FDA Re. Potential Flavor Ban

[DC2]

In my rush to post the above, I didn't realize there was more...

Inside the glass cube on Lake Neuchatel researchers working under former Novartis executive Manuel Peitsch are conducting tests in petri dishes and on human cells using the cutting-edge technique known as systems biology to try to assess how the new devices affect known pathways to cancer and other smoking-related diseases. It’s a shortcut compared with running years-long human trials, but PMI hopes it can persuade the FDA and health authorities in the EU by the results. PMI is also testing a device developed by Duke University researchers including Jed Rose, coinventor of the nicotine patch, which uses a chemical reaction to deliver nicotine. All of the PMI devices are designed to prevent users from inhaling dangerous fumes from the heating element, a knock against the Reynolds products.

At the same time the company is using scores of outside researchers to study how consumers use the products and whether they will attract new smokers. This is critical, because the public health impact of reduced-risk products is a numbers game: If they are 80% safer and used by the 20% of U.S. adults who smoke, that’s a public health win. If they create a bunch of new nicotine addicts, not so much. PMI, in other words, is trying to prove to regulators that its great new product won’t actually attract new customers. Such is life in the perverse cigarette business.

Do I have to highlight the relevant parts, or do they speak for themselves?

 

[DC2]

OMG. People should read this article. It's chock full of sounds bytes that scare me...

Disruptive innovations like e-cigarettes are going to arrive more frequently, the chief executive says, and PMI has yet to work things out with the most important partner in its business: the taxman. Cigarettes deliver tax revenue as efficiently as nicotine. Of PMI’s $80 billion in revenue last year, $48.8 billion went to the taxing authorities. It’s as if 12 out of the 20 cigarettes in every pack are sold by some form of government.

In PMI’s ideal world there’d be little or no tax on the new products, assuming they prove to have reduced risk. That would encourage current smokers to switch. But Calantzopoulos is a realist: He assumes full, cigarette-level taxation in his financial models, knowing that governments will loathe losing revenue, especially since the new products continue to deliver nicotine.


The worst tax, from PMI’s perspective, is a simple sales tax based on the wholesale price. That encourages manufacturers to engage in price wars, since most of the cost is borne by tax authorities, hurting premium brands. If there is to be a tax–and so far only Italy has announced a policy on these new products–Calantzopoulos prefers a per-cigarette excise tax. Since they contain tobacco, if they make it to the U.S. they’ll also be subject to the massive 1998 settlement with state attorneys general in the U.S., which still generates billions of dollars in revenue (and hundreds of millions of dollars in legal fees each year for the private lawyers who helped negotiate it).

 

[Jman8]

Can you clarify the concern you have so that I can figure out whether or not to like your post?

Concern is that the number (5000) is another propaganda tool designed to keep smaller players from entering into a big boys game. Or big girls.

That would be the succinct version of what I'm getting at.

 

[Jman8]

Here is another interesting tidbit I just ran across...
Philip Morris International Bets Big On The Future Of Smoking - Forbes

The extensive scientific research was inadequate becomes it did not include long-term human studies.

... to establish that it was indeed safer than smoking.

As a poster, who you dislike and thus shall be unnamed has said, that if one vaping device is approved, then it would behoove all others seeking approval to follow their roadmap.

Currently, it could be said that no vaping device/product would be allowed under the proposal (regardless of who puts it forth) if the criteria is "it must satisfy criteria that establishes this is safer than smoking tobacco, AND that must include studies that are min. of 10 years in length."

 

[zoiDman]

"A judge ordered Reynolds to pay $8.3 million in 2013 after determining the company’s extensive scientific research was inadequate because it didn’t include long-term human studies."

Wow... $8.3 Million really Must have hit PMI Pretty Hard.

Philip Morris International Inc. (PM) | Assets

I wonder if this $8.3 Million was Capped under Vermont Law?

 

[Jman8]

In my rush to post the above, I didn't realize there was more...



Do I have to highlight the relevant parts, or do they speak for themselves?

It tangentially relates to what I'm getting at, but falls way short on specifics.

I appreciate the efforts though. Keep trying if you feel it will help.

 

[DC2]

Concern is that the number (5000) is another propaganda tool designed to keep smaller players from entering into a big boys game. Or big girls.

That would be the succinct version of what I'm getting at.

Fair enough. I hope you're right.

 

[DC2]

It tangentially relates to what I'm getting at, but falls way short on specifics.

I appreciate the efforts though. Keep trying if you feel it will help.

You keep talking about specifics.
Maybe you should ask the FDA for specifics.

I'm sure they will be glad to provide them.
Excuse my laughter.

Perhaps that is a better route for you than the experts I have provided earlier links to?

I really don't want to discourage you in these efforts, but if you're serious then you should not be asking us.
We are mere mortals here.

 

[Jman8]

Here is another interesting tidbit I just ran across...
Philip Morris International Bets Big On The Future Of Smoking - Forbes



The extensive scientific research was inadequate becomes it did not include long-term human studies.

I think it needs to be stated and made abundantly clear that this product failed based on way it was marketed. And relates to all those pro-vapers who think eCigs ought to market themselves as 'reduced risk.'

Here is link from the Forbes article that I feel makes that abundantly clear, and that information spelled out.

On July 26, 2005, Attorney General William Sorrell sued tobacco product manufacturer R.J. Reynolds for consumer fraud and violation of the Tobacco Master Settlement Agreement. Vermont is collaborating in this matter with attorneys from other States’ AG offices and with NAAG. The lawsuit charges that Reynolds’ advertising for its “Eclipse” brand cigarettes—claiming that smoking Eclipse cigarettes is less harmful than smoking other brands of cigarettes—violates Vermont’s consumer protection statutes, and also the Master Settlement Agreement, which prohibits the tobacco companies from making material misrepresentations regarding the health consequences of tobacco products.

The case was tried over a period of five weeks in the fall of 2009, with the Court issuing a ruling in March 2010. The Court found that R.J. Reynolds’ advertising claims of a “reduced risk” cigarette were deceptive and misleading, in violation of Vermont’s Consumer Fraud Act and the Master Settlement Agreement. On June 3, 2013, the Court issued a final judgment that requires R.J. Reynolds to pay the State of Vermont $8,328,000 in penalties, and permanently prohibits the company from making "risk reduction" claims for its tobacco products without supporting studies that have been accepted by the scientific community.

Though one might argue this is a prohibition against tobacco companies and not against vaping manufacturers (who are not tobacco companies). Yet, I pity the eCig manufacturer who dares to go down that road when it really (really really) is not necessary.

 

[Jman8]

You keep talking about specifics.
Maybe you should ask the FDA for specifics.

I'm sure they will be glad to provide them.
Excuse my laughter.

Maybe I will ask the FDA.

In the meantime, I'm asking those who have bought into this information hook, line and sinker.

I really don't want to discourage you in these efforts, but if you're serious then you should not be asking us.
We are mere mortals here.

"mere mortals" ought not to treat FDA numbers like they are something that will prevent industry from surviving and likely thriving.

Well that is, unless they have actual reason to believe those numbers and can readily cite those reasons when asked.

An appeal to authority (experts) is not sufficient given how this data is allowed to manipulate discussions on open forum.

 

[DC2]

This discussion has been about studies, when they are needed, how long they take, and how much they cost.
I have sited a number of examples,

I am done for now.

 

[Jman8]

This discussion has been about studies, when they are needed, how long they take, and how much they cost.
I have sited a number of examples,

I disagree with this, but appreciate the effort.

I am done for now.

That's cool.

 

[Jman8]

I may have found someone that can help, so am prepared to drop this tangent in this thread and will gladly report back any information for anyone that may share the concern I have.

Update: the person I sought help from (and had great discussion with) ended up not helping with this tangent. They made points that from FDA's perspective this is not about science (at all) and is instead about legal politics and "cherry-picked, non-peer-reviewed, junk science."

Which is essentially what I'm getting at. The 5000 hours number is a sham / propaganda tool and needs not be referenced as if this pertains to actual scientific studies by vaping vendors/manufacturers.

If someone still believes it is not a propaganda tool, and that the 5000 hours for each application review makes sense, please feel free to PM me as I have what I consider legitimate questions in how that figure was arrived at. I stand by the notion that it is grossly inflated and presented as a scare tactic by which certain people (namely vendors) are lead to believe it is 'legitimate estimation for product review and scientific analysis.'