Only Big Tobacco and Big Pharma want e-cig regulation
- Ivo Vegter
- 02 Dec 2014 01:16 (South Africa)
“[Electronic cigarettes] are nicotine delivery devices intended to be used like a cigarette. What happens to someone who stops inhaling the tars of cigarettes and inhales only nicotine? We don't know. There is at least the potential for harm.”
So says Dr Norman Edelman, chief medical officer of the American Lung Association, quoted in an online medical magazine. Sound plausible? I thought not.
The effect of nicotine administered on its own has been studied for decades, in multiple products designed to help smokers quit. We do know what happens, contrary to what the good doctor says. Similar in its stimulant effect to caffeine, nicotine has been proposed as a therapy for several conditions, and is considered a “cheap, common, and mostly safe drug”. No study, ever, has found that nicotine alone causes any harm other than the harm caused by nicotine alone. (Do excuse the tautology. Dr Edelman made me do it.)
To make over-the-counter access to nicotine replacement therapy more easily available, the US Food & Drug Administration (FDA) last year removed restrictions on patches, gum, inhalers, mouth sprays and lozenges, noting in particular that these products “do not appear to have significant potential for abuse or dependence.”
But they are for the most part unpleasant to use, and the morality police wants to keep it that way. Smokers must suffer.
E-cigarettes and similar devices heat up a liquid containing nicotine, to create an inhalable vapour (hence “vaping”). The liquid is some combination of propylene glycol and vegetable glycerin, both of which are well-understood and safe for consumption. The liquid can optionally be flavoured with anything, and such flavouring is much more pleasant than it sounds.
The e-cigarette market has grown rapidly, and is worth $3 billion today. It is a market that the World Health Organisation is keen to see heavily regulated, despite its own report, which claims that “it is very likely that average ENDS (electronic nicotine delivery system) use produces lower exposures to toxicants [sic] that [sic] combustible products.”
According to the WHO, 466 brands are competing for the e-cigarette market, which is expected to grow by a factor of 17 by 2030. No self-respecting tobacco company or pharmaceutical giant can pass up a market worth north of $50 billion, of course.
Tobacco companies have been buying e-cigarette makers to protect their turf, and we saw last week how cosy their relationship with government is. Pharmaceutical companies aren’t standing idly by either. If their profitable nicotine replacement therapies are to become obsolete, they want in on the action. Boots, the giant UK pharmacy chain, has already signed an exclusive deal with Imperial Tobacco to sell the Puritane brand of e-cigarettes.
In the US, the regulator’s first instinct was to ban e-cigarettes as unapproved drug delivery devices. A protracted court battle ensued. This year, the FDA determined that e-cigarettes aren’t medicine at all, but would be regulated like tobacco instead. Across the pond, European Commission made the same ruling.
A company named Totally Wicked is set to challenge the European dictat in 2015, but it remains to be seen if regulators will permit e-cigarettes to be regulated on their own merits, instead of under the onerous laws that govern the pharmaceutical and tobacco industries.
Our ruling class evidently finds the idea of a dynamic, rapidly innovating, and flourishing private industry just too horrible to contemplate.
The battle has become absurd more than once. In Australia, a major tobacco firm has been lobbying to have e-cigarettes declared to be medicine. Obviously it isn’t quite as concerned about “making smokers healthier” as it claims. After all, it sells carcinogenics to those same smokers. So how would it benefit? Well, smaller independent e-cigarette manufacturers would suddenly be at a huge disadvantage, having to get products approved for pharmaceutical use. Meanwhile, Big Tobacco dodges the advertising ban that would ensue if e-cigarettes were declared to be tobacco.
A US tobacco company took a different tack. It also pretended to be concerned about the health of its customers, and slapped huge warnings on its own e-cigarettes. After resisting health labelling for cigarettes forever, tobacco companies are suddenly ahead of the regulators? I’ll call that bluff.
The truth is that tobacco companies do not want you to use even their own e-cigarettes. Next thing you’ll quit smoking, and that is bad for business. According to research firm Euromonitor, global cigarette sales volume plateaued in 2008, and started to decline in 2012. Tobacco companies have been keeping the ship afloat by raising prices. They don’t like products that generate less revenue.
“We are concerned about the potential for addiction and abuse of these products,” says Rita Chapelle, a spokesperson for the tobacco ind... sorry, the FDA. “We don't want the public to perceive them as a safer alternative to cigarettes.”
The US regulator does not cite actual cases of alleged harm caused by e-cigarettes, despite there being millions of users worldwide. The FDA claims not to know enough about e-cigarettes, but happily issues warnings about health risks, and claims that they are “not safe”. Very few studies support this view, and those that do are terrible on the basis of their argument alone. (Inhaling a substance reduces oxygen uptake? Call the Nobel Committee!)
Some small manufacturers might be dodgy, but a study of twelve different brands of e-cigarette found toxic trace components to be at least an order of magnitude, and up to 450 times lower than those in tobacco. The ingredients were as safe as those found in a nicotine inhaler. Other tests of the liquids generally find the only toxic component to be nicotine itself. Most e-liquid manufacturers voluntarily label their products with a number of warnings, include that it is toxic, not suitable for pregnant women, not for sale to children, and very harmful when swallowed or absorbed via the skin.
The notion that e-cigarettes have to be regulated like medicine, simply because some smokers use them to quit the more harmful habit of smoking tobacco, is absurd. So is the notion that a product that can help smokers quit should be regulated like tobacco.
The Pharmacy Council of South Africa refused to endorse e-cigarettes in 2009, instead referring the question to the Medicines Control Council (MCC). According to a legal opinion published by the Cancer Association of South Africa, they are now regulated as medicine, and can only be sold in pharmacies. Suspiciously, the same tobacco company that lobbied for exactly this outcome in Australia has a virtual monopoly in South Africa.
Another lawyer agrees, but says “...nicotine, when sold as a substitute for a tobacco product, will be classified as an S3 substance, unless the product is registered by the MCC after consideration of its safety, quality and efficacy [like patches, chewing gum, mouth sprays and lozenges]. All other nicotine-containing e-cigarettes that are used as a tobacco substitute, whether registered with the MCC or not, may therefore be sold only on prescription.”
That is clear as mud. The very same product can either be a prescription drug, or not, depending on whether it is used as a tobacco substitute?
Naturally, vendors of e-cigarettes do not describe their products as a tobacco substitute, nor claim that they can help to quit smoking. They’re not allowed to do so. That leaves them with only one other marketing option: to advertise “vaping” as a cool thing to do whether or not you smoke cigarettes.
That, ironically, annoys the regulators on different grounds: that e-cigarettes will undo decades of “denormalisation”, as they call their campaign to stigmatise and marginalise smoking. And despite clear evidence to the contrary, regulators claim that e-cigarettes may act as a gateway to cigarettes or even harder drugs, rather than a way for smokers to quit.
They’ll say anything to justify regulatory intervention.
It stands to reason that having to go to a doctor to get a prescription for quitting smoking is a barrier to many people. Doctors are expensive, and so are the things they prescribe.
According to Jean-François Etter, a researcher at the Institute of Global Health at the University of Geneva: “Because nicotine medications are not very appealing and are seldom used as a long-term alternative to tobacco, people who need nicotine are forced by current laws to smoke tobacco. These laws are responsible for a public health disaster (700 000 tobacco-related deaths in the EU each year) and they have to change.”
Conversely, many people buy e-cigarettes because there is no medical stigma to them, and they look cool, clean and modern. They are completely odourless and practically harmless to bystanders. They taste good, and there is evidence that they work.
That evidence can be quite dramatic. Belgian researchers tested the devices on smokers with no intention to quit, and found that 21% of them had quit, and another 23% had halved their tobacco use. By comparison, only 3% to 5% of smokers who do want to quit succeed by willpower alone. Another study found that a particular e-cigarette significantly reduced the desire to smoke, but was more pleasant to use than a conventional nicotine replacement therapy. A survey of thousands of e-cigarette users found that almost all used them to quit smoking, and four out of five ex-smokers feared relapsing if they stopped using their e-cigarettes. A US survey had even more impressive results, finding that 31% of e-cigarette users had quit smoking six months later, and a third of those weren’t using the e-cigarette any more either. Several individual case histories confirm the effectiveness of e-cigarettes, even in smokers who were unable to quit using traditional nicotine replacement products and cessation counselling.
There are studies that are less dramatic, but even the most pessimistic study I could find found that e-cigarettes were modestly effective, and possibly more so than both nicotine patches and a placebo.
A South African study, available since 2009, found that 45% of smokers quit within eight weeks of starting to use e-cigarettes, and participating doctors were unanimous that they were both safe and effective. One called it “the most effective treatment method on the market for quitting tobacco smoking.”
I know several people who have used e-cigarettes to quit. In fact, I did so myself. I had a pack-a-day habit of full-strength Camels for 29 years. I tried several nicotine replacement therapies, but they didn’t work and tasted vile. I hated them. In early March this year I bought an e-cigarette, and it was the first nicotine delivery device that actually tasted good. Mechanically, the device was a bit fussy, but no more so than a pipe. I enjoyed using it. I quit smoking tobacco two weeks later. I needed the e-cigarette for the first few weeks, but after three months I noticed I was hardly using it, without even trying to give it up. Today, neither cigarettes nor e-cigarettes tempt me.
The Medicines Control Council, the Pharmacy Council, the Food & Drug Administration, the European Commission and the World Health Organisation can go swivel. They should stop trying to protect Big Tobacco and Big Pharma and start caring about public health. If they were consistent, they’d hand out e-cigarettes like condoms.
“Applying rules to e-cigarettes designed initially for medicines and tobacco would be disproportionate, and have serious adverse consequences for public health,” wrote Etter. “If wisely regulated, e-cigarettes can make cigarettes obsolete. The stakes are high, and we need to play it right.”
There is no substantive evidence that e-cigarettes are harmful, beyond the nicotine they contain. There is also no reason to believe they might prove harmful in future. They are certainly far preferable to tobacco. They do not act as a gateway drug that causes addiction. Most vendors voluntarily include the right health warnings and safety precautions related to nicotine. There is substantial and growing evidence that they do help smokers quit.
Yet makers of e-cigarettes are not allowed to advertise them for their greatest feature. Well I sure can, and I do. E-cigarettes are amazing. They make it easy to quit smoking. Tell your friends. Tell everyone. And if the law says you can’t buy them without a prescription, smuggle the things. The law is an ass.
Now would someone please come and arrest me for whatever laws I broke to quit smoking? DM