Comments Please on AAPHP Petitions to FDA

[Vocalek]

This just in from Dr. Nitzkin:

About two weeks ago I submitted two tobacco-related petitions to FDA. The first requested that FDA reclassify electronic cigarettes from a drug to a tobacco product. The second requested a follow-up press conference to correct errors and misinterpretations of errors in their July 22, 2009 press conference. That press conference left many with the erroneous impressions that E-cigarettes might be more harmful than conventional cigarettes, that they are being marketed to teens, and that there is no information available to address these issues.

Neither I nor AAPHP have any financial relations ship with any tobacco-related or pharmaceutical enterprise. I have addressed this issue on behalf of the AAPHP Tobacco Control Task Force because of our perception that the possibility exists to save the lives of 4 million of the 8 million adult American smokers who will otherwise die of a tobacco related illness over the next 20 years. Per our analysis, the only way we can achieve this huge public health benefit will be through addition of a harm reduction initiative to current tobacco control programming by which current smokers are informed of the differences in risk profile presented by different types of tobacco products. In that context, e-cigarettes appear to be the very-low-risk product likely to be acceptable to most current smokers. With strict FDA regulation of manufacturing and marketing -- it should be possible to achieve this public health benefit without increasing the numbers of teens initiating tobacco use. FDA regulation of this product as a drug would mean a de-facto ban until clinical trials not required of other tobacco products can be completed.

Please note that the provisions of the newly adopted FDA/Tobacco law will require that FDA grant full FDA approval to currently marketed conventional cigarettes, and that the Supreme Court is virtually sure to rule that FDA cannot prevent the cigarette manufacturers from informing smokers of the FDA approval. Thus, the standard for comparison regarding the safety of alternate nicotine delivery products should not be the usual drug safety standards -- it should be in comparison with conventional cigarettes.

The two petitions (about 20 pages each) plus a common set of attachments (303 pages) are posted on the tobacco issues page of our www.aaphp.org web site. The petitions, but not the attachments are accessible and available for comment on the www.regulations.gov web site. To access the petitions there, go to www.regulations.gov and type in the docket number in the Keyword field. The docket number for the petition to reclassify is FDA-2010-P-0095-0001. The docket number for the petition regarding the press conference is FDA-2010-P-0093-0001.

Joel L. Nitzkin, MD, MPH, DPA
Chair AAPHP Tobacco Control Task Force
(AAPHP = American Association of Public Health Physicians)

[Vocalek]

My comment on the FDA Lab Report petition, entered as "Individual Consumer".

The FDA lab report (http://www.fda.gov/downloads/Drugs/S.../UCM173250.pdf) has been cited in numerous news stories as "proof" that smoking tobacco cigarettes is less hazardous than using an electornic cigarette.

As a result, countless smokers who were considering substituting vaporized nicotine for inhaling tobacco smoke decided to continuing inhaling tar, CO, particulates, heavy metals, thousands of toxins, and hundreds of carcinogens along with their nicotine. I sincerely hope that this was an unintended consequence.

The harm that has been done is incalculable. Do the right thing.

If it is too embarassaing to print the truth about the study conducted in May 2009, then conduct a new study. Compare the output from an electronic cigarette to the smoke from an equivalent number of tobacco cigarettes. Provide what was missing in the May 2009 toxicology report: quantitative analysis. Smokers should be told that 20 cigarettes deliver 5,500 to 11,000 ng/g of TSNAs, compared to 8 ng/g in a 16 mg. cartridge from an e-cigarette. Smokers should be told the substances (and quantities) delivered by smoke that are absent in the vaporized nicotine.

Tell the public that although this product cannot be declared "safe" in an absolute sense, it is thousands of times less hazardous than continued smoking.



Comment Tracking Number: 80ab3df9

[Mister]

This is simply awesome! The work Dr. Nitzkin and those helping him have done on these petitions is wonderful, deserving of all the thanks we can give. As well as what their immediate purpose is, the petitions and attachments are a treasure trove of useful information about smoking harm reduction.

[Katmar]

And Vocalek is a TREASURE herself.

[trailblazer6]

And Vocalek is a TREASURE herself.

I Agree 200%. Thank you Vocalek for your diligence. I for one am proud of the level of professionalism our Board and member staff of CASAA.org present. My hat is off, My glass is raised high. Vocalek, May you never lose your passion for bringing truth to the light.

[Vocalek]

A lot of work went on behind the scenes to provide AAPHP with references. I'm not going to attempt to name all the names, for fear of leaving someone out. Suffice it to say there was a cooperative effort by CASAA and other activist groups.

I grew up in Cleveland (yes, Ohio) where the Scripps-Howard newspaper had as its motto: Give light and the people will find their own way.

[nojoyet]

Mister, Katmar and Trailblazer said it and I agree 100%.

Thank you to all involved

My comment, as an individual consumer, briefly said
- no justification to classify as drug delivery device.
- that FDA should be actively supporting availablity of this public health opportunity.
- taxed lower with resulting lower consumer cost to encourage switch to e-cig.

80ab465e

[CES]

Here's mine:

I would like to share my experience with using an electronic cigarette (e-cig) . I began using an e-cig in October 2009 as a method for allowing myself to continue to utilize nicotine without the harm associated with smoking combustible cigarettes. The harm reduction aspects, in my case, have been strong. My blood pressure (systolic and diastolic) has decreased 10 points, my hemoglobin has decreased to the middle of the normal range, and my ability to breathe deeply without coughing has also improved.
I am PhD researcher who studies and has published papers about the effects of activation of neuronal nicotinic receptors. I am thus well acquainted with the literature related to endogenous cholinergic systems, as well as those that are affected by nicotine use and/or smoking. Studies of smoking as mechanisms for learning about the effects of exogenous nicotine are strongly confounded by the additional chemicals and products of combustion associated with smoking. Additionally, anticholinergic agents are used in the treatment of Alzheimer’s disease and glaucoma, thus activation of nicotinic receptors in and of themselves is not always harmful. Although the studies in the use of e-cigs are currently limited, classification of e-cigs as drug delivery devices would result in my return to smoking cigarettes, as approved NRTs did not work for me. Unfortunately one of those studies is the highly publicized FDA study, the conclusions of which appear to say that the products of smokes/combustion are safer for me to inhale than the vapor produced by e-cigs.
Yes, it is incongruous that an individual who studies the cholinergic system is/was a long-term smoker. It seems no less incongruous than the fact that other tobacco products, “proper” use of which results in the inhalation of over 4000 chemicals, some of which are well known to be toxic and carcinogenic, remain easily accessible, and will likely soon be marketed as “FDA approved”.

Comment tracking number 80ab487a

[cruisedoc]

Remember all of this next Nov. when we have the opportunity to vote for smaller, less in-your-face government. Let's cut the agency budgets in half, especially the FDA. They are there to work FOR us, not against our best interest. The e-cig remains the only thing to ever work in getting me off of regular cigarettes. One would think that the FDA and ant-smoking lobby would embrace the e-cig. This folks is not what gov. is for. I deserve the freedom to make my own personal choices, without 'big brother' out there to protect me. Dr. E.G.

[DC2]

For the first petition...

I am strongly in favor of NOT regulating electronic cigarettes as drug devices. If that were to happen, I would be sent back to smoking Camel Lights until electronic cigarettes are once again approved. This, in spite of the fact that I have been free from cigarettes for over eight months now. And when they are finally approved it is most likely they would be have been rendered completely useless, just like all other smoking cessation products. The end result therefore being that I will never be able to quit smoking again.

And for the second...

It is hard to understand the misleading conclusions draw from the FDA testing in question. And it is disturbing beyond words the way those conclusions were presented to the media for mass consumption. There are millions of lives as stake, and countless numbers of those lives can and will be saved if a press conference were held to correct the obvious misrepresentations of the test results, and the erroneous conclusions being drawn by both the media and the public at large.