A Letter from Dr Nitzin to the FDA
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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
www.aaphp.org
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 product 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.
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 be 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:
delivery devices to an impossibly stringent safety guideline... will only protect Altria/Philip
Morris cigarette sales and profits."
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 www.aaphp.org 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 www.aaphp.org, "tobacco issues"