Unapproved Does Not Equal Unsafe
By Lindsay Fox Posted September 25, 2013
This article is part 15 of the Top 20 Rebuttals to Win an E-Cigarette Debate
One of the most frequently cited “issues” with e-cigs is that they aren't currently FDA-approved and therefore must be either unsafe or ineffective for their chosen purpose. The problem with this line of reasoning is that the FDA – although it should be – is not the ultimate word on safety and efficiency. In fact, you could go so far as to argue that when it comes to objective assessments of e-cigs, the FDA has a pretty dismal track record (read FDA and Electronic Cigarettes, a Timeline).
Regulations have long been in the pipeline, but even if it never comes, the fact that e-cigs are unapproved doesn't really mean anything when it comes to safety and efficiency.
The main reason the FDA cites for having not taken action regarding e-cigs is that they “have not been fully studied”. This statement is extremely misleading, because e-cigs have actually been studied pretty well indeed (read Top 10 Studies on E-Cigs You Need to Know About).
The fact that they haven’t been around for too long means that long-term safety studies haven’t yet been completed, but if you’re willing to use a little common sense and don’t have significant reason to doubt the research done thus far, it would be absurd to assume there is a real risk. This is all the more true if you make the fair comparison between e-cigs and the tobacco equivalent.
The fact is that the components of e-cig vapor are well-known and well within safe limits. There are trace amounts of carcinogens, but the quantities are so small that they pose essentially no risk whatsoever. Of course, the presence of any carcinogens means that e-cigs aren't absolutely safe, but if you’re in any doubt look no further than FDA-approved nicotine products like patches, gums and inhalers.
SEE ALSO: Nicotine Patches & Gums Vs. E-Cigs
It turns out that approved nicotine inhalers contain formaldehyde, acetaldehyde, cadmium, nickel, lead and o-methylbenzyne, and patches and gums contain tobacco-specific nitrosamines. These are the big bad chemicals people use to claim e-cigs aren't safe, but yet they’re found in equal quantities in FDA-approved products (and for inhalers, users are exposed to higher quantities over a days’ use).
So what’s the FDA’s issue with e-cigs?
The fact that they kicked up a fuss when they detected nitrosamines in e-cigs tested but didn't issue warnings about the findings for patches, gums and inhalers tells you that something isn't quite right with the FDA’s approach. The points raised about approved nicotine replacement therapies aren't intended to say that they aren't safe; it’s merely pointing out that e-cigs are just as safe, if not safer in some cases.
Additionally, just because something is FDA approved doesn't mean it is safe. Take a look at Chantix, an approved stop smoking drug which has been shown to cause suicidal thoughts and psychological problems in addition to increasing users’ risk of heart attacks. It now has a black-box warning, but is still freely sold under approval.
SEE ALSO: Is Chantix Safer than E-Cigs?
The FDA’s approval clearly isn't a reliable barometer against which to measure the safety of e-cigs. If you’re going to make a decision, you have to use existing evidence and – more importantly – common sense. Although more research is needed, anybody who assumes there is going to be some drastic long-term health impact from using them isn't basing their opinion on the best currently available research; it’s nothing other than baseless fear-mongering.