FDA Regulations on eCigarettes are discussed by our Spinfuel opinion writer Julia Barnes
On Monday, December 17th, the FDA held a public hearing on nicotine replacement therapies and smoking cessation products. This 1-day public hearing was scheduled in an effort to obtain input on questions related to upcoming(?) regulations for NRTs, (nicotine replacements therapies) from the public as well as the people working in the trenches in various ‘fields’ of NRTs.
People representing the ecigarette industry and eLiquid industry were in attendance and offered up their ‘side’ of the argument. On the whole, the 9-hour hearing was a levelheaded, unemotional discussion on how best to achieve one simple goal: getting people to stop smoking.
(Rather than reiterate statements made or questions asked I’ve linked the FDA website and a terrific “Live Blogging” of the hearing by ecigadvanced.)
That’s a lofty goal, for sure, and if the FDA is reasonable, unbiased, and truly looking for the best alternative to cigarette and tobacco use than the electronic cigarette industry has a potentially bright future indeed. But that’s a big ‘if’.
Does the FDA really and truly wish to do the right thing for American citizens plagued with the addiction to tobacco or is all this just a ruse? Have they already made up their mind, or are they seriously considering looking at the issue with a ‘modern’ set of eyes?
After listening to hours of testimony and reading further highlights of the testimony part of me is confident that the FDA does understand the role that ecigarettes currently play and more importantly the role it can and will play in the future. But a part of me believes that the real decisions, and the real testimony will happen behind closed doors and the decisions made will be the decisions desired by the biggest donors to various campaigns, or the ‘nanny-state’ policy makers wish to save people from themselves.
Confident?
The reason I’m only half-confident that the FDA may truly look at the evidence as it pertains to ecigarettes is the way certain questions were asked of the people giving testimony. You can often get a good idea of how someone feels about a topic by the questions they ask about them. No one on the panel attacked ecigarettes, and no one seemed hell-bent on banning them. They seemed to be genuinely interested in the efficacy of replacing cigarettes with ecigarettes and other forms of NRT’s.
As for the people that gave testimony, particularly the individuals speaking on behalf of ecigarettes and other smokeless products, while their words were impassioned they often lacked any hard evidence, statistics, and studies. Granted, these things cost millions of dollars to generate and the industry isn’t flush with cash, but unless there is something to backup the words of the impassioned speakers the panel cannot, and should not, be swayed by the words alone.
Common Sense
Many of the statements made relied instead on common sense rather than studies, particularly when applied to statements declaring ecigarettes to be dramatically safer than cigarettes. When asked if certain statements could be backed up with some kind of evidence or study various excuses were given, “I’m not prepared…” “I can’t answer that…” or “Can’t answer that today…”
I’m not criticizing that kind of response because this was, after all, a simple 1-day public “discussion” not a congressional hearing or court of law. Every statement made about the positive effects of ecigarettes were just statements, nothing more. Those statements may carry some weight if measured with a dose of common sense, but they cannot be relied upon as statements of facts because they weren’t backed up with ‘facts’.
Monday’s hearing was just one tiny step toward regulation; there will be many more down the road before anything definitive happens. It certainly wasn’t a bad day for ecigarettes, quite the opposite really. Nothing was gained by this hearing, but nothing was lost either. This is going to be a slow process no matter which way it eventually goes.
Slow To Act – fda regulations on ecigarettes
For a good example of how dreadfully slow the FDA can be (or how downright corrupt they can be) take the drug Chantix for example. Chantix came up a lot on Monday, and the unanimous condemnation toward the drug was remarkable.
This is a drug used for smoking cessation that just so happens to make “some” people verifiably insane. It can cause people to become murderous, suicidal, and more, but it’s still on the market. Why?
There were a several incidences during the hearing where it was said that Chantix should be immediately withdrawn from the market and it was glossed over by the panel every time. You got love this from David Abrams, PhD, Schroeder Institute for Tobacco Research and Policy Studies at Legacy:
Panel: “Fast-track occurred with Chantix and it’s looking bad. Is there a difference?”
Abrams: “It needs to be handled on a case by case basis. Certainly a drug is in need of more sufficient testing. In the case of Chantix, the excess risk involved at a population level are relatively small in comparison to continued smoking. I believe these concerns are largely overblown and nearly insignificant at a population level…” (emphasis added)
Which means, while it’s certainly true some people go nuts and kill themselves or others (or both), not enough people do it to warrant taking it off the market. Look at the bigger picture. Bullshit.
Since this horrible medication is still on the market today it should tell us one of two things; how slow the FDA is, or how corrupt it is. Take your pick. If Chantix can survive the FDA with strong anecdotal proof of its dangers what chance does ecigarettes have to be banned unless the ban was based on reasons that are not legitimate?
Important Or A Waste Of Time
I’ll admit that I didn’t listen to the entire hearing, but I had it tuned in and watched and listened to 80% or more. I have since gone back to the FDA website (you’ll need to install a bit of Adobe software in order to watch) and watched parts I missed the first time around. While it wasn’t vitally important and nothing was decided it is still an interesting hearing and I suggest you give it a look-see when you have the time.
I don’t hide the fact that I have no confidence left in our government. I’m neither a liberal nor a conservative, but big government is nobody’s friend. I am somewhat inclined to believe that the FDA will make real, common sense, mature, and levelheaded decisions when it comes to tackling the issue of smoking cessation and NRTs and how vital ecigarettes can be in that ultimate goal. At the same time I am just as inclined to believe that the ‘fix’ is already in and that whatever decision they want to make they will make, evidence notwithstanding.
With respect to this particular administration, no one can possibly believe that it is not a big believer in ‘nanny-state’ policies. Some people want that kind of government, some don’t. But either way I wouldn’t be surprised if the FDA’s ultimate goal of complete and total cessation of any kind of tobacco use will include a total ban on ecigarettes. (Though I don’t expect it) But the current administration, like many before it, are whores who sell themselves to the highest bidder. So who knows what they will do, or when they will do it.
Monday was one small step toward a final resolution on the eCigarette industry and the future of NRTs. If the FDA is capable of seeing the issues as they are, this one small step should lead to something good. Let’s hope they can see past the current administration’s ‘most likely’ agenda.
Julia Barnes
