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Is Vaping Safe?

Are E-Cigs Safe?

“Are e-cigs safe?”

Let us begin by saying we hate the use of the term e-cig as it isn’t accurate and automatically comes with the unfortunate negative stigma of being a type of cigarette.  We like to think of them as PVD’s or personal vape devices.  For the sake of understanding, we will use the word e-cig since it’s what everybody either knows or thinks of–for now.

‘Safe’ is a loaded word in our society. We’re taught conflicting ideas from an early age; one such conflict is that there are such binary states as ‘safe’ and ‘unsafe’ and yet we should always look both ways before crossing any street, no matter how empty or unused. The simple reality is that there is no such thing as ‘safe’ but instead only varying degrees of risk: there is an extremely small yet non-zero risk that you will be struck dead by a meteorite from deep space. Therefore, the key becomes having enough information that any risks you take are informed ones; for example, the risk of death-by-random-meteorite is so small (1:750,000,000) that it should not preclude you from going about your daily routine.

Conventional cigarettes consist of hundreds of chemical ingredients which become thousands of compounds when combusted, so their risk can only be truly known via thorough scientific study due to the high likelihood of compounding factors. E-cigarettes—or particularly the ‘juice’ that fills them—have only a few ingredients and do not actually induce any chemical reactions in them (unlike burning) and so a realistic prediction of their risk is similarly simpler: take each ingredient in turn and look at its health effects.

Since the reaction of various ingredients is dependent upon context, we should consider the e-cigarette mechanism itself. An e-cigarette is technically a vaporizer and, in essence, is no more than a battery hooked up to a heating element which heats up to between 300 and 450 degrees F. This is enough to vaporize—i.e. boil—the fluid in them but not enough to set the fluid alight. The ingredients in the juice change their state but chemically, for the most part, remain the same. Vaporizers as a technology are a known quantity to the point where they are used by chefs to flavor dishes.

To reiterate: vaporizers work by simply turning juice ingredients into a mist rather than actively burning them (and thus causing them to react chemically with the air and each other) like conventional cigarettes do. It’s this context which allows us to look at the risks of the ingredients individually.

The main constituent of any e-cig juice is propylene glycol, a simple compound derived from mineral oil that is commonly used in cosmetics to increase penetration of the skin, medical vaporizers as a medium for carrying medicine (the use from which e-cigs are derived), and pills to act as a solvent for medications that are not water-soluble. You may also recognize the name from automotive antifreeze, which is a much more concentrated version.  In the low concentrations used in e-cigs (and cosmetics and medicines and whatnot), propylene glycol is classified as Generally Recognized as Safe (GRAS) by the Food and Drug Administration (FDA). In terms of risks, studies have shown that some people can have allergic reactions to it but otherwise there is no indication of acute or chronic poisoning at low doses, nor is it known to be carcinogenic.

You wouldn’t want to drink it by the gallon in a contest, but otherwise, it’s a very low-risk ingredient.

The propylene glycol is usually mixed with vegetable glycerin, also known as glycerol. It’s a very common food additive found in low-fat foods, frosting, certain liqueurs, and whatnot. It’s also used as a lubricant in laboratory settings. Even industrial strength glycerol is benign stuff; a 180-lb man would have to eat over two pounds of it to get a lethal dose; the usual dosage is on the order of single milligrams. In concentrated form it can irritate some people’s skin, but there is no clinical evidence of it being chronically toxic or carcinogenic; as such, it’s another GRAS ingredient according to the FDA. The human body can metabolize it for energy.

Glycerol is so low-risk that you could literally slather it all over yourself and then play slip-‘n-slide across linoleum floors to your heart’s content with no fear of catching anything from it… unless you happen to have skin sensitive to it, at which point doing so may be mildly uncomfortable until you wash it off.

E-cig juice flavors come from, well, those ‘natural and artificial flavors.’ Clandestine Vapes™ sources its flavors from a supplier that uses all-natural concentrates with no added preservatives or sweeteners. While chemically complex, these flavorings retain the chemical composition of their source fruit, nuts, herbs, and whatnot. Therefore, they’re no more risky, once diluted in an e-juice, than their original sources. After going through a vaporizer, they’re probably less risky than cooked versions of their sources due to less likelihood of chemical reactions causing burnt (and therefore usually carcinogenic) areas.

Since you eat food, the flavoring used in Clandestine Vapes™ juices are probably not an appreciable increase in risk to your everyday lifestyle.

Finally, the optional ingredient: nicotine. This is an honest-to-goodness drug, albeit one classified as Over-The-Counter by the FDA. It is obtained (mostly) from tobacco plants, which use it as a natural insecticide. In the human body, it has several effects. At low doses, it causes glucose, adrenaline, and dopamine release, acting as a psycho-stimulant. At higher doses, it suppresses nerve function and causes serotonin release, acting as a mild sedative and pain-killing narcotic. This variable effect (called “Nesbitt’s Paradox”) makes nicotine unique when compared to alcohol or caffeine. It is known to be addictive, and is the most toxic ingredient on the list: spilling a large amount of pure nicotine on one’s skin can be lethal. It has been found to be carcinogenic in rats and, at least when part of smoking, can increase the risk of birth defects. To be fair, the diseases most commonly popularly associated with nicotine—emphysema and cancers of the mouth, throat, and lungs—are more scientifically associated with smoking, due to chemical reactions within smoke and the physical damage of inhaling burning smoke particulates.

We’re not pulling any punches here. Taking nicotine is a risk, and it’s best if it’s an informed one. However, one needs to put it in context of other commonly used honest-to-goodness drugs.  Caffeine is similarly toxic at higher concentrations and similarly addictive, albeit with less severe withdrawal symptoms. Unlike nicotine, caffeine is nothing but a stimulant and so overdoses can lead to heart or liver failure, especially in people with liver damage. Alcohol’s health effects are so well-documented and advertised that Wikipedia is a sufficiently credible source. These are understood as informed risks; whether they are acceptable or not is an exercise for the individual and their support structure.

(Just like with everything, there are actually certain health benefits associated with controlled nicotine usage; however, that’s a discussion for you and a doctor rather than some guy lecturing in a FAQ.)

So you’ve read this far. Are e-cigs ‘safe?’ Without nicotine, e-cigs are probably about as pharmacologically active as the homeopathic water pills they sell down at Whole Foods and, at most, are as pharmacologically active as the FDA-unregulated herbal pills they sell at any nature store. With nicotine, they’re about as ‘safe’ as nicotine patches, which are considered over-the-counter drugs in the United States and regulated accordingly.

Whether they’re ‘safe enough’ for you is for you to decide.

“What’s the difference between e-cigs and cigarettes?”

Well, the name ‘e-cigarette’ is something of an unfortunate one, given the grim history surrounding cigarettes. In reality, they’re two entirely different things: cigarettes (and all pipes) burn their contents and produce smoke; e-cigarettes boil their contents and produce vapor. As such, e-cigarettes are more technically termed ‘vaporizers,’ but that name has been taken by the medical and marijuana industries and thus has their connotations associated with them.

Everyone knows how cigarettes work: stick some tobacco leaves in a paper tube, ignite it, and breathe in the smoke. The burning cigarette is a self-sustaining chemical reaction between the cigarette’s components (rolling paper, tobacco, whatever else is in there), the atmosphere, and each other. This is where the “thousands of carcinogenic compounds” you’ve heard about in anti-smoking ads come from, and those anti-smoking ads are perfectly accurate in the concerns they raise about them. Those thousands of chemicals, radically altered from their original form via chemical reactions, are inhaled into the lungs in the form of smoke, which consists of ‘particulates’ (basically soot and dust) suspended in air. These particulates can cause physical damage by abrasion, by clogging, and by heat (in the case of cigarettes and pipes) in addition to whatever effect the ingested chemicals have. Water pipes may have a ‘smoother’ smoke, but they still produce smoke: particulates and chemicals and all.

E-cigarettes, on the other hand, produce a relatively low-temperature vapor. Vaporization is a physical change, not a chemical one; it’s exactly like boiling water to make steam: the steam is simply gaseous water. As far as ‘particulates’ are concerned, vapor particles are effectively tiny droplets that cannot abrade or, at the temperatures involved, burn. They can still clog, but anyone who’s breathed very dense steam from a sauna or a very hot shower knows that. The chemical effects of e-cigarettes can be relatively easily predicted from their ingredients, as the ingredients stay the same throughout the entire process: there are no chemical reactions involved as there are in smoking.

 “Do e-cigs help stop smoking?”

To be honest, not enough science has been done yet. There’s quite a lot of anecdotal evidence to support it, but to make an actual claim of effectiveness would require scientific studies and trials which simply haven’t been done yet. This being said, initial studies have supported that e-cigarettes are about as effective as nicotine patches in smoking cessation.

In short? It doesn’t seem unreasonable to say that they could, but no one really knows for sure.

“How are e-cigs regulated?”

It depends.

E-cigarette vaporizers are currently regulated as electronic consumer goods akin to electric toothbrushes or razors.

E-juice that doesn’t contain nicotine is unregulated outside of the county health inspector showing up every so often to make sure that it’s not being mixed together in a septic tank. This makes sense, since all the ingredients in e-juice aren’t much different from the ingredients one would find in a bakery or a confectionery.

E-juice that does contain nicotine is, for the moment, in something of a grey area. Nicotine is an over-the-counter drug which can be bought in any quantity for any purpose short of murder (just like aspirin). Plenty of science laboratories source nicotine for their experiments this way. There’s also, currently, no law or regulation explicitly regulating mixing nicotine with other things and selling it. This is why there’s an argument with proposed regulations about regulating them as either tobacco products or therapeutic pharmaceuticals, both of which—in their current state—are imperfect solutions.

So as of this moment, it goes back to the county health inspector who makes sure that the conditions are right and the ingredients are as advertised. If you can trust your local bakery, you can probably trust your local e-juice maker.

“What about proposed new regulations?”

There are generally two routes of proposed regulation with regards to e-cigarettes: as tobacco products or as therapeutic devices. The former is the more likely, so it’ll be discussed first and in greater detail.

The FDA has the broad authority to regulate ‘tobacco products’ as it sees fit and is aiming to increase the definition of ‘tobacco products’ to include e-juices containing nicotine. On the face, this seems relatively reasonable: nicotine is derived from tobacco and it is a drug worthy of regulation. Once this definition is expanded, the FDA would require any e-juice manufacturer to register its products, get a permit, and either prove the safety of its product or show that any new product is “Substantially Equivalent” (including capital letters) to something already approved and on the market. On the face, these all seem rather reasonable as well.

However, the catch is that the FDA’s enforcement and regulation structure for ‘tobacco products’ is based on the history of ‘tobacco products:’ particularly cigarettes that have to be burned to work.  The FDA “Substantially Equivalent” regulation system is based on submitting a 510(k) report, which is a scientific report trying to show that a new product is pretty much the same as an old one.

Predicting the health effects of a burning product is difficult and therefore requires a significant amount of laboratory testing to make sure that this blend and that blend burn to produce roughly equivalent amounts and kinds of chemicals, and that the health effects of these chemicals is known. Thus, to prove Substantial Equivalence, a manufacturer at the very least has to contract out to a laboratory to test its proposed product and see what comes out of it.

Given the complex chemical reactions that occur when tobacco (and any additives) burn, this testing is required for any and all changes to the product: change the paper? Testing. Change the tobacco blend? Testing. Change any additives? Testing. This is where the “millions of dollars” that e-cigarette advocates opposing the rule change comes in: the amount of testing required, and the cost, effectively limits the process to established players in the tobacco industry.

That the tobacco industry has lobbied for this is probably indicative. Cigarettes, for good reason, are culturally stigmatized and a common public health target. The tobacco industry needs to get into the next big thing, which looks to be e-cigarettes (usually called ‘smokeless tobacco’). That’s why they’re buying into the e-cigarette market. Old e-cigarette models may be grandfathered in, but only established companies with millions of dollars to spend on testing can conduct the research necessary to write a 501(k) and get new products to market. As e-cigarettes are currently mostly a mom-and-pop, small business industry this would have the effect of annihilating all competition without those resources.

On the other hand is the argument that e-cigarettes should be regulated as medical devices. Many e-cigarette advocates don’t help their case by playing up the ‘smoking cessation tool’ use of e-cigarettes. Any medical product that makes a medical claim (like stopping smoking) needs to prove that claim with science, and then it goes back to the requisite millions-of-dollars testing for e-juice blends (arguably, vaporizers themselves should only have to be tested to show that they work at vaporizing, the same way that toothbrushes need to show that they can brush teeth).

The herbal supplement industry gets away with avoiding FDA regulation by saying that ginkgo biloba is good for a case of the bad ju-ju but having a disclaimer on the back saying that their pills treat no medical condition, they make no claim of them doing so, and one should take them for effectively amusement purposes only.

And that’s one of the directions e-cigarette advocates should go. People take nicotine, alcohol, and caffeine to feel good and have fun. The issue is that they should do so responsibly, and regulations should exist to aid in fulfilling that responsibility. The relative simplicity of e-juices makes them equivalent to alcoholic beverages and the regulation should be similar.

E-juices should be, at the very most, the equivalent of craft beers.

Why so? Well, a craft beer consists of a whole bunch of inactive ingredients (water, the unfermented parts of hops, malt, and grains; berries, nuts, chocolate, vanilla, hot sauce, gold flakes, whatever) and a single active ingredient (alcohol). The only thing that’s regulated is the alcohol; the brewer has to know how much alcohol is in it, label it in percent by volume, put on a few Surgeon General’s Warnings associated with alcohol, and they’re done. The county health inspector comes around every so often to make sure that their brewing vats don’t have dead rats rotting in them and that there really is so-much-percent alcohol in solution, and the job’s done. Likewise, e-juice contains some inactive ingredients (water, propylene glycol, glycerol, flavors) and a single active ingredient (nicotine, maybe).

What’s important is how much nicotine is in solution in the juice and that what’s advertised matches what’s in the bottle. Label the nicotine concentration, add the appropriate nicotine-specific (not tobacco-specific, they’re different risks) warnings, and have the county health inspector check to make sure everything’s on the level.  Again, this should be as fierce as it gets–but keeps the Mom & Pop shops in the market to compete, with realistic regulations they can afford to do so.

Ideally it should be as simple as a stainless steel mixing table in a clean minimalized commercial kitchen environment, stainless steel sinks, refrigeration for ingredients, and left up to a city or county health inspector as noted above–and that should do it for regulation.

 

#LetMeCompete

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