In a press announcement, the FDA has extended the deadline for new e-cigarette product applications an additional four years, until August 8th, 2022. The additional time is intended to allow the FDA to research more reasonable standards on non-combustible nicotine products, including e-cigarettes and e-liquid.
https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm568923.htm
https://www.engadget.com/2017/07/28/fda-change-of-heart-about-e-cigarettes/
People keep talking about the four year extension and that's great but the even bigger deal to me is what they said, their reasoning. They are a conservative institution which moves extremely methodically and slowly but they are clearly backing vaping and want it work to get people off of cigarettes, which they spelled out as the real killer.
>A key piece of the FDA’s approach is demonstrating a greater awareness that nicotine – while highly addictive – is delivered through products that represent a continuum of risk and is most harmful when delivered through smoke particles in combustible cigarettes.
"Smoking is the real enemy, we are coming to the realization that vaping is indeed a safer alternative."
>Envisioning a world where cigarettes would no longer create or sustain addiction, and where adults who still need or want nicotine could get it from alternative and less harmful sources, needs to be the cornerstone of our efforts – and we believe it’s vital that we pursue this common ground.”
Fucking wow. They basically said vaping needs to be the cornerstone of their anti-smoking efforts.
>The FDA is committed to encouraging innovations that have the potential to make a notable public health difference and inform policies and efforts that will best protect kids and help smokers quit cigarettes.
This also clearly refers to vaping, which is where the innovation is happening. They want to foster an environment where that innovation continues. Obviously that wont happen if every new product has to pay millions to get approved -- so this to me is a very positive sign about what the ultimate regulations will look like.
Yeah, Gottlieb's head seems to be on straight, more than I would have guessed was possible for the head of the FDA.
I do worry though that this is just him, pretty much, and that there's an entrenched bureaucracy that does not feel this way at all. Presidents and their appointees come and go but civil servants are forever...
Well, even so this is clearly good news.
No, it clearly refers to other NRT like patches and gum, which don't work very well and keep people smoking. The FDA also announced that it plans on slowly cutting back the amount of nicotine in cigarettes, which will do nothing more than to make smokers smoke more.
Make no mistake, the FDA isn't backing off because they're realizing that vaping is healthier. They're backing off to find a way to crush us without having to fight off a bunch of lawsuits. If this was about public health they would be trying to ban cigarettes.
> it clearly refers to other NRT like patches and gum
none of those things are even mentioned in this release while much of the release was about e-cigs and the extension of the e-cig deadline was the major announcement -- so i question how you arrived at your determination of what that 'clearly' referred to and suspect you are making assumptions based on your pre-existing pessimism and cynicism of FDA motives and intent, likely grounded in conspiracy theories of them being bought and paid for by corporations.
>Make no mistake, the FDA isn't backing off because they're realizing that vaping is healthier. They're backing off to find a way to crush us without having to fight off a bunch of lawsuits.
Once again something with no basis in what they said and likely based in your own conspiracy theories and cynicism.
Does this mean that we can still make and hustle to local BnM?
If you don't have a record of selling your product before August 8, 2016, then no. The new product freeze has not been lifted, just that products made between 2007 and 2016 don't have to submit the application for approval until 2022.
That being said, no one is paying attention to the freeze, and they aren't enforcing it, so proceed at your own risk.
Yeah, it does kind of seem as if it might be (legally) viable to start a juice company at this point. If the regs aren't enforced...
Still, it would be a bit dodgy, since there'd always be the sword of Damocles hanging over you. And I'm not sure the normal limitations of liability incorporating normally gives you would apply if you'd personally decided to willfully disregard the regs. So def still a bit dodgy, but... I imagine we'll see more people introducing new lines.
Two things to note,
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They specifically mentioned regulating flavors, meaning the impetus is on us an industry to self regulate- not necessarily flavors appealing to children (because let's face it, we're adults and we love flavors too), but the marketing perceived as marketing towards children. We as consumers have the ultimate power in any industry- and that power is the choice to buy products we support, and boycott ones we do not. I urge each and every one of you to support companies who market their flavors responsibly.
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This is a minor bandaid that allows our industry to survive. We still have A LOT of work to do. Just on the federal level, the predicate date needs changed, legislators across the nation need to be educated on these products, ideally a new category would be created for ecigarettes to be regulated under good manufacturing practices instead of the cumbersome PMTA process. We are also fighting local and state wide taxation, flavor bans, and tobacco 21 initatives. This is a great step forward, but understand there are many lurking issues to be addressed and we must stay vigilant!