Help me draft a response to the FDA

[TokenVapor]

My letter to the FDA was forwarded to the Center for Drug Evaluation and Research (CDER). Their response follows. I would like help to respond with an accurate and informed rebuttal. Feel free to contact them @:
CDER DRUG INFO (DRUGINFO@fda.hhs.gov)

Thanks

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Thank you for writing the Division of Drug Information, in the FDA's Center for Drug Evaluation and Research.
At this time, we are not aware of any data establishing electronic cigarettes, cigars, or pipes as safe and effective for their intended uses. Based upon our review of a number of these products, they are drug/device combinations that require approval by FDA before they may be legally marketed in the United States.

None of these so-called electronic cigarettes, cigars, and pipes, or their components has been approved by FDA. Therefore, the marketing of them in the United States is subject to enforcement action. As a matter of policy, however, we limit communications about the regulatory status of specific marketed products to those responsible for them, and we do not discuss our enforcement actions except with the targets of those actions.

There may be a perception among some users that electronic cigarettes, cigars, or pipes are safer alternatives to conventional tobacco products. There may also be a perception that these products are a safe and effective means to quit smoking conventional forms of tobacco. However, FDA is not aware of any scientific data to support those perceptions. Since these products have not been submitted to the FDA for evaluation or approval, the agency has no way of knowing, except for the limited testing it has performed, the levels of nicotine or the kinds and amounts of other chemicals that the various brands of these products deliver to the user. The FDA’s Division of Pharmaceutical Analysis analyzed the ingredients in a small sample of cartridges from two leading brands of electronic cigarettes. In one sample, the FDA’s analyses detected diethylene glycol, a chemical used in antifreeze that is toxic to humans, and in several other samples, the FDA analyses detected carcinogens, including nitrosamines. FDA also found varying levels of nicotine in cartridges labeled as containing the same level of nicotine as well as the presence of nicotine in cartridges labeled as containing no nicotine. These test results indicate that these products are manufactured under inadequate or non-existent controls.

FDA is concerned that electronic cigarettes, cigars, or pipes may introduce young people to nicotine use which may lead to an increase in the use of conventional tobacco products with well-known, adverse, health consequences. Additionally, it is unclear what health effects these products could have on users or if misuse or product failure could lead to nicotine poisoning or other serious adverse health consequences.

There are a number of proven safe and effective cessation aids that smokers can use to quit smoking. The U.S. Public Health Service’s, Treating Tobacco Use and Dependence: 2008 Update recommends using a combination of proven cessation interventions including FDA-approved nicotine replacement therapy and/or non-nicotine medications and counseling to more than double a smoker’s chances of quitting successfully. Free help is available to smokers in all states by calling 1-800-QUIT-NOW or by visiting www.smokefree.gov.

Again, we appreciate the time that you have taken to contact us.

Best regards,

 

[Vocalek]

Challenge the claim of "effectiveness" for the FDA-approved medications. Talk of your own personal experience. Which products--and combinations of products--failed to help you quit? How many years did you smoke? How many years went by as you tried and failed repeatedly to quit smoking? Then hit him with the research:

Researchers performed a meta-analysis of NRT treatments and found that quit rates at one year average 10.7% (6.6% to 14.8%) declining further to an average of 7.2% (3.8% to 11.3%) at 4.3 years follow up. The authors concluded, "Because the long-term benefit of NRT is modest, tobacco dependence treatment might be better viewed as a chronic disorder, requiring repeated episodes of treatment."

Etter, et al (2006). Nicotine replacement therapy for long-term smoking cessation: a meta-analysis. Tobacco Control 2006;15:280-285.
http://tobaccocontrol.bmj.com/content/15/4/280.abstract

Unlike the FDA-approved NRT products, electronic cigarettes are not intended to be a treatment to cure cigarette smokers of nicotine addiction. Since the intended use is not medicinal, there is no reason the products should be subject to FDA approval. They are intended to serve as a replacement for smoking tobacco.

They work extremely well for this purpose, as over 80% of regular e-cigarette users report that they have stopped smoking tobacco cigarettes altogether. But even if they only worked for 50% or 20% of users, they would still be several times more effective than the FDA's nicotine weaning approach.

Next, challenge the FDA's conclusion that the products are unsafe. Point out that you are no longer inhaling tar, carbon monoxide, heavy metals, and particulates found in smoke from burning tobacco. The FDA did not find these substances in the vapor, and these are the substances that cause the lung disease, cancer, and cardiovascular disease associated with smoking.

Describe the effect switching away from tobacco smoke has had on your health.

Point out that you are much less worried about cancer, now that the product you are using contains the same amount of nitrosamines found in the FDA-approved nicotine patch (0.8 ng/g), instead of the 6,600 ng/g of nitrosamines found in a single Marlboro cigarette.

Ask him if he has some reason to believe that -- for those who can't give up nicotine -- smoking tobacco is safer than using an electronic cigarette; and if so, what evidence there is for this belief.

 

[Vapor Pete]

Challenge the claim of "effectiveness" for the FDA-approved medications. Talk of your own personal experience. Which products--and combinations of products--failed to help you quit? How many years did you smoke? How many years went by as you tried and failed repeatedly to quit smoking? Then hit him with the research:

Researchers performed a meta-analysis of NRT treatments and found that quit rates at one year average 10.7% (6.6% to 14.8%) declining further to an average of 7.2% (3.8% to 11.3%) at 4.3 years follow up. The authors concluded, "Because the long-term benefit of NRT is modest, tobacco dependence treatment might be better viewed as a chronic disorder, requiring repeated episodes of treatment."

Etter, et al (2006). Nicotine replacement therapy for long-term smoking cessation: a meta-analysis. Tobacco Control 2006;15:280-285.
http://tobaccocontrol.bmj.com/content/15/4/280.abstract

Unlike the FDA-approved NRT products, electronic cigarettes are not intended to be a treatment to cure cigarette smokers of nicotine addiction. Since the intended use is not medicinal, there is no reason the products should be subject to FDA approval. They are intended to serve as a replacement for smoking tobacco.

They work extremely well for this purpose, as over 80% of regular e-cigarette users report that they have stopped smoking tobacco cigarettes altogether. But even if they only worked for 50% or 20% of users, they would still be several times more effective than the FDA's nicotine weaning approach.

Next, challenge the FDA's conclusion that the products are unsafe. Point out that you are no longer inhaling tar, carbon monoxide, heavy metals, and particulates found in smoke from burning tobacco. The FDA did not find these substances in the vapor, and these are the substances that cause the lung disease, cancer, and cardiovascular disease associated with smoking.

Describe the effect switching away from tobacco smoke has had on your health.

Point out that you are much less worried about cancer, now that the product you are using contains the same amount of nitrosamines found in the FDA-approved nicotine patch (0.8 ng/g), instead of the 6,600 ng/g of nitrosamines found in a single Marlboro cigarette.

Ask him if he has some reason to believe that -- for those who can't give up nicotine -- smoking tobacco is safer than using an electronic cigarette; and if so, what evidence there is for this belief.

Couldnt have said it better! Nice post Volcalek. I nominate you for our new spokeswomen!

My best,
-VP

 

[TokenVapor]

Thanks Vocalek!! I will start drafting my response tonight when I return.

 

[Thulium]

Point out that you are much less worried about cancer, now that the product you are using contains the same amount of nitrosamines found in the FDA-approved nicotine patch (0.8 ng/g), instead of the 6,600 ng/g of nitrosamines found in a single Marlboro cigarette.

I don't want this point to get passed over. Note that the measurement at play here is by weight (grams). Each Marlboro cigarette has about a gram of tobacco, therefore a pack-a-day smoker is subjecting themself to 132,000ng compared to a 1ml/day vaper who gets less than one nanogram.

Most people have referred to e-cigarettes as being 99.9% "safer" than analogs...But if the numbers you have here are correct, then aside from the fact that e-juice doesn't have most of the thousands of toxins in smoke....the one known toxin left is reduced by 99.99924% (Even if you vape 3 grams of e-liquid to replace 20g of tobacco, its still just 2.4ng vs 132,000ng for a 99.99818% reduction)

 

[SusanB]

great arguments Vocalek

 

[Vocalek]

I don't want this point to get passed over. Note that the measurement at play here is by weight (grams). Each Marlboro cigarette has about a gram of tobacco, therefore a pack-a-day smoker is subjecting themself to 132,000ng compared to a 1ml/day vaper who gets less than one nanogram.

Most people have referred to e-cigarettes as being 99.9% "safer" than analogs...But if the numbers you have here are correct, then aside from the fact that e-juice doesn't have most of the thousands of toxins in smoke....the one known toxin left is reduced by 99.99924% (Even if you vape 3 grams of e-liquid to replace 20g of tobacco, its still just 2.4ng vs 132,000ng for a 99.99818% reduction)

I love your math skills.

 

[kinabaloo]

Good points VocalEK and Thullium

On the 'might lead to smoking': this sounds fair at first, though unlikely; but when one considers it is even easier to just go straight to smoking, it doesn't really make sense. At the end of the day it's about weighing up risks and benefits.

 

[oldlady]

It looks like Vocalek and Thulium have it pretty much covered. However, you may want to cite some of Michael Seigel's (University of Boston) work, comparing e-cigs with a variety of NRTs and tobacco. Also, the work the American Association of Physicians has done to call out the FDA on it's studies (which do sort of reek of Big Pharma corruption) is very impressive.

Bill Godshall has posted some good links, etc. in the thread about Marion County.

Can't wait to see what you come up with!

 

[TokenVapor]

Response so far:

The intended use of electronic cigarettes is to eliminate the risk of developing the health problems associated with inhaling cigarette smoke, without eliminating the physical and mental addiction. Regardless of what you have been told or led to believe. They are neither a smoking cessation device nor are they a nicotine replacement therapy. Therefore, by definition, they do not require the approval of the FDA.

The data on the harmful effects of cigarette smoke, as well as the known chemicals and carcinogens it contains, is a well established fact and very well documented. I’m surprised that the FDA chose to ignore that data when evaluating the relative safety of the electronic cigarette during the review process.

 

[HeyYouComOvrHere]

You know, the FDA keeps talking about the one chemical found in the two carts...the diethylene glycol. Is there any way to create a long list of the chemicals found in regular cigarettes and then have two columns, one for e-cigs and one for analog cigs and simply say "Yes" or "No" next to each chemical? I would image you will end up with one LOOOOOONG column of YES's for analogs and a LOOOOOONG list of NO's for e-cigs. Then, take a percentage. Of the 4,000 chemicals found in analog cigarettes, 3,987 of them are bad which is approximately 99.9999999235% (I made that number up ) Of the 10 chemicals found in e-cigs, 1 is bad which is 10%....you do the math Mr. FDA. Wouldn't THAT be a nice little metric to throw at them? I'm not sure why no one has done that before...

 

[HeyYouComOvrHere]

The only other thing I would caution you on is, WHO is the person you are talking to? Is it some lacky in the FDA that is just simply going to email back and forth with you until they get tired of talking? Or will they forward it to the appropriate person. I would almost suggest you CC the lawyers for NJOY and SMoking Everywhere with WHATEVER you send the FDA...they could probably USE whatever fire power you come up with in their case....THAT is where the decision ultimately will need to be rendered...

 

[Bill Godshall]

The FDA's letter stated:

"There may be a perception among some users that electronic cigarettes, cigars, or pipes are safer alternatives to conventional tobacco products. There may also be a perception that these products are a safe and effective means to quit smoking conventional forms of tobacco. However, FDA is not aware of any scientific data to support those perceptions."

The last sentence is inaccurate, as I sent the FDA (back in May) laboratory studies on the Ruyan e-cigarette, the petition with several thousand testimonials by e-cigarette users, and links to this and other websites/blogs with far more testimonials.

Subsequent laboratory tests and surveys also have been sent to the FDA.

In sum, the FDA is lying.

 

[HeyYouComOvrHere]

Bill,

Is there a way you can point us to where the information is you sent to the FDA? I personally would LOVE to send copies to my local paper, the Washington Post, as well as my local congressmen.

 

[KermieD]

Challenging them on their own turf is silly and is guaranteed to land your reply in their trash pile. Simply reply that you live in the USA and that, while you can respect their assertion that the FDA has not demonstrated the safety of an e-cigarette, they have not demonstrated that they are unsafe as well. As such, until the FDA can demonstrate that an e-cigarette is unsafe, by over 200 years of precedent if not by law, there should be no reason to restrict the use of an e-cigarette beyond any age restrictions that have to do with any product containing nicotine.

The fact is that, right now, we're on the losing side of the science. Nobody's done a study in our defense. All we have is another lab putting out a document trying to say the FDA was stupid and even then, the only real arguments against the study are the size of the study and the lack of a control reference, which, for real science is damning, for governmental studies is the equivalent of going all PeeWee Herman on their butts. Frankly, every government agency in existence gets attacked like that every single day by some special interest group or another and they all end up in the trash.

You should just reply that, until any dangers ARE properly and scientifically established, the practice should not be restricted in any way. Should any dangers be identified by thorough and appropriate scientific study, both via primary and secondary exposure, then and only then should any restriction take place.

 

[TokenVapor]

This is what I went with:

To Whom It May Concern,

"At this time, we are not aware of any data establishing electronic cigarettes, cigars, or pipes as safe and effective for their intended uses."
http://www.healthnz.co.nz/RuyanCartridgeReport30-Oct-08.pdf
The data is out there, you are simply ignoring it. I'm sure your inbox is flooded by now with evidence supporting the use of electronic cigarettes

The intended use of electronic cigarettes is to eliminate the risk of developing the health problems associated with inhaling cigarette smoke, without eliminating the physical and mental addiction. The efficacy of the product is clear. Regardless of what you have been told or led to believe. They are neither a smoking cessation device nor are they a nicotine replacement therapy.

The FDA has not proven that electronic cigarettes are unsafe with respect to the dangers of cigarette smoke. Any restrictions should be lifted or remain non-implemented until such time as they can be proven otherwise.

Sincerely,
.../George E. Seder