FDA NEW: "...Experimental Studies on Consumer Perceptions of Modified Risk Tobacco Products"

[SeniorBoy]

Published today in the Federal Register: 11/19/14

Title: Agency Information Collection Activities; Proposals, Submissions, and Approvals: Experimental Studies on Consumer Perceptions of Modified Risk tobacco Products

Comments Topics Extract:

"With respect to the following collection of information, FDA invites comments on these topics: (1) Whether the proposed collection of information is necessary for the proper performance of FDA's functions, including whether the information will have practical utility; (2) the accuracy of FDA's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques, when appropriate, and other forms of information technology."

SEE: Regulations.gov

 

[bigdancehawk]

We're sorry, but we could not load document FDA_FRDOC_0001-5262

 

[NorthOfAtlanta]

We're sorry, but we could not load document FDA_FRDOC_0001-5262

That's interesting, wonder what they are changing? If they put it back up I'll compare it to the PDF I downloaded yesterday.

 

[readeuler]

Read: we've "done" our homework, would you please check our answers?

Interesting.

 

[AndriaD]

We're sorry, but we could not load document FDA_FRDOC_0001-5262

Yeah I got the document load error too.

Andria

 

[Kent C]

Federal Register, Volume 79 Issue 223 (Wednesday, November 19, 2014)

 

[SeniorBoy]

Hmmmmmmmmmmmmmmmmmm.... Strange?

This should work and I just tested it:

Regulations.gov

and Details at:

http://www.regulations.gov/#!documentDetail;D=FDA-2014-N-1855-0001

 

[AndriaD]

Ok, I finally got the document to load... but I'm puzzled as to what, if anything, I'm supposed to do with it? When we did the FDA comments earlier in the year, there were clear instructions at CASAA's site about how to comment -- what kinds of things were important to say, and the actual technical means of submitting it so that the FDA found it acceptable. This page, even the details page, is so much governmentese, I can't figure out much about it.

If we're supposed to do something with this, instructions are necessary. I don't speak government.

Andria

 

[DrMA]

Since there's no such thing as MRTP according to FDA, I don't understand how they intend to pursue this study... OTT, it looks like it's another underhanded attempt to manufacture data that shows tobacco products claiming to be lower risk (without FDA approval) serve as a "gateway" to smoking for children 0-18 yo. All of this on taxpayer money.

 

[Nate760]

it looks like it's another underhanded attempt to manufacture data that shows tobacco products claiming to be lower risk (without FDA approval) serve as a "gateway" to smoking for children 0-18 yo.

If they abandon (or even de-emphasize) the "gateway" fantasy, they really don't have anything left, except to admit that the last 28 years of US government tobacco policy has been built on a foundation of lies and deceit.

 

[Oliver]

My first thought is - about time some primary research is done on the communication of risk.

My concern is that experimental studies are just one part of understanding this, and that the results will almost certainly be used out of context to "demonstrate" all sorts of inappropriate things.

 

[csardaz]

Results - We currently have Deadly versus 'not a safe replacement'. Can we say 'safer' at all without people assuming 'nearly safe'? Are their synonyms for 'safer' that don't include the word 'safe'? If we have e-cigs, Snus, smokeless, Baked, Pipes and Cigars, Cigarettes - and we have to communicate the risks of Snus and Baked because they earn MRTP - can we do it without also revealing that whole continuum? Can we keep making companies go thru $50Mill of hoop-jumping for the MRTP certification without actually revealing how much risks are reduced? Can we reveal the reduced risk without also giving a free ride to other less-risky products that haven't jumped thru the hoops?

We're so incompetant that we assumed lower-nicotine light cigs wouldn't mean people inhaling more tar to get their desired Nic levels. Such nincompoops that some air holes in the sides of filters fooled us. How many times can we say 'we were fooled' before people attach 'fool' to us? Is there some way to keep the gravy train rolling till the beach house is paid off?

 

[Nate760]

Can we say 'safer' at all without people assuming 'nearly safe'?

The government has done such a great job of conflating "safer" with "safe" (see smokeless tobacco warning labels) that this has become entirely more difficult than it should be.

Are their synonyms for 'safer' that don't include the word 'safe'?

"Reduced risk" is probably the best one, but it's a non-starter as far as the government is concerned, because it's contrary to their ironclad mandate that all tobacco/nicotine products have to be portrayed as being just as hazardous as cigarettes, and any descriptor that implies otherwise is strictly verboten. "Modified risk" has gained some popularity recently, but I'm not really a fan of it, as I think it's too ambiguous.

 

[DC2]

Assuming, of course, that they do some day allow a Modified Risk Tobacco Product to be approved...
Why the hell would they care what the consumer perception of such a product would be?

It almost sounds like an assumption that if they grudgingly admit such a thing exists, they are concerned that consumers might learn something.

Or if you put on your happy glasses...
Maybe they just want to understand how best to communicate to consumers about such a wonderful new harm reduction option?

But if that were the case, wouldn't they instead be asking how to best communicate this great news to the consumer?
That seems a more appropriate question to be asking if one really believes in harm reduction.

 

[Kent C]

That seems a more appropriate question to be asking if one really believes in harm reduction.

They say they do - in certain cases - iow, they can't find any reasonable way to reject the fact that many have reduced harm to the themselves by quitting or reducing cigarettes. HOWEVER, they don't 'believe' it to be good for the 'net population'... soooo.... the harm reduction that exists for some, doesn't result in a harm reduction (greatest good) for all (greatest number).

 

[DC2]

They say they do - in certain cases - iow, they can't find any reasonable way to reject the fact that many have reduced harm to the themselves by quitting or reducing cigarettes. HOWEVER, they don't 'believe' it to be good for the 'net population'... soooo.... the harm reduction that exists for some, doesn't result in a harm reduction (greatest good) for all (greatest number).

Yeah, you're right.

And that's a valid reason why they would be asking what consumer perception might be.
In other words, if they tell consumers that it's safer, will more people start using it who never smoked.

But I guess this mindset requires buying into the idea that it is bad if anyone starts using MRTP if they never used tobacco products before.
Which of course requires having a deep-seated belief that all tobacco products are bad, even if the risk is shown to be negligible.

 

[Nate760]

There's only one reason (and it's a very stupid one) why government/tobacco control/"public health" refuse to countenance any form of THR. It's that whole thing about "we can't send the wrong message to the children." In the moral absolutist fantasy world they inhabit, if you honestly tell people that any tobacco product is less hazardous than cigarettes, the result will be that every child in the country will rush out to start using it because they think it's 100% safe.

 

[Kent C]

Yeah, you're right.

And that's a valid reason why they would be asking what consumer perception might be.
In other words, if they tell consumers that it's safer, will more people start using it who never smoked.

But I guess this mindset requires buying into the idea that it is bad if anyone starts using MRTP if they never used tobacco products before.
Which of course requires having a deep-seated belief that all tobacco products are bad, even if the risk is shown to be negligible.

Two things - if there was any 'saving grace' from the Summit - the fact that your point made by many with specific nods to Clive and Dr. F - that they (ANTZ) at least SHOULD be telling people it's safer but they're not!

And the second point, imo, it is because they are NOT saying it is safer and in fact, in some cases saying it may be less safe - may be the reason for their perceived 'gateway effect' for kids ... (the it's bad, so therefore we should do it syndrome ...something that someone at the Summit also mentioned - forget who it was now - but not West or Arnott (as close to a true ANTZ one could get without being one, btw).

 

[Kent C]

There's only one reason (and it's a very stupid one) why government/tobacco control/"public health" refuse to countenance any form of THR. It's that whole thing about "we can't send the wrong message to the children." In the moral absolutist fantasy world they inhabit, if you honestly tell people that any tobacco product is less hazardous than cigarettes, the result will be that every child in the country will rush out to start using it because they think it's 100% safe.

It's not the only reason and imo, not the primary one. The primary one is told as well as possible by Zeller in the HELP committee and it is the greater good argument. The children shield ploy is more of a propaganda tool to fulfill the primary goal, not the real goal. They acknowledge THR for hard core smokers with a grimace, but the 'collective' is more important. The grimace helps sell the greatest good, while acknowledging that THR is 'a' good - just not 'the' greatest good.

 

[DC2]

But I guess this mindset requires buying into the idea that it is bad if anyone starts using MRTP if they never used tobacco products before.
Which of course requires having a deep-seated belief that all tobacco products are bad, even if the risk is shown to be negligible.

I suppose I should add the following to my post above...

It does not necessarily require a deep-seated belief that all tobacco products are bad.
It could also be a tactic to trick the public into continuing to buy into their agenda.

I guess it just depends on if the person saying it is a liar, or an idiot.