FDA panel: Dissolvable tobacco could reduce risks

[Bill Godshall]

FDA panel: Dissolvable tobacco could reduce risks (this is a huge victory for tobacco harm reduction and public health)
http://www.boston.com/lifestyle/health/articles/2012/03/22/fda_panel_dissolvable_tobacco_could_reduce_risks/ http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/TobaccoProductsScientificAdvisoryCommittee/UCM295842.pdf
http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/TobaccoProductsScientificAdvisoryCommittee/UCM295994.pdf

 

[Bill Godshall]

This TPSAC report on dissolvables and the title of the AP news article are extremely important advances for tobacco harm reduction and public health. Its the first time a federal health agency has issued anything truthfully claiming that smokeless tobacco products are far less hazardous alternatives to cigarettes.

All smokeless tobacco products and e-cigarettes should be primary beneficiaries of this report, as it will be very difficult for the FDA or other governement health agencies to claim that e-cigarettes are not safe alternatives to cigarettes.

And since there is no evidence that dissolvable tobacco products cause mouth cancer, gum disease or tooth loss, the FDA should propose removing those inaccurate warning labels that are currently required on all dissolvable tobacco products and advertisements, and all other smokeless tobacco products.

The FDA should also remove the intentionally deceptive mandatory warning on dissolvables and other smokeless tobacco products that states "This product is not a safe alternative to cigarettes," which has misled most Americans to inaccurately believe that smokeless tobacco products are just as hazardous as cigarettes.

If federal, state and local health agencies simply and truthfully informed cigarette smokers (and the public) that smokefree tobacco/nicotine products are far less hazardous alternatives to cigarettes, cigarette consumption in the US could decline two or three times more rapidly than it's been declining during recent.

 

[wfx]

great news. thank you.

 

[Stubby]

After making a number of positive remarks about dissolvables they come to some amazingly non-committle conclusions.

Needs more study and close observation seems to be the call.

But overall, after watching the FDA hearings, it is much better then expected.

With regard to benefit, the TPSAC concludes that exclusive use of DTPs by an individual would greatly reduce risk for smoking caused disease compared with regular use of cigarettes. The TPSAC framework indicates several ways that DTPs could reduce the population disease burden caused by tobacco use: 1) decreasing the number of smokers, if availability of DTPs increases successful cessation or decreases the likelihood of initiation and use of smoked products, and 2) decreasing the risk of tobacco caused disease, if availability of DTPs sufficiently reduces cigarette smoking.

The TPSAC framework indicates how DTPs could increase the population disease burden caused by tobacco use: increasing the number of smokers, if availability of DTPs decreases successful cessation or increases the likelihood of initiation and use of smoked products.

Of course you could greatly reduce the amount of people who take up smoking, or continue to smoke, by simple telling the truth about the relative harm of different tobacco products. I have enough faith in people to trust that if told the truth they will make good decisions for themselves. Whether or not tobacco use in general goes up or not is essentially irrelevant. As long as smoking rates go down public health will increase for the better.

 

[Vocalek]

Well, let's see. They require the misleading warning labels on smokeless products, in the belief that if smokers think about switching and see those labels, they will suddenly decide to quit using tobacco altogether. Uh-huh. How's that been working out?

Next, they study a group of military recruits, many of whom began using smokeless tobacco in boot camp. When they followed up later on, they discovered that quite a few had switched to smoking. They point to this as proof that smokeless tobacco is a "gateway to smoking." It never occurred to these geniuses that these young men might have taken the warning labels literally, and seeing no warning labels for mouth cancer on cigarette packs, decided that it would reduce their risks if they switched to smoking.

The irony: The relative risk (RR) for mouth cancer ranges from 0.7 to 1.1 for users of moist snuff and chewing tobacco, when compared with the risks for non-users of tobacco. Since a value of 1 represents the risk for non-users, and any value less than 2 is not considered significant, we see that there is no excess risk for mouth cancer with these products. Dry snuff has a higher RR, at 4. But what the government doesn't tell you is that the RR for smoking is 10.

To quote Agent Moulder:

The truth is out there!

You just won't find it on tobacco product packages.

 

[Vocalek]

Just published a story on All Voices: Victory for Tobacco Harm Reduction

 

[Bill Godshall]

Richard Craver wrote an excellent article in the Winston-Salem Journal on the TPSAC report (Reynolds' headquarters is in Winston-Salem).

Report: dissolvable tobacco products safer
Report: Dissolvable tobacco products safer | JournalNow.com

 

[Hummingbird]

Well, let's see. They require the misleading warning labels on smokeless products, in the belief that if smokers think about switching and see those labels, they will suddenly decide to quit using tobacco altogether. Uh-huh. How's that been working out?

Next, they study a group of military recruits, many of whom began using smokeless tobacco in boot camp. When they followed up later on, they discovered that quite a few had switched to smoking. They point to this as proof that smokeless tobacco is a "gateway to smoking." It never occurred to these geniuses that these young men might have taken the warning labels literally, and seeing no warning labels for mouth cancer on cigarette packs, decided that it would reduce their risks if they switched to smoking.

The irony: The relative risk (RR) for mouth cancer ranges from 0.7 to 1.1 for users of moist snuff and chewing tobacco, when compared with the risks for non-users of tobacco. Since a value of 1 represents the risk for non-users, and any value less than 2 is not considered significant, we see that there is no excess risk for mouth cancer with these products. Dry snuff has a higher RR, at 4. But what the government doesn't tell you is that the RR for smoking is 10.

To quote Agent Moulder:

The truth is out there!

You just won't find it on tobacco product packages.

Hi Vocalek, To my knowledge recruits can't smoke in boot camp. Smokeless tobacco is an alternative during this time. They more than likely went back to smoking analogs after boot camp. Just a thought! Thank you for all the work you all do!

 

[Jim Bob]

Thanks for posting and for all the work you do and anyone else who is in the trenches for us all!

 

[Vocalek]

Hi Vocalek, To my knowledge recruits can't smoke in boot camp. Smokeless tobacco is an alternative during this time. They more than likely went back to smoking analogs after boot camp. Just a thought! Thank you for all the work you all do!

And might they have stuck with smokeless if the warning label said: "Users of this product have no increased risk of cancer," instead of "This product may cause mouth cancer"?

Or how about something like this: "Unlike smoking, this product does not increase risks of heart attacks" or "Unlike smoking, this product does not cause lung disease" or "Unlike smoking, this product does not cause gum disease or tooth loss."

All of the above are true statements.

 

[Lydia]

Hi Vocalek, To my knowledge recruits can't smoke in boot camp. Smokeless tobacco is an alternative during this time. They more than likely went back to smoking analogs after boot camp. Just a thought! Thank you for all the work you all do!

Hummingbrd, when this is truth, the study of a group of military recruits is an example of junk science and can’t be used for claiming as a proof of the “gateway to smoking-theory”…it's just a deception if they do.

 

[rothenbj]

Hi Vocalek, To my knowledge recruits can't smoke in boot camp. Smokeless tobacco is an alternative during this time. They more than likely went back to smoking analogs after boot camp. Just a thought! Thank you for all the work you all do!

That's the NEW Army, not the one I got pulled into. Back in the 70's it was "Smoke 'em if you got 'em".

Elaine, as to British nasal snuff, there's snuffin like it!

 

[Hummingbird]

And might they have stuck with smokeless if the warning label said: "Users of this product have no increased risk of cancer," instead of "This product may cause mouth cancer"?

Or how about something like this: "Unlike smoking, this product does not increase risks of heart attacks" or "Unlike smoking, this product does not cause lung disease" or "Unlike smoking, this product does not cause gum disease or tooth loss."

All of the above are true statements.

I agree with you 100%. Guess I didn't do a very good job with my point. They report half truths and spin stories to their benefit, as well as using junk science. Maybe these recruits smoked before boot camp and used smokeless tobacco during boot camp. Then reverted back to smoking after their training. Leaving out of the report that they were smokers to begin with. Thus trying to prove their point. If you can't smoke you might use smokeless tobacco for that period of time. I am well aware of the health risks you stated, the mislabeling of tobacco products and junk science. Guess I read into this too much. Again, thank you for all you do!

 

[sailorman]

They're still holding that line that in order for these ST products to benefit public health is if their use results in cessation. That was the common theme throughout the TPSAC meetings. They will not acknowledge any benefit in these products in a dual use scenario. They're still stuck in their quit-or-die mode.

That philosophy is why they'll never take the "not a safe alternative" warning off these products. The only safe alternative to smoking they acknowledge is not smoking.

 

[rothenbj]

The only safe alternative to smoking they acknowledge is tobacco/nicotine abstinence. Well, that is until the FDA modified risk products are approved for long term use- gum, patches, lozenges provided to you by their favorite clients.

 

[Bill Godshall]

Here are two sound viewpoints about TPSAC's report on dissolvables.

ACSH: They melt in your mouth
They melt in your mouth... > Facts & Fears > ACSH

Jeff Stier - FDA Scientific Panel: Dissolvable Tobacco Could Reduce Disease
FDA Science Panel: Dissolvable Tobacco Could Reduce Disease - Amy Ridenour's National Center Blog - A Conservative Blog


Then there's CTFK's press release at
FDA Advisory Committee Report Raises Concern Dissolvable Tobacco Products Could Increase Overall Tob - Campaign for Tobacco Free Kids
that misrepresents TPSAC's dissolvables report and health risks/benefits of the products, and still refuses to admit that:
- dissolvables and other smokefree tobacco products are far less hazardous alternatives to cigarettes,
- the health of smokers improve every time a smokefree alternative is used instead of a cigarette,
- switching to smokefree alternatives reduces disease risks nearly as much as quitting all tobacco use, and
- several million smokers in the US have already quit smoking by switching to smokefree alternatives.

 

[Vocalek]

There was a link in Jeff Stier's article that led to this good article, that he co-authored with Henry I. Miller.

The Cigarette Smokescreen | Hoover Institution

 

[teissenb]

Neither FDA nor TPSAC can alter smokeless tobacco labeling, which is mandated by congress (see below, excerpted from FSPTCA). If you want changes in the labeling, railing at FDA or TPSAC serves no useful purpose. A constructive approach might be to lobby congress.


‘SEC. 3. SMOKELESS TOBACCO WARNING.

‘(a) General Rule-

‘(1) It shall be unlawful for any person to manufacture, package, sell, offer to sell, distribute, or import for sale or distribution within the United States any smokeless tobacco product unless the product package bears, in accordance with the requirements of this Act, one of the following labels:

‘WARNING: This product can cause mouth cancer.

‘WARNING: This product can cause gum disease and tooth loss.

‘WARNING: This product is not a safe alternative to cigarettes.

‘WARNING: Smokeless tobacco is addictive.

 

[Vocalek]

But fortunately Section 205 of the law gives the FDA the authority to “adjust the format, type size, and text of any of the label requirements.”

The FDA should make sure that any labels they require are scientifically accurate. Congress may have been given bad information which they used to author the law, but it's FDA's job to get the science right.