My glass is quite full right now. But it has nothing to do with e-cigs, the FDA or why I'm not wearing any pants right now.
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FDA Proposed regulation is available
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Roger, would you do me (and others) a kindness and expand on this a bit, please? My reading of the proposal led me to believe that
1. The window was open to products on the market between the '07 date and the effective date of the final published rule.
2. They can't make the effective date retroactive (i.e. 2011).
3. They need to make an explicit rejection of an application to "kill" an existing product (i.e. a vendor can submit an application in month 24 of the grace period and is okay to operate until the FDA states that they have to desist -- different from the rules for products introduced after the effective date.)
Many thanks,
Dan
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Once the rule becomes final, the 2 year filing clock starts to run. You're right that they can introduce new products as long as they file w/i 2 years of the rule finalization date, and those products can stay until reviewed and rejected. However they still have to fulfil the basic burdens of the statute for either new or stubstantially equivalent products. Which means that the FDA can reject the application any time, and require that the product be pulled from the market. Under those circumstances, would you be investing in new plant and equipment? Or R&D? How would you react if you were a distributor (you'd probably want some kind of contract that forced the manufacturer to take any rejected products back, right?)
It's worth noting that the EU's TPD deadline is also in 2016 (March I believe). Between the US and the EU, how much of the world equipment market is covered? Unless China's vaping market starts booming, there's no place left to sell lots of things like APVs and ego batteries.
Frankly I don't know how the FDA intends to assert component jurisdiction over a drip tip. Seems a bit silly, doesn't it
And what's a mech manufacturer supposed to say in an applcation? (That a 14 y.o. isn't going to use it in class to bonk the teacher over the head with??) Unfortunately this sort of thing is going to deter investors. Maybe we'll get lucky and they'll back down after being pepped with questions from every carto, battery, etc. manufacturer. (Or perhaps the manufacturers will just retool and make something else that's less of a hassle.)On the bright side, consider this:
1) The FDA are laggards. I just checked and my favorite RYO "pipe" tobacco is still available, actually it's on sale for about 10% less than I paid when I bought my last 5# lot in Dec. (Which is still in my basement in a ziplock. I need to find someone to give it to). So all your favorite products except e-liquid may still be available from fasttech or their equivalent in five or ten years (and if you buy e-liquid from them now, the FDA is probably doing you a favor, methinks). Just be prepared to have every third or fourth shipment siezed, and to pay that premium when you order. (As it is right now in Canada, or so I hear.) However the industry may be frozen in terms of innovation, and the distributors such as FastTech's successor(s) - if any - will only cater to "hobbyists."
2) We have seen two or three cycles so far of "prohibitionist hide-and-seek" - first we had regular cigarettes and then RYO (injector machines), now we have vaping. In the future, there will probably be other devices as I mentioned earlier like the vitaCig and the herb cookers which will be designed to not use tobacco as any form of input. Then Congress will get scared about minors and we'll have another statute passed which defines yet another regulatory framework. Technology will advance again via something like 3D printers. And ... the game will be played on, ad nasueum.
Ten years ago before the PACT act was passed, and before they started jacking cigarette taxes up through the ceiling, no one could've predicted the huge growth in injector machines and the RYO movement that started around '05 and became fully live by '10. Now there's vaping. Five years from now, there will be heaven-knows-what. And around and around we'll go, same old "Velvet Glove, Iron Fist" games. We've gone from "tobacco prohibition" to "nicotine prohibition" and now Denmark's health minister wants to ban (or at least strictly regulate) nic-free vaping. The Tobacco Control/Nicotine Control/Vaping Control/God-knows-what-control Industry will remain. Technology will advance. Concerns, Worries, Fears, and Unknowns about chldren will always be there, and there will always be a need to demonize some group of people who are doing something that needs to be controlled.
Vaping as we know it may vanish in a few years. But there will be something else. The song remains the same:
I had a dream. Crazy dream.
Anything I wanted to know, any place I needed to go
Hear my song. People won't you listen now? Sing along.
You don't know what you're missing now.
Any little song that you know
Everything that's small has to grow.
And it has to grow!
California sunlight, sweet Calcutta rain
Honolulu Starbright - the song remains the same.
Sing out Hare Hare, dance the Hoochie Koo.
City lights are oh so bright, as we go sliding... sliding... sliding through.
(I don't think I have to attribute those lyrics
FOr myself personally at least I have some idea what I am up against. 2 years gives me plenty of time to better set myself up to vape for the rest of my life. The people I feel very bad for are the ones who have not yet made the switch and in the future might well have a difficult time finding effective devices to make the switch with.
Meanwhile I will continue what I have been doing for the last year. Stockpiling those things that I can make last and those quality of life things that will not.
Meanwhile I will continue what I have been doing for the last year. Stockpiling those things that I can make last and those quality of life things that will not.
I happen to agree with you that the vaping industry will thrive in the future. I always have. More to the point of this thread, I believe that even if the FDA ultimately wishes us harm, it's a tactical error on their part to let the ecig market breathe for the next two years -- or even for the next few months. The longer the genie's out of the bottle, the better for all of us.
Still, prepare for war to facilitate peace. We know that our opponents in the faux-public-health lobby will do or say anything to promote their irrational crusade against so-called non-communicable diseases. We also know, from past history and from the FDA's own statements in the very proposal that is our topic du jour, that the authorities are not friendly to our cause; even now, the FDA refuses to acknowledge the vast bulk of the evidence in the ecig's favor. There are any number of battles to come, and although we have the truth on our side -- although I believe we will eventually win -- we do ourselves a disservice if we devalue our own efforts to effect that victory.
Again, we are all on the same side. Even if I believed with all of my heart that the ecig industry is doomed to die, I wouldn't lay money on an outcome that I'm actively fighting to preclude. Just as I imagine you'd never bet against your Packers or Brewers.
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I've seen free liquor samples offered in California--even in supermarkets. That actually surprises me, considering that almost everybody here has to drive a car to get to a store. Last week, at my local Albertsons, whiskey samples were being offered to shoppers--nobody seemed to object.
I'm not trying to start an argument--just reporting what I have witnessed myself. I'm not sure about the legality of that practice.
Sorry for the off topic comment.
You are introducing rationale thought into things that are rooted in moral conscience. "Drunk and Stupid" seems to be more acceptable in our culture than "harmless" harm reduction.I've seen free liquor samples offered in California--even in supermarkets. That actually surprises me, considering that almost everybody here has to drive a car to get to a store. Last week, at my local Albertsons, whiskey samples were being offered to shoppers--nobody seemed to object.
I'm not trying to start an argument--just reporting what I have witnessed myself. I'm not sure about the legality of that practice.
I've seen free liquor samples offered in California--even in supermarkets. That actually surprises me, considering that almost everybody here has to drive a car to get to a store. Last week, at my local Albertsons, whiskey samples were being offered to shoppers--nobody seemed to object.
I'm not trying to start an argument--just reporting what I have witnessed myself. I'm not sure about the legality of that practice.
Sorry for the off topic comment.
Here as well, local wineries are quite free with the samples. It's not illegal AFAIK.
It probably should be (Kodiak's drunk and stupid is not a problem, but driving sure is), but it doesn't seem to be.
Okay, when we shop online, we give our credit/debit card info, which holds our personal info. The online shops seem to be doing their part already. As far as free samples, the vendor I ordered from sends small sample bottles, after I paid! I can see banning sales to minors, but if kids are caught vaping by police, shouldn't that be on the parents? What if the kids used a parent's card to buy. What if the kid went from cigarettes to vaping? Too much of a gray area. Back when I was a kid, the legal ages were 18 to buy, 16 to smoke. Maybe they should go to that for vaping.
Now, for vendors and shops, how about inspections from the health dept? Make sure the family pet isn't roaming where juice is being mixed, gloves are worn, product is kept in boxes, or dust-free areas. Stuff like that.
I find it funny how the people on this forum have better ideas than the FDA, or the rest of our government. I can guarantee nobody from the FDA lurks this forum. If they did, they would have something more realistic to put on the table. If vaping was so bad, why did they wait until now to do something?
Sent from my bird in a moist little package
Now, for vendors and shops, how about inspections from the health dept? Make sure the family pet isn't roaming where juice is being mixed, gloves are worn, product is kept in boxes, or dust-free areas. Stuff like that.
I find it funny how the people on this forum have better ideas than the FDA, or the rest of our government. I can guarantee nobody from the FDA lurks this forum. If they did, they would have something more realistic to put on the table. If vaping was so bad, why did they wait until now to do something?
Sent from my bird in a moist little package
If the verbiage stays the same, a cartomizer pre-filled with nicotine liquid will be classified as a "tobacco product." A blank cartomizer, or one pre-filled with zero-nic liquid, will not. Nicotine delivery is the whole pretext for FDA regulation. If it has no nicotine in it, or can be used for purposes that don't involve nicotine delivery, there's no basis for the FDA to exert their authority over it.
You know how head shops can sell {name of illicit device redacted} with total impunity as long as they call them "tobacco water pipes?" The same principle would apply here. If the FDA tried to exert control over PVs and accessories on the basis that they're nicotine delivery devices (which, in legal terms, would be a doomed effort to begin with), all you have to do is slap a sticker on the thing that says "not intended for use with solutions containing nicotine." Problem solved.
I hope you are right. I have a sneaking suspicion though that this is just the opening salvo in a longer war. They left lots of wiggle room for later draconian measures.
The only thing I feel more comfortable about now that we have seen the proposal is that I now know how long I have to finish preparing. 2 years give or take a bit.
Back when I ordered (I DIY now), I got the same.
I suppose they can just list liquids as "30 ml of Our Famous Cheesecake + 3 ml of a surprise liquid for only..." Then you're technically paying for it.
Too sensible.
Personally? I'd ban sales to minors, but not use by minors. If the parents wish to make the decision to purchase, so be it.For all I know, Jenny and Johnny used to have a 2 pack a day habit, and their parents are gladly purchasing eGos and liquid for them. None of my business.
Quite sensible, although a listing of ingredients would be necessary as well--and some assurance that the vendor is keeping to those recipes.
1) Money. Industry is quite famous for not looking too far past the present quarter. Until vaping began to threaten other industries, it wasn't considered a factor. Now it is.
2) Politics. Optimally, it would never interfere in health issues but good luck with that. A variety of political moves delayed this for several years. Even so, there's a 2 year window where nothing takes effect, and that's a lifetime in product cycles and public opinion.
3) Bureaucracy. At the best of times, it moves slowly by design. At the worst of times, it's glacial.
Sent from my bird in a moist little package
Sent from my dog in a package that is less moist, and far less little.
That's kind of why I doubt this is a war; 2 years is far too long for an opening salvo to launch and strike.
In that time period, we may very well have another million vapers, or another million people to get annoyed and complain. Politicians hate that.
As I've repeatedly said, never attribute to malice what can be adequately explained by stupidity. This smells more like stupidity, which is not going to work very well. They didn't strike when the iron was hot, back in 2011 or 2010, they let the proverbial iron in question become so massive it almost can't be moved any longer.
Another two years will see a ton of studies coming out, many of which are going to support vaping and the relative harmlessness of it. If they wanted to shut it down, you don't leave a window like that and you don't delay until studies are already underway. You cut it off at the knees early.
I respectfully disagree.
From page 7 (bold and underline added by me): "Components and parts are included as part of a finished tobacco product or intended for consumer use in the consumption of a tobacco product. Components and parts that would be covered under this proposal include those items sold separately or as part of kits sold or distributed for consumer use or further manufacturing or included as part of a finished tobacco product."
The construct of the deeming regulations creates the basis for the FDA to exert their authority.
"You know how head shops can sell {name of illicit device redacted} with total impunity as long as they call them "tobacco water pipes?". Illicit drugs are not under the domain of the FDA and regulation of potential delivery devices falls under state and local jurisdiction -- which is why some (most?) jurisdictions can allow the legal sale of a device and then turn around and charge the consumer for illegal possession of said device.
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Oh, I don't doubt for one second that they have designs on going much farther than this framework currently allows them to. But as often happens in government/politics, by the time they get the chance, there will be a new administration in the White House and a new leadership regime at the FDA, and they may not wish to pursue this matter with quite as much zeal as the current group.
And lawsuits. Don't forget the lawsuits.
It's a clear over-reach for the FDA to attempt to control a non-medical device, and there's a vast amount of precedent of them never doing it before.
I'm not really concerned about that paragraph as things stand now, because 1) it attempts to exert authority that's plainly outside the parameters of the agency's power, and 2) no judge, however scientifically illiterate, or vaping-naive, is going to accept the argument that a PV and its constituent parts have no conceivable purpose except the delivery of inhalable nicotine. The very existence of zero-nic liquid, and the sizeable market share it currently enjoys, renders this argument a non-starter.
With the FDA getting involve it might start small but better believe they will not stop. I'm looking for them to put taxes on anything to do with e-cigs.
The FDA has no authority to levy taxes. Only Congress can do that.
Ok but here is another take on it.
DO we have hard numbers on how big the 0 nic industry is? I have never seen them from a credible source? DO we know what percentage qualifies a device under the same loophole that head shops use?
Government agencys have a long standing tradition of keeping lawsuits in court until the person that is bringing the suit runs out of money or until they government agency finally gets the judgement they want (judge shopping). I do not doubt that is exactly what they would do.
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