded, beating itself with pieces of wood and presumably chanting obsequies to the e-cigarette category: Pie Iesu domine, dona eis requiem, thwack. Pie Iesu domine, dona eis requiem, thwack ….

Or could it be that the FDA is simply taking its time over the issue of e-cigarettes? Its latest initiative is referred to as a multiyear plan, which when translated from agency speak probably means multi-decade plan, except that is in the case of reducing nicotine levels in combustible cigarettes.

Even the National Tobacco Reform Initiative (NTRI), which is generally supportive of the FDA’s plan, in July 2018 tried to encourage a sense of urgency in carrying out all aspects of the plan. In a letter to the FDA commissioner, Scott Gottlieb, on the one-year anniversary of his announcement of the plan, the public health leaders who are part of NTRI said that while they had seen progress during the past 50-plus years in respect to declining smoking prevalence, an estimated 32 million U.S. adults still smoked cigarettes. “Cigarette smoking remains this nation’s leading cause of preventable disease and death, responsible for about 480,000 deaths each year and costing this country approximately $300 billion in healthcare costs and lost productivity,” the NTRI said in a press note that accompanied the letter. “With so many lives on the line each year, there must be an urgency to take bold, visionary actions immediately to reduce the disease burden that smoking addiction inflicts on the health of Americans.

“While the NTRI fully supports the FDA’s announced visionary initiatives, we are concerned that the FDA is/will become mired in overly bureaucratic processes that will delay taking necessary and obvious steps to protect the public’s health. While some attention is being focused on the priority to consider reducing nicotine levels in cigarettes, the other equally important priority to establish a more workable and flexible regulatory framework to regulate all tobacco and nicotine products based on their risks and relative risks (continuum of risk) is nowhere to be seen.”

HERD INSTINCT

Why has the agency’s attitude toward e-cigarettes reached such a pass? It’s down to an ideology that afflicts a large section of tobacco control. In a piece published at the beginning of May, Alex Berezow, senior fellow of biomedical science with the American Council on Smoking and Health, made the point that, not long ago, if a company had invented a far safer way to deliver nicotine to addicted smokers, politicians would have been celebrating. But today, partisanship had ruined just about everything.

“I knew something was amiss when I spotted an advertisement in a Seattle light rail car,” Berezow said. “The ad warned potential vapers not to be ‘fooled’ by e-cigarettes, which it said were toxic, addictive and unsafe. Yes, they are addictive (because they contain nicotine), but calling them toxic and unsafe is absurd. Compared to regular cigarettes, vaping devices are 95 percent safer, according to the U.K.’s NHS [National Health Service]. In other words, if Seattle smokers follow their own public health department’s advice, they are likelier to die. Why on earth would a public health department give such terrible advice? Because the debate over vaping isn’t about science; it’s about ideology.”

As I was about to finish this piece, Gottlieb and Mitch Zeller, director of the FDA’s Center for Tobacco Products, issued a note in which they outlined updates and new initiatives from the FDA on the anniversary of the Tobacco Control Act and the FDA’s Comprehensive Plan for Nicotine. But, according to my reading, what they said would have done little to relieve the concerns expressed above.

Berezow is surely right about the agenda’s being driven by ideology. But it is also being driven by the herd instinct and panic. The fuss in the U.S. over e-cigarettes and, especially, the Juul beggars belief. Some tobacco control advocates in the U.S. have put it about, on no evidence as far as I can see, that e-cigarettes constitute a gateway product. That is, those who use these products move zombie-like toward combustible cigarettes and, therefore, a wasted life of utter degradation. These messages have been picked up by the press and, on reading the press reports, the tobacco control advocates point to them and say, “We told you so.” In the U.S., which I always saw as the place where the market was king, the Juul, a hugely successful product with the potential to shift many smokers from combustible cigarettes to vaping, has been demonized. Anyone reading reports about it would believe that teenagers who use vapor products are immediately sold into slavery.

In a country where 7-year-olds can work on tobacco farms, Gottlieb and Zeller could hardly contain themselves in expressing their zeal to keep nicotine products out of the hands of what they like to refer to as kids, children, youth … until you’re not sure how old some of these youngsters are. “We’ll use every tool available to protect our nation’s kids,” they boldly declared. In fact, this goal is so important to them that part of the heading of their update is: Advancing Tobacco Regulation to Protect Children and Families. That is, they take the children out of the families and set them apart.

I’m certain that these two men are sincere, and I accept that they’re under tremendous pressure from those who live at the butt end of the quit-or-die rainbow, but the emphasis on e-cigarettes is simply over the top. Google “child poverty in the U.S.” and what you will read is really disturbing. If even half of what is described is true, it is shameful in such a rich country.

According to the Feeding America website, “[F]or the nearly 13 million kids in the U.S. facing hunger, getting the energy they need to learn and grow can be a day-in, day-out challenge. Although food insecurity is harmful to any individual, it can be particularly devastating among children due to their increased vulnerability and the potential for long-term consequences.” And Feeding America went on to say that such disadvantaged children were more prone to illnesses, performed badly at school and were less likely to do well in the job market. “Studies have also shown time and time again that even mildly undernourished children may potentially suffer abnormal brain, cognitive and psychological impairment that, if not corrected, can be irreversible,” the note said.

Where is the alarm, the anger and the indignation over this situation? Where are the lofty declarations that every tool will be used to end this situation? The irony is that the word “food” is in the FDA’s title, whereas the word “e-cigarette” is not. Sure, the FDA’s remit is probably about food safety. But surely food safety should involve food security—making sure every child has nourishing meals every day. There’s no point in spending money making sure food is unadulterated if it doesn’t get eaten. As can be seen by the Gottlieb and Zeller statement, the FDA expends a lot of resources trying to keep e-cigarettes out of the hands of youngsters. Those resources would be better spent making sure that nourishing food gets into the hands of youngsters.

The FDA seems to be worried about the better-off children who can afford e-cigarettes, and I would agree that they shouldn’t be ignored. But everything points to the fact that these youngsters are at little risk except in the minds of the Janus heads who believe that young people are attracted to e-cigarettes by their sweet flavors and then to cigarettes, presumably by their not-sweet flavors.

But what are the facts? Well, according to Robert Goldberg, vice president at the Center for Medicine in the Public Interest, a recent survey found that 2 percent of respondents who hadn’t previously smoked cigarettes began doing so after using e-cigarettes.

In an opinion piece published at the end of July on www.insidesources.com, Goldberg said that a new survey of e-cigarette users conducted by the independent Center for Substance Use Research in Glasgow had added to a growing body of evidence suggesting that the negative association between e-cigarettes and smoking was causative, not merely correlative. “The center surveyed nearly 19,000 users of Juul e-cigarettes, which command about half the U.S. market share,” he said. “Nearly two-thirds of respondents who were current smokers at the time they began using e-cigarettes quit smoking as a result. Compare this quit rate to other nicotine-replacement therapies, including gums and patches, of less than 7 percent. More than half of cigarette smokers in the survey who weren’t able to quit were nevertheless able to cut their cigarette consumption by 50 percent to 99 percent after they began using e-cigarettes.

“Meanwhile, just 2 percent of respondents who hadn’t previously smoked cigarettes began doing so after using e-cigarettes. This suggests the gateway effect that e-cigarette critics fear is minimal to nonexistent. For every one respondent who started smoking after using an e-cigarette, 137 quit. Many more significantly reduced their consumption.”

These results were in line with other research, Goldberg said.