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

[Nate760]

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.

When you get below the upper tiers of the "public health" leadership, I think their rank-and-file are for the most part absolute true believers in the "wrong message to the children" orthodoxy. People at the Zeller/Frieden/Hamburg level know what the actual score is and they lie on purpose. So you're correct that it's a propaganda tool, but I would submit it's directed just as much at mid- and lower-level "public health" bureaucrats as it is at the general public.

 

[Kent C]

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.

I think that is better

On 'liar or idiot' - I find it usually comes down to this - for people who are stating falsehoods - either they know what they are doing (evil intent) or they are ignorant of the facts. The breakdown goes along these lines - true ideologues of anti-human philosophy know what they are doing. People who buy their propaganda, are ignorant (in the nice definitional way - lacking knowledge, uninformed - not 'stupid' as Gruber said).

 

[pamdis]

Consumer perception is required under the FSPTCA for modified risk products.

As I read the section, they must prove:

• significantly reduce harm and the risk of tobacco-related disease to individual tobacco users
• benefit the health of the population as a whole taking into account both users of tobacco products and persons who do not currently use tobacco product
• the magnitude of the overall reductions in exposure to the substance or substances which are the subject of the application is substantial, such substance or substances are harmful, and the product as actually used exposes consumers to the specified reduced level of the substance or substances;
• the product as actually used by consumers will not expose them to higher levels of other harmful substances compared to the similar types of tobacco products then on the market unless such increases are minimal and the reasonably likely overall impact of use of the product remains a substantial and measurable reduction in overall morbidity and mortality among individual tobacco users

The labeling

• is limited to an explicit or implicit representation that such tobacco product or its smoke does not contain or is free of a substance or contains a reduced level of a substance, or presents a reduced exposure to a substance in tobacco smoke
• testing of actual consumer perception shows that, as the applicant proposes to label and market the product, consumers will not be misled into believing that the product—(I) is or has been demonstrated to be less harmful; or (II) presents or has been demonstrated to present less of a risk of disease than 1 or more other commercially marketed tobacco products;

So it sounds to me like if you have a modified risk product, you can only state things like "contains less xxx", but if this statement leads consumers and non-consumers of the product to think it is less harmful then you will not be approved.

You must prove it is less harmful, but you can not tell the public, or even let them think it.

But I could be wrong, as I'm not into interpreting legal language. The statement 'consumers will not be misled into believing' seems ambiguous. How can they be misled into believing the things that have to be proven for approval?

And perception must be followed up post market too:
An order under this paragraph shall be conditioned on the applicant’s agreement to conduct postmarket surveillance and studies and to submit to the Secretary the results of such surveillance and studies to determine the impact of the order on consumer perception, behavior, and health and to enable the Secretary to review the accuracy of the determinations upon which the order was based in accordance with a protocol approved by the Secretary.

 

[Kent C]

When you get below the upper tiers of the "public health" leadership, I think their rank-and-file are for the most part absolute true believers in the "wrong message to the children" orthodoxy. People at the Zeller/Frieden/Hamburg level know what the actual score is and they lie on purpose. So you're correct that it's a propaganda tool, but I would submit it's directed just as much at mid- and lower-level "public health" bureaucrats as it is at the general public.

Yes. See my 'breakdown' to DC2.... ideologues vs. others - sometimes it's hard to tell who's who until you engage them Basically it's the difference between those who write "Media Matters" and those who read Media Matters, or writers of say the "National Review" and most readers. Not all in both cases.

 

[Nate760]

Consumer perception is required under the FSPTCA for modified risk products.

As I read the section, they must prove:

• significantly reduce harm and the risk of tobacco-related disease to individual tobacco users
• benefit the health of the population as a whole taking into account both users of tobacco products and persons who do not currently use tobacco product
• the magnitude of the overall reductions in exposure to the substance or substances which are the subject of the application is substantial, such substance or substances are harmful, and the product as actually used exposes consumers to the specified reduced level of the substance or substances;
• the product as actually used by consumers will not expose them to higher levels of other harmful substances compared to the similar types of tobacco products then on the market unless such increases are minimal and the reasonably likely overall impact of use of the product remains a substantial and measurable reduction in overall morbidity and mortality among individual tobacco users

The labeling

• is limited to an explicit or implicit representation that such tobacco product or its smoke does not contain or is free of a substance or contains a reduced level of a substance, or presents a reduced exposure to a substance in tobacco smoke
• testing of actual consumer perception shows that, as the applicant proposes to label and market the product, consumers will not be misled into believing that the product—(I) is or has been demonstrated to be less harmful; or (II) presents or has been demonstrated to present less of a risk of disease than 1 or more other commercially marketed tobacco products;

There are so many internal contradictions here I would scarcely even know where to begin in enumerating them.

 

[DC2]

When you get below the upper tiers of the "public health" leadership, I think their rank-and-file are for the most part absolute true believers in the "wrong message to the children" orthodoxy. People at the Zeller/Frieden/Hamburg level know what the actual score is and they lie on purpose. So you're correct that it's a propaganda tool, but I would submit it's directed just as much at mid- and lower-level "public health" bureaucrats as it is at the general public.

Bingo.

............

 

[DC2]

The statement 'consumers will not be misled into believing' seems ambiguous. How can they be misled into believing the things that have to be proven for approval?

That is exactly where the rubber meets the road.
And why this seems a bit of a sham to me.

 

[Kent C]

Consumer perception is required under the FSPTCA for modified risk products.

As I read the section, they must prove:

• significantly reduce harm and the risk of tobacco-related disease to individual tobacco users
• benefit the health of the population as a whole taking into account both users of tobacco products and persons who do not currently use tobacco product
• the magnitude of the overall reductions in exposure to the substance or substances which are the subject of the application is substantial, such substance or substances are harmful, and the product as actually used exposes consumers to the specified reduced level of the substance or substances;
• the product as actually used by consumers will not expose them to higher levels of other harmful substances compared to the similar types of tobacco products then on the market unless such increases are minimal and the reasonably likely overall impact of use of the product remains a substantial and measurable reduction in overall morbidity and mortality among individual tobacco users

.....
So it sounds to me like if you have a modified risk product, you can only state things like "contains less xxx", but if this statement leads consumers and non-consumers of the product to think it is less harmful then you will not be approved.

You must prove it is less harmful, but you can not tell the public, or even let them think it.

But I could be wrong, as I'm not into interpreting legal language. The statement 'consumers will not be misled into believing' seems ambiguous. How can they be misled into believing the things that have to be proven for approval?

And perception must be followed up post market too:

An order under this paragraph shall be conditioned on the applicant’s agreement to conduct postmarket surveillance and studies and to submit to the Secretary the results of such surveillance and studies to determine the impact of the order on consumer perception, behavior, and health and to enable the Secretary to review the accuracy of the determinations upon which the order was based in accordance with a protocol approved by the Secretary.

This list above fits into the 'greater good' argument and the specifics are likely the reason for all the talk about nano-particles, etc. They have to 'prove' it.

Your summations are right on point.

 

[Nate760]

This list above fits into the 'greater good' argument and the specifics is likely the reason for all the talk about nano-particles, etc. They have to 'prove' it.

I'm also struck by the fact that "public perception" is one of the tests that must be satisfied, but no effort is made to define or quantify the term. Is there a certain percentage of "the public" that has to perceive the product in a certain way? How big a sample group do you use in determining what the perception is? How do you select the sample group? Who does the testing? Who determines the methodology of the testing? I could go on for quite a while, but you get the point.

It seems like a classic example of the practice of using a sufficient number of ambiguous/undefined terms in the language of a statute that the meaning ultimately winds up being "whatever we want it to mean."

 

[Kent C]

I'm also struck by the fact that "public perception" is one of the tests that must be satisfied, but no effort is made to define or quantify the term. Is there a certain percentage of "the public" that has to perceive the product in a certain way? How big a sample group do you use in determining what the perception is? How do you select the sample group? Who does the testing? Who determines the methodology of the testing? I could go on for quite a while, but you get the point.

It seems like a classic example of the practice of using a sufficient number of ambiguous/undefined terms in the language of a statute that the meaning ultimately winds up being "whatever we want it to mean."

I do get the point .... the 'wide stroke' was used - 'put out the most damaging lies and misinformation that you can - include poisoning and nano-particles - something to do with cancer and make it seem that ecigs are not only not safer but perhaps even worse the cigarettes and you've done your job for 'public perception' well.'

 

[Nate760]

I do get the point .... the 'wide stroke' was used - 'put out the most damaging lies and misinformation that you can - include poisoning and nano-particles - something to do with cancer and make it seem that ecigs are not only not safer but perhaps even worse the cigarettes and you've done your job for 'public perception' well.'

Of course, the most widespread perception this is likely to create (and which these buffoons have been creating for the last 28 years, blissfully unaware all the while) is "Well, I guess I'll just keep smoking cigarettes."

 

[NorthOfAtlanta]

I'm assuming that Modified Risk Tobacco Product has to be on the label somewhere and yet this

testing of actual consumer perception shows that, as the applicant proposes to label and market the product, consumers will not be misled into believing that the product—(I) is or has been demonstrated to be less harmful; or (II) presents or has been demonstrated to present less of a risk of disease than 1 or more other commercially marketed tobacco products;

says you can't inform anyone that it is one.

I mean isn't a MRTP by definition less harmful.

Don't you just love circular logic and bureaucratic BS.

 

[Nate760]

Don't you just love circular logic and bureaucratic BS.

If the intent of the wording was ensure that no MRTP product application can ever be approved (which I tend to suspect it was), then they did quite a brilliant job.

 

[Kent C]

Of course, the most widespread perception this is likely to create (and which these buffoons have been creating for the last 28 years, blissfully unaware all the while) is "Well, I guess I'll just keep smoking cigarettes."

And they back it up with regulations that if enacted as is, will almost assure it.

 

[Whitewolf2014]

And they back it up with regulations that if enacted as is, will almost assure it.

Sounds like decades of planning and getting all their ducks in a row have finally paid off..

 

[Kent C]

Sounds like decades of planning and getting all their ducks in a row have finally paid off..

History we are doomed to repeat??

wiki: During the Progressive Era (1890–1920), hostility toward saloons and their political influence became widespread, with the Anti-Saloon League superseding the Prohibition Party and the Woman's Christian Temperance Union as the most influential advocate of prohibition....

Same basic coalition

 

[Nate760]

Same basic coalition

And the same basic mentality: "If everyone is forced to live the same way I do, the world will be perfect."

 

[Krashman Von Stinkputin]

FDA Translator:

Should we do a study that will prove that children (Oh and the rest of you) will be more likely to try nicotine if they are fooled into thinking there are "safer" products....
Inevitably leading them to start smoking cigarettes..
Which proves that MRTPs don't exist and even if they do are nothing but gateway products

 

[pamdis]

UCSF has submitted several comments on the Sweedish Match MRTP application. Lots of perception arguments in these.

Summary of UCSF public comments to FDA on Swedish Match MRTP application | Center for Tobacco Control Research and Education

In brief, we found that the proposed warning label (“WARNING: No tobacco product is safe, but this product presents substantially lower risks to health than cigarettes”):

significantly lowered perceptions of harm of snus among exclusive smokers
significantly increased positive attitudes towards moist snuff among dual snuff/cigarette users
significantly lowered perceptions of harm of moist snuff among non-users of tobacco

These results demonstrate that while the modified label might benefit current exclusive smokers, the effects might not be beneficial for dual users (by promoting continued dual use) and would not be beneficial to non-users of tobacco (by encouraging them to start using snus).

any reduced-risk claim that obtains an MRTP order should be permitted to be delivered only to the users of the higher-risk tobacco products (the only persons who could possibly benefit from using the reduced-risk product) and be required to be delivered in such a way as to minimize any exposure to the reduced risk claim among youth or adult non-tobacco-using populations (who might be prompted to start using) or even among current users of the reduced-risk product (who might be prompted to keep using instead of quitting) is minimized.

Putting aside the fundamental question as to whether the MRTP process can be used to request changes to the use or content of government warning labels, the text changes to the warning label requested by Swedish Match would be only on the alleged reduced-risk products, meaning that the primary audience receiving the proposed reduce-risk text would be those already using the product (who would likely respond to the message by being less likely to try to quit or reduce consumption) and the claim would not be effectively delivered directly to smokers (those who would be the most likely to benefit from switching to the reduced-risk product).

In addition, to ensure that future MRTP applications do not suffer from this problem, FDA should issue a Guidance making these points.

In brief, the warnings will work in giving consumers the truth, but only exclusive smokers should be allowed to receive it. So, we should start putting this information about snus on cigarette packages? Or better yet, have two cigarette packages - one with the snus message for those that don't already use snus, and one without the snus message for those that already do. And it will be the sales clerk's job, after verifying age, to determine which package the smoker receives.

 

[Kent C]

In brief, the warnings will work in giving consumers the truth, but only exclusive smokers should be allowed to receive it. So, we should start putting this information about snus on cigarette packages? Or better yet, have two cigarette packages - one with the snus message for those that don't already use snus, and one without the snus message for those that already do. And it will be the sales clerk's job, after verifying age, to determine which package the smoker receives.

Another dumping of gov't regs on business - like the withholding tax - then making them responsible for the insanity.

And if the sale's clerk determines wrongly.. what? they will have to 'exit' the business?

Imagine the small mind that thinks that such 'micromanagement' would have any success... but this is the way these people think.