FDA "I think they're crazy..."

[sonicdsl]

Well, ta dah! ta dah! Kayta, they came out recently (yesterday?) with a new possitive study in England that concluded e-cigs are 60 percent more effective than any other NRT!!!! 5,000 people in study over 5 yrs.......Think that's right.

Just think what that means to Australia, Canada, and England! Even to us! It's being posted in a lot of places. It will give you a warm feeling all over.

It did!

And I hope that Australian vapers will again be able to vape... Fingers crossed!

They sure did!

And SJ started a thread about it here: http://www.e-cigarette-forum.com/fo...ore-effective-than-nrt-smoking-cessation.html

Talking about perhaps figuring out how to do one in the US as well.

 

[Katya]

Talking about perhaps figuring out how to do one in the US as well.

I suggested to SJ that Stanton Glantz should be contacted. I'm sure that UCSF, perhaps with the cooperation of the CDC and FDA, could conduct the study.

They have money and they want to help us quit smoking! Win-win!

 

[sonicdsl]

I suggested to SJ that Stanton Glantz should be contacted. I'm sure that UCSF, perhaps with the cooperation of the CDC and FDA, could conduct the study.

They have money and they want to help us quit smoking! Win-win!

8-o

 

[AndriaD]

I don't understand the mentality that adults don't want good tasting anything. Where does it say that after adulthood (whatever that is) people gravitate to bland tasting foods, drinks, etc. I certaintly don't want to vape castor oil...

It's the puritanical mindset that "we must not" enjoy the pleasures of life because it's a "sin." Phooey!!!

I agree, and have long felt that puritans were the worst thing that EVER happened to America. I wish England would take them back, but they don't want 'em either!

I feel like the puritan influence is behind all these nosey-parker busybodies who want to know "you're not going to do THAT forever, are you?" to which I always answer "Why not?" And they stutter and say inane things like 'well, because...' but they never do manage to come up with any compelling reason -- the main reason seems to be that THEY wouldn't want to "do THAT forever." As if that has anything to do with anything. I'd be willing to bet that the same people have sex in the dark, under the covers, and solely for procreation -- and certainly never do it standing up, because someone might think they were dancing.

Andria

 

[AndriaD]

They sure did!

And SJ started a thread about it here: http://www.e-cigarette-forum.com/fo...ore-effective-than-nrt-smoking-cessation.html

Talking about perhaps figuring out how to do one in the US as well.

Well I'm with whoever said it first, why isn't this SCIENTIFIC STUDY applicable everywhere? Why does it have to be replicated? Isn't science international? Aren't we all human? Isn't smoking a global phenomenon, and a serious health problem wherever it exists?

I don't get it.

Andria

 

[Katya]

Well I'm with whoever said it first, why isn't this SCIENTIFIC STUDY applicable everywhere? Why does it have to be replicated? Isn't science international? Aren't we all human? Isn't smoking a global phenomenon, and a serious health problem wherever it exists?

I don't get it.

Andria

I assure you that the results of the study are (will be) forwarded to all agencies here. Besides, Zeller and Hamburg and even Harkin can read--the news has been picked up by all the major US papers, including the NYT and LA Times.

The thinking is that it would be better if if we had similar studies (as in more of them) also done in the US--to confirm, hopefully, the British and French findings.

 

[AndriaD]

I assure you that the results of the study are (will be) forwarded to all agencies here. Besides, Zeller and Hamburg and even Harkin can read--the news has been picked up by all the major US papers, including the NYT and LA Times.

The thinking is that it would be better if if we had similar studies (as in more of them) also done in the US--to confirm, hopefully, the British and French findings.

Yeah I guess I can see that; that's the thing about science -- if it's true, you can duplicate the results of any experiment. The more tests they do that say hey, guess what, e-cigs DO help you quit smoking -- at some point they will have to bow to FACTS.

But frankly I'm shocked and amazed to learn that Hamburg and Harkin can read. They appear to have the approximate IQ of a tree stump... if that isn't dissing tree stumps.


Andria

 

[Katya]

Yeah. Also, please remember that this is not hard science. This really was a survey. Nobody can prove or disprove that the answers were truthful--there were no cotinine tests administered, as there would be it were a true scientific study.

 

[aikanae1]

Yeah. Also, please remember that this is not hard science. This really was a survey. Nobody can prove or disprove that the answers were truthful--there were no cotinine tests administered, as there would be it were a true scientific study.

But it can be. If the same study was repeated with the same results, that validates it = hard science. I think there's been a couple of others in the past that have reported similar results (New Zealand?). Part of the scientific process is peer review and repeatablity. That also means if someone were to take the Gantz tests and duplicate it with different results that puts Gantz's results into a limbo until someone else came along and tried it again (barring any design or methodology flaws). If the FDA / CDC aren't interested in reproducing the same study in the US, but choose to fund others, that can say a lot too, i.e. a review of the studies the FDA chooses to use vs. those they leave out.

The problem with these is that saying ecigs are more effective than NRT is that we're putting ecigs back into the "drug" medical or modified risk category. Those have higher standards. Modified risk is where vaping bumps into "public health standaed" meaning people won't use them in ways that could potentially cause greater harm - interrupt complete cessation efforts or use them rather than staying abstinent, dual use, toxins in vapor, etc. UGH. Full of catch 22's. The reason behind that is from "light" cigarettes were not really "light" the way people actually used them. At least that's my understanding.

http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/UCM348930.pdf

C. Achieving Reductions in the Harm Associated With Continued Tobacco Use

To date, no manufacturer of a drug or device product has demonstrated to FDA that its product is safe and effective for reducing the harm associated with continued tobacco use. Likewise, no manufacturer has demonstrated to FDA that its tobacco product significantly reduces the harm and the risk of tobacco-related disease to the individual tobacco user and that its product will 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 products. FDA anticipates having additional discussions with stakeholders on issues related to reducing the harm associated with continued tobacco use.

A number of stakeholders, however, have argued for a so-called “harm-reduction” approach to tobacco use based on the idea that many currently available products that contain tobacco or nicotine may be less harmful to users than cigarettes. These stakeholders argue that if consumers are given appealing alternatives to smoking and adequate information about the related risks, consumers will shift to these alternative tobacco products and thus experience reduced harm. These stakeholders have also argued that presenting other tobacco products as harm-reducing alternatives is a potential tool for reducing cigarette smoking prevalence.

Other stakeholders have countered that the strategy of moving users to purportedly “safer” sources of nicotine will simply serve to sustain and expand tobacco use and addiction. In addition, FDA cannot assume that all of these nicotine-addicted users would completely give up smoking, or that once “shifted” to alternative tobacco products, they would not subsequently switch back. Other potential concerns raised by this strategy of shifting to “safer” sources of nicotine include increased initiation, reductions in cessation rates, and an overall negative impact on the public health.

The so-called “harm-reduction” approach therefore raises issues similar to those discussed in connection with the continuation of nicotine addiction following smoking cessation (see Section V.A above), and the phenomenon of dual use (see Section V.B).

FDA also has the authority to issue tobacco product standards, which can be used in a variety of ways, including to regulate nicotine (thereby reducing addictiveness); to regulate toxicant levels; or to require the reduction or elimination of an additive, constituent, or other component. By mandating product changes to reduce the harmful effects of tobacco use, tobacco product standards could provide an additional means to develop product changes to decrease the morbidity and mortality from tobacco use.

PS. This document also lists an approved mist by prescription in the US. What it is, who knows. Maybe I should pay more attention to tv ads to find out.

 

[Gato del Jugo]

Do they not have internet access in DC?

Honestly, all they need to do is spend some time at ECF & other forums..


They'll find boatloads of people who have either significantly cut back on smoking or more likely quit altogether (& stay that way), who have decreased their nicotine usage, that vapers are now much healthier, have more money in their pockets for the more important things in life (like education for their children, for example), & that adults actually do, indeed, enjoy all sorts of different flavors -- and apparently are pretty picky about it!


But since that doesn't fit their agenda & put enough money in they & their buddies' pockets, all that will be dismissed -- at the expense of the nation's health...

 

[Kent C]

"A number of stakeholders, however, have argued for a so-called “harm-reduction” approach to tobacco use based on the idea that many currently available products that contain tobacco or nicotine may be less harmful to users than cigarettes. These stakeholders argue that if consumers are given appealing alternatives to smoking and adequate information about the related risks, consumers will shift to these alternative tobacco products and thus experience reduced harm. These stakeholders have also argued that presenting other tobacco products as harm-reducing alternatives is a potential tool for reducing cigarette smoking prevalence.

Other stakeholders have countered that the strategy of moving users to purportedly “safer” sources of nicotine will simply serve to sustain and expand tobacco use and addiction. In addition, FDA cannot assume that all of these nicotine-addicted users would completely give up smoking, or that once “shifted” to alternative tobacco products, they would not subsequently switch back. Other potential concerns raised by this strategy of shifting to “safer” sources of nicotine include increased initiation, reductions in cessation rates, and an overall negative impact on the public health."

1.* This is the 'entrenched' view as evidenced by Zeller's comments to Burr on 'harm reduction' vs. 'impact on public health'. Basically it's the difference between a habit of smoking vs. a nicotine addiction. This is what they 'struggle with', (wincing when saying it), but they are convinced by the last paragraph.

2. I don't even think they believe that "addicts" will go back to cigs, but that's their best 'pragmatic' argument. It allows them to hide their puritanical/controlling philosophy, behind a fake and flawed 'practical' argument - that people will opt for 4000 harmful chemicals instead of just 4 that are rather benign.

3. I think their true problem is people's addiction. It's like they resent, or are jealous of, something moving in on their territory of 'control of people'.

4. It's the action of smoking and vaping that publically shows individualism and pleasure. It's why they're not that concerned with patches and gum, although there was a time when even gum was also a slap in the face of their authority.

*for Katya....

 

[aikanae1]

Actually, I think underlying this is the defense of the NRT industry. Reading the document, NRT's usege times were extended, included dual use and allowed for use with cravings WITHOUT additional studies based on "stakeholder" claims that they were loosing sales to ecigs. The "data" would be collected after they were on the market. The FDA pointed to 3 petitions. Unless I missed something, that was all the FDA required. (I think "we" could do that). It makes me wonder if the drug/device delivery is really tougher than the tobacco standards that the FDA is throwing at vaping. This is what isn't adding up in my brain.

I think the actual reality is that if a vaping product were to attempt the drug route, they would face even more restrictions and the NRT industry has been granted special permissions to "fast track innovations" (another standard FDA needs to satisfy).

The FDA / CDC know better. This is not ignorance or stoopidity or being misguided (like congress).. These are smart people making bad decisions in the name of "public health".

So, vaping can't advertise or be promoted as a safer alternative, can't say it helps with cessation, and can you imagine the reaction if it were promoted as fun or convienent? Oh wait - isn't that the war on flavors and indoor bans? At this juncture, I'd ask FDA what they would reccomend. The answer would be interesting and probably illegal.

Am I missing something or does this whole thing suck in that there is no way to win.

 

[Kent C]

Actually, I think underlying this is the defense of the NRT industry. Reading the document, NRT's usege times were extended, included dual use and allowed for use with cravings WITHOUT additional studies based on "stakeholder" claims that they were loosing sales to ecigs. The "data" would be collected after they were on the market. The FDA pointed to 3 petitions. It made me wonder if the drug/device delivery was really tougher than the tobacco standards that the FDA is throwing at vaping. This is what isn't adding up in my brain.

This, basically, is the other 'conspiracy theory'. If the underlying reason is money to BT and/or BP for BG contributions and their continued existence, then there is no other outcome than a ban or a tax and regulation scheme that is so burdensome, where either cigalikes or nothing will be available legally, and where people will go underground or quit (or die). And the only solution is change the makeup of government with people that wouldn't be so influenced.

Whether that is even possible, the vaping community isn't large enough to effect that change. It must come from a much wider movement that isn't just concerned with single issues.

If it really is all about money, then we lose, imo. If it isn't, then our only chance is to bring enough info to the table to show that 'harm reduction' trumps their specious 'public good' argument. That helping people off cigarettes is a greater public good, than curing their addiction to nicotine.

 

[aikanae1]

Then why were restrictions eased on NRT based on 3 petitions, using "fast track".

I do see hightened standards being applied to vaping that are't applied elsewhere. Some is our fault in that vaping dances between the definition of drug or tobacco. The last line is what vaping struggles with (the public health standard).

Drugs are defined under the FD&C Act to include “articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease,” as well as “articles (other than food) intended to affect the structure or any function of the body.” Medical devices are defined in very similar terms. The so-called “intended use” of an item is therefore critical to FDA’s ability to regulate drugs and devices. An article’s intended use is determined by FDA based primarily on the claims that are made about the product.

The term “tobacco product,” by contrast, is defined to include “any product made or derived from tobacco that is intended for human consumption.” FDA’s authority to regulate tobacco products, therefore, depends first on the product’s physical makeup. The definition of “tobacco product” excludes any item that falls within the definition of a drug, a medical device, or a combination product― for example, any item whose “intended use” involves the diagnosis, cure, mitigation, treatment, or prevention of disease.

As discussed above, the definition of “tobacco product” explicitly excludes products that meet the legal definition of “drugs” or “devices.” In Sottera, Inc. v. FDA, the U.S. Court of Appeals for the D.C. Circuit took up the question of whether electronic cigarettes containing nicotine derived from tobacco fall within the definition of “tobacco product” (and are therefore regulated by CTP), or fall within the definition of “drugs” or “devices” (and are regulated by CDER/CDRH).

The answer, the court ruled, depends upon the intended use of the product. Nicotine- containing products as “customarily marketed” (including traditional cigarettes) ― provided they are not also marketed for what the court described as “therapeutic” purposes ― can be regulated by CTP. Nicotine-containing products that are marketed for “therapeutic” purposes cannot be regulated as tobacco products, but can be regulated by CDER/CDRH as drugs/devices. Because no evidence had been presented to the court that the electronic cigarettes at issue in the case had been marketed with “therapeutic” claims, the court held that they could not be regulated as medical products.

Generally speaking, drugs and devices must be approved for a particular intended use in individuals. New or modified tobacco products are subject to different criteria that take into account the product’s impact on the health of the population as a whole.

 

[Kent C]

Then why were restrictions eased on NRT based on 3 petitions, using "fast track".

I do see hightened standards being applied to vaping that are't applied elsewhere. Some is our fault in that vaping dances between the definition of drug or tobacco. The last line is what vaping struggles with (the public health standard).

"fast track" is only for the politically correct illnesses and solutions. It's why there's more 'sympathy' for using methadone for an alternative, than ecigs as an alternative. Some 'victims' of addiction are politically correct, others aren't.

 

[aikanae1]

Well then maybe vaping should be fast tracked as a NRT and become politically correct.
Our best defense is to jam up the wheels and prevent them from turning.

 

[Gato del Jugo]

Am I missing something or does this whole thing suck in that there is no way to win.

The good news is that we, the vaping consumers, aren't alone in this..


There are lots of other people & entities fighting this fight alongside us, like vape companies, trade associations, advocate groups, lawyers, lobbyists, etc.. And who knows who else might end up jumping in*.. Obviously our support/assistance & what we do, as consumers, is important, too.. But there is lots of other stuff going on at different levels & coming from different angles, things that many of us might not even be aware of...

Heck, one could argue that at least in some sense, the BT cigalike-makers are our semi-ally in this, at least at times & in some areas, and are fighting on a different front (and with their own agenda, of course).. BP could be considered one of their enemies in this -- and isn't the enemy of our enemy, our friend? (Yes, I winced when I wrote that .. But that doesn't make it any less true)...


Bottom line is, I don't think we need to feel like it's only a handful of consumers fighting this war.. We are simply soldiers taking part in a much larger & diverse (and certainly capable) military, so to speak...



*I wish the medical community would step up their public game a little more.. Seems like many doctors (including my own), for example, are fairly happy that some of their smoker patients have switched to vaping.. Perhaps some would like to see us eventually give that up, too, but it's a step in the right direction, at least in their eyes... Maybe we could help push them a little to join in our fight & to publicly speak up in our defense...

 

[Katya]

But it can be.

Absolutely. It is a respectable study, well thought out and conducted. It also mirrors the French study, the New Zealand study, and Dr. Farsalinos's study of 19,000 vapers. Each subsequent study adds credibility to previous studies. The more the better. It won't be easy to dismiss them all.

 

[Katya]

Do they not have internet access in DC?

They do, but I'm not sure if our leaders know how to use it. Sen. Harkin doesn't seem to be familiar with modern (21 century) technology.

 

[aikanae1]

I've been thinking about number 2. On one hand there are a lot of vapers who say they will never go back to smoking. I wonder how true that is if their choices were limited? The result of the Proposed Rules could be a spike in smoking and cigarette sales. Currently, the HHS Economic Anyalsis predicts no loss in sales. I would probably go back to smoking (once my reserves ran out).

1.* This is the 'entrenched' view as evidenced by Zeller's comments to Burr on 'harm reduction' vs. 'impact on public health'. Basically it's the difference between a habit of smoking vs. a nicotine addiction. This is what they 'struggle with', (wincing when saying it), but they are convinced by the last paragraph.

2. I don't even think they believe that "addicts" will go back to cigs, but that's their best 'pragmatic' argument. It allows them to hide their puritanical/controlling philosophy, behind a fake and flawed 'practical' argument - that people will opt for 4000 harmful chemicals instead of just 4 that are rather benign.

3. I think their true problem is people's addiction. It's like they resent, or are jealous of, something moving in on their territory of 'control of people'.

4. It's the action of smoking and vaping that publically shows individualism and pleasure. It's why they're not that concerned with patches and gum, although there was a time when even gum was also a slap in the face of their authority.

*for Katya....