Legacy urges FDA to ban all e-cigs by “immediately” imposing the “deeming” regulation, makes more false fear mongering claims

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tombaker

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Atchafalaya

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Atchafalaya: Legislation News is already on the front page if you click "Forum" at the top left, you'll see a list of all the top-level sub-forums. Scroll down a little past the General Discussion sub-forums, and there is Legislation News, Media & General News, a little further is the CASAA sub-forum, etc.

Best bet is to put links in your signatures, as I have done, to help spread the word to those who might not even realize they should be looking. :)

Thanks! I'll do that this weekend. :):p
 

Jman8

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You absolutely MUST listen to this...
http://www.e-cigarette-forum.com/fo...red-do-you-want-feel-better-about-things.html

You might come away with a different opinion.

I started where you suggested people start and around 52 min. mark Bill says (I paraphrase): if you keep showing up for these meetings, and keep showing opposition, this is how you defeat these proposals. Which is quite a different message / style than, deeming regulations would ban all eCigs. One strikes me as message of hope, perseverance and 'yes we can' while other comes across as 'game over. FDA will ban these. Done deal.'

59:00 mark (looking to quote accurately here): "I'm pretty confident FDA is not going to propose that, or if they do propose that, the deeming regulation, they're also going to be proposing some amendments to it, some changes... because they can't... it's going to be pretty difficult, especially because if they try to propose, enact a 2007 ban on eCigarettes, it's going to go to court and they're going to lose again."

Followed by more along that line and around 59:45 message that says, (I paraphrase): they're going to say keep all the current products on the market (thru end of 2013) and let's wipe the slate clean from this point on, and then enforce the 'new product' regulation from now on.

Now, I'm not sure if what I just noted was tombaker talking and making legal stuff up or Bill Godshall, but if I go strictly by stuff written on ECF, I'd have to match the voice up with tombaker, for Bill Godshall, of ECF, is not conveying message of 'things will be amended, and 2013 will be the date they go with. Cause if they go with earlier date, they'll lose in court, again.'

Around 1:04:00 mark - Bill notes how he helped write legislation to ban cig sales to minors and now thinking FDA will do same with this other tobacco product called eCigs. IMO, both were wrong, and to not see the earlier legislation as having direct connection to the later proposal is, to me, how you say, short sighted on principle of the matter. IOW, you made your bed, now you can sleep in it.

Around 1:10:00 area is about Bill encouraging BT to get into ecig market. But hopefully (according to ECF writings) FDA doesn't handover ecig industry to BT, cause that would be bad(?).

Listened up to about 1:20:00, then jumped to 1:39:00 and after a couple minutes of that felt like I was again hearing words of tombaker and decided to bring this post to a close.
 
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kristin

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Sorry, but I gotta disagree here. OP (Bill G) says would. Not for the first time or only time. It says "would" and it says "ban ALL eCig products currently on the market."

That doesn't leave much room for could or might.

Then there is just the fact that Bill carries more weight in these threads than anyone else. Doesn't have to be that way, but it clearly is and I'm certain I could make this point abundantly clear if asked to do so. Plus, I actually thought Bill was head of CASAA until I learned otherwise about 5 weeks ago in one of these threads. That he's not would seem to take away, a little bit, from first sentence of this paragraph, but I stand by it.

I'm sorry if people mistakenly thought Bill was the head of, or was on the board of, CASAA, but he's not and never was. I don't know why some people think that, but how are we held accountable for someone else not knowing that fact? We have never represented that he is/was a CASAA director nor has he ever been listed on our website as such. He is and always has been an advisor to CASAA. While we do greatly value their opinions and insight, just as the directors don't always agree on everything, CASAA doesn't always agree with our advisors.

So, I stand by what I said, too. ;) CASAA has never said we know what "will" happen.
 

Oliver

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Around 1:10:00 area is about Bill encouraging BT to get into eCig market. But hopefully (according to ECF writings) FDA doesn't handover eCig industry to BT, cause that would be bad(?).

I don't think there's a contradiction here. For one, BT has immense resources which it can put into play to either quash e-cigs now, or develop them further. I know which one I'd prefer.

In the best of both worlds, we'll have a competitive environment which stops BT from whittling the market down to a small number of highly commoditized products, as a result of competition from the independent, privately owned, sector.

If the FDA were to hand the sector to BT now we would lose this competitive element entirely, and I don't think BT would really wish to take it further (they're a very conservative industry, and are doing fine right now, thank you very much).

Oh, and not to mention that, eventually, BT might come out with a product proposition that actually appeals to many smokers/vapers!
 

kristin

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Tom, 99% less hazardous does not translate to 99% less incidences and most oral cancer is caused by smoking, alcoholism and HPV.

The reason we started claiming that e-cigarettes were likely 99% less hazardous than smoking is because of the known science on snus - a smokeless tobacco. Snus has not been shown to increase the risks of ANY disease, including oral cancer. And modern, western chew has only a very slight higher risk than snus. The risk is so low that they don't even report actual deaths from smokeless tobacco. Bill's estimate of 10% is just that - an estimate. And a high one, at that.

Dr. Phillips, CASAA's Scientific Director, is an epidemiologist and an expert on smokeless tobacco and tobacco harm reduction. These facts come from him. I'm sending him a copy of your miscalculations so he can answer them properly. I'll post when I have it.
 

Jman8

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I'm sorry if people mistakenly thought Bill was the head of, or was on the board of, CASAA, but he's not and never was. I don't know why some people think that, but how are we held accountable for someone else not knowing that fact? We have never represented that he is/was a CASAA director nor has he ever been listed on our website as such. He is and always has been an advisor to CASAA. While we do greatly value their opinions and insight, just as the directors don't always agree on everything, CASAA doesn't always agree with our advisors.

So, I stand by what I said, too. ;) CASAA has never said we know what "will" happen.

I concede on the point that I made regarding Bill being seen as head of CASAA.

But stand by the point that Bill's words carry more weight on ECF than any person currently in CASAA or on the board.
 

Jman8

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I don't think there's a contradiction here. For one, BT has immense resources which it can put into play to either quash e-cigs now, or develop them further. I know which one I'd prefer.

In the best of both worlds, we'll have a competitive environment which stops BT from whittling the market down to a small number of highly commoditized products, as a result of competition from the independent, privately owned, sector.

If the FDA were to hand the sector to BT now we would lose this competitive element entirely, and I don't think BT would really wish to take it further (they're a very conservative industry, and are doing fine right now, thank you very much).

Oh, and not to mention that, eventually, BT might come out with a product proposition that actually appeals to many smokers/vapers!

I think if BT is encouraged to get into eCig market, one ought to expect they will be in the game to win and not simply to advocate.

If there was no FDA / heavy regulation, the competitive market would not favor BT, IMO. But because heavy regulation could mean smaller businesses have a tough time, whereas big business sees those not only as small hurdle but great way to gain competitive advantage, it does appear to work against vaping community as a whole. Yet, if BT is in, I think they ought to be pressed for agreeing with core issues, like online sales, flavors, level of nicotine, multiple devices. And if not agreeing or remaining neutral, then making it clear that they are only in it to win, and not for advocacy.

Which is what I ultimately get from Bill's comments. Here though, the current rhetoric like "handing over industry to BT" comes off as fear mongering, and alienating a potential ally. If you (Bill) were once encouraging them to get in, then it's hard to see how you can be negative about handing the industry over to them. Or I guess at very least explain the sound bite so it shows that you want them in the game, and want them advocating along with us, but have fear they will just go with big business mindset and possibly use regulations to quash smaller / upcoming businesses.

I'll also just add that if BT did somehow manage to quash smaller competitors and that was ever found out, they'd be pretty much hated by everyone, which currently is close to being the case anyway. Get on board with eCigs and advocate for them, and I'm thinking you'd win back some support for your company, even if some of us once loyal users now despise your brand.
 

kristin

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I concede on the point that I made regarding Bill being seen as head of CASAA.

But stand by the point that Bill's words carry more weight on ECF than any person currently in CASAA or on the board.
I'm really confused then.

I said CASAA never said "will."

You quoted that and replied "Sorry, but I gotta disagree here. OP (Bill G) says would" and that Bill's words carry more weight.

Bill's statements, which are not CASAA and carry more weight than CASAA, is why you disagree that "CASAA" isn't telling people what "will" happen?
 

kristin

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I think if BT is encouraged to get into eCig market, one ought to expect they will be in the game to win and not simply to advocate.

It's a shame that the tobacco industry can't see the huge potential of winning back so many customers who have been convinced they are evil. Have customers not shamed by using the product and not hating them for "killing them" with their product. If they used their considerable influence to instead fight for a diverse and open e-cig market, they could even be seen as heroes.
 
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Jman8

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I'm really confused then.

I said CASAA never said "will."

You quoted that and replied "Sorry, but I gotta disagree here. OP (Bill G) says would" and that Bill's words carry more weight.

Bill's statements, which are not CASAA and carry more weight than CASAA, is why you disagree that "CASAA" isn't telling people what "will" happen?

Post #33, by you, mentions Bill. That's where my disagreement came from. Specifically, when you said:
No one on this forum - not Bill, nor Tom, nor I - knows what was submitted to the OMB or what the FDA will finally release for public comment (unless they work for the FDA.) But we can tell you what the FDA could legally do and I'm pretty darn certain that CASAA has that part correct.

You include Bill in the we statement and later say "could" with emphasis. Hence I vocalized disagreement to this.

Bill is a person on this forum. Bill carries more weight than most, if not all, people on this forum. Bill has said "would ban ALL eCig products."

If you disagree with Bill on this, then welcome to tombaker's camp. I am in that camp and don't agree with all things tombaker conveys, especially incessant bashing of CASAA. If you don't wish to publicly disagree with Bill, that's fine.
 
{MODERATED}

Yes. Badly. I am not even quite sure where to start with it.

Indeed, I will just skip the faulty math and focus on the faulty premises. Most of the numbers that appear there seem to be pretty much random, having nothing to do with the equations they are being entered into. On what basis are you claiming that ST causes any lung cancers? The 10% as much as smoking for oral cancer (OC) is pulled out of thin air.

Estimates for the RR for oral cancer for smoking are in the 5-10 range (which are probably a bit high because they are based on studies that did not recognize what as been obvious for a long while, that a lot of OC is sexually transmitted). The RR for ST is well below 2 (as far as we can tell it is 1.0, but the methods are not good enough to rule out, say, 1.2). Thus, ST causes far less risk for OC alone, to say nothing of all the other diseases.

That 75% number was wrong when it was first interpreted the way you do -- it comes from a study by Bill Blot that concluded that 75% of OC come from smoking and alcohol combined. It is even more clearly wrong now, since it has become apparent (as some of us realized even when the study came out) that a large fraction of OC is sexually transmitted (most or all via HPV).

Apart from those strange details, the core error is not understanding the most important number you are using, the "about 99% less harmful" number. That is a total for all risk (for all mortality risk, in particular). Where does the remaining ~1% come from? From cardiovascular disease risk caused by nicotine use. Any too-low-to-measure risk for oral and a few other cancers is a rounding error that does not influence that estimate.

Since the residual risk (if there is any at all -- keep in mind the "about") is not about cancer, your entire line of reasoning is faulty, as is your suggestion that e-cigarettes ought to be less hazardous. The main reason the estimated risk is not lower than "about 1%" is the nicotine, which is common to both products. The main reason that we can estimate that all smoke-free tobacco products (NRT, ecigs, etc.) are very low risk is because we know that ST is very low risk. There is no other basis for making that claim. If you spent a little time reading before writing, you would probably have learned this.
 
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kristin

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Better yet, Carl decided to answer himself! ^^

Post #33, by you, mentions Bill. That's where my disagreement came from. Specifically, when you said:


You include Bill in the we statement and later say "could" with emphasis. Hence I vocalized disagreement to this.

Bill is a person on this forum. Bill carries more weight than most, if not all, people on this forum. Bill has said "would ban ALL eCig products."

If you disagree with Bill on this, then welcome to tombaker's camp. I am in that camp and don't agree with all things tombaker conveys, especially incessant bashing of CASAA. If you don't wish to publicly disagree with Bill, that's fine.

I have publicly disagreed with Bill. (Remember the "devices will be banned post," where I disagreed with Bill and even CASAA president Elaine Keller?)

No one on this forum - not Bill, nor Tom, nor I - knows what was submitted to the OMB or what the FDA will finally release for public comment (unless they work for the FDA.) But we can tell you what the FDA could legally do and I'm pretty darn certain that CASAA has that part correct.

In fact, that post was me saying that even Bill doesn't know what was submitted to the OMB. Nor does Tom, who also disagrees that it even "could" happen. So, no, I'm not in Tom's "camp." ;)
 
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DC2

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I started where you suggested people start and around 52 min. mark Bill says (I paraphrase): if you keep showing up for these meetings, and keep showing opposition, this is how you defeat these proposals. Which is quite a different message / style than, deeming regulations would ban all eCigs. One strikes me as message of hope, perseverance and 'yes we can' while other comes across as 'game over. FDA will ban these. Done deal.'

59:00 mark (looking to quote accurately here): "I'm pretty confident FDA is not going to propose that, or if they do propose that, the deeming regulation, they're also going to be proposing some amendments to it, some changes... because they can't... it's going to be pretty difficult, especially because if they try to propose, enact a 2007 ban on eCigarettes, it's going to go to court and they're going to lose again."

Followed by more along that line and around 59:45 message that says, (I paraphrase): they're going to say keep all the current products on the market (thru end of 2013) and let's wipe the slate clean from this point on, and then enforce the 'new product' regulation from now on.
That's why I suggested you listen to that, noting that you might come away with a different opinion.
:)
 

Atchafalaya

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DC2

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I think if BT is encouraged to get into eCig market, one ought to expect they will be in the game to win and not simply to advocate.

If there was no FDA / heavy regulation, the competitive market would not favor BT, IMO. But because heavy regulation could mean smaller businesses have a tough time, whereas big business sees those not only as small hurdle but great way to gain competitive advantage, it does appear to work against vaping community as a whole. Yet, if BT is in, I think they ought to be pressed for agreeing with core issues, like online sales, flavors, level of nicotine, multiple devices. And if not agreeing or remaining neutral, then making it clear that they are only in it to win, and not for advocacy.

Which is what I ultimately get from Bill's comments. Here though, the current rhetoric like "handing over industry to BT" comes off as fear mongering, and alienating a potential ally. If you (Bill) were once encouraging them to get in, then it's hard to see how you can be negative about handing the industry over to them. Or I guess at very least explain the sound bite so it shows that you want them in the game, and want them advocating along with us, but have fear they will just go with big business mindset and possibly use regulations to quash smaller / upcoming businesses.

I'll also just add that if BT did somehow manage to quash smaller competitors and that was ever found out, they'd be pretty much hated by everyone, which currently is close to being the case anyway. Get on board with eCigs and advocate for them, and I'm thinking you'd win back some support for your company, even if some of us once loyal users now despise your brand.
Big Tobacco involvement with electronic cigarettes is a very complicated issue, and can not be explained in sound bites.
And it seems to me what impact they can/will have on the market depends on what the final version of the deeming regulations say.

Their money can be critical to our fight if used for good.
On the other hand regulations can potentially give them the entire market.

The only people who can decide that are the regulators, and the only people that can influence things in our direction is us.
 

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Bill Godshall

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Virtually everything posted by tombaker about the the deeming regulation, about Chapter IX of the TCA, about CASAA and about me are lies.

The deeming regulation would legally apply all of the several hundred provisions in Chapter IX (that currently apply to a "tobacco product") to all of the ten thousand or so e-cig products currently on the market, and all of the thousand or so e-cig manufacturers and importers that market those products in the US.

Unless and until the FDA exempts e-cigs from Section 905(j) and Section 910, the deeming regulation would (by the rule of law) ban ALL e-cig products currently on the market. All of the several dozen lawyers I've communicated with during the past two and a half years (including tobacco and e-cig industry lawyers) agree with my interpretation of the legal ramifications of the deeming regulation, and none have disagreed.

I was also asked by Food and Drug Law Institute lawyers to present about the deeming regulations at the FDLI's annual conference in DC last year, which was attended by dozens of attorneys.

The FDA could exempt e-cigs from the prohibition and other disasterous provisions of Chapter IX (as I've been urging them to do since 2011, and as I suspect they may do to avoid losing another federal lawsuit).

But the FDA has made no indication that it will, is planning to, or is even considering to exempt e-cigs from ANY of the many Chapter IX provisions.

As such, it would be foolish for anyone to assume or claim FDA won't ban e-cigs, as tombaker has insisted upon several dozen times on various ECF legislative threads during the past two weeks.

Its clear to me that tombaker is working for an e-cig prohibitionist group, and has only posted stuff on ECF in recent weeks to deceive vapers to believe the FDA supports e-cigs, to create divisiveness within the vaping community, and to discourage vapers from taking any actions to protect their rights and their lives.
 
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Eric A. Blair

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Big government agencies and bureaucracies are very concerned about your health. You have to trust them.

They are us. They are "we the people".

They cannot be influenced by big pharmaceutical money funding the FDA. Or by their reliance on cigarette taxes to fund their state and federal budgets and SCHIP program.
 
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