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FDA Publish E-Cig Regulation Proposals


On Thursday 25th April, the FDA published their long awaited 241 page deeming regulations of e-cigs. A 75 day period now commences which will allow for public comment. I’ve held off writing this up because I’ve been waiting for the dust to settle and for the experts to chime in. The proposals are 241 pages of legalese and to be perfectly honest, I’m no expert at dissecting FDA wording in order to ascertain precisely what’s on the table. In my experience with covering European regulation a lot of misinformation can get thrown around in the wake of these reports being published.


Some key points:

No ban on internet sales
No advertising ban
No initial ban on flavorings (but this could be subject to change)
No more juice bars
No more free samples
No more health claims 
Ingredients and manufacturing processes must now be submitted to the FDA for assessment


My initial impression was that it was very reasonable and certainly not the doomsday scenario that most vapers anticipated. Instead of rehashing what has already been written I think it’s best to link to the best pieces that have covered the report to date. Judging from the commentary from the experts who have gone over it with a fine comb, it seems it’s anything but reasonable.


You can head over to Dr. Michael Siegler’s blog to read his views and the CASAA have also published their views, both articles cover different points. As far as I’m concerned it’s a much better deal than what was passed in Europe but there’s clearly still much confusion and far too many sticking points. It’s worth noting that for now, these are just proposals and nothing is set in stone yet. Even if they come to pass, they may well open the door to a tidal wave of legal action.


If you’re a vendor or you’re involved in the industry in anyway shape or form then you’ll want to listen to the VP live round table discussion, it’s a real eye opener and it goes into the proposals in great depth and discusses some key issues. It’s quite long and they only get down to business around the 9 minute mark.


Like Dr. Siegler says there’s some good, bad and ugly within the proposals. In effect the FDA will yield a looming ban hammer in exactly the same sense that some aspects of European regulation panned out with regards refillables, this is of grave concern. Refillables and flavors are still very much under threat. The FDA themselves have openly admitted that they can only do so much with their initial draft. However, once they’ve established a regulatory foothold, they will be free exact far more extreme regulatory measures which could for example see a ban on some flavors. My fear is that the proposals are only reasonable because it’s the best they can do for now.


I’m curious about the FDA and European Parliament’s obsession with attempting to remove refillable devices them from the market. Perhaps there is a genuine health concern here (models prone to leaking) and maybe it’s a good thing because it will ensure that manufacturing standards are improved and maintained. However, the sceptic within me can’t help but notice that a considerable portion of disposable e-cigs are manufactured by big tobacco. By and large it’s these companies that have the biggest financial clout too, even those that aren’t run or owned by big tobacco have a Lion’s share of the cigalike market.


I can certainly understand the need for quality assurance but what’s interesting is that this tactic plays right into the hands of Big Tobacco and other companies who sell cigarette style models. This is something the EP and the FDA were apparently stringently against, that is, giving big tobacco any advantage in the market. Yet the proposals on refillables do just that (not all disposables ecig models/companies are owned by big tobacco, but it’s their main focus in the market). The process for approval of refillables as currently offered by the FDA appears to be a very costly and lengthy process which very few (if any) manufacturers will be able to afford. In Europe there was a also an attempt to impose an outright ban on refillables, though this didn’t happen there does appear to be scope within the directive for this to happen in the future. If refillable devices are deemed to be of sufficient quality standards without having to jump through unreachable hoops, then what’s the problem?


I should also point out the continual echoes surrounding regulatory proposals with regards concerns that e-cigs normalize smoking. I’ve pointed this out before, if this is a major concern of theirs, then why in God’s name are they continually trying to remove all models EXCEPT those that resemble cigarettes, it’s hypocritical and illogical.
Clearly there is a need for robust industry standards and there are some very good aspects to what the FDA have put forward but you have to remember this. The FDA have admitted themselves, it’s as far as they can go for now and you have to wonder, just how far are they willing to go on their crusade against vaping. The proposals generally seem to vilify e-cigs, rather than embrace them and the philosophy of harm reduction. The general feeling among experts and vapers is that the FDA’s position is that all nicotine products are bad, mmkay.


I strongly urge vapers and anybody else involved in the industry to submit your comments to the FDA once you’ve armed yourself with all the necessary information on their regulatory proposals for e-cigs.  Please also remember that whoever in the FDA reads your comments will almost certainly be more receptive to those made in a cool, calm and concise manner. It’s also wise to leave out the conspiracy theories, just stick with the facts by outlining your concerns with their proposals.

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