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

[sailorman]

I heard them working this one. The irony is that they took the fact that some research showed most smokers weren't switching as evidence that most smokers wouldn't switch, but didn't take into account that most smokers are still under the mistaken belief that smoke-free is just as dangerous as smoking (so why switch when you enjoy smoking?)



This is the one I thought could be huge for CASAA Call to Actions - especially in blocking excessive taxation that has been popping up. This supports the argument that smoke-free reduces risks associated with smoking and therefore counters the argument that smoke-free tobacco products should be taxed at the same punitive rate as cigarettes. If something is reducing "the population disease burden" then it should not be treated the same as cigarettes. Additionally, this statement suggests that, in order to be successful in reducing diseases, smoke-free needs to be available and smokers need to be encouraged to switch. This would aid in blocking all-out sales bans on smoke-free tobacco products and also argues for ending the deceptive practice of denying the public information about the reduced risks (ie. requiring manufacturers to tell smokers that smoke-free is not a safe alternative to smoking without admitting the significantly reduced risks.)

All that would be true if not for the fact that they continued to insist that smoke free tobacco products have no benefit until, and unless, they lead to the complete cessation of tobacco product use. These people do not believe in harm reduction. Any of these products have value only to the extent that they lead to cessation, and that means no tobacco and no nicotine.

When they're up against the wall, they'll concede that smokefree products are less harmful than smoking. But they'll turn right around and qualify that with fantastical theories about potential damage they do by encouraging people to continue to use tobacco and not become totally tobacco-free.

This is what we are going to be facing when they address e-cigs. They will agree that e-cigs are less harmful than cigarettes. But they will not relent until hard data proves that they are a 100% effective cessation device and we all ultimately vape 0 nic or quit vaping altogether. That is their criteria. Quit or die. They do not, and will not, accept anything that amounts to nicotine maintenance therapy. E-cigs will be expected to act as a cessation device, yet at the same time they will not be allowed to be marketed as a cessation device. This was brought up in the case of the DTPs when the Nazi member to the right of the chair smugly posed the solution of doing all the trials for DTPs to get a NDA as a cessation product.

So, there they are insisting that any tobacco product is harmful unless it's shown to be a cessation product. Yet they wouldn't agree to allow a product to be marketed as one unless it goes through the full FDA approval process.

 

[sailorman]

I wonder how he'd view someone who smoked 50 cigarettes a day before and now 4-5 snus portions and a ml of nicquid every couple days with no cigarettes for over 2 years? Probably one moment from picking up my next cigarette (if he can just figure a way to discourage use of those other products.

He would say that the minute you pick up that next cigarette you forfeit all the health benefits you got from not smoking for 2 years. That's his position. Anyone listening to him would be discouraged from even trying to quit. Cutting back to 1 cig a day isn't good enough. Might as well not even start. It was surreal to hear him speak. He recognized all the studies showing that harm is proportional to how many cigarettes you smoked. He couldn't deny them. But he kept on saying that there is no health benefit from using snus until they completely 100% replaced cigarettes.

 

[Vocalek]

He would say that the minute you pick up that next cigarette you forfeit all the health benefits you got from not smoking for 2 years. That's his position. Anyone listening to him would be discouraged from even trying to quit. Cutting back to 1 cig a day isn't good enough. Might as well not even start. It was surreal to hear him speak. He recognized all the studies showing that harm is proportional to how many cigarettes you smoked. He couldn't deny them. But he kept on saying that there is no health benefit from using snus until they completely 100% replaced cigarettes.

Someone needs to conduct surveys and then write an article: Dual Use: Stepping Stone on the Path to Smoking Cessation

My husband, who is not a vaper, pointed out that most smokers do not go from a pack a day (or more) to zero overnight. Many go though a period where they are using something else, whether that be snus, the patch, or whatever while they still smoke some (but much fewer) cigarettes. He quit smoking by using the patch. More power to him! Of course the fact that he had a suspicious growth on his larynx was a motivator to stay quit. It was cancerous, but they got it all. He's coming up on 5 years clean.

I went thorough several years of dual use, when I cut down to 10 cigarettes having substituted 5 pieces/day of nicotine gum. After I got the e-cigarette, I smoked mostly tobacco cigarettes and only used the e-cigarette occasionally. Finally, I made up my mind to stop inhaling smoke. I took off a couple of days totally from nicotine (most of which I slept through) and then started back up with the gum and the e-cigarette but no longer felt the need for the tobacco cigarettes.

 

[Vocalek]

While looking for something else, I just came across this abstract from the SRNT conference I attended this past week.

PA15-2
PRIMARY AND DUAL USERS OF CIGARS AND CIGARETTES; PROFILES,
TOBACCO USE PATTERNS, AND RELEVANCE TO POLICY
Amanda Richardson, Ph.D., M.S., Haijun Xiao, M.S., and Donna M. Vallone, Ph.D.,
M.P.H., Department of Research and Evaluation, Legacy, Washington, DC


Data indicate that 12.5% of cigarette smokers are dual-users of cigars. Dual-users are more likely to be male, 18-29 years of age, non-Hispanic black, of lower educational attainment and either unemployed or out of the work force. Adjusted regression analyses showed that dual-users were less likely than cigarette-only smokers to be daily cigarette smokers (OR=0.57, 95% CI: 0.32, 1.02), more likely to have made a recent quit attempt (OR=2.39, 95% CI: 1.44, 3.97), and more likely to have used at least one other alternative product (OR=2.26, 95% CI: 1.26, 4.05), including snus, e-cigarettes, dissolvables and chewing tobacco. As greater restrictions on cigarettes become implemented in the U.S., it will be critical to monitor increased dual-use of cigars in order to inform prevention and treatment strategies and guide more comprehensive policy efforts.

 

[TennDave]

Dual Use- such a loaded word.
The FDA and their off-spring organizations continue talk about vigilantly keeping an eye out regarding this (I forget the exact term that they use)....it certainly sounds like spying. I wonder if they check out those out-side video cameras at hospitals, etc. to see if an e-cig user takes a puff of a real cig when he is forced to use his PV around smokers? Personally, I join these people- I can learn a lot about what's REALLY going on at any establishment and I'm not tempted one iota to take a puff of a Nasty. If anything, a smoker might take a puff of my PV as they tend to become interested in what I'm doing and that I'm not smoking. I suppose the ANTZ then view this smoker as a Dual User because they took a puff off of my PV and then chalk it up to them not being able to quit... It's a crazy world we live in- And, from what I gather from different documents, users and how they are being used is being watched, even if it's a glimpse here and there....and even when the personal stories and "whole stories" are not known. These "glimpses" become part of some statistic which they will ultimately try to use against e-cigs and other less harmful alternatives.

 

[kristin]

Before he started using snus, my husband was a "dual user" but not why they usually think (to bypass smoking bans.) He just couldn't give up that ONE cigarette a day (down from 1 pack per day) because something was "missing" in e-cigarettes. I have a hard time believing that smoking 1 a day was anything near the same health risks as 20 per day!

But that is another way they pigeonhole us - assuming dual users are such only when they cannot smoke or are trying to "get away with something" like "smoking" where it is prohibited. It is beyond their comprehension that there is anything in tobacco that people are dependent upon besides nicotine.

He is still a "dual user" because he vapes and uses snus, but the assumption that a dual user also has higher levels of exposure is not always true. He vapes half of what I do during the week (uses snus as a suppliment at work) and about equally when he is home on weekends. And he probably consumes less than half of what the typical snus-only user consumes. It seems to completely elude them that most smokers don't go beyond a pack per day, maybe two. It's not like narcotics, which often seems to escalate to the point where they can overdose and die.

 

[sailorman]

Dual Use- such a loaded word.
The FDA and their off-spring organizations continue talk about vigilantly keeping an eye out regarding this (I forget the exact term that they use)....it certainly sounds like spying. I wonder if they check out those out-side video cameras at hospitals, etc. to see if an e-cig user takes a puff of a real cig when he is forced to use his PV around smokers? Personally, I join these people- I can learn a lot about what's REALLY going on at any establishment and I'm not tempted one iota to take a puff of a Nasty. If anything, a smoker might take a puff of my PV as they tend to become interested in what I'm doing and that I'm not smoking. I suppose the ANTZ then view this smoker as a Dual User because they took a puff off of my PV and then chalk it up to them not being able to quit... It's a crazy world we live in- And, from what I gather from different documents, users and how they are being used is being watched, even if it's a glimpse here and there....and even when the personal stories and "whole stories" are not known. These "glimpses" become part of some statistic which they will ultimately try to use against e-cigs and other less harmful alternatives.

Haha..I remember you voicing concerns about this in a previous post. The activity you're referring to is "surveillance". I understand your paranoia, but they're not using the word in the way that the layman would. They're not yet advocating cameras or health nazis with clipboards and binoculars sneaking around smoking areas and schoolyards. "Surveillance" is a fancy word for consumer surveys and the auditing of sales data to establish statistics about patterns of use.

Personally, I refuse to go skulk around smoking areas. I don't need the stink and, the way I see it, anything I do to associate e-cigs with smoking plays into the hands of the enemy and associates e-cigs with cigarettes in the minds of the public. As you can see from my sig, I hate to hear pvs called e-cigarettes in the first place. An "e-cigarette" is no more a cigarette than an electric toothbrush is an e-carrot.

 

[sailorman]

Before he started using snus, my husband was a "dual user" but not why they usually think (to bypass smoking bans.) He just couldn't give up that ONE cigarette a day (down from 1 pack per day) because something was "missing" in e-cigarettes. I have a hard time believing that smoking 1 a day was anything near the same health risks as 20 per day!

Probably because every single study done has demonstrated that the harmful effects of smoking are roughly proportional to the number of cigarettes smoked. That point was reluctantly acknowledged by the members, but tossed aside in the discussion over snus.

But that is another way they pigeonhole us - assuming dual users are such only when they cannot smoke or are trying to "get away with something" like "smoking" where it is prohibited. It is beyond their comprehension that there is anything in tobacco that people are dependent upon besides nicotine.

I think the marketers are partly responsible for that misconception. They can't market DTPs and smokeless tobacco products as cessation aids, so they resort to marketing them as an adjunct to cigarettes for use where analogs are prohibited. The members assume that people use them for the purposes the marketers suggest. It's sort of a self-fulfilling prophecy. Maybe since they're so hellbent on surveillance, this would be a good place for them to start.

He is still a "dual user" because he vapes and uses snus, but the assumption that a dual user also has higher levels of exposure is not always true. He vapes half of what I do during the week (uses snus as a suppliment at work) and about equally when he is home on weekends. And he probably consumes less than half of what the typical snus-only user consumes. It seems to completely elude them that most smokers don't go beyond a pack per day, maybe two. It's not like narcotics, which often seems to escalate to the point where they can overdose and die.

That point was driven home in the discussion about DTPs. Nicotine is somewhat self-limiting and they were reminded of this by John L. It seemed like that was beyond their comprehension when they kept insisting that someone would just munch on DTPs until he died of a nicotine overdose.

I don't think the assertion that a dual user has a higher exposure is nearly ever true. It certainly wasn't for me when I used snus. I doubt the members of TPSAC even had that in mind, or believe it, or even care one way or the other. Their concerns with dual use revolve around the possibility that it discourages people from total abstinence. Dual use allows smokers to avoid the richly deserved browbeating society has gone through a lot of trouble preparing for them when they indulge their nicotine addiction. When smokers can circumvent the societal pressures and universal condemnation they deserve, they're less likely to quit tobacco products entirely. That is their major concern. The thought of pleasure without pain or consequence drives them insane.

I know this psychology. If a magic pill were invented to 100% guarantee that people could enjoy tobacco and ingest nicotine with absolutely no harmful effects, people like some of the TPSAC members would be against it. They'd deny the science first and when the evidence became overwhelming, their heads would explode. Pleasure cannot be allowed without corresponding pain. It is a proposition counter to their core being and runs against everything this type of psychology believes.

The attitudes, arguments and mindset of some of the TPSAC members seems identical to that of harm reduction opponents and absolutists in the field of drug addiction, and the abstinence-only proponents in the field of sex education. Absolutists are absolutists in any field, I guess. They'd rather more Hepatitis and AIDS than risk a needle exchange program discouraging an addict from quitting. They'd rather more teenage pregnancies and STDs than risk a teenager using a condom as an excuse for promiscuity. They'd rather people die from smoking than risk the smoker who uses a DTP or ST or e-cig to delay or abandon the idea of total tobacco cessation. These people aren't scientists. They're moralists.

 

[rothenbj]

Well I'm no dual user. I'm a tri user, thanks to my snus buddies. A little whiff of nasal snus on occasion, just as a dessert between SmokefreE-cigarettes and Snus keeps me in this elite group. Thank you dark side!

 

[Bill Godshall]

The FSPTCA requires the FDA TPSAC report on dissolvable tobacco products to be published by this Friday, March 23.

Our efforts to educate TPSAC on the exponential differences of morbidity and mortality risk for dissolvables (and other smokefree tobacco producs) compared to cigarettes have made a huge impact on the committee's report. Had we not educated the TPSAC, the final report would likely have claimd that dissolvables aren't safe alternatives to cigarettes and that dissolvables are target marketed to youth, and would recommend that FDA ban sales of the products. But don't expect TPSAC's report to encourage FDA to truthfully inform smokers that these products are far less hazardous alternatives to cigarettes, nor will urge FDA to remove the inaccurate and misleading mandatory warning labels on dissolvable tobacco products that are smokeless tobacco.

 

[kristin]

I have used thirst as an analogy for nicotine use and it could make a good point about dual use, as well.

There is a difference between drinking some beer because you are thirsty or drinking it to get drunk. Someone who is just thirsty craves something to drink and will stop drinking when their body tells them they they have had enough to sake the thirst; someone who is drinking to get drunk will drink and drink and will only stop when his body cannot take any more and shuts down in some way.

Nicotine use is not like drinking to get drunk and everything like being thirsty - we use nicotine until the craving goes away.

Dual use is like drinking both tap water and also sports drinks until your are no longer thirsty - you don't drink more than your body wants just because you are using two different liquids!

 

[Cyatis]

The FSPTCA requires the FDA TPSAC report on dissolvable tobacco products to be published by this Friday, March 23.

Our efforts to educate TPSAC on the exponential differences of morbidity and mortality risk for dissolvables (and other smokefree tobacco producs) compared to cigarettes have made a huge impact on the committee's report. Had we not educated the TPSAC, the final report would likely have claimd that dissolvables aren't safe alternatives to cigarettes and that dissolvables are target marketed to youth, and would recommend that FDA ban sales of the products. But don't expect TPSAC's report to encourage FDA to truthfully inform smokers that these products are far less hazardous alternatives to cigarettes, nor will urge FDA to remove the inaccurate and misleading mandatory warning labels on dissolvable tobacco products that are smokeless tobacco.

Thank you to all that went. You did the best you could, you gave them the facts you have. I don't expect anything out of the TPSAC, however you gave them no excuse to be ignorant. When states do decide to go the wrong way, and ban electronic cigarette indoors for example, they might at least have an alternative to use for that time. You might be saving more lives than you know.

I wish you all the best.

 

[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.

 

[Thulium]

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.

Those "warnings" are so close to meaningless, I personally don't much care if they remain on smokeless products that have not been shown to reduce risks. ANY product "can" cause mouth cancer, gum disease, or tooth loss. Nothing is safe in absolute terms, and just about any recreational product can be habit forming.

However, I think it would be reasonable to change the warnings on cigarettes to read:

WARNING: Daily cigarette smoking is associated with increased risk of Emphysema, Bronchitis, Chronic Obstructive Pulmonary disease, Coronary artery disease, Peripheral artery disease, Colorectal cancer, Liver cancer, Prostate cancer, Erectile dysfunction in men, Stomach cancer, Bladder and kidney cancer, Abdominal aortic aneurysm, Acute myeloid leukemia, Cataracts, Cervical cancer, Kidney cancer, Pancreatic cancer, Periodontitis, Pneumonia and also contributes to Hip fractures due to reduced bone density, Complications from diabetes as a result of peripheral vascular disease, Higher incidence of post surgical wound infections, and Reproductive complications, such as problems conceiving.

 

[Vocalek]

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.

But fortunately Section 205 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.

 

[Thulium]

But fortunately Section 205 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.

That's why I suggested the warning above. Congress directed the FDA to develop larger warning labels on cigarettes to use, I believe, 40% of the space of the pack. Why not simply list any and all diseases for which there is epidemiological data that shows a statistically significant (RR > 2) risk associated with it's use? I suspect that could fill 40% of a pack of cigarettes and still need to be a fairly small font!

If it will make an ANTZ feel like they accomplished something, I don't care if disposable e-cigs have a "Warning: There is no safe tobacco" label. SmokefreE-cigarettes are not a safe alternative to smoking in exactly the same way that reading books is not a safe alternative to burning them.

 

[IronHorse]

That is why we have such a difficult task: Every individual who works for any of those government agencies and/or pharmaceutical companies KNOWS that they are financially dependent on sales of drugs to treat diseases caused by smoking, but like historical Pharaohs and Caesars have they justified their the infanticide or "genetic cleansing" or any other form of eugenics by belittling or "denormalizing" and generally treating people inhumanely. Nobody wants to admit their share of such institutionalized evil, but in truth every one of us shares in this responsibility: The healthcare and pharmaceutical industry represents a significant portion of the overall economy, for good or bad, and the fact that drug companies now exert their political influence to maintain demand for drugs* is blood that is on the hands of every one of us who purchases, prescribes, or invests in pharmaceuticals.

*especially drugs that are known to be barely more effective than placebo and supposedly less dangerous than the diseases they are meant to treat...especially if that disease happens to afflict a hated subgroup.

Well spoken!!!