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

[Stosh]

I'm intrigued by this comment, Katya - are you saying that there's better evidence for the safety of snus than for the relative degree of harm reduction associated with vaping (vis-a-vis tobacco cigarettes)? Seems reasonable given what little I know, but can you elaborate, please?

Tweety is once again right on. Swedish snus has been in use for decades in Sweden, with a huge drop in the smoking rate, but not a reduction of nicotine / snus use. They are able to and have done studies based on the entire population of the country, for the cancer rates and any other effects. E-cigs have not been around long enough or in use in the same concentration in any population for any such studies to be possible.

Yet for some reason the science has not affected the FDA in how it is regulated, go figure. Kills any optimism I would have that the FDA would apply it's regulatory powers in a sensible manner.

 

[DC2]

I'm intrigued by this comment, Katya - are you saying that there's better evidence for the safety of snus than for the relative degree of harm reduction associated with vaping (vis-a-vis tobacco cigarettes)? Seems reasonable given what little I know, but can you elaborate, please?

Might want to take a look at this...
http://www.estoc.org/key-topics/the-swedish-experience

 

[Roger_Lafayette]

<snip>
I would like to publicly apologize for making such an Aholeish remark to Alex....Though I disagree with his points, I am embarrassed for my remark, it was not clever, or appropriate, or true, and I regret it....<snip>

In the interests of fair play and decorum, I owe you an apology for losing my cool at one point, and addressing you in an inappropriate way. I don't have an excuse, and I'm sorry about that. It was wrong.

Rehashing that call is most respects strikes me as unproductive. As far as I'm concerned, you had more than enough of a platform to broadcast assertions that were both unhelpful and unsupported by the facts, although most were adequately dealt with.

***

For what it may be worth, I exchanged several e-mails with Kev that afternoon, in which I politely declined to follow his suggestion that I call in, on the grounds that I have few if any original or noteworthy thoughts on the topic of FDA regs, and also that the caliber of his guests had generally been very high w.r.t. that topic.

Kev, my hope is that you and/or Dimitri might be able to get another roundtable or perhaps some smaller group discussions (even one-on-ones) arranged with folks like Mike Siegel, Brad Rodu, Bill Godshall, C.V. Phillips, Greg Conley, Azim Chowdhury, Rolygate, plus some CASAA people like Julie Woessner, Kristin Noll-Marsh, Elaine Keller, and so forth. Leading Youtube and other commentators such as Phil Busardo or Grimm Green might also be helpful, in large part because I believe they understand the seriousness of the situation, and have a significant following. (BTW I'm not listing any of these folks in any particular order. I'm too lazy to go back and alphabetize the sequence.)

While I think I understand your rationale for having the odd "controversial" figure on your show, the level of informed discussion that the sorts of guests listed in the previous paragraph might offer on this particular topic is also highly desireable, as I know you recognize.

Anyway, far be it from me to tell you how to run your show. Those are just my And thanks for your good work Now, more than ever, it's critical that everyone stay together here, and focus on the goal of fighting these reg.s and other battles (e.g. the Sen. hearings just announced, state fights are ongoing still and so forth).

IMO, it's going to be a long one, the comment period is only the beginning.

 

[Gato del Jugo]

I'd like to add to that list.. Dr. Gilbert Ross & Jeff Stier...

 

[Jman8]

My POINT WAS: Its a liablity for E-Cigs to have CASAA being an adocate for traditional leaf type chewing tobacco. I simply do not want E-Cigs to be burdened and anchored by all that liablity, perception, and problems. I don't care about those types of alternates to Analogs.....let them have their own adocacy. E-Cig advocacy needs to nimble and focused only on Vaping.

This is a decent point, but don't you think it is too late in the game for consumers to find an organization, that is for the consumer, and is focussed only on eCigs?

Personally, I'm not sure if it is for sure too late, but do think this is a legitimate point you are raising, though not a deal breaker for a serious vaper who is politically aware and has fair idea of what CASAA has been up to with regards to eCigs/vaping advocacy.

 

[Jman8]

Upon reflection I am bit more concerned about the "Study" because if it is not fully expressed, and only communicated out to the 110 vendors, which a good chunk are using Diacetyl, claiming that they do not. This then essentially is a publicly funded testing of E-Liquids which is given back to the vendors. Might as well well just donated to each company a free lab test report. Sure you can get an aggregation of test results published, plenty of peer reviewed journal that can accept and aggregation of data, with reasonable conclusion. But its not new science, its a count. Demetri seemed to be all to deferential to vendors some who was on a first name basis. All this consideration because Demetri blamed Vapers for using it, when in fact many bought the juice based on the claims of not Diacetyl. We shall see what is actually done, but it was funded by the public, and Demetri insisting he can not disclose the specific results (rather that he can not even decided if the results are released) is kinda a joke. The monetary control should not change the results, but they are at the same time entitled to all the exact results, and need not be blinded to items that were tested. Blinding the raw data should be a problem for the peer reviewing also......but again, its not as yet published....but heck....Blame the Vapers. GMAFB

I understood Dmitri's point that if he attempts to assert authority over these vendors, it sets him (or funders) up as a regulatory body, which they are not, and do not desire to be.

Yet, I think your point, on the whole outweighs that. If consumers do not know which vendors are actually using diacetyl in their product, then there is almost no chance of correcting the issue except by demanding product testing. Which is what FDA is getting at. That all companies producing juice, ought to be providing test samples, and paying for the costs of that. So, if none are going to be named at this point to the concerned vaping community, then vaping community can assume that 7 out of all 10 vendors are operating with this perceived problem and 'diacetyl-free' advertisements cannot be trusted. It could be any of the 30% saying this, and they could be entirely accurate, but consumers still have good reason for not trusting that.

So, either pay the $200 now as a company to help eradicate the problem, and address the public perception, or rejoice in the scenario that industry and own scientist just served up on a silver platter great rationale for why FDA needs to be involved in this sort of market, where the $200 figure will appear like incredible bargain for overcoming hurdles that lead to 'generally regarded as safe juice.'

I would think if ANTZ did this sort of study and intentionally left off the results of which companies tested positive for diacetyl, we (vapers) would a) question legitimacy of their findings and b) demand to know which companies they sampled, and which were testing positive.

ANTZ / mainstream media will have a field day with this sort of information and the public perception hysteria that is likely to ensue.

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. But, the public perception around this will be that vaping community didn't wish to self regulate, in organized fashion, and is why FDA is absolutely necessary to be involved in this market.

 

[Jman8]

In the interests of fair play and decorum, I owe you an apology for losing my cool at one point, and addressing you in an inappropriate way. I don't have an excuse, and I'm sorry about that. It was wrong.

This is good to read.

Rehashing that call is most respects strikes me as unproductive. As far as I'm concerned, you had more than enough of a platform to broadcast assertions that were both unhelpful and unsupported by the facts, although most were adequately dealt with.

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.

It seems like it is easier, and more desirable, for some in vaping community to simply dismiss opposing views than to tackle them with reason and open minded debate. That might work here on ECF and among our own, but doesn't bode well for us in general public, going forward, IMO.

Kev, my hope is that you and/or Dimitri might be able to get another roundtable or perhaps some smaller group discussions (even one-on-ones) arranged with folks like Mike Siegel, Brad Rodu, Bill Godshall, C.V. Phillips, Greg Conley, Azim Chowdhury, Rolygate, plus some CASAA people like Julie Woessner, Kristin Noll-Marsh, Elaine Keller, and so forth.

I'd certainly like to hear this sort of roundtable discussion, minus Bill G. And I mean just in terms of roundtable type discussion. In previous one, he spoke and/or interrupted much of the show. Thus not so good for roundtable discussion. Have him on as own guest, like was done with Tom B., where going in it is perceived his voice is the one that matters most. But in roundtable, I feel it could be situation of Bill G. speaking 80% of the time and rest of guests getting their share of the remaining 20% of time.

I really wanted to hear more from SmokeyJoe in first roundtable, but realized by halfway point that it wasn't really possible.

 

[Kent C]

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.

I ran into this here:
http://www.e-cigarette-forum.com/fo...ing-regulation-proposals-19.html#post12959454

And then a few follow ups from others. My 'excuse' was that I don't get around much anymore Until interest in the media threads, I confined my posting to only a few threads for quite a while now.

I had no idea the reference, since I had never read any tom's posts before or if I did, they didn't raise a flag, didn't connect the name. I still don't really 'get it'.

 

[Stubby]

My POINT WAS: Its a liablity for E-Cigs to have CASAA being an adocate for traditional leaf type chewing tobacco. I simply do not want E-Cigs to be burdened and anchored by all that liablity, perception, and problems. I don't care about those types of alternates to Analogs.....let them have their own adocacy. E-Cig advocacy needs to nimble and focused only on Vaping.

You want to talk about all those in the mouth tobacco....great....I don't care....but you are in the wrong forum.....go to a chewing tobacco forum and get all into the spit vs swallow question in the Copenhagen sub section of Chewing for Fun and Profit....I don't care. Neither do most Vapers. Get it?

There are very good reasons to care about the 9 million or so ST users in the US, but first a few facts.

Smokeless tobacco, contrary to common myth, has the same low risk factor as vaping. That includes not only snus and dissolvable, with the science on snus being backed up by some 150 studies out of Sweden, but US type smokeless as in dip and chew. I did listen to the show and you brought up the 99% less harmful issue that Bill G. uses and your claim was that the number was plucked out of thin air. That is about as far from the truth as can be gotten. The 99% less harmful then smoking number is based on decades of studies and is on very solid ground. It is not a made up number but is what the science tells us.

For decades we have been conditioned (brainwashed) about the dangers of ST to the point where most people (including many electronic cigarette users) believe ST has the same risk as smoking, or if not that it surely must be significantly more risky then vaping. That is a false assumption and the science does not back it up.

The same lies that have been used against ST are the same lies that are being used against vaping. You have fallen for the lies of the ANTZ to the point where you are trying to disassociate yourself from a proven low risk tobacco product based entirely on lies and propaganda. You can't claim to support harm reduction if you don't support ST.

(Thanks for the kudos, BTW.)

I'm intrigued by this comment, Katya - are you saying that there's better evidence for the safety of snus than for the relative degree of harm reduction associated with vaping (vis-a-vis tobacco cigarettes)? Seems reasonable given what little I know, but can you elaborate, please?

There where no studies on electronic cigarettes when they first came out. The reason it was suspected that electronic cigarettes where significantly less harmful then smoking was because we already had lots of science on smokeless tobacco. It was already known from the studies on ST that the real cause of disease from tobacco was the smoke. Get rid of that and you get rid of about 99% of the harm.

As far as ST being more or less harmful then vaping is really splitting hairs. There are some people who think ST may be a bit less harmful then vaping and others that claim vaping is a bit less harmful then ST. If there is a difference it would be so small as to not show up in population studies. Whatever gets you off of inhaling smoke is the winner.

 

[Jman8]

There are very good reasons to care about the 9 million or so ST users in the US

One can also make the case that there are very good reasons to care about the other millions of smokers.

The same lies that have been used against ST are the same lies that are being used against vaping.

And some of these same lies are used against smoking. Feel free to quote the scientific data against smoking, without using something commissioned by ALA, ACS, CDC, FDA or others who just so happen to have scientific data regarding the harms of vaping.

Tom's bottom line point was:

E-Cig advocacy needs to nimble and focused only on Vaping.

Which is a decent point. To the degree that is deemed not so good point, and worthy of debate, then I'd like to add smoked tobacco to the mix for consideration of what to advocate for as it relates to FSCPTA. I recognize that can be huge distraction and throw us off our focus on eCigs. Which gets back to main point Tom was raising.

 

[Racehorse]

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.

But many aren't. I guess I just don't get why not put the information out on the table, test your products and be able to supply your consumer with what is in the liquid they are inhaling?

How hard is that? Why not just cut to the chase, get it done, and be done with it. That way, it's off the table and nobody can continue to tell lies about what's in there.

By not doing so you allow others to cast aspersions.

To me, this isn't even "self regulation". To me, this is just the most basic level of providing simple information to your consumers (Here is what's in this bottle) about what they are inhaling and/or injesting.

People are accustomed to having that information nowadays. I know I am.

penny wise is pound foolish

 

[Stosh]

There are very good reasons to care about the 9 million or so ST users in the US, but first a few facts.

Great place to start...

Smokeless tobacco, contrary to common myth, has the same low risk factor as vaping. That includes not only snus and dissolvable, with the science on snus being backed up by some 150 studies out of Sweden, but US type smokeless as in dip and chew.

Gotta love real science, peer reviewed studies over decades.

The 99% less harmful then smoking number is based on decades of studies and is on very solid ground. It is not a made up number but is what the science tells us.

Stand back, we're going to try science!!

There where no studies on electronic cigarettes when they first came out. The reason it was suspected that electronic cigarettes where significantly less harmful then smoking was because we already had lots of science on smokeless tobacco. It was already known from the studies on ST that the real cause of disease from tobacco was the smoke. Get rid of that and you get rid of about 99% of the harm.

As far as ST being more or less harmful then vaping is really splitting hairs. There are some people who think ST may be a bit less harmful then vaping and others that claim vaping is a bit less harmful then ST. If there is a difference it would be so small as to not show up in population studies. Whatever gets you off of inhaling smoke is the winner.

Vaping should be trying to be associated with the 99% harm reduction that ST has proven scientifically for a very long time. The problem isn't with the science but with getting the FDA (and EU, and ...) to actually pay attention to the studies already done. If e-cigs can be proven to have the same harm potential as ST, it would be a huge step forward.

 

[Jman8]

But many aren't. I guess I just don't get why not put the information out on the table, test your products and be able to supply your consumer with what is in the liquid they are inhaling?

I hear you, and I do realize for many it is a genuine concern.

How hard is that? Why not just cut to the chase, get it done, and be done with it. That way, it's off the table and nobody can continue to tell lies about what's in there.

By not doing so you allow others to cast aspersions.

To me, this isn't even "self regulation". To me, this is just the most basic level of providing simple information to your consumers (Here is what's in this bottle) about what they are inhaling and/or injesting.

But if the information already being supplied is 'diacetyl-free' and study by Dr. F. says otherwise, then some sort of third party regulation would need to be in effect to overcome what is either incompetence or deception.

How do you see it being supplied if not going way of some sort of regulation (whether it be from within industry or by government)?

 

[Racehorse]

I hear you, and I do realize for many it is a genuine concern.

Jman, it's not so much that it's even a personal *concern* so much as consumers are used to being able to see ingredient labels nowadays.

I remember when I first joined ECF and there was a topic What Do We Want from Vendors or something like that, almost 2 years ago, and there were quite a lot of posts asking to know what is in their ejuice.

For some people it could be other stuff, like food colorings or dyes or even splenda. I remember back when providing PG/VG ratios wasn't a big deal, but now pretty much everyone wants to know and orders specific ratios.

ALL the bodybuilders and people at gym I know, they read the ingredients of their protein powder, smoothie shake, etc. carefully. They are carefully balancing what they put into their bodies.

So unless a person is against labelling in general (which is an entirely diff. subject) I guess I'm asking why this is such a big deal???

And I think one reason people want to know is because they were lied to by BT about what was in their cigarettes, and they don't want to go thru that again?

Again, I do not see providing ingredient list/lab test to consumers as "regulation". I buy homemade soap at a crafts fair, it even has all the ingredients listed. And they aren't regulated. To me it's just the minimum requirement of running a biz ???

when I was working w/a nutritionist to track down a food allergy, I was always reading labels, cutting them out for my nutritionist so she could look at them scientifically. I also had to look up what went into a few fast food items, because on a road trip I may need to utilize them if I don't pack a cooler to travel or if something happens to my packed food....

 

[Racehorse]

ALL the bodybuilders and people at my gym read carefully the labels on their protein powder jars and smoothie shakes, etc. They are carefully balancing their chemistry and what they put into their bodies. To acheive certain health goals for themselves, etc.

This just seems normal to me.

Unless you are totally against labelling in general (and that's a diff. topic) I guess I don't get why this is such a big deal? It just seems like a normal expectation in this day and age, that consumers have. Everyone I know at least.

 

[Bob Chill]

I haven't read the entire thread so I apologize in advance if this has already been touched on. Vaping ingredients are really low tech and uncomplicated with one exception, the flavors and additives. There aren't even than many flavor manufacturers out there. If I had to guess, over 90% of the flavors vaped come from less than 10 sources. The burden of what's in the flavorings should be top down and the flavor vendors themselves should be responsible for testing them all imo and providing precise chemical breakdown to the vendors that mix the juice.

Mixing juice isn't like brewing beer. The only art is how much of what flavor. Everyone follows the same exact process including DIY folks. We measure precisely, add, and shake. It's not unthinkable to have "FDA approved flavorings for inhalation" at the manufacturer level. How many things do we eat that say "natural and artificial flavors" on the ingredients list?

People who bake cookies don't need to say exactly what artificial flavors are in their cookies as long as they simply disclose that they are there in general. The approval for consumption is a level or 2 above the person baking them. I don't see why juice wouldn't work the exact same way. Ingredients "USP PG, VG, Nicotine, Natural and Artificial Flavors". Is pretty simple in my mind. 90% of the premix juice could simply be labeled just like that. Food and drinks already are.

Flavor manufacturers have the pockets and enough at stake (vaping is a huge boom for TPA, FA, Capella's, etc). Heck, they should be racing to have "approved flavors for inhalation". Placing that burden on juice vendors is redundant and burdensome. Makes no sense to test Store A's Grape Splash and Store B's Grape Frenzy when they are using the same grape flavor to start with. It's asinine honestly.

Things get muddier with naturally extracted brews. I don't think a small NET vendor stands a chance if the screws are turned on them. Any extracted flavor will likely be moved to peoples kitchens and 1000s of new youtube videos will be posted.

 

[Katya]

(Thanks for the kudos, BTW.)

I'm intrigued by this comment, Katya - are you saying that there's better evidence for the safety of snus than for the relative degree of harm reduction associated with vaping (vis-a-vis tobacco cigarettes)? Seems reasonable given what little I know, but can you elaborate, please?

You're welcome. Just to add to what Stosh, Stubby and DC2 already said. Snus has been around for much longer and has been studied more extensively than e-cigarettes. One of the biggest studies was published by Lancet:

http://www.thelancet.com/journals/lancet/article/PIIS0140-6736(07)60677-1/abstract

There was little difference in health-adjusted life expectancy between smokers who quit all tobacco and smokers who switch to snus (difference of 0·1—0·3 years for men and 0·1—0·4 years for women).

That is a pretty powerful finding. We can't make such claims about e-cigarettes yet because e-cigarettes have not been around long enough.

So yes, Bill G. is right, switching to snus is just like quitting smoking--99%. And yet, despite that, the EU banned snus and US included snus in the PACT Act as a tobacco product. So much for caring about people's health and lives and being on our side.

Death by regulation: the EU ban on low-risk oral tobacco « The counterfactual

 

[Jman8]

Jman, it's not so much that it's even a personal *concern* so much as consumers are used to being able to see ingredient labels nowadays.

<snip>

So unless a person is against labelling in general (which is an entirely diff. subject) I guess I'm asking why this is such a big deal???

And I think one reason people want to know is because they were lied to by BT about what was in their cigarettes, and they don't want to go thru that again?

Again, I do not see providing ingredient list/lab test to consumers as "regulation". I buy homemade soap at a crafts fair, it even has all the ingredients listed. And they aren't regulated. To me it's just the minimum requirement of running a biz ???

In the above, you added "lab test." As I type this, I'm drinking some soda, out of a bottle. On that bottle it lists ingredients. I agree that this is the norm. Nowhere on the label am I seeing lab tests that were performed to reassure me of the safety of the product. Are you saying that many products nowadays have labels on them with lab test info regarding the specific batch?

Even with that said, let's say label says, "diacetyl-free" on it. And Dr. F. tests that same product and the results show it contains diacetyl, then what? Can they go ahead and keep selling that inventory of product with label on it that says "diacetyl-free?" I mean what would be the issue with this except for someone that is against labels? That's what I hear you saying in response to what I was bringing up.

Issue with FDA proposal, as vaping consumers understand the situation, is lab tests will cost umpteen billion dollars per test, per ingredient. I exaggerate, but may as well be that high figure. If there is not a third party that will verify the test results, and hopefully one that consumers, government, and even ANTZ can trust, then I'm thinking this issue will be with us forever where company can claim whatever they want on a label, but third party testing may show general public that the label is in error.

 

[Katya]

Unless you are totally against labelling in general (and that's a diff. topic) I guess I don't get why this is such a big deal? It just seems like a normal expectation in this day and age, that consumers have. Everyone I know at least.

There is a difference between listing "ingredients" and listing every possible molecule that may be present in an ingredient. When you read food labels, they all list "natural or artificial flavorings' or "spices" without disclosing any chemical components and certainly those manufacturers are not obligated to perform lab tests for their "strawberry flavoring." Those flavorings and spices are considered GRAS by the FDA and are OK to be added to food. Can you imagine a bakery having to pay for lab tests of every flavor molecule they add to their breads and cookies? They'd be out of business in no time.

The ingredients of most eliquids are already listed--PG, VG, nicotine, flavoring, sweetener, coloring--all GRAS. Just like ingredients listed on food and cosmetics and such.

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

ETA: I agree with Bob Chill--we need flavorings and sweeteners that are formulated specifically for vaping. That of course will be a problem for artisanal juice makers who extract their own flavorings... It's not going to be easy...

Coloring should be banned from eliquids altogether, IMHO.

 

[tombaker]

Roger, I specifically un-ignored (nice you have that option post by post) I really do the settings to ignore your postings, I encourage DC2, and some freak with a Avatar of a woman corseted, bound, and tied up, to actually USE the forum tools to ignore my postings.

You Do Not owe me no apology, it was all fair game, and I said you had a better phone than me, for a reason. Please edit it out of your post. 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.

My message remains, the local bans can be fought now, they are winning now, local stores are being zoned out, restrictions on Bars, most of the focus instead is the FDA.

The FDA at best can not do something in 4 years time, if people have their filings in, they can not do anything until they disposition those filings. People are complaining about the speed that they are dispostion the filings, so if like Analogs, worried it could take years potentially. But again those products remain on the shelves until dispositioned on the applications. So we could be 4 to 6+ years before anything is ACTUALLY done by the FDA, if anything beyond approvals. 2020.

Meanwhile the local bans are really starting to hurt, can you imagine 6 more years of that. CASAA is going to near zero effect on the regulations for manufacturers, personal stories are wonderful and all, but those are for politicans, not the regulators who are just working what Congress told them to do.

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}.

The theory that APV hardware is covered by the FDA, for the nervous was clarified by FDA already, for paranoids, ITS ABOUT TO HAPPEN.

2+2=(11-3)*77/154

In the interests....

Rehashing that call is most respects strikes me as unproductive. As far as I'm concerned, you had more than enough of a platform to broadcast assertions that were both unhelpful and unsupported by the facts, although most were adequately dealt with.