While perhaps less ‘scientific’ than the American way, there’s something to say for the British approach to vapor product regulation.
By George Gay
Although it is generally frowned upon to make generalizations about countries and their people, it is common to do so. Generally, each country will have two sets of generalizations appended to it: one, generally positive, scripted by the people of that country; and another, generally negative, written by those of other countries, often neighboring countries.
Great Britain is a good example and, since I live there, I shouldn’t get into too much trouble for using it as such. In 2006, Gordon Brown, the then chancellor of the Exchequer but soon-to-become prime minister, in part described British ideals as a commitment to fairness for all. But elsewhere, many people refer to us collectively as perfidious—“perfidious Albion” being the famous phrase. The contrast couldn’t be more jarring.
To me, a more accurate generalization of Britishness is one that describes us as people who muddle through, and a good example of such muddling was due to unfold in February—possibly as you read this piece—as our latest EU hokey cokey (“You put your left leg in, you take your left leg out …”*) was due to come to a head. And as well as being a more accurate generalization, muddling through is more useful because it can be seen as both positive and negative; it can be used by both British people and others.
I raise this point because it strikes me that the British ability (positive) or tendency (possibly negative) to muddle through is what has in no small part caused the significant—and otherwise rather hard to explain—differences in the approach to e-cigarettes that have been seen in Britain and the U.S. of late.
In my view, the British approach has been better in that it is providing for a quicker, more positive response to these products than is the case in the U.S. And in my view, the reason why this is so is that muddling through provides an opportunity for the development of a strategy that sits between the scientific and the spiritual—between proof and faith. It relies on neither one, but each one can be conjured up when needed. The U.S., on the other hand, has been wedded to the idea of science, or a particular form of science, even though most of the science is unclear and will be for some time.
The British approach was nowhere more apparent than during a question time exchange in the U.K. Parliament on Dec. 16. According to a Hansard report, the Conservative MP Mark Pawsey said that by the time the House of Commons next met for question time, many people would have started on their New Year’s resolutions, and, for many, one of those resolutions would be to give up smoking. “Given that Public Health England recently stated that e-cigarettes are 95 percent safer than tobacco and half the population is unaware of that fact, will the prime minister join me in highlighting the role that e-cigarettes can play in helping people give up tobacco for good?” he asked.
In replying, Prime Minister David Cameron initially made the point that he was speaking as someone “who has been through this battle a number of times, eventually relatively successfully.” He said that lots of people found different ways of giving up smoking and that clearly for some people e-cigarettes were successful. “We need to be guided by the experts, and we should look at the report from Public Health England, but it is promising that over 1 million people are estimated to have used e-cigarettes to help them quit or have replaced smoking with e-cigarettes completely. We should be making it clear that this [is] a very legitimate path for many people to improve their health and therefore the health of the nation.”
It seems to me that the timing of Pawsey’s question was spot on. As he said, it was in the runup to the time when people would be making New Year resolutions, and, though he didn’t spell it out, there was still time for smokers’ friends and families to go looking for e-cigarettes to give as Christmas gifts. And I think that Cameron pitched his reply perfectly in respect of a technology that suggests it is a near-safe alternative to smoking but that still needs to stand the test of time.
What I liked also about this exchange was that the prime minister was not afraid to lay out his credentials as the head of a nation of people dedicated to muddling through—dedicated to doing things “eventually relatively successfully.” We do our international relations that way, we play sport that way, and we learn foreign languages that way.
THE SCIENTIFIC ROUTE
As I understand it, the president of the U.S., Barack Obama, has also had a battle with smoking, but I’m not sure whether he has been completely successful or is holding out to be relatively successful eventually. But what is clear is that the U.S. Food and Drug Administration (FDA) has not been muddling through in respect of e-cigarettes. It, we are told, has been taking the scientific route, which ordinarily would probably be all well and good, but which in the case of the new and emerging technology of e-cigarettes seems to be leading to a dead end. On Dec. 18 I read a piece by Robert King in The Washington Examiner in which he says that a major lobbying effort to save e-cigarettes from falling victim to U.S. federal regulation has failed. King said that a $1.1 trillion spending bill released on Dec. 16 did not include a rider to change the “grandfather” date in upcoming federal regulations governing e-cigarettes.
The grandfather date, Feb. 15, 2007, which was originally established by the U.S. Tobacco Control Act of 2009, signaled that any tobacco cigarette or smokeless tobacco product (those products that were initially put under the authority of the FDA) on the market up to that date would not have to be the subject of burdensome applications for approval by the FDA, whereas those firstly marketed after that date would be subjected to such applications. Now, as part of its so-called deeming regulations, the FDA has proposed that e-cigarettes should be subject to the same grandfather date.
Given that the “deeming regulations” deem that e-cigarettes are tobacco products, this approach seems to deliver a consistency, at least until you think about it for a few seconds. The first problem here is that e-cigarettes are not tobacco products, unless you are prepared for an argument about whether all of those breakfast cereals fortified with niacin are also tobacco products.
But, even if you accept that e-cigarettes are tobacco products, there is a gulf between how tobacco cigarettes have been treated and how it is proposed that e-cigarettes should be treated. The difference: Whereas the tobacco cigarette market was well-established with products by 2007, the e-cigarette market was only just taking off. So the decision means that a majority of the e-cigarettes on U.S. shelves will need to undergo burdensome applications that their suppliers, which are generally small- to medium-sized companies, are unlikely to be able to afford.
Some observers believe that the FDA requirements will kill off that part of the industry not supplied by the major tobacco manufacturers. And these people are not only those with a financial vested interest. Writing at the beginning of December, at a time when some still hoped that the grandfather date might be changed in respect of e-cigarettes, two respected U.S. health experts asked why it should be that the most toxic consumer products on the market—combustible cigarettes—have to do absolutely nothing to stay on the market, while a burdensome and prohibitively expensive applications system is being proposed for much safer, tobacco-free e-cigarettes.
In a blog published in The Hill, Michael Siegel, a professor in the Department of Community Health Sciences at the Boston University School of Public Health, and Scott Ballin, a health policy consultant and former vice president and legislative counsel for the American Heart Association, went to some pains to point up how irrational such proposals were. “This means that every cigarette brand on the market is allowed to continue being sold, without any changes in nicotine content, without eliminating menthol—which is known to appeal to youth—and without lowering the levels of any of the more than 60 known carcinogens in these products,” they wrote.
“Therefore, it may come as a surprise to many to find out that despite the lack of any safety regulations for deadly cigarettes, the FDA has sent for executive branch approval a set of regulations for e-cigarettes—devices that contain no tobacco, involve no combustion and have been shown to be orders of magnitude safer than cigarettes—that require every e-cigarette product to submit burdensome, expensive and technically near-impossible applications just to stay on the market.
“The FDA has apparently decided that e-cigarettes pose a much greater threat to the health of the public than the extremely toxic tobacco cigarettes that are killing more than 400,000 Americans each year.”
ON NODDING TERMS
So why is it that, in my view at least, science has failed where muddling through has succeeded? This is an interesting question that led me to ask another: Could all issues be better solved by applying the principles of muddling through rather than science? It seems unlikely. Sending a man to the moon, building a nuclear power station and designing a new vaccine are probably all examples where you really need science, along with other, possibly linked, disciplines.
So could it be that the science wasn’t given enough time? Hardly. Concern had been expressed about what the FDA was up to from at least early in 2013, and the FDA announced its new e-cigarette rules—described by some as “long-awaited”—in April 2014.
No, I think the answer is more straightforward than that. I think the problem is that, despite the hype, what the FDA gets up to in respect of tobacco and nicotine often is only on nodding terms with science. At the end of their piece, Siegel and Ballin said they believed that the federal government needed “a more rational approach” to the regulation of tobacco and nicotine products that regulated all products based on their risks and relative risks. Protecting the cigarette industry while stifling innovation of new and much safer products did not achieve that goal and would damage public health efforts, they added. Of course, rationality and science are not one and the same thing, but they are closely related, and it seems to me that the only way that the scientists at the FDA could have followed the science and, as seems to be the case, come up with an irrational proposal would be if the task they had been set was irrational. That is a possibility.
But it is also a possibility that minds get made up early on and it is difficult to change direction. Early in 2013, Elaine Keller, president of the Consumer Advocates for Smoke-free Alternatives Association, a nonprofit, volunteer organization formed in 2009 by e-cigarette consumers to promote tobacco harm reduction policies, made the point that the FDA had firstly tried to remove all e-cigarettes from the market by calling them “drug delivery devices.” “Having failed in their attempt to ban e-cigarettes, the FDA has announced its intent to propose a ‘deeming’ regulation to apply Chapter IX of the Family Smoking Prevention and Tobacco Control Act to e-cigarettes,” she said. “However, portions of Chapter IX would essentially ban all e-cigarettes from being sold, and other provisions would decimate the e-cigarette industry, protect cigarette markets and otherwise threaten public health.”
Muddling through is quicker, cheaper and, at least in some cases, more likely to come up with a sensible, satisfactory result. And, to my mind at least, it has the advantage that tens of thousands of laboratory animals don’t have to be sacrificed on the altar of an esoteric science.
*If you’re unfamiliar with this dance form, you should watch this video of Bill Bailey and Kraftwerk.