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/ScienceResearch/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.

 

[Bill Godshall]

Alert: Urge FDA to protect health of smokers and vapers, not cigarettes

Dockets now available to submit comments urging FDA to protect the health of smokers, not cigarettes

The Citizens Petition by the American Association of Public Health Physicians (AAPHP) urging the FDA to reclassify and regulate electronic cigarettes (nicotine vaporizers) as tobacco products (instead of trying to ban the products by classifying them as drugs or devices) is at Regulations.gov

To submit a comment urging supportive action by the FDA, go to Regulations.gov

Suggested talking points:
- since e-cigarettes (nicotine vaporizers) are derived from tobacco, the FDA can legally reclassify and regulate them as "tobacco products",
- by choosing to classify e-cigarettes as "drugs" or "devices", the FDA was/is attempting to ban the products,
- hundreds of thousands of smokers already have significantly reduced their health risks by switching to e-cigarettes,
- by reclassifying e-cigarettes as tobacco products, the FDA would ban their sale to minors, can establish other reasonable and responsible product regulations, would help to reduce (instead of maintain) cigarette consumption, and would save taxpayers money that FDA continues to waste,
- in SE vs FDA, federal Judge Richard Leon has ruled that the FDA can regulate e-cigarettes as "tobacco products", but not as "drugs" or "devices",
- sales and use of e-cigarettes have continued to sharply increase despite the FDA's ongoing attempt to ban the products,
- banning e-cigarettes would primarily protect cigarette markets at the expense of consumer and public health,
- if applicable, describe your personal experience using e-cigarettes.

- - - -

The Citizens Petition by the American Association of Public Health Physicians (AAPHP) urging the FDA to clarify/correct inaccurate and misleading claims about electronic cigarettes (nicotine vaporizers) made at the FDA's July 22, 2009 press conference, and to truthfully inform the public of existing evidence about the products is now available at Regulations.gov

To submit a comment urging supportive action by the FDA, go to Regulations.gov

Suggested talking points:
- the FDA Electronic Cigarettes grossly mispresented its own laboratory test findings on two brands of e-cigarettes http://www.fda.gov/downloads/Drugs/ScienceResearch/UCM173250.pdf
- in contrast to claims made at the FDA's press conference, there is no evidence that e-cigarettes have ever harmed any user or nonuser, and there is no evidence that e-cigarettes are marketed to youth,
- the FDA failed to acknowledge any evidence (sent to the agency) that e-cigarettes are far less hazardous alternatives to tobacco cigarettes, and that thousands of e-cigarette users informed the agency they had quit smoking by switching to the products,
- cigarette smokers have a human right to truthful information about, and legal access to, less hazardous alternatives,
- FDA officials have an ethical duty to protect consumer health and to provide truthful health risk information,
- if applicable, describe your personal experience using e-cigarettes.

- - - -

More than TWO YEARS have passed since NY State Health Commissioner Richard Daines submitted a Citizens Petition to the FDA at Regulations.gov to (1) allow FDA approved Over The Counter NRT products (i.e. nicotine gums, patches and lozenges) to be sold in all stores that sell cigarettes; (2) allow NRT products to be sold in less expensive daily dose units; and (3) change labels on NRT products to inform consumers of the health benefits of NRT compared to cigarettes, to eliminate unsubstantiated health warnings, and to encourage use of NRT if tobacco use continues.

To submit a comment urging supportive action by the FDA, go to Regulations.gov

Please note that another petition very similar to Richard Daines' petition was recently submitted by SRNT and ATTUD, which is now awaiting docketing by the FDA.

Suggested talking points:
- many more smokers would try using NRT products if they are sold in $5-$10 packages instead of just in $35+ packages,
- more smokers would try using NRT products if they are sold at more retail stores alongside cigarettes,
- current warning labels on NRT products mislead many consumers to believe they pose far greater health/safety risks than is the case,
- NRT products are far less hazardous than cigarettes, and are often used as temporary and/or long term substitutes for cigarettes,
- smokers can reduce their health risks by concurrently using NRT products and cigarettes, with risk reduction proportionate to cigarette reduction,
- many/most NRT products are consumed by people who have used the products longer than the twelve weeks currently approved by the FDA, and
- although clinical trials find that just 7% of NRT users remain smokefree after six months, many NRT users consider them acceptable alternatives to cigarettes.


Bill Godshall
Executive Director
Smokefree Pennsylvania
1926 Monongahela Avenue
Pittsburgh, PA 15218
412-351-5880
smokefree@compuserve.com

 

[NatureBoy]

I don't agree with classifying them as tobacco products either, so unfortunately I cannot sign you first petition. The second one, I have no problems with.

 

[Thyestean]

Comments posted. Thanks to those who keep us informed of such things.

 

[maxx]

Classifying e-cigs as tobacco products just opens the door to excise tax them just like cigarettes....doesn't it? I vape because I can't afford to smoke. Reclassification would just send me back to square one. I also think that is exactly what the FDA wants in the first place....keep the tobacco tax money flowing. Or am I misreading?

 

[LTNuLL]

Classifying e-cigs as tobacco products just opens the door to excise tax them just like cigarettes....doesn't it? I vape because I can't afford to smoke. Reclassification would just send me back to square one. I also think that is exactly what the FDA wants in the first place....keep the tobacco tax money flowing. Or am I misreading?

I am going to have to agree. We were paying twice as much in taxes than the cigarettes. Cigarettes cost $2 a pack other $4 was taxes. I will not pay that for e-cigs and I believe classifying them as tobacco products will lead to the same taxes as all the SOBS want a piece of the pie be it the tobacco pie or e-cigarettes. As long as they get a cut I doubt they care. I will gladly sign the second petition though.

 

[natura]

I read this and see no reason to support this group AAPHP. They are NOT out to help us in my opinion.

excerpt from petition 2
"The tone and content of the initial press conference left the impression that FDA would not
consider either reclassification of E-cigarettes from drug-device combination to tobacco product or
consider a related harm-reduction initiative. FDA is urged to review the content of the two petitions
with consideration of the possibility that the information herein provided will justify a change in the
current FDA stance on these issues."

I wasn't aware they had classified it as a drug device?
No go on both petitions for me. Do not care they misrepresented something a year ago! They made an error? If they do it again- then it's something to talk about.

 

[Bill Godshall]

Per comments by Max, the FDA has no legal authority to tax anything, and the issue doesn't even register on its radar screen.

Although state legislatures and/or US Congress have the authority to tax anything they desire (including drug devices and banned substances/activities), e-cigarette sales are still so tiny that it would cost states and/or the federal government far more money to establish a taxation system for e-cigarettes than they would generate in tax revenue.

Maxx also should understand that the FDA has been trying to ban e-cigarettes by classifying them as unapproved drug devices. Unless the FDA reclassifies and regulates e-cigarettes as tobacco products, there are no assurances that e-cigarettes will remain on the market.

 

[Mister]

Classifying e-cigs as tobacco products just opens the door to excise tax them just like cigarettes....doesn't it? I vape because I can't afford to smoke. Reclassification would just send me back to square one. I also think that is exactly what the FDA wants in the first place....keep the tobacco tax money flowing. Or am I misreading?

Additional taxation on e-cigs in one form or another seems inevitable if/when they gain recognized legitimacy. But note that the petition repeatedly emphasizes moving toward treatment of e-cigs as reduced harm tobacco products. Recognition of this aspect of tobacco control will pave the way for lower taxation than that which applies to cigarettes. Once reduced harm is recognized as a goal, it will be apparent that taxation should be lower for lower harm products to encourage switching.

Also note that if taxation were the main thing motivating the FDA in regard to e-cigs they'd have classified them as tobacco products long ago, and there's nothing any of us could do to stop that. It is the least harmful (to vapers) possible outcome at the moment.

 

[maxx]

That first petition is giving away the store IMO. It seems to be based on the assumption (a huge one) that people are moving to vapor for health reasons only. Classify as tobacco products....and we will pay the same as smokes...AND....they will also be banned in public just like cigs. I'm sorry...but not only would I not sign that first petition, I would be more inclined to sign a petition that directly countered it. It's a sell-out to the FDA.

 

[natura]

Per comments by Max, the FDA has no legal authority to tax anything, and the issue doesn't even register on its radar screen.

Although state legislatures and/or US Congress have the authority to tax anything they desire (including drug devices and banned substances/activities), e-cigarette sales are still so tiny that it would cost states and/or the federal government far more money to establish a taxation system for e-cigarettes than they would generate in tax revenue.

Maxx also should understand that the FDA has been trying to ban e-cigarettes by classifying them as unapproved drug devices. Unless the FDA reclassifies and regulates e-cigarettes as tobacco products, there are no assurances that e-cigarettes will remain on the market.

There isn't any assurances EITHER WAY