FDA Discussion of SFATA conference & FDA proposal on VP Live radio

[Jman8]

I did a body check with a caller, and it was a If you think that, "then you are".....It should have been ...."then THAT is" The rest I fully stand behind and maintain.

<snip>

The theory that the FDA is going to hand everything over to Big tobacco, because the FDA and BT are lovers, is a {MODERATED} dream, if your leader tells you that, you know one thing, they use {OTHER STUFF}.

I'm thinking that you meant to say in the second paragraph, if you believe in the theory that the FDA is going to hand everything over to BT, because FDA and BT are lovers, then THAT is ludicrous.

Of which I agree. But your wording reads way more inflammatory than what I think you are actually saying and that actually makes sense.

 

[tombaker]

Me, and I believe many vapers, can accept the idea that we are vaping trace amounts of this substance, and are okay with it going forward. Hence, I personally don't need a regulatory body to correct this issue be it from vaping community or government.

Right, I mean if you want to be a fool, nobody should stop you. Since you think that a flavoring is somehow a trace amount, that super expensive equipment can only detect. Like that super expensive hard to find tongue in every human's mouth.

Diacetyl-induced bronchiolitis obliterans. Lets see, how hard is this to figure out the latin of the medical term.
Bronchiolitis = Lung, obliterans = Obliterated hmmmm sounds reasonable, Is Obliterated Lungs dangerous?

This disease is irreversible and severe cases often require a lung transplant. Oh, but it must take a long time.

If I start to notice it, I can just quit it fast......OR "The symptoms can start gradually, or severe symptoms can occur suddenly."

Elsewhere you imply that you think that it would be wrong to inform people that they are being lied to by sites claiming they are Diacetyl Free, and are not.

Sooooo, if one thinks its OKIE DOKIE to be sucking Diacetyl specifically into your lungs, nothing much else to say, except there are many things you should avoid to causing brain damage also, and my guess would be that advice was ignored.

Anyone selling publicly as labeled "Diacetyl free" E-Liquid, should be told that publicly. They destroy the inventory, because it all a bad batch. Many options from there, but the easist thing to do responsibly, is just explain how they are testing, or what big brand flavorings they are using, and then do testing.

Jman8, go ahead, out-think a rare and life-threatening form of non-reversible obstructive lung disease in which the bronchioles (small airway branches) are compressed and narrowed by fibrosis (scar tissue).

Not so bad, it will get better, if you just give it some time....oh wait.

 

[tombaker]

As far as I'm concerned, it would be helpful as the show clearly demonstrated bias from moment Tom was on the air until the end, and that bias is allowing unsubstantiated ideas to permeate our approach to politics of legal vaping and particularly with regards to comment period of FDA proposed regulations.

"our approach" just exactly who is this "we" that you are speaking for, I spoke for myself, and pointed to my source information. Did you not hear the host explain the context of the discussion, and during a call in show, ask people to Call In?

 

[Racehorse]

There is a difference between listing "ingredients" and listing every possible molecule that may be present in an ingredient.

Diacetyl, acetoin, acetyl propionyl, formaldehyde, arsenic etc. are not ingredients in that sense. That's the problem as I see it.

Yes, I see. You are right.

In the craft soap example olive oil is listed as an ingredient, not broken down into it's chemical components. Labels would otherwise be the size of .PDF documents.

Somewhere though, you will see a pharmacological study on skin + squalene, which is in olive oil, etc. and how certain lipids behave on human skin.

At any rate you guys are correct that there won't be time or money to fit decades of studies into the small time frame we have to get ejuice approved....and ejuice certainly should not be held to a higher standard of labelling than other consumer products....although just saying that gives me mixed feelings?

So, Bob Chill's 90% of flavorings are from 10 companies......so can't Dr. F. test the major flavorings used in ejuice.

There was a person on medical mystery battling crippling migraines for 15 years....her massive headaches appeared on her way to work, so kept getting sent to shrinks suspectiing psychosomatic aversion to her job. Turned out to be the "mint" in her toothpaste. She got the migraines on weekends, too.

How would I know anise is an ingredient flavoring if it is not listed? However if each flavoring was listed, the vendor would be giving away their recipe, in essence?

 

[Katya]

Dear Racehorse, it's a mess...

I have no answers or easy solutions. Sorry....

 

[Jman8]

Right, I mean if you want to be a fool, nobody should stop you. Since you think that a flavoring is somehow a trace amount, that super expensive equipment can only detect. Like that super expensive hard to find tongue in every human's mouth.

Dang, now I'm getting the wrath of Tom.

So, just to be clear, you are saying that diacetyl is not a trace substance in the juice we vape?

Elsewhere you imply that you think that it would be wrong to inform people that they are being lied to by sites claiming they are Diacetyl Free, and are not.

Can you quote where you are getting this from?

Sooooo, if one thinks its OKIE DOKIE to be sucking Diacetyl specifically into your lungs, nothing much else to say, except there are many things you should avoid to causing brain damage also, and my guess would be that advice was ignored.

Your advice is duly noted.

Wouldn't it be accurate to say that in my adult life, as a smoker/vaper, I've been sucking all sorts of things into my lungs? If yes, then would my desire to continue doing this be one that is up to me, as well as the assertion that I'm okay with it?

Anyone selling publicly as labeled "Diacetyl free" E-Liquid, should be told that publicly. They destroy the inventory, because it all a bad batch. Many options from there, but the easist thing to do responsibly, is just explain how they are testing, or what big brand flavorings they are using, and then do testing.

And you're thinking I'm disagreeing with this? Based on what you've read where?

 

[Racehorse]

Wouldn't it be accurate to say that in my adult life, as a smoker/vaper, I've been sucking all sorts of things into my lungs?

So let's go backward instead of forwards, ethically, and be more like BT and NOT tell people about all the stuff they are sucking into their lungs?

Or am I misunderstanding your stance?

Are you saying that the ethical standard the vaping industry must meet need only be as good as that which BT met?

 

[Jman8]

"our approach" just exactly who is this "we"

The vaping community.

I spoke for myself, and pointed to my source information. Did you not hear the host explain the context of the discussion, and during a call in show, ask people to Call In?

To me, an example of the bias you were up against is found around 15 min. mark where you and Kev are discussing 'cracked tanks' and you explain that it is really the material melting. Then around 17:20 mark, Kev makes loaded assertion of never hearing of problem of eLiquid making a tank melt. As if only in Tom Baker's world/experience this could possibly happen.

Even though you had already explained the point.

And this, IMO, is just one example of many (many many) in this one show. This one being rather incidental really.

What I'm getting at more in my assertion is that vaping community, the politically aware and vocal members, are self-convinced vaping, as we know it will be banned. You, Tom Baker, don't subscribe to that thinking. And you were on a show that was essentially confronting that while partially up against a bias that would love nothing more than to see your entire credibility undermined, and your position downplayed to oblivion.

I am not in that camp, but it humors me that you are addressing me as if I am. Kinda just shows how much that bias is permeating the vaping community. The bias that is operating under a defeatist attitude.

 

[Jman8]

So let's go backward instead of forwards, ethically, and be more like BT and NOT tell people about all the stuff they are sucking into their lungs?

Or am I misunderstanding your stance?

Are you saying that the ethical standard the vaping industry must meet need only be as good as that which BT met?

Yes, you are misunderstanding my stance, and I would say misrepresenting it. Feel free to reference post #71 which is where I entered this tangent.

I am compelled to say more, provide another example to help in understanding what I already said before, but in the way you've addressed my points thus far, I feel like you are only focussed on one portion of it, which is my personal choice/acceptance of diacetyl in vaped juice. Obviously, for me, that matters going forward, but prior to that assertion in post #71 was main point I was getting across, even while the final sentence of that post is one I think is biggest point going forward.

 

[Stosh]

In the craft soap example olive oil is listed as an ingredient, not broken down into it's chemical components. Labels would otherwise be the size of .PDF documents.

Without giving the consumer useful information. Artificial flavoring is a chemical cocktail, would make a "Twinkie" label look simple and the vaunted Natural flavorings...would "essence of beaver .... emissions" really make anyone feel better....

So, Bob Chill's 90% of flavorings are from 10 companies......so can't Dr. F. test the major flavorings used in ejuice.

A rather expensive proposition, and depending on the percentage used in any eliquid any trace amounts might be skewed

How would I know anise is an ingredient flavoring if it is not listed? However if each flavoring was listed, the vendor would be giving away their recipe, in essence?

It's why flavoring are just labeled as such in products, being recognized FDA GRAS. But the GRAS rating is for ingestion, not inhaliation, hense our quandry.

Dear Racehorse, it's a mess...

I have no answers or easy solutions. Sorry....

AMEN sister!!!

 

[Kent C]

One should simply contact your eliquid vendors and ask. If they don't know, don't care, don't test and don't ask their flavor suppliers - stop buying from them.

If they know, if they test themselves or have verification from flavor suppliers - they can put it online - then buy from them. If the demand or contacts regarding this is great more vendors will verify. If not, they won't, unless it is important to them.

 

[aikanae1]

Why are people splitting hairs over this?

BTW the flavor banana is a list of 13 chemicals. The chemicals are the same whether they are synthetic or "natural" (whatever that is) = identical and the FDA makes no distinction. "Natural and artifical flavorings" covers everything. If YOU want a more detailed listing then the FDA needs to have authority over ecigs and that is what DEEMING does. Eliquids need to come under FDA authority first before the FDA can regulate stricter standards.

Right now we are at the FDA deeming stage - A day after these rules are published and go into effect, the FDA could ban all flavors. Then this whole conversation about flavorings and ingredients would be a mute point and a waste of time.

Labeling changes and premarket submissions are the most costly requirements, and are there most likely to trigger exit.

When I read the economic impact there was mention that labeling was the second most expensive thing (the first was pre-market or new product application). It has to do with getting the SKU and getting it correct. It gave me the impression there's another application procedue to register them and that may take several tries / time too. I imagine someone more famialar with retail would know more.

There is a lot more to this than just the draft regulations that we've seen. The draft doesn't go into detail about what all is required. I know enviromental studies are and they aren't cheap. I know there has to be certification of GMP's or good manufacturing practice which also doesn't sound cheap and can last years. Even a change in source - say to a different nicotine supplier can require an entirely new product application. A vendor can't just re-type up a new form with different dates on it either. It's not like a manufacturer of mods can start using a new switch or connector either.

These deeming regulations put the entire vaping industry into a deep freeze - forever.

it is important to note, however, that a reduction in product variation does not necessarily imply reduction in total sales volume or production capacity.

There are currently a large number of electronic cigarette products being marketed, some of which have very little market share while others represent minor product variation among larger market players. Products that do not have sufficient sales to justify incurring the costs of complying with the proposed rule would exit. Products with larger sales will more likely bear the costs to come into compliance with any final rule, but we expect some reduction in the variety of products offered even among the larger players. Therefore, we expect that considerable product consolidation and exit would occur; much of it among low-volume products and driven by a reduction in the number of product variants, as opposed to complete brand exit. Consumers would choose from the remaining products. A reduction in product variation does not necessarily imply reduction in total sales volume.

Chapter IX of the FD&C Act requires submission of a listing by brand and quantities by brand or sub-brand of all tobacco product constituents (including smoke constituents) identified by the Secretary as harmful or potentially harmful, beginning three years after enactment of the statute.33 FDA would set a compliance date for submission of this information three years after a final deeming rule becomes effective. Although this provision would create an obligation that imposes costs, the Secretary is also required to promulgate regulations concerning the testing and reporting of constituents.34 We will estimate the cost of compliance with testing and reporting when those regulations are promulgated;

The Economic Census is conducted every 5 years, and the relevant data from the 2012 census has not been released yet. The 2007 data predates widespread electronic cigarette retailing. These totals do not include establishments that primarily sell electronic cigarettes.

They have already figured out how much we'll pay too;

The amount tobacco users’ are willing to pay to participate in cessation programs gives us information about their gains from stopping tobacco product use. Warner et al. (Ref. 64 [2004]) use the choke price, or the price at which no cigarette smokers would participate in cessation programs, to estimate an average willingness-to-pay among potential cessation program participants.

And all this was because I couldn't find the quote I was going for. AARRGGHH. It was from the director of the FDA when the act passed. He said it would be impossible for the FDA to approve ANY tobacco product because it was impossible for a tobacco product to ever be "safe".

 

[Gato del Jugo]

Right now we are at the FDA deeming stage - A day after these rules are published and go into effect, the FDA could ban all flavors. Then this whole conversation about flavorings and ingredients would be a mute point and a waste of time.

Don't worry.. we'll still be able to get our "delicious" albeit soon-to-be ridiciously-overpriced & heavily-taxed flavored nic from BT, who managed to pull off one of the biggest industry heists, thanks to their collusion with the FDA (& BP)... FTC.. Antitrust laws? Huh, what?


And for those with a little know-how, we'll still be able to enjoy our DIY zero-nic unflavored, which I hear works wonders for smokers trying to quit.. Perhaps if we're feeling a bit saucy some Friday evening, we can even stop at the grocery store on the way home from work & pick up some food flavorings to mix in...

And if we're really jonesin', maybe we can even boil up some BP patches (as we pray we don't blow the house up as the children sleep) & vape our attempted nic extraction (hoping we got all the rubbing alcohol out) using our jerry-rigged mods that Uncle Louie had bought from some guy in an alley on the wrong side of town, crossing our fingers that the battery doesn't explode in our faces at every next push of the button...


"Fortunately," we had a Plan B & also bought a pack of smokes when we stopped at supermarket..


It's what Mitch Zeller wants, after all..

And it took him only 241 pages to say that...

 

[Katya]

Please, don't.

I need a cigarette...

 

[Kent C]

Why are people splitting hairs over this?

BTW the flavor banana is a list of 13 chemicals. The chemicals are the same whether they are synthetic or "natural" (whatever that is) = identical and the FDA makes no distinction. "Natural and artifical flavorings" covers everything. If YOU want a more detailed listing then the FDA needs to have authority over ecigs and that is what DEEMING does. Eliquids need to come under FDA authority first before the FDA can regulate stricter standards.

One would think that this would be obvious, but it needed to be said. Thanks for saying it so well.

 

[tombaker]

So, just to be clear, you are saying that diacetyl is not a trace substance in the juice we vape?

trace substance (or trace): A substance which is found during analysis in a small concentration, high enough to be detected , but to low to be quantified accurately by standard testing methods.

So no, it not a trace substance, its an intended flavoring ingredient. The FDA does know the difference also.

Wouldn't it be accurate to say that in my adult life, as a smoker/vaper, I've been sucking all sorts of things into my lungs? If yes, then would my desire to continue doing this be one that is up to me, as well as the assertion that I'm okay with it?

Just ask yourself first, before asking someone to think for you. Lots of questions for YOU to answer.

 

[tombaker]

blappedy blap

Bias of host ...? I mean the host (Kevin) asked if I wanted to play hockey. I said sure. I said, I am fine with body checking, just let me get some stuff out first, all that happened. I made a single cheap shot in my own book, to which I think nobody else even cared, but it bugged me, so I said sorry....the end....could not thank the host enough, and continuing. And Dino loved my summary, clearly he kept an open mind without bias, my summary became a moment of instant Karma and clarity to him, Dino almost made me tear up, with his praise at the end. Sniff Sniff. its really touching to know that.......

Tank Melt Crack http://www.e-cigarette-forum.com/forum/blogs/the-ocelot/3786-eeekkk-its-melting.html The video of the melting in real time is gone, quite the shame

 

[aubergine]

This thread is all weird.

 

[Jman8]

Just ask yourself first, before asking someone to think for you. Lots of questions for YOU to answer.

Already answered from my end. And mentioned to you. And then you responded as if I'm foolish, and then I chose to ask the questions I did to you to help you see the foolishness in your judgment.

 

[Jman8]

Bias of host ...?

Yes, bias of host. Glad to point out the additional times I observed it during the program as well as when others engaged in it, including yourself.

Really won't be too difficult.