FDA Why Isn't Vaping the FDA Center for Tobacco Product's Biggest Ally?

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Katya

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What does the situation of any given person have to do with this? I'm talking about public health as a whole.

And I'm talking about an e-cigarette being a tobacco product, albeit much, much healthier than traditional, comparable tobacco products.

When we start emphasizing "health benefits and "smoking cessation," clearly forbidden under the Soterra ruling, we're making medical claims and potentially opening a big can of very ugly worms, if you ask me.
 
Jan 19, 2014
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I'm no scientist, but how could anyone go about proving that more people are dying from cigarettes because some vapers are dual users rather than "quitters"?

I'm not either but if you read (say) Glantz's blog or some of these junk studies, the clear inference is that there's a certain statistical baseline - i.e. about 5% of smokers quit annually on average, assuming that they don't have something like vaping as a crutch. Now if the presence of vaping reduces this quit rate, then vaping increases mortality.

Take the Grana, Popov & Ling junk study - what they did was use an online survey (which is dreadful science right there due to the small sample and self-selection of respondents, even I know that), and they discovered that the quit rate from a population of 988 smokers who were never-vapers was higher than the quit rate from 88 smokers who were ever-vapers.

Now this is junk science according to Siegel: http://tobaccoanalysis.blogspot.com/2014/03/new-study-on-electronic-cigarettes-by.html
... but primarily because it looked at smokers who didn't express an interest in quitting.

(My engineering/math background makes me want to mutter about the sample sizes - if a few more of the 88 "ever vapers" had quit, then the results woud've been different. Or as CDC Dir. Frieden says: "anecdotes are not data" But never mind.)

So the point is that they are not showing proximate or 'but for' or any other type of causation here. It's reasoning based on populations.

And it kinda makes sense from their point of view, I think. If we assume that the goal is to reduce mortality, then they are simply using statistical expectation.
 
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Jan 19, 2014
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Ahem. Again--strictly forbidden under Soterra.

Whoa. We need to be careful here. Yes you are correct - if a specific manufacturer touts their product as cessation therapy then they get zapped.

However that manufacturer may argue (and indeed almost certainly must argue) to the FDA that there is not less quitting, in order to win under the FSPTCA's "appropriate for public health" standard.

However we are not talking about specific products here, we are talking about vaping as a whole.

And this doesn't run into the Soterra problem, because we are siimply saying that there's a net benefit to public health. Not that vaping with a specific product is going to help people quit.

And what Bobbilly and I are both saying is that we have to make that argument in the pubic policy arena.

Otherwise more vaping ==> lless quitting ==> more death.

This is precisely why Glantz and his ilk keep trying to churn out more junk studies that show that vaping implies less cessation.
 
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Bobbilly

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Whoa. We need to be careful here. Yes you are correct - if a specific manufacturer touts their product as cessation therapy then they get zapped.

However that manufacturer may argue (and indeed must argue) to the FDA that there is not less quitting, in order to win under the FSPTCA's "appropriate for public health" standard.

However we are not talking about specific products here, we are talking about vaping as a whole.

And this doesn't run into the Soterra problem, because we are siimply saying that there's a net benefit to public health. Not that vaping with a specific product is going to help people quit.

Bingo. However I still think no argument will suffice if the desire is to heavily restrict the usage.

Energy needs to be directed at the legislation.
 
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Bingo. However I still think no argument will suffice if the desire is to heavily restrict the usage.

Energy needs to be directed at the legislation.

Yeah but we can affect how congress puts pressure on the FDA by touting the cessation thing. If we get another West toolkit study done here in the US, we might even be able to get so much pressure on the FDA that they never finalize the rule.

This has happened before - Bill Godshall reported that OSHA tried to ban indoor workplace smoking in '94. They got a million comments, and were never heard from again on that one.
 

Kent C

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Exactly!

By definition, the dual users of NRT and tobacco cigarettes are "trying to quit." So they already count as "quit attempters [sic]" And a certain fraction of quit attempts are successful.

McAfee said their were 1.6 million 'attempts' and 100,000 'quits'. Harkin applauded that. :facepalm:

So... just over 6% their NRTs vs. 60% greater than NRT's for ecigs. (from one study).
 
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tombaker

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That option has already been tried. CASAA sat down with the FDA and presented them with the scientific evidence on vaping. The proposed Deeming Regulations are the result.

So explain again how your method is going to make a difference???????????????????????????

Do you actually think that the Deeming Regulations are the result of any CASAA meeting with the FDA, where items were given to the FDA? Do you actually believe what you wrote? The Deeming is a result of what? Exactly what are you proclaiming?
 

Bobbilly

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Right, but so is smokeless tobacco which is a whole lot less dangerous. And vaping of course.

Not in my world. Vapour is recreational nicotine. And unless it's approached that way no argument in the world will get it less restricted than the TCA.

Look how well it worked for ST
 
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Katya

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Whoa. We need to be careful here. Yes you are correct - if a specific manufacturer touts their product as cessation therapy then they get zapped.

However that manufacturer may argue (and indeed almost certainly must argue) to the FDA that there is not less quitting, in order to win under the FSPTCA's "appropriate for public health" standard.

However we are not talking about specific products here, we are talking about vaping as a whole.

And this doesn't run into the Soterra problem, because we are siimply saying that there's a net benefit to public health. Not that vaping with a specific product is going to help people quit.

And what Bobbilly and I are both saying is that we have to make that argument in the pubic policy arena.

Otherwise more vaping ==> lless quitting ==> more death.

This is precisely why Glantz and his ilk keep trying to churn out more junk studies that show that vaping implies less cessation.

Sorry, Roger. I have to bow out at this point, as gracefully as I possibly can. I really don't understand the finer points of political advocacy and what needs to be said in the "public policy arena." I believe in simply telling the truth, as I know it. So I'll just wait for the CASAA lawyers to tell me what to say in my comments to the FDA. They speak the language--I don't.

And, to quote H.L. Mencken one more time:

I am strongly in favor of common sense, common honesty, and common decency. This makes me forever ineligible for public office. ;)
 

aikanae1

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Sorry, but I already disagree with you right here. When I bought my first Green Smoke kit, I did so because it was advertised as a "smoke everywhere" product. I was looking for a smoking substitute in those places and situations where smoking was not allowed. At that time, I used Nicorette gums, snus or Nicotrol inhaler when I couldn't smoke, but the idea of a non-combustible cigarette that also gave me the "hand-to-mouth" satisfaction was very appealing to me. I never dreamed that it might lead to quitting.

"acciedental quitting" is a new category that hasn't been looked at before and seems specific to vaping. i think that could be included in the public health arguement. People buy ecigs for other purposes.
 

tombaker

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One of the most interesting comments from the presentations at the SFATA conference came from Ralph Tyler of law firm Venable.

He said: "don't expect the FDA or any government organisation to understand what they are regulating. It is your job to educate them"

There were chuckles from the audience to which he replied: "That's not meant to be a joke. I'm serious."

As someone who has read the appellate arguments of the FDA asking stop all importation of E-Cigs, and vacate the Judges ruling and injunctions against the FDA....I recognize Ralph Tyler as the Chief Counsel of the FDA, whom is responsible for putting forward the appeal.

Tyler Argued: The Harm Caused By The Importation Of “ Electronic Cigarettes” Is Immediate, Irreparable, And Contrary To The Public Interest http://casaa.org/uploads/FDA_Appeals_Brief.pdf

Tyler chose to proceed with the appeal, and lost BIG. At SFATA he claimed that the 2009 Act was written only for combustibles, and told people to write the FDA with that information. Anyone familiar with the 2009 knows that is manifestly false.

Tyler put his arguments against E-Cigs forward, lost, was wrong on the law according to the appeal, was fast-tracked out of the FDA quickly, and now is misreading the law and advising incorrectly that on the intent and breadth of the 2009 act.

Tyler then topped it off with his next point that a teenager could some day make nicotine out of an existing chair. Fun and games stuff, comic relief.

Speculation of what motivates these new statements as a Pro E-Cig attorney after being the lead of the opposition by lodging the appeal of Sottera, is unknown, he would have to explain.

But one thing is clear, none of the explanations of how all this come to be, start or end with, Ralph Tyler as having a good track record, or evidencing a strong skill-set.

When the Former Chief Counsel of the FDA who attempted to re-instated the import restriction on E-Cigs of 2009, starts incorrectly telling people that 2009 Act is only for Combustibles......something is Wrong
 
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