After months of eager anticipation within the community by vapers and vape companies alike, the latest FDA administration released their first public comments that outlined how they’ll be approaching vaping and ecigarette products.
The initial reaction? Fairly positive. The FDA has shifted their policy towards e-cigarettes and vaping to a neutral viewpoint, at the very least, and appear to be signaling a willingness to help ensure the industry continues to grow, that public opinion will be heard, and most importantly, that science will be considered.
You can watch the full comments from FDA Commissioner Scott Gottlieb, M.D in this video:
Now before everyone assembles for a victory parade, let's remember that FDA regulations are an ever changing dynamic, and the big focus on these latest announcements centers around the idea of nicotine reduction, leading to harm reduction in an attempt to further limit the health impacts of nicotine. This is a highly debated and flawed foundation for the FDA to make their stand, but it’s what we’re going to be working with going forward.
The important thing to remember at this point is that that fear about the vaping industry being crushed by over regulation appears to be over, for the time being. So if you want to hold a small parade for that, feel free.
So what does this all mean?
Right off the bat, the FDA drops what feels like a positive bombshell in their press release.
“To make certain that the FDA is striking an appropriate balance between regulation and encouraging development of innovative tobacco products that may be less dangerous than cigarettes,”
For years the FDA’s (and the government in general) battle cry has essentially been trying to eliminate anything related to tobacco from the country. Chances are that last sentence made you chuckle because it’s fundamentally ridiculous. It’s the same as trying to prevent people from drinking alcohol, it’s not going to happen.
The FDA, at least in theory, wants to eliminate cigarette use, and by saying they want to encourage the development of innovative tobacco products, the FDA appears to be changing its tone for the better, and seemingly coming to a realization that many of us have already had concerning the benefits of vaping.
The Food and Drug Administration’s focus on nicotine appears to be grounded in a desire to reduce the amount of it found in tobacco products, which could have it's own unintended consequences for public health.
"To be successful all of these steps must be done in concert and not in isolation."
While vague, this could hint at the FDA planning on limiting nicotine levels in ecigarette products as well. The fact is, we don’t know, but it’s good to be aware that this could part of their plan. What that would look like is speculation at this point, but it could be something as straightforward as putting a limit on nic levels by telling producers that bottles cannot contain over 3mg.
Nearly everyone who vapes realizes there are already innovative products available to help people quit smoking cigarettes. Thanks to more and more scientific research, we’re starting to get mainstream factual backup for what some have written off as opinion and FDA Commissioner Dr. Gottlieb is taking notice.
One such study from the British Medical Journal studied the effects of e-cigarettes on the US population and concluded a substantial increase in e-cigarette use has led to a significant increase in people quitting smoking the classic analogs.
We’ve identified three big talking points from the FDA’s announcement that directly impact vapers and the vaping industry, so let’s take a few minutes to address each one in depth.
FDA Approval Process Deadline
This issue remains confusing and rather sticky for everyone involved. The FDA’s original deeming rule remains in place, preventing new products from entering the market for the time being.
The big positive out of the announcement is that the looming deadline that would’ve forced vape juice and hardware producers to go through an expensive Premarket Tobacco Applications process has been extended. All products that were on the market before August 8, 2016 must have proper paperwork filed by August 8, 2022.
At this point, all we know is that the FDA intendeds to give us more information about their vaping regulations.
“Among other things, the FDA intends to issue regulations outlining what information the agency expects to be included in Premarket Tobacco Applications (PMTAs), Modified Risk Tobacco Product (MRTP) applications, and reports to demonstrate Substantial Equivalence (SE). The FDA also plans to finalize guidance on how it intends to review PMTAs for ENDS.”
Basically, more information is forthcoming.
While the deeming rule deadline remains, the bigger takeaway from this shift is that the FDA now appears to be open to working on fixing the overly strict requirements and changing them up to ensure that the public will be receiving safe products while the vape industry continues to grow and thrive.
Fears of nearly every vape company being forced to shut down appear to be quelled. Instead of an FDA poised to be the Goliath to all vapers, it seems more likely that they will be friendly and open to discussion. Or at least that the vape industry is hoping for.
The FDA has been getting blinded by new scientific studies all the time, their public statements have signaled a willingness to accept that research, which is great.
With every new study that is released, the growing mountain of evidence supports the claims that vaping is both safer than cigarettes and an excellent tool for helping people kick the habit.
We all knew this, but the FDA being willing to listen and utilize that science in their decision making is a big positive for everyone in the vape community.
One point of concern in the statement comes from Mitch Zeller, J.D., director of the FDA’s Center for Tobacco Products:
“Public input on these complex issues will help ensure the agency has the proper science-based policies in place to meaningfully reduce the harms caused by tobacco use.”
To be fair, this is confusing more than concerning, but it’s still something to watch moving forward, at least in terms of getting some clarification. We all want “proper science-based policies” in place but it seems like public input is not the right way to get that. Unless Mr. Zeller is referring to scientist outside the government as “public input”, in which case, a quick explanation of his intent would solve any concerns surrounding this.
The FDA also stated that public comment and discussion would be an important part of the on-going process. We mentioned the British Medical Journal study earlier, but there’s many more scientific studies out there that back-up how most vapers feel about how vaping has changed their lives for the better.
“In order to further explore how best to protect public health in the evolving tobacco marketplace, the agency also will seek input from the public on a variety of significant topics, including approaches to regulating kid-appealing flavors in e-cigarettes and cigars.”
With the FDA asking for public input, your voice will be more important than ever. Vape advocacy groups will also be able to have a louder voice with the FDA. It’s what the vape community has wanted all along.
With any major shift in governmental policy, there’s always going to be concerns about what will actually happened compared to what is publicly stated.
That’s why we’re encouraging everyone to get involved with groups like CASAA, AVA, and the SFATA, just to name a few. Organizations like these have been leading the fight on behalf of vapers for years, but they need your help though to continue to the fight, so you should definitely see how you can get involved, especially at a local level (many states have Smoke Free Association groups you can join) to help push vaping forward.
With the FDA Regulations appearing to soften the federal government’s stance, the vaping community will likely face new challenges from state or city governments. Heavy taxation on vape-related products will continue to be an issue, as will short sighted legislative acts or city ordinances like the San Francisco flavor ban.
We must continue to push the FDA towards better regulations, but we can’t forget that ensuring vaping is treated fairly at the local level is just as important.
We also don’t know how the major pharmaceutical companies will react to this FDA ruling. The FDA threw them a seemingly sizable carrot in their statement:
“Additionally, the agency plans to examine actions to increase access and use of FDA-approved medicinal nicotine products, and work with sponsors to consider what steps can be taken under the safety and efficacy standard for products intended to help smokers quit.”
Big Pharma have been heavily pushing their drug-based anti-smoking options whether in the form of patches, gum, or pills like Chantix, Wellbutrin, and other potentially harmful antidepressants for years, and chances are they won’t slow down. The pharmaceutical industry has a ton of money and even more influence, so they will likely be heavily involved with trying to affect FDA policy to benefit themselves as much as possible.
Don’t forget Big Tobacco as well. Companies like Philip Morris are sure to react to the FDA’s push to move people away from smoking, and we all know how much weight they carry in terms of lobbying. There’s also an entire discussion that should take place about the possible unintended consequences of limiting the amount of nicotine in traditional cigarettes. It’s logical to assume that users getting less nicotine per analog could increase the amount they smoke, leading to further health impacts.
Overall, this appears to be a big win for ecigarette users, vapers and the vape industry. There are still many unknowns, and this is just the first statement on this issue and we still have a lot to learn about how the new FDA regs will look.
That said, after years spent worrying about whether the vape community would survive regulation, it looks like brighter days are ahead and consumer freedom is in our future.
For all you vapers out there we can’t stress enough the importance of getting involved at the local level. Pay attention to the news, join a vape advocacy group, do whatever you can to help the cause.
Together we can help ensure that vaping products remain accessible to everyone who needs it to ensure we all have access to a viable and safer alternative to smoking those nasty analogs.
Posted by Zach on Aug 2nd 2017