FDA FDA deeming regulation proposals

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Jman8

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My choice to fight the FDA however I can on these deeming regulations is NOT fear mongering, so please stop labeling those who oppose these regulations as fear mongering. TY.

If you, or anyone, says, "I oppose these regulations," I will not call that fear mongering. If you say, "I will fight these regulations," I will not call that fear mongering.

If you express supposition that says this will lead to the end of vaping within 2 to 3 years, and no small business will have any chance of marketing vaping products under these proposed regulations, I will likely call that out as fear mongering.
 

DC2

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Does this or does this not ALL come down to whether or not one trusts the FDA?

They have proposed regulations that give them the exact tools we feared they would use.
And many of us that feared they would use them are no less afraid today.

They have scattered in their long document a couple of possible concessions.
Some would say that is reason for hope, others would say it is a way to keep us calm and quiet while they proceed.

Bottom line is I don't trust them as far as I can throw them.
They've given me absolutely no reason to do so in the last five years.
 

thanswr

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The only historic moment is they are ignoring a chance to eradicate tobacco use for future generations by serious looking at this as a alternative. They are blindly moving ahead on a anti tobacco agenda

The real "historic moment" was in 1963 when Herbert Gilbert invented the "electronic cigarette". He apparently received a patent for it, but it went nowhere. After the patent expired, his invention was "invented" again and the rest is history.

Can you just imagine how many millions of lives could have been saved if the FDA and the Surgeon General had followed the real historic moment?

http://www.ecigarettedirect.co.uk/a...w-inventor-e-cigarette-herbert-a-gilbert.html

Patent US3200819 - Smokeless non-tobacco cigarette - Google Patents
 

DC2

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If you express supposition that says this will lead to the end of vaping within 2 to 3 years, and no small business will have any chance of marketing vaping products under these proposed regulations, I will likely call that out as fear mongering.
Do you believe that the actions CASAA recommends we take will not be appropriate?
 

Jman8

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Does this or does this not ALL come down to whether or not one trusts the FDA?

IMO, it comes down to trust in yourself. But as that is philosophical point that I'm always up for exploring, I just assume leave that discussion for another time.

In vein you are asserting, I don't think it is trust as much as respect, and really respect for a process that is outside the control of any one person/group.

I think a decent (not great) analogy would be with the law in general. Like, I've been pulled over for a traffic violation and found officer to be disrespectful to my position on the matter. Law is the law, and excuses don't matter to LEO. Yet, LEO's constantly give out warnings or let people go, so that shows it can be bent, overcome, based entirely on human judgment, or even mood. In one case where I got a traffic violation, I had to go to court (or pay huge fine, lose points, yadda yadda yadda). I did not trust the system simply because the ticket, even to this moment, seemed unjustified. I understand why I got it, but it was, IMO, based on 'mood of the moment.' Warning would've had same effect. Yet, I respected the process, which included a few calls to attorney types and one of those just so happened to personally know the judge that would try my case. Then, I was in room right before you go to court, and essentially being told of plea deal that is best I could hope for. I'm like, okay, whatever. By time I got to judge, he gave me even better deal than the plea one, and while not equal to warning the LEO could've given me, it was on par with that. I attribute this to my respect for the system, even while I continue to lack trust in how 'business as usual' appears, both in my very limited experience and more so in what is often reported as gross injustices being carried out.

I respect what FDA is doing with the proposed regulations, even while I don't implicitly trust what FDA does from day to day. I think they have a very poor track record in what is their stated mission. Yet, if not them regulating, it'll be some other federal department. I see no possible way, within shared reality, for a federal department to not regulate eCigs. Thus, regulation, of some sort is inevitable. Again, I fully believe everyone reading this already knew that.

And none of us were saying before 4/24/14 that FDA is going to be totally kind to eCig vendors/consumers and it's going to be peachy king with those proposed regulations come out. No, instead we had Tobacco Act as tool of reference, plus rhetoric galore from ANTZ and media to see ways in which this could all go down. Many 'experts' I believe anticipated the worst and some expressed what that'll look like. I believe that list of 'worst items to expect' included:
- online sales will be addressed/attacked
- flavors will be subject to outright ban with limitation for menthol and tobacco flavors only
- all vaping gear will be immediately proposed for ban from the market, heavily enforced, and not allowed back on unless it is approved (read as never)
- secondhand vapor will be cited as public hazard on par with secondhand smoke and suggested that it be regulated as such
- plus other things, but those were the biggest items.

IMO, all of that is still on the table from ANTZ perspective and possibly from political/FDA perspective. I think it will be on the table indefinitely, or as long as unquestionable ban for minors is overriding logic at work. Being realistic, I think these items could one day come about.

But this proposed piece of regulations didn't go there, and is not as heavy handed as some were suggesting.

So, it seems to me because FDA didn't propose a regulation that amounts to explicitly stating, "eCigs are awesome, they are here to stay, and the market is wide open for everyone, no questions asked," that there are some who see it as heavy handed as it is right now. Saying that it will be end of vaping in 3 years or less. Or at best, as in most we can possibly hope for, is that eCig industry will continue, but it will only be run by BT and maybe 3 or 4 other big eCig vendors.

They have proposed regulations that give them the exact tools we feared they would use.
And many of us that feared they would use them are no less afraid today.

They have scattered in their long document a couple of possible concessions.
Some would say that is reason for hope, others would say it is a way to keep us calm and quiet while they proceed.

Bottom line is I don't trust them as far as I can throw them.
They've given me absolutely no reason to do so in the last five years.

And I would say respect them, which you will in whatever response you send. CASAA will advocate for this, and you already know you will be sending a respectful correspondence to an organization that you do not trust.

But you can (learn to) trust the process. I see reasons for optimism, and fairly strong indications that 3 to 5 years from now vaping will be thriving. For sure it'll continue to thrive in next 3 years. After 5 years, not so sure, but too many factors, most of which aren't known, to consider that I just assume cross that bridge when it comes.

For me trusting the process means trusting in higher self, trusting that vaping community has some momentum, for sure has short term on our side and trust that manufacturers are thus far greeting this with a 'yes we can' type attitude.

If all that doesn't work, take comfort in idea that Glantz didn't like this proposal. Can't you find some solace in that?
 

DC2

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Well reading all that you'd almost think we are nearly on the same page.
It's as if your goal in this thread is just to encourage folks to not get so riled up about all this.

If all that doesn't work, take comfort in idea that Glantz didn't like this proposal. Can't you find some solace in that?
:laugh:
 

Jman8

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Do you believe that the actions CASAA recommends we take will not be appropriate?

Based on initial reaction that CASAA had, I am wary on what actions they might recommend.

If manufacturers and say 10,000 vapers (many of which haven't even heard of CASAA) are all basically okay with this, and CASAA is pushing for outright rejection, I think CASAA will lose. Regulations will then go into place, and CASAA could be either irrelevant or very slow to adapt to (then) current playing field.

But I think CASAA, of which I am a member, could take a balanced approach that fights tooth and nail on certain points while essentially being okay on other points.

From my perspective, rejecting this proposal and advocating for it to be rejected is counterproductive. FDA, if given more time, could plausibly go more heavy handed. If CASAA ain't happy with proposal and Glantz isn't happy, and FDA is looking to update the proposal to please someone that is asking for it to be updated, I could see Glantz camp getting its way, or at very least getting a few truly heavy handed items in there that mean the next 3 to 5 years will be more harsh than I currently anticipate.

There is room for all vapers, everywhere, to shape how final regulations look, as there is room for ANTZ to do the same. I do not, even a little bit, advocate for vapers to sit back and trust that the proposed regulations will be hunky dory. There are talking points that are worthy of being addressed / changed.
 

Talyon

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If you, or anyone, says, "I oppose these regulations," I will not call that fear mongering. If you say, "I will fight these regulations," I will not call that fear mongering.

If you express supposition that says this will lead to the end of vaping within 2 to 3 years, and no small business will have any chance of marketing vaping products under these proposed regulations, I will likely call that out as fear mongering.

Ty for that, I'm revering to the beginning of your post.

As for the later, I don't see making people aware of possibilities as fear mongering but simply keeping them informed and allowing them to draw their own conclusion and not under coercion from you or me. Notice I'm not using a label.
 

Myk

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If you, or anyone, says, "I oppose these regulations," I will not call that fear mongering. If you say, "I will fight these regulations," I will not call that fear mongering.

If you express supposition that says this will lead to the end of vaping within 2 to 3 years, and no small business will have any chance of marketing vaping products under these proposed regulations, I will likely call that out as fear mongering.

I'd call that a fact. No small business can afford the filing fees and lawyer fees to produce the parts for one complete mod sold separately. That's 7 items and will cost somewhere between $100,000 and $3,000,000 each. However if you sold it as a complete ecig you could probably get by with those costs once.

Problem is things don't always work like that (or even rarely for this business). We import. Each clone import will have to get approved by each importer. Chinese like to change things up without warning so you may sell 100 Kraken clones and then have to go through a who knows how long wait to get the next batch approved.
Let's go with the lower estimate (that is much MUCH lower than the FDA's estimates BTW), will you pay $1050 for a Kraken clone?

How about drip tips. At the higher estimate which is in line with the FDA's estimates (but at accountant wages not lawyer wages), you would have to sell every vaper in the US a drip tip just to break even. But that's making them here, most will import and again China likes to change the specs. So again you end up selling 100 units and the specs change, you go back to the application process. How about $100,000 drip tips?

The only thing that will be fairly safe are stagnate cigalikes from big tobacco. One or two application fees from someone who can afford to have money tied up in fees for years. Things will stagnate because nobody wants to sink another million into improving their product.

It is a fact that no small business will be able to pay for these regulations declaring every piece of an ecig to be a "tobacco product" that has to go through approval.
 

Danoman

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Personally, I believe they are about to be sticking a stick at a hornets nest with all those that vape. I believe the response from everyone is going to completely overwhelm them. On one hand, I see only TWO responsible things being proposed.

1. The age limit of no sales to minors (that's the job of the shops and vendors to do.
2. Listing if the ingredients in the e-juice, and possibly regulating that it can only be of USP grade (which most of us do anyhow)

The rest is yet to be seen... although, having to submit an application to the FDA on every flavor and the cost of that application I believe is where they are completely out of touch. It'd only be seen as yet ANOTHER business tax the government is tacking on that will do nothing but hurt businesses in the vaping industry, which I believe is the whole point and direction that's intended. To me, it seems obvious exactly what they are doing...
 

Myrany

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Personally, I believe they are about to be sticking a stick at a hornets nest with all those that vape. I believe the response from everyone is going to completely overwhelm them. On one hand, I see only TWO responsible things being proposed.

1. The age limit of no sales to minors (that's the job of the shops and vendors to do.
2. Listing if the ingredients in the e-juice, and possibly regulating that it can only be of USP grade (which most of us do anyhow)

The rest is yet to be seen... although, having to submit an application to the FDA on every flavor and the cost of that application I believe is where they are completely out of touch. It'd only be seen as yet ANOTHER business tax the government is tacking on that will do nothing but hurt businesses in the vaping industry, which I believe is the whole point and direction that's intended. To me, it seems obvious exactly what they are doing...

Also realize that no sales to minors could effectively shut down internet sales depending on what the FDA is willing to accept as proof of age.
 

Devonmoonshire

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I have not posted in most of the forums in a while. However I feel this might actually get some action if I post it here as I know there are members of this forum that are familiar with how to extract nicotine alkaloids from tobacco.

The Belladonna Plants Leaves are also a significant source of nicotine. If we can devise a method to extract the nicotine used in the liquids for electronic cigarettes from the Belladonna plant in a cost effective manor then the FDA can no longer group these devices into the Family Tobacco Control Act as they would no longer be a Tobacco Derived form of Nicotine.

So I say rather than try and fight a losing battle, let us simply change the battlefield to our own advantage and take ourselves out of their arena.

Make them do the work, not us.

Source Link for this information on Belladonna:

Plants Containing Nicotine | eHow
 

Myrany

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They clearly say they do not want to shut down internet sales and there are ways to have age verification online.

It would be the first time they say one thing clearly and then proceed to do the opposite on the backside? All they have to do is conclude that there is no acceptable way to verify age short of face to face and internet sales are gone. They can claim they didn't try to shut down sales but no one has found a legal way to continue them.
 

Danoman

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Also realize that no sales to minors could effectively shut down internet sales depending on what the FDA is willing to accept as proof of age.


That is a very true point to be made Myrany... proof by credit card only...? I don't know how it could be monitored in any effective way, unfortunately though. Difficult situation...
 

Myrany

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That is a very true point to be made Myrany... proof by credit card only...? I don't know how it could be monitored in any effective way, unfortunately though. Difficult situation...

The only way I can see is very cumbersome.
Fax a copy of legal ID. Then Skype (with live camera active) the vendor. The vendor compares the photo id that was faxed with the person on skype. Of course that is time consuming, cumbersome and a problem for people with no live camera (Don't know about you guys but my ancient equipment wont do it).

I remember in an online virtual world I was involved with they went to an age verification system where you filled out a form and they used a big data base clearing house firm to verify age. It was such a fuster cluck that my cat could get verified (she was 19 btw).
 

Bobbilly

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If you express supposition that says this will lead to the end of vaping within 2 to 3 years, and no small business will have any chance of marketing vaping products under these proposed regulations, I will likely call that out as fear mongering.

How many small companies produce cigerettes or nrt products?
 
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