Tobacco Harm Reduction Advocates and CASAA confront FDA and its TPSAC about risks of different tobacco/nicotine products

[Bill Godshall]

Last Thursday, more than a dozen tobacco harm reduction advocates (including many CASAA members) presented during the public comment period of the FDA's TPSAC meeting on dissolvable tobacco products in Rockville, MD.

More than a half dozen CASAA members told FDA and its TPSAC that they quit smoking by switching to e-cigarettes and/or other smokefree alternatives, while I and other harm reduction advocates urged the FDA and its TPSAC to truthfully inform the public that dissolvables and other smokefree tobacco products are far less hazardoud alternatives for cigarette smokers (in TPSAC's forthcoming report).

The public comment period begins at 5:20 (i.e. 5 hours, 20 minutes into the meeting) of the archived video at
https://collaboration.fda.gov/p49817128/

I suggest that all e-cigarette and tobacco harm reduction advocates watch/listen to these public comments, and to the Q & A by FDA and TPSAC members.

The three day TPSAC meeting can be seen/heard at:
January 18: [URL]https://collaboration.fda.gov/p24943709/[/URL]
January 19: https://collaboration.fda.gov/p49817128/
January 20: https://collaboration.fda.gov/p36812959/

 

[TennDave]

I skipped around but listened to the crux of all 3 days of the committee hearings.
It is interesting to me that they really make no conclusions to pass on to the FDA (at this point) but the members do seem convinced that switching to smokeless alternatives is much less dangerous than staying with combustible tobacco. That said, they also seem convinced that most people who use smokeless tobacco products also continue to also smoke to some degree and they conclude that this is potentially just as harmful as smoking. One thing I continued to hear was that "More Surveillance" of those using smokeless products is needed (big brother?). They are also convinced that smokeless products can be the gateway to smoking for youth and on the final day, a youth group who researched dissolvables and their appeal to youth showed their data (of over 8000 surveyed) concerning how many saw these things as candy, mints or gum and would be willing to try them (smokers and non-smokers alike)- and the figures were in the percentage range of 20's-high 30's. This was disconcerting but it is difficult to know how valid their data was. Another point that was made was that a whole lot depended on the product itself and how they are being marketed including packaging, flavors, etc. It will be interesting to see what comes out of this committee. More discussion on March 1st and 2nd, with final recommendations to the FDA by March 23rd.

 

[Penner]

Unfortunately, these are all using a flash player, which I cant use on an ipad. the govt needs to not use flash, its out-moded & old technology. Theres plenty of newer video modes that work, that cost nothing.

 

[Placebo Effect]

Unfortunately, these are all using a flash player, which I cant use on an ipad. the govt needs to not use flash, its out-moded & old technology. Theres plenty of newer video modes that work, that cost nothing.

Here's Jeff Stier's excellent presentation



Jeff's tech guy told me how he clipped video from the FDA presentation. We'll try and get the whole public comment session (and maybe the entire meeting, but that's probably too much work) up on YouTube soon.

 

[Penner]

Thank you, this format is what I was looking for. I only wish the video was on minimizing risk for current smokers (or ecig users). This video is on the hypothetical issue of current & future (as yet as unborn) children using nicotine products.

I think the most post haste issue (re: Tobacco Harm Reduction) that should be addressed, is that: are these various modalities (ecigs, snus, nic lozenges etc), a reasonable way to reduce harm for current smokers, or current users of these things.

Lets save lives now, not be "blue skying" about as yet unborn children, or children that haven't started smoking yet.

My 2 cents.

 

[ByStander1]

Here's Jeff Stier's excellent presentation

Question: Where is the "scientific data" the one panelists (male) asks regarding children going from smokeless use to cigarettes? I am unaware of any such evidence; but would like to be made aware if there is any such critter?

Thanks! (as always!)

 

[Bill Godshall]

ByStander1 wrote

Where is the "scientific data" the one panelists (male) asks regarding children going from smokeless use to cigarettes?

That man was Tim McAfee, who used to run Free and Clear (that promoted only drug industry products for cessation) and who recently went to CDC. Tim is clueless about tobacco harm reduction, and he appears to truly believe (from his comments and questions during the TPSAC meeting) abstinence-only anti-tobacco propaganda is scientific evidence. The data McAffee referred to (when claiming that smokeless tobacco is a gateway to cigarette smoking) was probably a 15 year old junk science article by Scott Tomar who cherry picked selective data (which is Tomar's trademark, just as he did during his presentation to TPSAC on Wednesday morning) to demonize and scare people about smokeless tobacco.

Tomar's 15 year old claim that smokeless is a gateway to cigarettes has been debunked by many more recent, more comprehensive, and far more objective studies, several of which I cited in the written comments I sent to TPSAC (which they didn't even read). See the section titled "Smokeless tobacco is not a gateway to cigarette smoking"
http://www.e-cigarette-forum.com/forum/legislation-news/251011-next-fda-tpsac-meeting-3.html

TennDave wrote

on the final day, a youth group who researched dissolvables and their appeal to youth showed their data (of over 8000 surveyed) concerning how many saw these things as candy, mints or gum and would be willing to try them (smokers and non-smokers alike)- and the figures were in the percentage range of 20's-high 30's. This was disconcerting but it is difficult to know how valid their data was.

That was the unscientific push-poll that I also exposed and criticized in my written comments. The FDA was fully aware this was a junk science push-poll (and it was also discussed at July's TPSAC meeting), but they invited that YStreet group to present it anywhow, demonstrating that the FDA wants to promote anti-tobacco propaganda disguised as scientific evidence. Elaine and I also addressed this issue in our oral comments on Thursday.

On Friday, CTFK issued a press release about YStreet's bogus dog and pony show, and falsely claimed dissolvables appeal to youth
htttp://www.tobaccofreekids.org/tobacco_unfiltered/post/2012_01_20_yaya/?utm_source=alert&utm_medium=email&utm_campaign=tobacco_unfiltered

Two years ago, the YStreet group bought dissolvable tobacco products from out-of-state, then found candy products/packages that looked nearly the same, then took pictures of the products side-by-side (carefully displayed so they looked similar), then showed several different pictures (of a dissolvable tobacco product beside a similar looking candy product) to several thousand youth (in a so-called survey), then asked the youth if the tobacco products looked like candy. That's the only reason 37% of the teens subsequently agreed that the dissolvables looked like candy, as virtually none of the teens had ever seen the dissolvable products before (as most of the dissolvables shown to the VA youth weren't even sold in Virginia, but only in test markets of Portland, Columbus and Indianapolis).

That's not science, but rather push-poll propaganda deceitfully disguised as science.

Besides, tobacco products are located separately from candy products in all retail stores, so nobody would consider dissolvable tobacco to look like candy (unless/until anti tobacco extremists show and tell them to think that).

 

[TennDave]

Bill, I agree with you but at the same time, I think that Tobacco Companies (Big Tobacco) should make marketing of their dissolvables to look much less like tic tacs, etc. This would be helpful.

On another note, how in the world would a bottle of e-juice remotely resemble anything tobacco like...
"This juice contains nicotine...." Most youth would go "yuck" and leave it alone, no matter what the flavor.
I think in regards to e-juice, we do have the upper hand until Big Tobacco starts repackaging their products in a more ethical manner. Btw, the nicotine gum that is sold by Pharma is no better than regular gum in it's little rectangular form.

 

[kristin]

Here's Jeff Stier's excellent presentation

Jeff's tech guy told me how he clipped video from the FDA presentation. We'll try and get the whole public comment session (and maybe the entire meeting, but that's probably too much work) up on YouTube soon.

Want to share that info with me and I'll work on it? Would love to at least have our testimony for CASAA's YouTube channel!

 

[kristin]

Bill, I agree with you but at the same time, I think that Tobacco Companies (Big Tobacco) should make marketing of their dissolvables to look much less like tic tacs, etc. This would be helpful.

Yet it's ok that Big Pharma makes their nicotine dissolvables look like tic tacs?

Sorry, but their argument that some of them "look like candy" (others are colored brown and in foiled bubble packages & look more like medicine) is a red herring and completely hypocritical.

This is what the Arivas looked like that I bought to sample recently (and it wasn't wasy to find them for sale.) They look white in the picture, but they are light brown and the product was difficult to remove from the package for me, let alone a child getting into them.

These look like pills/medicine, NOT candy.

 

[DC2]

I'm going to pass out some of those Nictorette lozenges next Halloween.
They look YUMMY just like candy!!

 

[Vocalek]

Be sure to let your wife know where you hid the bail money.

 

[Bill Godshall]

After 16 tobacco harm reduction advocates (including more than a half dozen CASAA members) confronted the FDA and its TPSAC with 75 minutes of scientific evidence, the truth and common sense that smokefree tobacco/nicotine alternatives are exponentially less hazardous alternatives to cigarettes, and that many smokers have quit smoking by switching to smokefree alternatives (including e-cigarettes), I'm dissappointed that there are only 545 views of this thread, and just 12 posted replies.

Everyone who desires ending the FDA's propaganda campaign to mislead/scare the public about e-cigarettes, everyone who wants to prevent the FDA from proposing/approving another e-cigarette sales ban (which the FDA repeated at least three times its intent to do so during this meeting), and everyone who wants the FDA to simply tell smokers the truth about health risks of different tobacco/nicotine products should watch these tapes of the TPSAC meeting (especially the public comment period on Thursday beginning at 5:20 of the videotape).

 

[kyaku]

... I'm dissappointed that there are only 545 views of this thread, and just 12 posted replies.

Sorry, but I have to stay out of these threads because they make me so angry ... as in blood boiling angry.

 

[Ande]

If you're not mad, you're not paying attention.

Angry is good. Channel it into productive.

Ande

 

[Vocalek]

Bill: Think of it this way. We left them speechless.

 

[Bill Godshall]

On Friday morning of TPSAC's meeting at: https://collaboration.fda.gov/p36812959/
Mark Wolfson presented a very objective and informative survey (unlike the propaganda spewed by YStreet afterwards) of college students (at more than a dozen colleges in NC and VA) that found just 1% of non tobacco users indicated a willingness to try using chewing tobacco, snuff, snus or dissolvables after they were shown pictures of chewing tobacco, snuff, snus and dissolvables that were identified as such.

In contrast, their survey found that 3% of smokers indicated a willingness to try using chewing tobacco or snuff, 7% of smokers indicated a willingness to try snus, and 13% indicated a willingness to try using a dissolvable.

Unfortunately, Wolfson failed to point out these striking findings (i.e. smokers were 7 times more interested in trying snus, and 13 times more interested in trying dissolvables than non tobacco users), and that less than 1% of non tobacco users expressed an interest in trying any smokefree toabcco product, which contradict the claims by many other presenters (i.e. that dissolvables appeal to non tobacco users and teens).

Another key finding by Wolfson's survey was that respondents believed that dissolvables were less hazardous than snus, and that snus was less hazardous than chewing tobacco and snuff.

Wolfson's survey also found that although respondents inaccurately believed that chewing tobacco and snuff posed a greater risk for mouth cancer than cigarettes, respondents didn't believe that snus and especially dissolvables posed a significant risk for mouth cancer.

These finding indicate that the 25 year campaign (by CDC, NCI, ACS, AHA, ALA, ADA, AMA) to deceive Americans (to believe that smokeless tobacco products are as hazardous as cigarettes) isn't being believed when it comes to snus and dissolvables (and of course e-cigarettes, although Wolfson's study didn't include them).

Unfortunately, Wolfson's verbal presentation to TPSAC didn't mention or downplayed these findings, and instead focussed on two other findings (i.e. that smokeless tobacco users were more likely than smokers to express an interest in trying snus and dissolvables, and that dual users of cigarettes and smokeless tobacco were the most likely to express an interest in trying dissolvables and snus).

In contrast to Wolfson's objective survey, YStreet misrepresented their push poll of VA youth as an objective scientific survey, and nobody on TPSAC challenged or question their intentionally biased research method, while many members of TPSAC congratulated YStreet for the excellent scientific inquiry and urged them to publish it.

Please note that YStreet's so-called survey showed several pictures to youth containing dissolvable tobacco products (that the youth had never seen or heard of) beside a commonly known candy product (including Tic Tacs), and then asked the youth if they believed the tobacco products looked like candy, and if they might be willing to try using them.

Of course, had the VA youths never been shown the carefully arranged pictures (of unknown dissolvable tobacco products beside well known candy products), very few if any of those youth would have responded that believed the tobacco products looked like candy.

 

[Uma]

A huge thank you to Bill, Elaine and all participants in these important issues. I read when I can, (I'm a solar baby, need full sun to read the forums off my solar panels), and I always try to get caught up. I sometimes also become overwhelmed in trying to understand the issues, or in understanding what I've just read. Please have patience with us! Carry on...

 

[Tom09]

Highly needed, outstanding presentations by the harm reduction (and e-cig) proponents in the public comment section. You probably know that you are heroes. Nonetheless, my little thank you for your dedicated, well informed engagement.

Following CDC representative’s deflection on budget, there was quite an interesting concluding remark (at 6:33:53) by - as I think this was - Lawrence Deyton (director of FDA's Center for Tobacco Products), sounding something like: “Just for clarity sake, judge Leon’s court ruling was quite clear, FDA does not have jurisdiction over e-cigarettes at this time, and so there is no attempt that FDA is trying to ban any product we don’t have any authority over.”
Appears as if this speaker took utmost care about what he was putting on public record. Not stating that FDA is not trying to ban e-cigarettes, but stating that FDA is not trying to ban a product that it does not have jurisdiction over at this time. And “no jurisdiction over at this time” is the main qualifier. What Deyton did not reveal, is that FDA is presently about to get extended authority, including jurisdiction over e-cigarettes, see Godshall’s most detailed ECF thread here. Now re-read Deyton’s concluding statement. Can’t help, but this statement certainly reminds me of "nobody intends to build a wall" (W. Ulbricht, leader of the GDR in June 1961 - 2 months before the Berlin Wall was put up).

 

[DC2]

Appears as if this speaker took utmost care about what he was putting on public record. Not stating that FDA is not trying to ban e-cigarettes, but stating that FDA is not trying to ban a product that it does not have jurisdiction over at this time. And “no jurisdiction over at this time” is the main qualifier. What Deyton did not reveal, is that FDA is presently about to get extended authority, including jurisdiction over e-cigarettes, see Godshall’s most detailed ECF thread here. Now re-read Deyton’s concluding statement. Can’t help, but this statement certainly reminds me of "nobody intends to build a wall" (W. Ulbricht, leader of the GDR in June 1961 - 2 months before the Berlin Wall was put up).

And when you consider this, keep in mind that the FDA already tried to "ban" them once.
They were stopped from doing so by a ruling from Judge Leon.

If it weren't for Judge Leon, it is quite likely there would be no vendors of electronic cigarettes in America right now.
And it is equally likely that a whole lot of you would not be here, and would still be smoking death sticks.