Dr. Bertollini of the WHO on twitter - my response

[AgentAnia]

I'm a great fan of Puddlecote and his blog. He has that uniquely British way of blistering his opponents with sometimes elegant wit and sometimes in-yer-face down-to-earth language. He's not afraid to take on hypocritical bureaucrats and do-gooders, no subject is off limits to him. And he always seems to see what's REALLY at issue on whatever topic he addresses.

 

[DC2]

I left a comment. I can see it, but I'm not sure anyone else can.

PLOS ONE : accelerating the publication of peer-reviewed science

When I click the originally posted link I see all of the comments that have been noted in this thread except yours.
When I click the link you posted above I see your comment, but none of the others.

 

[AgentAnia]

From whatever link you arrive at the PLOSone site, click on the "article" tab. Once there, click on the "comments" tab. It will show 2 comments (GlANTZ and Keller) and all the replies to the first post. This worked for me. Hope it works for you.

Edit: Or, of course, you could simply click here: http://www.plosone.org/article/comments/info:doi/10.1371/journal.pone.0066317

 

[DC2]

I wish I could just leave a comment that says...

All these disagreements are pointless. Electronic cigarettes work, and they work extremely well. There are millions of people around the world that know this and would agree on how pointless it is to argue that fact. Stanton Glantz can try to pick apart this study all he wants. In the long run it's nothing more than an effort in futility, because electronic cigarettes are inevitable. There is nothing he can do to stop it, only slow it down. Some day soon he'll need to find another cash cow, because this one is being taken to slaughter.

 

[Elnroth]

I didn't realize that being the president of a CONSUMER advocacy group was a conflict of interest?

Can we submit complaints to plos that their editor is using his personal bias when moderating comments?

 

[DC2]

I wish I could just leave a comment that says...

Did I really just say "effort in futility" in that quote?
That's kind of embarrassing.

So yeah, "exercise in futility" is what I meant to say.

Coming from someone who posted this thread, I have to take a look at myself in the mirror now...
http://www.e-cigarette-forum.com/forum/lounge/309471-thats-not-how-saying-goes.html

 

[rothenbj]

If nothing else, the comment section is certainly entertaining. Nothing like getting ANTZ and editors who support the ANTZ into a commentary debate on competing interests.

 

[Oliver]

And finally, we have a definitive posting - this time by Rory Morrison, a self declared "research nerd" and who works for ASH Scotland has rebutted Stanton Glantz dismissal in full fashion.

If you are interested in research, I strongly recommend you read this post carefully, as it covers a number of perennial issues in research and stats in excellent detail.

It's a really, really good piece: PLOS ONE : accelerating the publication of peer-reviewed science

 

[Oliver]

By the way, Elaine's posting has been responded to by Stanton Glanz, who is evidently still unaware that the authors of the study he cites (as showing e-cigs do not help quitters) have explicitly rejected that interpretation.

Mike Siegel's own posting explains why this is the case (also on his own blog): PLOS ONE : accelerating the publication of peer-reviewed science

 

[Uma]

Bookmarking cuz I love you guys

 

[Coastal Cowboy]

I have some reservations about research into whether or not e-cigs are effective as a smoking cessation method.

In Soterra v US Food and Drug Administration, the DC Circuit Court of Appeals ruled that e-cigs were not being marketed as a therapy for this purpose at all. Instead, the majority reasoned, e-cigs were properly defined as a "tobacco product" and were being marketed as tobacco products customarily are. That decision prevented FDA from regulating e-cigs as a drug/delivery system, which is their broadest and most powerful authority.

If manufacturers and supporters of this alternative to smoking begin touting e-cigs as a smoking cessation therapy, then they run right back into the regulatory scheme FDA sought to impose in 2009. It opens the door for FDA to appeal the DC Circuit Court's opinion, on the basis that the industry misled the Court and that the true intent of the industry was to circumvent the requirements of the Food, Drug and Cosmetics Act and the regulations promulgated thereunder.

We are treading very close to a slippery slope, the end of which leads right to the maw of a bureaucracy that already knows exactly what it wants to do, and how to do it.

We can and should promote e-cigs as an alternative to smoking tobacco that is cleaner. They reduce fire hazards and therefore promote both personal and public safety. They reduce the likelihood of exposure to second-hand smoke. They reduce the amount of rubbish in landfills and promote environmental quality by reducing the amount of toxic cigarette butts in waterways and green spaces. I'm sure there are many other benefits that we could come up with that don't even come close to saying, "this will help you quit smoking."

Even though we all know that e-cig use is a very effective method of kicking the analog habit, we just can't go there yet. The DC Circuit Court gave this industry a path to grow. I think it's unwise to not follow that path.

 

[Vocalek]

I
If manufacturers and supporters of this alternative to smoking begin touting e-cigs as a smoking cessation therapy, then they run right back into the regulatory scheme FDA sought to impose in 2009. It opens the door for FDA to appeal the DC Circuit Court's opinion, on the basis that the industry misled the Court and that the true intent of the industry was to circumvent the requirements of the Food, Drug and Cosmetics Act and the regulations promulgated thereunder.

I suggest that you read Judge Leon's 32-page Opinion document carefully. You can download it from the CASAA site:
CASAA Smoking Everywhere vs. FDA

It's the link, "SE vs FDA Opinion".

Judge Leon specifically addressed the issue of whether the government is permitted to regulate products as a drug if anyone other than the vendor / manufacturer makes a health claim. The Answer is "No."

FDA references only three claims made in Smoking Everywhere's literature: (l) electronic cigarettes offer "smokers a chance of smoking in a much healthier way," (2) electronic cigarettes are "a great alternative to help ... stop smoking real cigarettes," and (3) "I've been smoking real cigarettes for over 20 years and really wanted to stop ... I've been using it for 3 weeks now and feel great." (ARDET 49,21; FDA Opposition [#14] at 21). The latter two claims are customer testimonials posted on the Smoking Everywhere website. None of these claims, on their face, suggests an objective intent to treat nicotine addiction and withdrawal. At best, these claims demonstrate that Smoking Everywhere markets its electronic cigarettes as an alternative-albeit a healthier alternative-to traditional cigarettes. IS FDA does not point to any representation by Smoking Everywhere that its product is intended to help wean smokers off of nicotine. Nor does FDA identify any product labeling that includes instructions about how to overcome nicotine addiction using electronic cigarettes. The clear import of Smoking Everywhere's advertising is that it wants consumers to use its electronic cigarettes for the same recreational purposes and with the same frequency as traditional cigarettes. 16

The key issue of whether any item can be regulated by the FDA as a drug is the products' intended use. The intended use is determined by the seller, not the buyer, not by scientific researchers, not by forums, and not anyone else. The seller would have to be making health claims.

So there is no slippery slope here. The Federal Courts have spoken and there is no danger that the FDA will appeal the decision. If you had followed the case closely, you would have seen that as far as this case is concerned, all appeals, except for the Supreme Court, have been exhausted.

A different court, however, is the court of public opinion. The opponents of harm reduction want to be able to claim that smoking and vapor are the same thing--and they are both bad.

The public needs to understand that the availability and promotion of low-risk alternatives is saving lives. The public needs to understand that these products are such an acceptable substitute for smoking that many of us are no longer endangering our health and shortening our lives by inhaling smoke.

 

[Coastal Cowboy]

I suggest that you read Judge Leon's 32-page Opinion document carefully. You can download it from the CASAA site:
CASAA Smoking Everywhere vs. FDA

It's the link, "SE vs FDA Opinion".

Judge Leon specifically addressed the issue of whether the government is permitted to regulate products as a drug if anyone other than the vendor / manufacturer makes a health claim. The Answer is "No."



The key issue of whether any item can be regulated by the FDA as a drug is the products' intended use. The intended use is determined by the seller, not the buyer, not by scientific researchers, not by forums, and not anyone else. The seller would have to be making health claims.

So there is no slippery slope here. The Federal Courts have spoken and there is no danger that the FDA will appeal the decision. If you had followed the case closely, you would have seen that as far as this case is concerned, all appeals, except for the Supreme Court, have been exhausted.

A different court, however, is the court of public opinion. The opponents of harm reduction want to be able to claim that smoking and vapor are the same thing--and they are both bad.

The public needs to understand that the availability and promotion of low-risk alternatives is saving lives. The public needs to understand that these products are such an acceptable substitute for smoking that many of us are no longer endangering our health and shortening our lives by inhaling smoke.

I've read that opinion and the Circuit Court of Appeals' opinion, too. While I agree that e-cigs are an excellent substitute for smoking, the Circuit Court's ruling is crystal clear. These are not to be marketed or promoted as a smoking cessation method. While research showing that they are only more firmly entrenches our convictions, they have to be marketed and promoted as something else.

We must find other methods of promoting their benefits. The cleanliness thing. The fire safety thing. The environmental thing. Anything but smoking cessation.

Now, in the court of public opinion... Well... You, I and everyone else can plainly speak of how it helped us quit smoking. Man to man, woman to woman, whatever. We know. But not everyone else does.

As far as convincing bureacrats and politicians from keeping their hands off of our devices, we need to stick to the path the DC Circuit Court gave us. That, they must listen to.

 

[DC2]

As far as convincing bureacrats and politicians from keeping their hands off of our devices, we need to stick to the path the DC Circuit Court gave us. That, they must listen to.

Her point is that anyone can talk about using them to quit smoking except those who sell them.
No claims by anyone other than sellers matters in the eyes of the court.

 

[Oliver]

A key issue here is the American versus the European regulatory positions. If the TPD (Europe) goes through as currently written, we'll be in a bizarre position in which Europeans regulate ecigs as medicines and Americans as tobacco products.

It's not surprising, therefore, that some researchers wish to conduct research regarding the efficacy of e-cigs for quitting. At some point, we have to say that scientific questions are important and have to be answered regardless of the regulatory position - that's all that is going on with the Caponnetto et al., paper - a specific question has been asked, and now people are quibbling over the results.

The really interesting aspect is looking at who is taking what side over the argument, and why. Faultlines are being exposed in public view.

 

[kristin]

I've read that opinion and the Circuit Court of Appeals' opinion, too. While I agree that e-cigs are an excellent substitute for smoking, the Circuit Court's ruling is crystal clear. These are not to be marketed or promoted as a smoking cessation method. While research showing that they are only more firmly entrenches our convictions, they have to be marketed and promoted as something else.

We must find other methods of promoting their benefits. The cleanliness thing. The fire safety thing. The environmental thing. Anything but smoking cessation.

Now, in the court of public opinion... Well... You, I and everyone else can plainly speak of how it helped us quit smoking. Man to man, woman to woman, whatever. We know. But not everyone else does.

As far as convincing bureacrats and politicians from keeping their hands off of our devices, we need to stick to the path the DC Circuit Court gave us. That, they must listen to.

The ruling/opinion did not say that e-cigarettes cannot be marketed as smoking cessation products. It said that the FDA cannot treat them as unapproved smoking cessation products in the absence of such claims and/or marketing. If an e-cigarette manufacturer decides it wants FDA approval as a smoking cessation product, it can seek approval as such and once it gains said approval, it can begin marketing as such. Even then, one or more e-cigarettes FDA-approved as smoking cessation products does not automatically make every other e-cigarette subject to drug approval as a smoking cessation product. Only if they claim to be a smoking cessation product does that drug approval requirement kick in. Here in the U.S., because of Judge Leon's ruling, we could eventually have the situation where some e-cigarettes are marketed FDA-approved as smoking cessation "drugs," and others are marketed as "tobacco products" without needing FDA approval as a drug.

Either way, as advocates, we do not need FDA approval to call them whatever we want nor will what we call them have any impact on how the FDA can regulate them. You are only limited in what you can say if you sell them. As such, we not only can, but have an obligation to, tell the truth to legislators what no e-cigarette manufacturer or retailer can currently say - even with continued, long-term use, these products have helped us quit smoking. Continued nicotine use is not the same as continued smoking, no matter how much the ANTZ would like them to believe that. So, removing access to or affordability of or effectiveness of these products while awaiting FDA-approval as either a smoking cessation products or a new, low-risk tobacco product would be unconscionable.

 

[Bill Godshall]

IBCR Media wrote:

I've read that opinion and the Circuit Court of Appeals' opinion, too. While I agree that e-cigs are an excellent substitute for smoking, the Circuit Court's ruling is crystal clear. These are not to be marketed or promoted as a smoking cessation method. While research showing that they are only more firmly entrenches our convictions, they have to be marketed and promoted as something else.

We must find other methods of promoting their benefits. The cleanliness thing. The fire safety thing. The environmental thing. Anything but smoking cessation.

I totally disagree with that statement, as well as the previous posting by ICBR Media for several different reasons.

First, there's a huge difference between claims made by "manufacturers" and those made by vapers and everyone else, as the FDCA only prohibits "manufacturers" from making therapeutic claims. The 1st Amendment protects everybody else's right to free speech (i.e. truthfully claiming that e-cigarettes help smokers quit). As one who has exercised my 1st Amendment right everyday since 2008 truthfully informing the public that e-cigarettes are effective smoking cessation aids, I strongly urge all vapers (who aren't manufacturers) to similarly exercise their 1st Amendment rights as often as possible.

Second, although the FDA has asserted (in letters to several e-cig manufacturers in Sept, 2010) that smoking cessation claims (and even smoking reduction claims) violate the FDCA, I'm confident that the federal courts would rule (if the agency is sued by a prosecuted e-cig manufacturer) that "smoking cessation" and "smoking reduction" claims are NOT therapeutic claims (and thus do not violate the FDCA) simply because cigarette smoking is not a disease or disorder. The FDA has never considered "smoking" to be a disease or disorder, and has never approved a drug for "smoking cessation" (even though many DHHS webpages inaccurately claim otherwise, which is why most people believe otherwise).

Rather, the FDA has only approved NRT, Chantix and other drugs as treatments for the so-called disorder of "tobacco dependence".

There's a huge difference between quitting smoking and quitting tobacco.

The FDA (and other DHHS agencies) and the drug industry funded anti tobacco groups have been deceiving the public (especially since Obama appointees took over DHHS in 2009) to inaccurately believe that all tobacco use is as hazardous as cigarette smoking, that quitting smoking is the same as quitting tobacco, and that making a smoking cessation claim violates the FDCA.

 

[Petrodus]

The FDA (and other DHHS agencies) and the drug industry funded anti tobacco groups have been deceiving the public (especially since Obama appointees took over DHHS in 2009) to inaccurately believe that all tobacco use is as hazardous as cigarette smoking, that quitting smoking is the same as quitting tobacco, and that making a smoking cessation claim violates the FDCA.

 

[the_vape_nerd]

This is a great discussion and thread.

I've read the rulings myself. Here's some questions I have and maybe you guys can answer them.

Did the court decision being discussed above legally declare ecigs a tobacco product? Or did it just suggest that the fda might be able to regulate them under it's existing tobacco product regulating authority?

If a deeming regulation is ultimately passed, is there any corporate will to oppose such a regulation? I.e., will our vendors or even BT litigate over whether they are tobacco products?

My assumption is that they'd lose on the merits. I mean yeah there's some nicotine in tomatoes and eggplants but that's not where our nic comes from.

 

[DC2]

Did the court decision being discussed above legally declare ecigs a tobacco product?

No.

Or did it just suggest that the fda might be able to regulate them under it's existing tobacco product regulating authority?

Yes.

If a deeming regulation is ultimately passed, is there any corporate will to oppose such a regulation? I.e., will our vendors or even BT litigate over whether they are tobacco products?

Bill Godshall has indicated in the past that if the FDA issues "deeming" regulations, there are people prepared to file lawsuits...
http://www.e-cigarette-forum.com/fo...acco-products-released-today.html#post4790722
http://www.e-cigarette-forum.com/fo...ata-misrepresenting-evidence.html#post6982918
http://www.e-cigarette-forum.com/fo...-approves-deeming-regulation.html#post5785843
http://www.e-cigarette-forum.com/fo...kes-new-report-press-release.html#post6857867

No further details have been made available.