And would this be a good or a bad thing?
You might have noticed certain phrases we use when we describe and talk about the role e cigarettes can play in your life. We don’t blatantly say they help you quit smoking, because if we did, we are then making a medical claim that they can cure you from your addiction to nicotine. Instead, we say ‘switch to e-cigs’, or ‘move away from tobacco’.
So why raise this question and talk about this now, some 9 years after e cigarettes came onto the market?
Because of an article in The Hill online magazine.
The Hill is a political website/magazine read by everyone in Washington, including, if the blurb is believable, the White House.
When an article is published on The Hill, one must ask is this opinion? Is this casting around for the general consensus, or, a warning shot across the bow as to what is to come?
What is the underlying motive for publication?
Now, the FDA have, according to The Hill announced a new steering committee for nicotine. The aim of this committee is to ‘modernise’ the FDA’s approach to Nicotine Replacement Therapy (NRT). The article states this new committee might consider the “pursuit of policies that are “more helpful in helping smokers quit combustible cigarettes.”
Of course, they mention e cigarettes and the ‘murky politics surrounding vaping.’
(Seems the journalist has done their research.)
The article didn’t initially come right out and said that vaping helps you quit smoking, no, they stated, “This is despite the ever-growing recognition that vaping can serve as a less harmful alternative to traditional tobacco products, and that flavors can help keep former smokers away from combustible tobacco products.”
Not too dissimilar to the phrasing we use.
However, they do come to the point later in the article, while they discuss some of the science, which, according to the Hill paints a complex picture of vaping.
On the one hand they say, there is straightforward evidence that frequent vaping assists with quitting tobacco, and that vaping and the vast array of flavors help to keep those that have quit, off the cigarettes. Then, it could be that vaping might lead to smoking in teens, (despite mounting evidence to the contrary, and that we continue to share with you.)
Discussing what to do with e-cigarettes, and how they could be promoted, the article mentions, “There is yet another policy option to ensure the continued attraction of vaping devices to smokers seeking to quit and reducing the appeal of e-cigarettes to young people — allowing e-cigarettes manufacturers to market e-cigarettes as smoking cessation products. According to recent research, this is typically how e-cigarettes are being used, yet is the very thing manufactures are not allowed to claim under current law.”
Is this a breath of fresh air, honesty and common sense, or should we be worried that this will come with a huge price tag for the Industry and vapers?
Is it a way for the Pharmaceutical Industry to muscle in?
Is it pure conjecture?
To understand why we are not allowed to market e-cigarettes as quit aides, here is a potted history.
During the years 2008 and 2009, the FDA were impounding e cigarettes left right and centre, stating they had jurisdiction over them as e cigarettes were unapproved drug delivery devices. Indeed, TW had imports impounded on more than one occasion.
Two other e cigarette companies, also subjected to the random impounding of their goods decided enough was enough and so sued the FDA. The e cigarette companies won their case in January 2010 ending the impounding of all e cigarettes.
Judge Leon, the Judge ruling on the case decided that e cigarettes were not drug delivery devices and were in fact a tobacco product. “Judge Leon characterized the FDA’s attempt to apply pharmaceutical standards to e-cigarettes as “bootstrapping run amuck.”
This ruling meant that the industry had to be very careful with its wording to ensure that it didn’t market e cigarettes as a drug delivery device, aka NRT, otherwise the FDA would have jurisdiction over them.
However, it didn’t take too long for the FDA to get their hands on e-cigarettes under the tobacco control act, and we are now where we are, due to the FDA’s misguided regulations.
Which leads us back to the question that if this new committee comes out and states that e cigarettes and vaping do help people transition away from smoking, and help them remain off the tobacco, and they state it in such a way that they are marketing e-cigarettes as quit aides; what ramifications would this have?
Already burdened with possible PMTA’s that have at present been delayed until 2021, will this be a double whammy for the Industry? Will e cigarettes have to comply with two new sets of regulations; one for the PMTA and one for the drug delivery device, or will common sense prevail, and they be treated as the recreational devices they truly are?
Will this mean the PMTA is totally removed or drastically changed to reflect e cigarettes and focus more on quality and safety?
Will it mean they become pure drug delivery devices?
Currently, this is all hypothetical speculation sparked from a comment in a political magazine.
Nothing may come of this.
However, this Kafkaesque situation does highlight beautifully, once again, the ‘murky’ politics surrounding a life saving product that is disrupting the status quo. It highlights just how difficult it is for those in power to see e cigarettes as recreational devices that just happen to help many transition away from smoking.
They can’t neatly stuff them it into one regulatory box and this sure gives them a headache.