Is FDA regulation of vaporizers coming?

I was reading something the other day and, maybe I misunderstood but is the making of vaporizers going to be FDA regulated in August?

From what I was reading this would affect even people like woodsmith (sorry, don't remember your actual u/n) and the others who are making stems for the VapCap. Retailers are subject if they mix their own e-juice flavors (which all around here do).

If I am reading and understanding this correctly, this could be the end of small vape manufacturers like many we have here.

Did I read this wrong or is this coming?
 
Hackerman,

Tranquility

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The impetus was discussed in another thread a while ago:

http://fuckcombustion.com/threads/f...16-end-of-vaping-devices-2018-in-the-us.22561

However, a couple of weeks ago, the FDA did seem to do some work on vaping regulations. It seems Richard Blumenthal a senator from Connecticut is trying to motivate the administration on the matter.
https://expertvaping.com/fda-ecig-regulation-can-the-fda-make-up-its-mind/
One particular US Senator seems to be leading the charge, and that would be Richard Blumenthal from Connecticut.

Blumenthal explained that he has “met with the appropriate officials at the administration” and is “pushing them hard to protect the public.”

The Senator plans to introduce legislation if FDA ecig regulation aren’t put into place to restrict ecigarette brands. If he has a better suggestion to help save smoker’s lives, he’s certainly not sharing it at this time.

“People smoke; they continue to smoke even in the face of the self-destructive, disastrous effects of smoking because they’re addicted,” Blumenthal said. “The overwhelming majority of smokers try to quit, and they can’t,” he concluded. Well, we can’t argue with him there, but the problem is that he apparently isn’t seeing ecigs for the solution that they can offer.​

There has not been any progress on the issue I've seen other than that. (Although the spat of articles in early April has me think something is up on determining the regulations.)
https://www.washingtonexaminer.com/...arettes-erupts-as-fda-clamps-down-on-nicotine
https://www.theregreview.org/2018/04/04/funderburk-smokers-quit-information-key/
https://www.dopemagazine.com/three-fda-regulations/
https://www.lexology.com/library/detail.aspx?g=deb05a4d-66ea-4ccf-bf16-c6b8caa978c2
 
After reviewing this again, it appears to be from 2016. Is this in effect now?

https://www.fda.gov/TobaccoProducts/Labeling/RulesRegulationsGuidance/ucm394909.htm

Couple of excerpts....

Do you.. make or modify any type of vaping device?

If you answered yes to any of these questions, you may be a manufacturer.

How does a manufacturer know if they need to conduct clinical trials?

What are the costs associated with submitting an application?


How can FDA regulate products that are clearly not made or derived from tobacco, such as the coils of an e-cigarette, as a “tobacco product?”

It would seem as though it was originally intended for tobacco related devices but if you read the definitions, anything that vapes is included. Seems a little strange that this id (obviously) not being enforced.
 
Hackerman,
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Well, since no one here (or several other places I posted) seems to know anything about this I contacted the FDA to ask them if all these little manufacturers are required to obtain FDA approval on their vapes before selling them. This would include clinical trials to preclude the use of dangerous materials that could gas off during use. Or, vapes that could be considered dangerous or unsafe to use.

If the devices are determined to be a "medical" delivery device that would probably be worse. A sterile process might be required if that becomes the case. There are a lot of complaints about dirty vapes in the threads that I have read.

I'm not a big fan of regulation but sometimes it is necessary to protect the people.

I expect to hear back from them rather quickly. When I do, I'll post whatever I find out.
 

Deleted Member 1643

Well-Known Member
Nice job, @Hackerman! You might want to check out FDA's recent draft ENDS guidance discussed in the thread @OldNewbie cites. Believe that has the most detail on FDA's current thinking. Also, below is Commissioner Gottlieb's press conference from July 2017 where he announces delaying enforcement along with some new policies.


If the devices are determined to be a "medical" delivery device that would probably be worse.

If they're regulated as medical devices, you might need a prescription to purchase them. It's very unlikely at this point in the US, but believe this is the case in Austria and Japan, maybe a few others. Come to think of it, marketing them as OTC might not be a bad idea. It would make them less accessible to youth, which is the most urgent concern.

I'm not a big fan of regulation but sometimes it is necessary to protect the people.

Regulation really is needed to protect the public. Large numbers of people are voluntarily, but unknowingly, exposing themselves to large numbers of uncharacterized hazards by the most sensitive route. If vapers do get sick, it could be very difficult to pinpoint the cause(s).

Edit: added links.
 
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analytika

Well-Known Member
The Trump Administration is pulling every hat trick in the book to dismantle the Obama administration's regulatory overreach including the seizure of jurisdiction over e-cigarettes that Obama's FDA began in 2007.

The most critical deadline the "industry" has been staring down, like the barrel of a 12 gauge shotgun, required device by device regulatory approval by the FDA (!). The rulemaking (read: powergrab) was postponed by Trump all the way until 2022.

In this case the "industry" meaning all the way from RJ Reynolds at the top end to Mom and Pop vaporizer companies including for "herbal use".

The proposed regulations were so bad that, under a hypothetical Hillary Clinton administration (aka "Obama's third term"), all the various vaporizer devices that are popular on this website would likely have been off the market last August.

It's my recollection that Trump's FDA did an initial one-year postponement from August 2017 to August 2018, then extended it all the way until 2022 -- that's forever in modern politics. Postponements of this kind are at executive discretion without a new rule making, which would have permitted the far left administrative agency judicial apparatus to immediately enforce Obama's rules.

The typical nicotine prohibitionists, Obamacare cheerleaders, and liberal cognoscenti have of course bemoaned Trump's actions. Cannabis activists and vaporents have largely been silent instead of thanking the Trump Administration for intervening in this travesty. You won't read anything positive about it in any mainstream news resource. But you can at least get a few of the facts, laced with hyperbole, distortion and Trump derangement syndrome, here:

https://www.usnews.com/news/busines...it-challenges-fda-delay-of-e-cigarette-review
 
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seaofgreens

My Mind Is Free
None of the currently listed vaporizers would have been off the market, as there was a grandfathering in period of time in which all prototype designs submitted before some deadline a while back would have been included. So we saw a flurry of random prototype designs being submitted from companies like Magic Flight and a couple others that were just hypothetical ideas thrown out there before it was too late.

And whether or not there was/is a postponement, the moment the FDA regulations that were going to be enforced last year started drawing close, you could see a big slow-down in new vape ideas coming out on this board. My assumption is that most innovative thinkers that had been drawn to vaporizer technology also recognize that these regulations were not disbanded, and it is risky to think about starting some new prototype design that would not be grandfathered in when/if these regulations do actually come into play.

So, imo, you are already seeing a large drag upon the industry just because the specter of these regulations is right there in the background.

And ... just gotta add... Trump didn't really do anything but sweep the issue under the rug for the next guy. So... What a solution...?
 
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analytika

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grandfathered ... Trump really didn't for anything ...
The day the regulations came into effect it would have been a product liability litigation field day against every company continuing to sell products not FDA cleared. The grandfather provision is a fantasy throwaway that has no real meaning in the regulated medical device market, in the modern litigation landscape. Come on, even a casual observer should know this.

Didn't do anything? LOL. Trump Derangement Syndrome. Trump has completely lifted the spectre of these regulations. They're dead and buried, as long as Republicans hold the presidency. PERIOD. The postponements were quick easy and NOT subject to review by administrative law judges or the federal courts.

Trump saved the industry. Obama, and Hillary, planned to SHUT IT DOWN last August, for good, until RJ Reynolds paid off the right Democrats.

Forward!

New rulemaking will come formally superceding the absurd, burdensome Obama regulations that were a death knell to vaporizer device makers. Again, even a casual observer knows this.

Meanwhile on Nancy Pelosi's home turf in San Francisco there is an anti vaping initiative proposition E coming up on the primary ballot!
 
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Deleted Member 1643

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there was a grandfathering in period of time in which all prototype designs

@seaofgreens - not familiar with this. If you have a reference, would you please cite it? Cover this issue professionally, and this wouldn't be the first time something learned on this forum helped.

Trump didn't really do anything but sweep the issue under the rug for the next guy.

That was the general opinion after Gottlieb's press conference last July - FDA gave up on regulating ENDS until the next administration. But, Gottlieb is following through on the plan he outlined above. The proposed rules he mentions are being promulgated.

AFAIK, Trump didn't do anything directly. Haven't seen any indication he's even aware of the issue.
 
Deleted Member 1643,

ensabbahnur

Hash Vacuum
Even if it is coming, so? In an age when the US government can oft not even fund itself to stay "open", and where I read yesterday that (I think this figure is high) but over 50% of items in a test from Amazon and Walmart.com were counterfeit (which has been going on FOREVER and specifically includes many, many Apple products, who tends to go after everyone and their uncle and uncles dog when it comes to taking their profits), and (if you've been in Cali or Colo for any amount of time in the past half decade or so you'll know what I'm talking about) certain states humorously lax policing of weed in general, let alone its gear AND how many internet "businesses" don't have any licensing at any level or even contemplate paying taxes.....I can't say as this is gonna effect anything for a long while (not until BIG money enters the fray) and even then, by then it may be to late to be effective. Im not arguing if regulation is right or wrong, don't really GAF about obama or trump, I just don't think there is much they are going to/can do about it.
 
ensabbahnur,
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Deleted Member 1643

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Almost retyped a post in that old thread, above. Most surprising, IMO, was FDA's inclusion of vape pens and personal vaporizers as ENDS (electronic nicotine delivery systems) - and leaving open the possibility of declaring still more products to be ENDS. Is FDA's specific intent to claim authority over devices used primarily for cannabis, to ends unknown? Or is it casting as broad a net as possible, so it can regulate anything it chooses?

Re-watched most of that press conference above. (Believe it or not, if you've seen a lot of these, this one is pretty compelling.)

Just spit-balling...:sherlock:

Restricting e-cigarettes to a few brands producing tamper-proof products in a limited number of flavors might well be the long-range (10-20 years) plan. This has been the fear in the vape industry all along. There are obvious advantages to such an approach, from a regulatory perspective, and they would have relatively little appeal to youth or non-smokers.

Restricting nicotine in combustible cigarettes to non-addictive levels seems to be a new wrinkle, but the idea has been quietly tossed around for some time. This would drive habitual smokers to even dull, highly-regulated products because of the much higher levels of nicotine available. Of course, they would most likely be produced by large tobacco companies in exchange for their support.

Thanks for starting this thread, @Hackerman. Even with the delay, FDA CTP is progressing, behind the scenes, perhaps laying the groundwork for dramatic changes in 2022 or whenever the regulatory climate is favorable.

Need to start thinking about these issues again - "flavor ban" comments are due next month. Don't forget to comment. Anyone can comment, not just professional advocates, and FDA will respond to your comments. (Not personally, but anonymously in a document likely to be ~500 pages long.)
 
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Tranquility

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https://cei.org/content/fear-profiteers

Executive summary:
The rise of a vibrant market for e-cigarettes has been a blessing for many smokers. After many failed attempts to quit, e-cigarettes provide an exciting new means for smokers to reduce their exposure to the harmful aspects of combustible cigarettes or even break their life-threatening smoking habit entirely.

Although research on e-cigarettes has yet to definitively calculate the precise long-term risk associated with vaping, reputable scientific institutions are increasingly coming to the same conclusion—e-cigarettes are vastly safer than smoking, help smokers quit, and are a net positive for public health. Despite this, public perception of e-cigarette safety has declined, while demands for stricter regulation—even bans on certain e-cigarettes—have only intensified.

That the public perception of e-cigarettes diverts so radically from the actual evidence raises the question: Why? This paper makes the case that the confusion is the intended result of an orchestrated disinformation campaign led by individuals and groups that ought to be among the most supportive of lower-risk tobacco alternatives—anti-smoking health advocates.

Instead of recognizing the historic opportunity e-cigarettes represent to displace traditional smoking, powerful charities like the American Cancer Society and the Campaign for Tobacco-Free Kids, state and federal health agencies, and some academics have condemned the proliferation of vaping products. Their influence on public opinion and public policy stems largely from their image as credible, apolitical entities motivated purely by an interest in protecting public health. As their approach to e-cigarettes demonstrates, this perception is inaccurate.

In addition to their public health goals, health agencies’ and health charities’ activities are also driven by a need to defend and expand the financial resources they need to pursue their respective missions. Whereas for-profit businesses raise funds by competing for consumer dollars, non-profits—and to a certain extent, health departments—compete for charitable donations and sometimes government funding. The two basic strategies health charities and agencies employ to court funding are to: 1) raise the perceived need to address the health problem on which they focus; and 2) promote their organization’s comparative effectiveness in addressing said health problem.

This approach to fundraising is generally uncontroversial in the non-profit arena, where organizations compete intensely in an environment where both attention and charitable dollars are limited. However, when an organization is part of a government agency or endorsed by government agencies, its efforts to raise awareness of an issue and its own clout can incentivize activities that clash with sound public health policy.

Furthermore, using e-cigarettes as a case study, this paper demonstrates how this negative effect is magnified when health charities, federal health agencies, and state health departments are financially co-dependent. Though perceived as independent health charities, many of the nation’s most well-respected health non-profits are, in effect, arms of federal health agencies. Groups like the American Cancer Society (ACS) receive money from agencies, like the National Cancer Institute within the National Institutes of Health. As such, it is in ACS’ interest to support or even lobby on behalf of the National Cancer Institute as it seeks to sustain or increase the funding allocated to it in the federal budget.

In turn, health agencies like the National Cancer Institute have an incentive to boost the reputation of their supporting health charities like ACS. Not only can these charities provide strong support during budget discussions, by echoing or even executing the Institute’s efforts throughout the year, they can make the Institute appear more effective and therefore more worthy of budget allocation.

A similar process takes place at the state level, where state and local health departments “partner” with respected health charities like ACS, the American Heart Association, and the American Lung Association. The health departments divert funding to the charities, while the charities do what health departments cannot—lobby state and local governments.

These health charity-government agency alliances have proven so effective and lucrative that it has given rise to a vast, nationwide network of groups that includes government bodies at the local, state, federal and international level; charities; grassroots organizations; universities; and even scientists. While seemingly independent from one another, these entities are in fact deeply financially interwoven.

In the case of e-cigarettes, this interconnected network of health groups and advocates has helped fuel public fears about tobacco alternatives. To the general public, these disparate groups appear to have reached the same conclusion about the health effects of e-cigarettes independently of one another.

Anti-smoking activists have reason to be skeptical about nicotine products advertised as intended to “reduce harm.” But, unlike the tobacco in- industry's previous efforts to promote safer cigarettes to sustain profits from smoking, e-cigarettes appear to be genuinely harm-reducing. At present, the evidence increasingly indicates that e-cigarettes not only carry significantly less risk than combustible smoking, but also help people to quit smoking and do not attract non-smoking individuals to nicotine use. In fact, smoking among both adolescents and adults is currently lower than it has ever been.

Health agencies should communicate this information in an unbiased way that allows consumers to make informed choices about the relative risk of using e-cigarettes versus smoking. Instead, health agencies, charities, health advocates, and the media have promoted the unfounded notion that e-cigarettes are as harmful as—or more harmful than—combustible cigarettes.

This campaign to restrict or ban e-cigarettes does a huge disservice to public health, decreasing the likelihood that smokers will utilize these devices as a means of quitting their deadly habit. Though concerns over e-cigarettes’ long-term effects are reasonable, that is not the impetus behind the anti-e-cigarette movement. Rather, as this paper demonstrates, it is the consequence of those groups and individuals vested with the power and funding of the government seemingly prioritizing their organizational interests over public health.
 
Tranquility,
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looney2nz

Research Geek, Mad Scientist
as far as e-cigarettes go, that whole scene is a nightmare, untested flavors without knowing what that heat does to them, additives that are BAD news.

You're going to see a new wrinkle in the next couple years for cannabinoids/terpenes, and it will not be a heat source vaporizer.
 
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