FDA Post-hearing reactions?

[toddkuen]

I'd like to suggest that focusing on flavors or combustible versus non-combustible is a mistake.

That's not how the statute is written. The FDA only has limited authority to make general pronouncements about all the products that fit a given description, although it has to regulate cigarettes differently from others, and can set up different rules for different delivery systems (gels versus cigars for example, or even premium cigars versus litle cigars).

Also, the FDA can't even consider approved therapies in some kind of public health balancing act. (In other words: if approved medical therapies such as Chantix or the patch killed every user, that would not have any bearing on how the FDA treats products under the tobacco act - the FSPTCA.)

By embracing vaping without killing it the FDA gets a whole lot of new non-smokers and more ammo against combustibles.

In a carrot and stick approach our carrot is that vaping helps the FDA get people off of combustibles by getting the number of truly new non-combustible-smokers to tick upward faster than it otherwise might.

(I think combustibles is a new code word - where has this word appeared before?)

Chantix is a drug, not a regulated tobacco product as it contains no tobacco derivatives.

Within products that fit a given class, the FDA can only approve or reject individual applications. And each application has to be individually supported by public health evidence for that particular product, whether that product is a 10 ml. bottle of 30% PG and 70% VG 2% nic. unflavored juice that's manufactured in a particular way, or a trippy tip that has this specific size, shape and color pattern.

Every particular juice (down to size/flavor/composition/etc. combinations) and every piece of hardware (down to the color, size, and composition of separately sold drip tips) will be treated as a separate new type of tobacco cigarette under the deeming regulations, and will be judged on its own merits with regards to its effect on public health.

So, for exampe, it's theretically possible that the FDA might conclude that one drip tip which happens to be black is okay based on the public health studies for that drip tip, but an identical drip tip made by the same manufacturer is not approved because it's made in a color which might attract children, based on the health data.

(That's an absurd hypothetical, because no one is going to do health effect studies on different colors of drip tips. But that's exactly what the statute requires for two types of tobacco cigarettes. Marlboro lights 100s are not the same as Marlboro liights kings. And the FDA has no power to make broad statements about 100s versus king-sized.)

And this is all provided, of course, that the applications are submitted - and have the required public health data.

If the applications aren't submitted, then the products will be illegal after the 2-year window closes. In fact, if they aren't registered within approx six months after the proposed rule becomes final, they'll also have to be pulled from the market.

So let's not be seduced by the general language in which these topics were discussed at this hearing. The FDA must operate according to the tobacco act (FSPTCA).

Your scenario assumes that vaping becomes regulated in the same way as all else.

But its not like "all else" because it creates new, non-combustible non-smokers.

Before anyone starts a war it never hurts to sit down with your presumed enemy and see if there isn't some means to come to an understanding that benefits both.

Of course, the bigger the army behind you in that negotiation the better your chances which is why we need to be ready for war.

But war doesn't do us or Zellor any real good.

More people die from smoking combustibles while the war goes on, perhaps for decades, and fewer will start vaping during the war - Zellor I think is smart enough to see that.

Vapers as a group, if the war goes badly for them, go to what I see as Zellors larger enemy's camp: combustibles.

So how does making more combustible smokers benefit him?

Sometimes my enemy's enemy is my friend.

 

[NorthOfAtlanta]

Two Words:

"Extreme Cost"

and

"Doesn't Matter"

Yes it does, listen to Zeller at 21:14 here FDA Deeming Teleconference 4/24/2014 it has to be derived from tobacco or the FDA has no control by statute.

 

[zoiDman]

Considering the low amounts we use what would the cost actually be?

Why doesn't it matter?

There have been some Past Threads where Numbers like 3 ~ 10 Times as Expensive and Tobacco Derived. I'm not sure if Anyone Really Knows seeing at there is a Plentiful and Cheaper source readily available.

 

[Stosh]

I think somethings were revealed: there is definitely a combustible/non-combustible ideology split.

I think that those who have already quite and do not use analogs were revealed as something they're not sure what to do with - perhaps an ace up the sleeve - nd I think Zeller basically admitted they can't be put back to analogs but is stuck weighing "long term public health" against that.

What are the number of true 6 mo+ quiters on patches etc. vs. 6 mo+ vape onlys? - If vaping starts to exceed their numbers they'll kind of have to listen.....

Check out some of the threads in New Members and General E-Smoking forums titled "How long have you been..." and "What was your quit date". There's usually a mix of noobs and vets, but a long list of over 6 month quitters.

I know it's a skewed population that's being sampled BUT having observed ECF for a while (I'm 3 years 10 months quit) there is a large number of long term quitters. And that's taking into account the number of members I have known to have been active for a year of more, and not longer see their avatars around anymore. I can't believe very many of the "missing" have resorted to smoking again after being cig free for a year or two.

 

[zoiDman]

Yes it does, listen to Zeller at 21:14 here FDA Deeming Teleconference 4/24/2014 it has to be derived from tobacco or the FDA has no control by statute.

Thank you for Posting that. I wasn't aware that the Statutory Definition is that has to be Derived from Tobacco.

I will edit my previous post.

 

[Stosh]

Vapers are not in a position to pick and choose what sort of regulatory framework will be used.

The FSTPCA is already there. You can't redesign it from scratch. Congress passed the law in 2009. It establishes very stringent standards for all tobacco products introduced after Feb '07.

This is not a negotiation.

The only negotiation is if e-cigs are deemed a tobacco product or not.

After that the FDA is free to accomplish what Scotta denied them.

 

[Kent C]

Indeed. Let's not forget that progressive thought was responsible for quite a lot of very hard censorship during WWI, prohibition, endorsement of eugenics practices (later including the Tuskegee syphilis experiments at the end of the progressive era), indeed the FDA itself (which in response to food safety concerns granted legitimacy to the large meatpackers while wiping out thousands of local butchers overnight), and many other overtly coercive practices. From the people who I know quite well, the intentions are good, and genuinely sincere. But you know what can be said about good intentions, and sincerity can change in an instant.

That said, I think some FDA regulation would be quite good. Think in terms of the Goldilocks principle. From my talks with the guys at the vape shops, they want some sort of official approval, some patina of genuine legitimacy. Something like FDA approval is a heuristic device, a mental shortcut for people that says "This is OK"; we all use them. The point is that if some sort of official approval will encourage more vapers, which then means an expanded market, more innovation, and likely a lot of other benefits that are impossible to foresee. This of course in concert with dramatic improvements in public health - but through the market mechanism, please.

I agree with everything except the 2nd paragraph lol. Look, I understand some people's need for 'official approval' but it makes no sense to me to get approval from a body that is so inefficient, where almost any area that they try to 'help' ends up worse off than before... etc. etc. A better 'approval agency would be BBB, UL listing, Consumer Reports (although not perfect, just better than gov't)...

 

[Bob Chill]

I don't think anyone has a problem with "some" regulation. Simple things like quality standards and age restrictions. Unfortunately, "some" regulation and proposed FDA regulation are miles apart. The foundational aspect of the proposal and all the grey areas of what they can and can't do now and in the future is ripe, and I mean REALLY ripe, for disastrous outcomes on the vape culture in the future.

There is no reverse gear with things like this. Once it starts it only gets worse. At a bare minimum, there has to be protections for 2 pieces of our world (bottled juice and current hardware). I know the price is going up. That's a no brainer. Mess with bottled juice and current hardware and our world is gone as we know it.

 

[Roger_Lafayette]

This post reflects myriad profound misconceptions about: (a) the statute under which vaping is going to be regulated; (b) the steps in the regulatory process; and (c) the prior actions of the FDA's CTP under Zeller with respect to both smokeless tobacco products as well as vaping.

I don't even know where to begin, so I'm not going to try. Maybe some other posters here who know what I'm talking about can pick off one or more of (a), (b), or (c) above.

At the risk of being tiresome, I'll repeat what I said before.

This is not a negotiation.

By embracing vaping without killing it the FDA gets a whole lot of new non-smokers and more ammo against combustibles.

In a carrot and stick approach our carrot is that vaping helps the FDA get people off of combustibles by getting the number of truly new non-combustible-smokers to tick upward faster than it otherwise might.

(I think combustibles is a new code word - where has this word appeared before?)

Chantix is a drug, not a regulated tobacco product as it contains no tobacco derivatives.



Your scenario assumes that vaping becomes regulated in the same way as all else.

But its not like "all else" because it creates new, non-combustible non-smokers.

Before anyone starts a war it never hurts to sit down with your presumed enemy and see if there isn't some means to come to an understanding that benefits both.

Of course, the bigger the army behind you in that negotiation the better your chances which is why we need to be ready for war.

But war doesn't do us or Zellor any real good.

More people die from smoking combustibles while the war goes on, perhaps for decades, and fewer will start vaping during the war - Zellor I think is smart enough to see that.

Vapers as a group, if the war goes badly for them, go to what I see as Zellors larger enemy's camp: combustibles.

So how does making more combustible smokers benefit him?

Sometimes my enemy's enemy is my friend.

 

[Traver]

There have been some Past Threads where Numbers like 3 ~ 10 Times as Expensive and Tobacco Derived. I'm not sure if Anyone Really Knows seeing at there is a Plentiful and Cheaper source readily available.

Thanks zoiDman. There was some discusion about buying synthetic nicotine. I don't remember if anyone ever found the price but the main problem is that it is only available in large quantitates. Something like a drum. That's a lot of nicotine.

Even at 10 times the cost compared to what I pay now it would be cheaper than cigarettes. So if synthetic nicotine is not affected by these regulations, for me it becomes a matter of cost and the ability to find a way to buy synthetic nicotine. I am guessing that someone will make it available in smaller quantities and as I stated before they can't ban food flavorings. So even in a worst case juice would still be sold but they might have to call it something else, like food or beverage flavoring. Just add nicotine.

 

[toddkuen]

I wrote this on the other thread that I created:

Smokers are victims of bullying from many sources.

The consensus model to me looks very much like "smoker psychology" - we're all doomed to have our rights taken, no sense in fighting, lets just give up and hope for the best.

I know it well and it shows in these posts.

But I am not a smoker (though I vape) and I come from a technology background.

I am very familiar with disruptive technologies - which vaping is - the internet is one, cell phones, many other modern conveyances.

I have created my own and I lived through the transitions of many others.

"Consensus" is always the enemy of any disruptive technology and in my view consensus posters are in fact the "best enemy" of vaping that I or anyone else could ever imagine.

What's their point here other than to dispense dogma, discourage, delay, and whip up hope for a "white knight?"

If I owned a tobacco company I would certainly want to employ these kinds of folks as "ringers" based on the comments I see here.

It is always the job "of very smart people" to appear to provide "consensus" understanding as to why things like buggy whips will still be needed in the age of the automobile.

Why not shut down the forum and stop wasting everyone's time with the illusions of hope?

I often tell people vaping is the "internet" of the 2010's for this very reason.

Vaping is a "disruptive technology" - invented who knows where by some little guy with an idea.

Like the light bulb, the automobile, the internet.

How do you think the horse and buggy industry reacted?

The gas light industry?

With the same certainty that there is no hope.

Ideas, legal arguments, strategies against regulation, like anything else, can also be disruptive as well.

But other posters here, it would seem, are quite certain there are NO POSSIBLE disruptive ideas available to vapers in the context of the FDA.

A remarkable ability to be sure.

 

[DeeLeeKay]

I am confused here. What is not negotiable?

The way I see it, there are 4 ways to deal with the FDA regulations.

1) Just deal with them the way the FDA wants to.
2) Work with the FDA in hopes that we can somehow come to some amiable compromise.
3) Launch an all out war with the FDA
4) Hope that there is some lawyer somewhere who can make the FDA pack it's bags.

I believe that we need to use all 4 options.

 

[zoiDman]

Thanks zoiDman. There was some discusion about buying synthetic nicotine. I don't remember if anyone ever found the price but the main problem is that it is only available in large quantitates. Something like a drum. That's a lot of nicotine.

Even at 10 times the cost compared to what I pay now it would be cheaper than cigarettes. So if synthetic nicotine is not affected by these regulations, for me it becomes a matter of cost and the ability to find a way to buy synthetic nicotine. I am guessing that someone will make it available in smaller quantities and as I stated before they can't ban food flavorings. So even in a worst case juice would still be sold but they might have to call it something else, like food or beverage flavoring. Just add nicotine.

I Shutter to Think that it May Come to what you Just Described. But the Jaded Realist that I am Knows that it is a Very Real Possibility.

If Synthetic or Non-Tobacco Leaf derived Nicotine became the ONLY Liquid Nicotine Available, the Price Would Skyrocket due to the Supply vs. the Demand.

And would Probably Price Out all but the Upper "2%" of Vapers.

---

BTW - Do you want to here Something Funny? Do you know that XL CE2's are still my Day-to-Day Clearo?

LOL

 

[Jman8]

At the risk of being tiresome, I'll repeat what I said before.

This is not a negotiation.

We are CLEARLY in a negotiation phase.

What was the purpose of the hearing yesterday if negotiation cannot happen? Harkin wants FDA to move fast on regulations and Burr was vocal about fighting for the rights of Americans to make their own choices. Why would either person express this if no negotiation is possible?

Why would CASAA or any organization/individual ask for an extension on comments if there is no negotiation?
And whether that extension is granted or not, why would anyone (on either side of this debate) submit comments if there is no negotiation?

IMO, regulation of some sort is inevitable. I believe some on our side are only looking to delay the inevitable, but willing to accept that what FDA has put forth (ambiguity and all) is what must happen once comment period does end. So, all those who feel strongly that this is the only route available would be disagreeing with what Burr was getting at about fighting for choice. And would likely characterize Burr as out of step with reality.

To me, it is abundantly clear that FDA doesn't know how to regulate eCigs. And if left completely up to them, would obtain full regulatory authority over as broad of a definition of 'electronic cigarette' language as possible, and then proceed to make rules that are designed to fit 'general population' whereby all flavors are restricted from the market. Wouldn't matter if x, y and z flavors help segment of population quit smoking combustibles, and scientific data clearly shows this. At that point, it could be said that negotiation wouldn't matter.

But here in comment period, negotiation very much matters. Congress has the authority to amend whatever it is FDA thinks might happen with regulatory power over tobacco products and proposed deeming regulations. This assumes congress is magically all on the same page, but reality is like anything that is legislated, it comes down to majority. Why is CASAA putting eggs (and funds) in basket of congressional quarterly if no negotiation is possible?

"There is no negotiation" is mantra for the defeatists. Keep posting it, and I'll keep challenging it as it is entirely non-sensical and counterproductive.

 

[toddkuen]

I Shutter to Think that it May Come to what you Just Described. But the Jaded Realist that I am Knows that it is a Very Real Possibility.

If Synthetic or Non-Tobacco Leaf derived Nicotine became the ONLY Liquid Nicotine Available, the Price Would Skyrocket due to the Supply vs. the Demand.

And would Probably Price Out all but the Upper "2%" of Vapers.

---

BTW - Do you want to here Something Funny? Do you know that XL CE2's are still my Day-to-Day Clearo?

LOL

Hey, people will get into the market and the price will drop.

{MODERATED}

After all the make lots of things (like human insulin) these days using this "disruptive" technology...

 

[zoiDman]

Hey, people will get into the market and the price will drop.

{MODERATED}

After all the make lots of things (like human insulin) these days using this "disruptive" technology...

I remember having the Same Thought about a Genetically Modified Eggplant to produce high level of Nicotine when "Eggplant" was the Buzz Word of the Day.

LOL

 

[zoiDman]

We are CLEARLY in a negotiation phase.

What was the purpose of the hearing yesterday if negotiation cannot happen? ...

Just a Quick Question Jman.

Does the FDA answer to or have to take Directions from Congress?

 

[Kent C]

"There is no negotiation" is mantra for the defeatists.

There's another group that might use that.

 

[Roger_Lafayette]

CASAA attended and presented information at the FDA's "listening sessions." Bill Godshall has sent numerous letters to them. These avenues are now closed. The comments are the only way presently available to vapers who wish to participate in the formal process.

Those of you who wish to set up an informal meeting w/ FDA rep.s can avail yourselves of the phone lines here:

Telephone Numbers Frequently Asked of FDA

Good luck.

 

[Stosh]

I am confused here. What is not negotiable?

The way I see it, there are 4 ways to deal with the FDA regulations.

1) Just deal with them the way the FDA wants to.
2) Work with the FDA in hopes that we can somehow come to some amiable compromise.
3) Launch an all out war with the FDA
4) Hope that there is some lawyer somewhere who can make the FDA pack it's bags.

I believe that we need to use all 4 options.

In the hearing yesterday Zeller flat out said:
We tried to regulate e-cigarettes out of existence but the courts (Scotta) wouldn't let us, we need to deem e-cigarettes to be tobacco products and we get to try again.

Option 3) seems viable....but waiting years on lawyers and appeals is looking for a "fairy godmother" to save us.