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Is FDA regulation of vaporizers coming?

Discussion in 'Cannabis News and Activism' started by Hackerman, May 1, 2018.

  1. Hackerman

    Hackerman Expiration Police

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    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?
     
  2. Jill NYC

    Jill NYC Portable Collector

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    Can you include url to article to which you are referring?
     
  3. OldNewbie

    OldNewbie Well-Known Member

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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

     
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  4. Hackerman

    Hackerman Expiration Police

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    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.
     
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  5. Hackerman

    Hackerman Expiration Police

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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.
     
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  6. Accept

    Accept Well-Known Member

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    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.

    Click to play YouTube Video


    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.

    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.
     
    Last edited: May 3, 2018
    Jill NYC and OldNewbie like this.
  7. Hackerman

    Hackerman Expiration Police

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    Great,thanks. I'll check out those things you mentioned.
     
  8. analytika

    analytika Well-Known Member

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    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
     
    Last edited: May 3, 2018
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  9. seaofgreens

    seaofgreens My Mind Is Free

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    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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  10. analytika

    analytika Well-Known Member

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    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!
     
    Last edited: May 4, 2018
    OldNewbie likes this.
  11. Accept

    Accept Well-Known Member

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    @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.

    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.
     
  12. ensabbahnur

    ensabbahnur Hash Vacuum

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    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.
     
  13. Accept

    Accept Well-Known Member

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    736
    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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