CASAA issues THIRD Call to Action in connection with FDA Proposed Regulations

[Bobbilly]

How do you think this looks to lawmakers? Imagine someone's actually on the edge; they really don't think anyone should be making claims of therapeutic value which have not been properly tested, but they think there's no reason to treat nicotine any differently from other natural supplements. Some vapers write and call and e-mail and helpfully explain that reputable companies are careful not to market e-cigs as therapeutic, they're just a modern alternative to cigarettes. Of course as with every industry, there will always be some fringe manufacturers around who make wild claims and refuse to follow regulations, but that shouldn't reflect badly on the majority. The lawmaker thinks, oh, you know, that makes sense.

Then they run across CASAA, the biggest group representing vapers, making claims e-cigarettes are therapeutic.

This is a great way to try to win the public, not Washington.

It's all a bunch of baloney. What do people think when they are vaping instead of smoking? Sounds like quit smoking to me. Therapeutic is 'it is healthy or cures something'

 

[snork]

After stewing on it, I wrote this short reply:

Thank you for your reply.
Unfortunately your response gives me the impression that you don't know very much about the subject, for example, electronic cigarettes are *not* regulated by the Center for Drug Evaluation and Research, and are *not* marketed as therapeutic devices.

I will be following each of my elected representatives' involvement and knowledge regarding this issue and vote accordingly.

 

[Not A One]

Well, that was both rude and arguably incorrect. The Center for Drug Evaluation and Research is the branch of the FDA that monitors drugs and reviews applications for new ones, and when e-cigs are marketed as therapeutic devices (which many of them are), they do fall into its area of responsibility.

I'm sure having vapers tell him he's an idiot made him super friendly, though.

 

[snork]

They are not regulated by the Center for Drug Evaluation and Research as he claimed. I didn't call him an idiot, I said he didn't know very much and expect him to get up to speed in order to receive my vote.

This product does not treat, diagnose or cure any disease, physical ailment or condition. This product is not marketed for use as a smoking cessation product and is not intended for use by non-smokers. This product and the statements made herein have not been evaluated by the FDA, or any other health or regulatory authority.

 

[kristin]

How do you think this looks to lawmakers? Imagine someone's actually on the edge; they really don't think anyone should be making claims of therapeutic value which have not been properly tested, but they think there's no reason to treat nicotine any differently from other natural supplements. Some vapers write and call and e-mail and helpfully explain that reputable companies are careful not to market e-cigs as therapeutic, they're just a modern alternative to cigarettes. Of course as with every industry, there will always be some fringe manufacturers around who make wild claims and refuse to follow regulations, but that shouldn't reflect badly on the majority. The lawmaker thinks, oh, you know, that makes sense.

Then they run across CASAA, the biggest group representing vapers, making claims e-cigarettes are therapeutic.

This is a great way to try to win the public, not Washington.

What you refer to as an "ad" is a public service announcement, directed at the public. So, it's whole purpose is to "win the public."

One of the main reasons CASAA formed was to say what manufacturers were forbidden to say per the law - that e-cigarettes help people quit smoking. But we contend that "quit smoking" is not even a therapeutic claim.

The objection to manufacturers making therapeutic claims (ie. a treatment or cure for a disease) is that the claims haven't been evaluated by the FDA and making therapeutic claims pushes the manufacturer under the umbrella of "unapproved drug." This is a restriction placed only on manufacturers, not on advocactes for tobacco harm reduction. There is no law forbidding consumer groups from truthfully telling the public that e-cigarettes are helping millions of people quit smoking.

It's CASAA's position that a product that allows a person to stop smoking by offering a substitute is not a product that is therapeutic in nature. Smoking is not a disease that can be treated or cured. Smoking is an activity that often leads to addiction (which seems to be considered a disease only in some instances) and decades of smoke exposure is what leads to the increased risk of disease. However, the act of smoking is not a disease, it's a behavior.

Drug companies that sell FDA-approved smoking cessation drugs (gums, patches) are really selling treatment for nicotine addiction, by offering a way to wean off of nicotine. Nicotine addiction is considered a "disease" in this context but, ironically, is not considered a "disease" when it comes to determining disability or discrimination. E-cigarette manufacturers should be allowed to state that e-cigs help you "quit smoking," because they are offering a nicotine alternative to smoking conventional cigarettes (not a disease), not a treatment for nicotine addiction (a disease.)

E-cigarette companies stating the devices can help you quit smoking are no more making "therapeutic claims" because smoking can cause diseases than a company selling diet food is making therapeutic claims because it helps reduce obesity and obesity causes disease (ie. diet foods help people "quit eating fatty/high calorie food" and eating fatty/high calorie food is not a disease anymore than inhaling cigarette smoke is a disease. They are activities that increase the risk of disease.)

The fact is, smokers who switch completely to vaping and no longer smoke conventional cigarettes HAVE quit smoking and reduced their health risks. By significantly reducing the health risks, it saves millions of lives. In no way is that a "therapeutic" claim that e-cigarettes are treating or curing any disease. E-cigarettes address the act of smoking. They change a behavior. They do not address an actual addiction to nicotine nor the diseases related to smoking.

This is an important distinction that we have to get to the public and to our lawmakers.

 

[GHB1]

Just saw that the White House has made their positions known, and it's good for us,
White House weakened draft of FDA's proposed tobacco regulations | Reuters
(Reuters) - White House changes to proposed rules for tobacco products significantly weakened language detailing health risks from cigars and deleted restrictions that might have prevented online sales of e-cigarettes, published documents show.

 

[sonicdsl]

Just saw that the White House has made their positions known, and it's good for us,
White House weakened draft of FDA's proposed tobacco regulations | Reuters
(Reuters) - White House changes to proposed rules for tobacco products significantly weakened language detailing health risks from cigars and deleted restrictions that might have prevented online sales of e-cigarettes, published documents show.

That refers to the changes that the OMB had FDA make prior to the April deeming was published. See this thread in Media & General News for discussion on this:
http://www.e-cigarette-forum.com/fo...ens-proposed-fda-e-cigarette-regulations.html

And this thread in the FDA Forum: http://www.e-cigarette-forum.com/fo...e-house-waters-down-fda-proposals-e-cigs.html

 

[bigdancehawk]

Well, that was both rude and arguably incorrect. The Center for Drug Evaluation and Research is the branch of the FDA that monitors drugs and reviews applications for new ones, and when e-cigs are marketed as therapeutic devices (which many of them are), they do fall into its area of responsibility.

I'm sure having vapers tell him he's an idiot made him super friendly, though.

The best cure for ignorance is firm, fact-based rebuttal. I want to cure my ignorance, so please post links to a few of the "many" e-cigarette purveyors marketing their products as a therapeutic devices.

 

[bigdancehawk]

I couldn't recall if I'd written in response to this CFA, so I wrote and added this:

I have no financial stake in this and I know what I'm talking about. I don't have any financial interest in tobacco products, e-cigarette products, pharmaceutical companies, or in any of the many self-styled experts and organizations who have made a very nice living opposing any sort of harm reduction strategy that doesn't benefit big pharmaceutical companies. (I doubt most politicians grasp what motivates these organizations and the extremes they will go to in order to promote their agendas). Rather, I'm merely a consumer and a constituent of yours who smoked at least a pack of cigarettes per day for 45 years. It seems that people like me are not considered "stakeholders" by the regulatory powers and so we are not afforded a seat at the table when decisions which directly impact our lives are being deliberated and implemented. And, incidentally, as far as I can tell, my previous emails to you on this topic have been ignored.

I tried all the FDA approved smoking cessation devices, methods and products. I have even tried hypnotism. I really wanted to stop smoking, but the habit was too strong and I was evidently too weak. And then along came e-cigarettes. Not the little cigarette look-alikes, but the 2nd and 3rd generation products manufactured and sold by small, creative entrepreneurs. As a direct result of these innovative products, I haven't smoked a single cigarette in over 2-1/2 years. I feel much better, I breathe much better, my lung capacity as measured by my doctor is much better, my circulation is much better, I no longer cough, my stamina has vastly improved and I don't smell of cigarette smoke and neither does my house, my office, my car, my closet or my wife.

I have carefully read a great deal of literature on the subject of e-cigarettes. The mound of disinformation and outright lies is astonishing. I feel like a voice crying in the wilderness and that very few people who have the power to influence these decisions are paying the slightest attention. Yet, there are literally millions of lives at stake. Do you have the courage to do something to help these people?