- Apr 2, 2009
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AAPHP sent the following letter to the FDA today.
From: Joel Nitzkin
To: Heather.Zawalick@fda.hhs.gov
Sent: Friday, May 01, 2009 11:18 AM
Subject: Please Cancel Proposed FDA Ban on Electronic Cigarettes
American Association of Public Health Physicians
The voice of public health physicians, guardians of the public's health
tobacco Control Task Force
Joel L. Nitzkin, MD, MPH, DPA - Chair, AAPHP TCTF
504 899 7893 or 800 598 2561; E-mail: jln@jln-md.com
Tobaccolegfeb07
May 1, 2009
To: Heather Zawalick
Healther.Zawalick@fda.hhs.gov
Subject: Please Cancel Proposed Ban on Electronic Cigarettes
Ms. Zawalick:
In my capacity as Chair of the tobacco Control Task Force of the American
Association of Public Health Physicians, I must vigorously oppose the
proposed FDA ban on electronic cigarettes.
Our objection to this proposed FDA action is based entirely on the
anticipated impact of such a ban on future tobacco-related illness and
death among current adult smokers. As I understand the FDA logic related to
this proposed ban, it is based entirely on the undocumented assumption that
electronic cigarettes may have the potential to attract additional
teenagers to nicotine use and addiction. I respectfully suggest that, if
this is the FDA concern, there are ways to address this in the context of
legislation now under consideration in the Senate that would inhibit teen
use of such products while allowing current adult smokers who are unwilling
or unable to quit to enjoy the health benefits this product can offer.
Among the many manufacturers and vendors of electronic cigarettes there may
be some who make unjustified claims of health benefits. While it would be
appropriate for FDA to address those manufacturers and vendors relative to
their specific claims, banning all electronic cigarettes would not benefit
the health of the public.
Conventional cigarettes kill about 400,000 adult American Smokers each year
from cigarette-related illness. Over the next 20 years this will total 8
million deaths among current adult smokers, most of which are now over 35
years of age. Cigarettes kill about 30% of consistent adult cigarette
smokers.
Smoking cessation rates among these smokers are abysmal - about 3% per
year. Pharmaceutical products with counseling, quit lines, etc, are little
better - resulting in quit rates no greater than 5% (as measured at 12
months post-intervention) among those willing to try these modalities. In
other words, current approaches fail 95% of smokers using them.
Adult American smokers are health conscious, as evidenced by the fact that
about 85% of them have switched to light and low-tar cigarettes, believing
(incorrectly) that they pose less health risk.
Research to date has clearly demonstrated that smokers smoke because they
are addicted to nicotine. This same research also shows that the illness
and death due to cigarettes is not due to the nicotine, but due to products
of combustion and, to a lesser degree, toxins in the cigarette tobacco.
Alternative nicotine delivery devices, including, but not limited to
electronic cigarettes, have no products of combustion and none of the
toxins in cigarette tobacco. On at least a theoretical basis, they could
and should be seen as generic equivalents of the pharmaceutical nicotine
products. As best we can tell, on the basis of currently available research
data, these products promise a risk of illness and death well under 1% of
the risk posed by cigarettes.
Stated another way - simply informing current adult smokers that they could
dramatically reduce their risk of tobacco related illness and death by
switching to alternative near-zero-risk nicotine delivery products could
possibly save 4 million or more of the 8 million current smokers who will
otherwise die of a tobacco-related illness over the next 20 years.
The Senate now seems poised to pass an FDA/Tobacco bill (H.R.1256 in the
House). This bill, if passed in its current form will provide, at least on
an interim basis, the FDA seal of approval on currently marketed
cigarettes. That being the case, the safety standard that should be used
for other tobacco products, and for alternative non-pharmaceutical nicotine
delivery devices, should the hazard posed by cigarettes, not a
pharmaceutical safety guideline.
All tobacco and nicotine delivery devices should be held to the same safety
guideline. Exempting cigarettes, while holding alternative nicotine
delivery devices to an impossibly stringent safety guideline, will not
protect current American smokers. It will only protect Altria/Philip
Morris cigarette sales and profits.
On behalf of the Tobacco Control Task Force of the American Association of
Public Health Physicians, I therefore urge to consider the following:
1. Withdraw of the proposed ban on electronic cigarettes.
2. Amendment of the proposed FDA/Tobacco bill to encourage the development
and marketing of safer alternatives to cigarettes, under strict but fair
FDA oversight, and with marketing restrictions in place to reduce the
numbers of adolescents who initiate use of cigarettes and other nicotine
delivery products.
The amendments we think will achieve these goals, and the results of our
analyses and literature reviews, are posted on the tobacco issues page of
our Tobaccolegfeb07 web site.
Joel L. Nitzkin, MD, MPH, DPA, FACPM
Chair, Tobacco Control Task Force
American Association of Public Health Physicians
c/o JLN, MD Associates LLC
jln@jln-md.com
office phone 504 899 7893
fax 504 899 7557
cell phone 504 606 7043
see Tobaccolegfeb07, "tobacco issues"
From: Joel Nitzkin
To: Heather.Zawalick@fda.hhs.gov
Sent: Friday, May 01, 2009 11:18 AM
Subject: Please Cancel Proposed FDA Ban on Electronic Cigarettes
American Association of Public Health Physicians
The voice of public health physicians, guardians of the public's health
tobacco Control Task Force
Joel L. Nitzkin, MD, MPH, DPA - Chair, AAPHP TCTF
504 899 7893 or 800 598 2561; E-mail: jln@jln-md.com
Tobaccolegfeb07
May 1, 2009
To: Heather Zawalick
Healther.Zawalick@fda.hhs.gov
Subject: Please Cancel Proposed Ban on Electronic Cigarettes
Ms. Zawalick:
In my capacity as Chair of the tobacco Control Task Force of the American
Association of Public Health Physicians, I must vigorously oppose the
proposed FDA ban on electronic cigarettes.
Our objection to this proposed FDA action is based entirely on the
anticipated impact of such a ban on future tobacco-related illness and
death among current adult smokers. As I understand the FDA logic related to
this proposed ban, it is based entirely on the undocumented assumption that
electronic cigarettes may have the potential to attract additional
teenagers to nicotine use and addiction. I respectfully suggest that, if
this is the FDA concern, there are ways to address this in the context of
legislation now under consideration in the Senate that would inhibit teen
use of such products while allowing current adult smokers who are unwilling
or unable to quit to enjoy the health benefits this product can offer.
Among the many manufacturers and vendors of electronic cigarettes there may
be some who make unjustified claims of health benefits. While it would be
appropriate for FDA to address those manufacturers and vendors relative to
their specific claims, banning all electronic cigarettes would not benefit
the health of the public.
Conventional cigarettes kill about 400,000 adult American Smokers each year
from cigarette-related illness. Over the next 20 years this will total 8
million deaths among current adult smokers, most of which are now over 35
years of age. Cigarettes kill about 30% of consistent adult cigarette
smokers.
Smoking cessation rates among these smokers are abysmal - about 3% per
year. Pharmaceutical products with counseling, quit lines, etc, are little
better - resulting in quit rates no greater than 5% (as measured at 12
months post-intervention) among those willing to try these modalities. In
other words, current approaches fail 95% of smokers using them.
Adult American smokers are health conscious, as evidenced by the fact that
about 85% of them have switched to light and low-tar cigarettes, believing
(incorrectly) that they pose less health risk.
Research to date has clearly demonstrated that smokers smoke because they
are addicted to nicotine. This same research also shows that the illness
and death due to cigarettes is not due to the nicotine, but due to products
of combustion and, to a lesser degree, toxins in the cigarette tobacco.
Alternative nicotine delivery devices, including, but not limited to
electronic cigarettes, have no products of combustion and none of the
toxins in cigarette tobacco. On at least a theoretical basis, they could
and should be seen as generic equivalents of the pharmaceutical nicotine
products. As best we can tell, on the basis of currently available research
data, these products promise a risk of illness and death well under 1% of
the risk posed by cigarettes.
Stated another way - simply informing current adult smokers that they could
dramatically reduce their risk of tobacco related illness and death by
switching to alternative near-zero-risk nicotine delivery products could
possibly save 4 million or more of the 8 million current smokers who will
otherwise die of a tobacco-related illness over the next 20 years.
The Senate now seems poised to pass an FDA/Tobacco bill (H.R.1256 in the
House). This bill, if passed in its current form will provide, at least on
an interim basis, the FDA seal of approval on currently marketed
cigarettes. That being the case, the safety standard that should be used
for other tobacco products, and for alternative non-pharmaceutical nicotine
delivery devices, should the hazard posed by cigarettes, not a
pharmaceutical safety guideline.
All tobacco and nicotine delivery devices should be held to the same safety
guideline. Exempting cigarettes, while holding alternative nicotine
delivery devices to an impossibly stringent safety guideline, will not
protect current American smokers. It will only protect Altria/Philip
Morris cigarette sales and profits.
On behalf of the Tobacco Control Task Force of the American Association of
Public Health Physicians, I therefore urge to consider the following:
1. Withdraw of the proposed ban on electronic cigarettes.
2. Amendment of the proposed FDA/Tobacco bill to encourage the development
and marketing of safer alternatives to cigarettes, under strict but fair
FDA oversight, and with marketing restrictions in place to reduce the
numbers of adolescents who initiate use of cigarettes and other nicotine
delivery products.
The amendments we think will achieve these goals, and the results of our
analyses and literature reviews, are posted on the tobacco issues page of
our Tobaccolegfeb07 web site.
Joel L. Nitzkin, MD, MPH, DPA, FACPM
Chair, Tobacco Control Task Force
American Association of Public Health Physicians
c/o JLN, MD Associates LLC
jln@jln-md.com
office phone 504 899 7893
fax 504 899 7557
cell phone 504 606 7043
see Tobaccolegfeb07, "tobacco issues"
