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American Association of Public Health Physicians writes on behalf of Electronic Cigarettes to the FDA

Aaron — Sun, 02 May 2010 02:40:50 +0000

For the past half century, the American Association of Public Health Physicians (AAPHP) has served as the national voice of physician directors of state and local health departments and other like-minded physicians. We have long been involved with tobacco control, with the singular goal of doing everything in our power to reduce tobacco related illness and death.

As you assume leadership of the new FDA Center for Tobacco Products, we urge you to consider the actions FDA can take, within the powers granted by this new legislation, to rapidly and substantially reduce tobacco related illness and death in current adult smokers.

Unfortunately, FDA has not gotten off to a good start. FDA condemnation of electronic cigarettes, in its July 22 press conference, and FDA insistence that electronic cigarettes should be regulated as a drug/device combination rather than as a tobacco product makes no sense from a public health perspective. It flies in the face of FDA laboratory findings on other products already approved by FDA. If one looks at electronic cigarettes as a sentinel for all tobacco products less hazardous than conventional cigarettes – the outlook for FDA action reducing tobacco-related illness and death among current adult smokers is dismal.

With this in mind, we respectfully request your consideration of the following actions:

1. We urge FDA to make public the laboratory data behind the July 22 condemnation of electronic cigarettes, along with comparable data on pharmaceutical nicotine products and conventional cigarettes. Then, on the basis of these data, either fully justify or retract the July 22 condemnation of electronic cigarettes.

2. We urge FDA to reclassify electronic cigarettes from a drug/device combination to a tobacco product. This will enable FDA to immediately regulate manufacturing and impose marketing restrictions during this initial period of FDA Tobacco Center development. This reclassification will eliminate pressure on the several hundred thousand current American users of electronic cigarettes to switch back to the much more hazardous conventional cigarettes.

This year, about 400,000 American adult cigarette smokers will die of a tobacco-related illness. Their second hand smoke will kill about 48,000 non-smokers. About 700 more will die in residential fires. Despite progress on other measures of tobacco use, per CDC estimates, this death count continues to inch up from year to year. In contrast, even though smokeless tobacco products represent about 20% of nicotine intake in the United States, the number of deaths per year from these products is too small for reliable estimates from the CDC.

Our (AAPHP) best estimate is that smokeless tobacco products currently cause about 700 cancer deaths per year in the United States. This is less than 1% of the more than 110,000 deaths that would occur each year if smokeless products carried the same mortality as conventional cigarettes.

This last week, Boffetta and Straif published a paper alleging evidence of an increased risk of fatal heart disease and stroke among smokeless tobacco users. This is a study sure to be referenced by those seeking evidence of the harmfulness of smokeless tobacco products. Unfortunately, this study suffers from major technical and ethical flaws, including failure to note in the abstract that they found no increased risk of non-fatal heart attack or stroke. Even worse, of the many studies reviewed, only two showed evidence of even a slight increase in risk of death – and these were the ones selected for the conclusion and abstract. That having been said, their allegations of a 13% increase in risk of fatal heart attack and 40% increase in risk of fatal stroke pale in comparison with the 180% to 300% increases in risk for men and women 35-64 years of age posed by smoking conventional cigarettes.

Contrary to prevailing conventional wisdom, virtually all the heart and lung disease from conventional cigarettes, and an estimated 98% of the cancer mortality, are due to direct inhalation of fresh products of combustion deep into the lung. Our best estimate (based on the work of Pankow et al and others) is that only about 2% of the cancer mortality from cigarettes is from the named carcinogens commonly found in tobacco products. Smokeless tobacco products carry little or no risk of heart disease and no risk of lung disease. They do not kill innocent bystanders and they do not burn down houses. The risk of cancer of any kind from smokeless products ranges from a high of about 5% of the risk of cancer posed by conventional cigarettes to a low well under 1% of the risk of cancer posed by conventional cigarettes. While definitive studies have not been done, we have reason to believe that tobacco products, such as electronic cigarettes, consisting of nicotine extracted from tobacco with only trace amounts of other chemical substances, should carry even less risk.

Most of the discussion to date around the new FDA/Tobacco bill has focused on reducing initiation of nicotine use by children and teens. The only discussion of current smokers has been limited to encouraging use of pharmaceutical products to aid cessation. This has been touted as doubling quit rates – but without mentioning that this doubling is from about 3% to about 5% per year. In other words, this option fails 95% of smokers willing to try it, even under study conditions with optimal counseling.

It should be possible to save the lives of 4 million or more of the 8 million adult American smokers who will otherwise die of a cigarette-related illness over the next twenty years. This could be done by making smokers aware of selected smokeless tobacco products (including but not limited to snus and electronic cigarettes) that promise to reduce the risk of tobacco-related illness by 99% or better for smokers who are unwilling or unable to quit. Rather than discouraging nicotine cessation, however, such an approach, even with no medical intervention, would be expected to triple the rate at which current smokers eventually discontinue their nicotine use.

Those writing the new FDA legislation endorsed a harm reduction component to current tobacco control programming, but in a most peculiar way. The law encourages cigarette manufacturers to develop “reduced exposure“ products and market them with no scientific proof that such reductions in exposure will reduce risk. The law then requires presumably new “scientific evidence” for smokeless products, already known to be of substantially lower risk. This makes no sense. The law encourages a harm reduction component to current tobacco control programming that might reduce tobacco-related cancer mortality by one or two percent; while actively discouraging switching to lower risk tobacco products that promise to lower total tobacco-related illness and death by 99% or better.

The secret to success, as we see it, will be to add an effective harm reduction component to current tobacco control programming while using the tools made available by this new law to prevent this new harm reduction
initiative from increasing the numbers of children and teens who initiate tobacco use.

Reconsidering the FDA stance on electronic cigarettes would be the most logical first step.

We look forward to working with FDA to use the powers granted by this new legislation to rapidly and substantially reduce tobacco-related illness and death, among both current and potential future tobacco users.

References:
The data on smoking attributable deaths on page 2 of this letter are from the Centers for Disease Control MMWR report of November 14, 2008. http://www.cdc.gov/mmwr/preview/mmwrhtml/mm5745a3.htm

The estimate that 20% of current nicotine consumption in the United States is from smokeless tobacco was generated by Mr. William Godshall, based on the formula utilized by Fagerstrom et al, when estimating 2002 nicotine consumption by type of tobacco product in multiple countries.

The discussion on risk of heart disease and stroke from smokeless tobacco products is from Paolo Boffetta and Kurt Straif : Use of smokeless tobacco and risk of myocardial infarction and stroke: systematic review with meta-analysis. Published August 18, 2009. BMJ 2009; 339: b3060 [Abstract] [Full text]

The data on relative risk of fatal heart attack and stroke from smoking, in men and women 35-64 years of age, are data from the American Cancer Society as quoted in “Changes in cigarette-related disease risks and their implication for prevention and control.” Smoking and Tobacco Control Monograph 8. Bethesda, MD: US Department of Health and Human Services,
Public Health Service, National Institutes of Health, National Cancer Institute 1997;305-382. NIH Publication no. 97-1213.

The other references to the scientific literature that back-up the points made in this letter can be found on the Tobacco Issues page at the http://www.aaphp.org web site. There is an October 2008 “Resolution and White Paper on Tobacco Harm Reduction.” This paper, on pages 6 and 13, includes then-current CDC and AAPHP mortality projections. “The Myth of the Safe Cigarette,” is based on the paper by Pankow et al (http://cebp.aacrjournals.org/cgi/reprint/16/3/584 ) and others. It makes the case that conventional cigarettes cannot be made measurably safer. The exchange of correspondence with Zhu et al, from a paper published earlier this year, deals with the difference in quit rates, comparing conventional cigarettes to smokeless tobacco products.

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Yours,
Joel L. Nitzkin, MD, MPH, DPA
Chair, AAPHP Tobacco Control Task Force
jln@jln-md.com
504 899 7893
Kevin Sherin, MD, MPH, FACPM, FAAFP
President, American Association of Public Health Physicians
ksherin@yahoo.com

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Anti Ecig Legislation From The State Of New York Is A Death Sentence For Smokers

Aaron — Sat, 24 Apr 2010 02:09:24 +0000

A9529: Prohibits the sale of electronic cigarettes to minors and items not defined as a tobacco product or approved by the FDA as a tobacco use cessation or harm reduction

Sponsor: Rosenthal (MS)
Co-sponsor(s): Titone, Englebright, Maisel, Fields, Galef, Miller M, Castro, Benjamin, Jaffee
Committee: HEALTH
Law Section: Public Health Law
A9529 Summary
Prohibits the sale of electronic cigarettes to minors; prohibits distribution or sale of any item containing or delivering nicotine that is not defined by law as a tobacco product or approved by the United States food and drug administration for sale as a tobacco use cessation or harm reduction product. Prohibits the sale of electronic cigarettes to minors; prohibits distribution or sale of any item containing or delivering nicotine that is not defined by law as a tobacco product or approved by the United States food and drug administration for sale as a tobacco use cessation or harm reduction product. Prohibits the sale of electronic cigarettes to minors; prohibits distribution or sale of any item containing or delivering nicotine that is not defined by law as a tobacco product or approved by the United States food and drug administration for sale as a tobacco use cessation or harm reduction product. Prohibits the sale of electronic cigarettes to minors; prohibits distribution or sale of any item containing or delivering nicotine that is not defined by law as a tobacco product or approved by the United States food and drug administration for sale as a tobacco use cessation or harm reduction product.

AN ACT to amend the public health law, in relation to prohibiting the sale of electronic cigarettes to minors and in relation to prohibiting the distribution or sale of any item containing or delivering nicotine that is not defined by law as a tobacco product or approved by the United States food and drug administration for sale as a tobacco use cessation or harm reduction product
A9529 Actions
A9529 – passed assembly – Apr 21, 2010
A9529 – delivered to senate – Apr 21, 2010
A9529 – advanced to third reading cal.726 – Mar 11, 2010
A9529 – reported – Mar 9, 2010
A9529 – reported referred to codes – Feb 23, 2010
A9529 Memo

BILL NUMBER:A9529

TITLE OF BILL: An act to amend the public health law, in relation to prohibiting the sale of electronic cigarettes to minors and in relation to prohibiting the distribution or sale of any item containing or delivering nicotine that is not defined by law as a tobacco product or approved by the United States food and drug administration for sale as a tobacco use cessation or harm reduction product

PURPOSE OR GENERAL IDEA OF BILL: This bill seeks to ban the sale and distribution of items containing or delivering nicotine that are not currently classified as tobacco products or approved as tobacco use cessation or harm reduction products by the U.S. Food and Drug Administration (FDA) and also to prevent minors from purchasing these products.

SUMMARY OF SPECIFIC PROVISIONS: The bill would amend the Public Health Law by amending

Section 1399-cc to include electronic cigarettes in each subsection and defining an electronic cigarette in subsection (d). The bill would also amend the Public Health Law by adding a new

Section 1399-mm-1. The section provides that products containing or delivering nicotine and intended for human consumption shall not be distributed or sold unless the FDA has given approval. The section further provides that the attorney general may issue an order compelling compliance with this provision and further grants the court the ability to impose a civil penalty for violations of this law.

JUSTIFICATION: Recent advertisements have touted “e-cigarettes” as a healthier alternative to traditional tobacco consumption and as a tobacco cessation product. These electronic cigarettes are battery-operated devices that vaporize cartridges filled with nicotine, flavor and other chemicals that the user inhales. Advertisements for these products omit any mention of FDA testing that found users inhale carcinogens and toxic chemicals such as diethylene glycol, an ingredient found in antifreeze. Given the unregulated nature of this product, there is no way of knowing the amount of nicotine in each cigarette, the amount that is delivered with each inhalation, or the contents of the vapor created in the process. “E-cigarettes” are often marketed and sold to young people and are readily available online and in shopping malls. They are produced in different flavors, such as chocolate and mint, in order to increase their appeal to all segments of the population. These products also lack any health warnings comparable to FDA-approved nicotine replacement products or conventional cigarettes. These devices are often made over seas in countries with less stringent standards for product quality than exist in the United States.

** A Note From RealEcig.com **

(The Highlighted statements above are totally un-true. The So-called FDA testing that found carcinogens found it in lesser amounts than is commonly found naturally occuring in peanut butter and celery. The diethylene glycol was found in only one of many samples tested from an inferior product. It is not a fact that: “E-cigarettes are often marketed and sold to young people” They are marketed specifically to people who are already tobacco users. The NY Senate’s “JUSTIFICATION” is totally unfounded and simply a flat out lie!)

*******

PRIOR LEGISLATIVE HISTORY: None

FISCAL IMPLICATIONS: None.

EFFECTIVE DATE: This act shall take effect immediately.
A9529 Text
S T A T E O F N E W Y O R K ________________________________________________________________________
9529
I N ASSEMBLY January 12, 2010 ___________
Introduced by M. of A. ROSENTHAL, TITONE, ENGLEBRIGHT, MAISEL, FIELDS, GALEF, M. MILLER, CASTRO, BENJAMIN — Multi-Sponsored by — M. of A. CAMARA, CYMBROWITZ, GOTTFRIED, LUPARDO, PHEFFER, SWEENEY, WEISENBERG — read once and referred to the Committee on Health AN ACT to amend the public health law, in relation to prohibiting the sale of electronic cigarettes to minors and in relation to prohibiting the distribution or sale of any item containing or delivering nicotine that is not defined by law as a tobacco product or approved by the United States food and drug administration for sale as a tobacco use cessation or harm reduction product THE PEOPLE OF THE STATE OF NEW YORK, REPRESENTED IN SENATE AND ASSEMBLY, DO ENACT AS FOLLOWS:

Section 1.

Section 1399-cc of the public health law, as amended by chapter 508 of the laws of 2000, subdivision 3 as separately amended by chapter 162 of the laws of 2002 and subdivision 7 as amended by chapter 13 of the laws of 2003, is amended to read as follows:

S 1399-cc. Sale of tobacco products, herbal cigarettes, ELECTRONIC CIGARETTES, rolling papers or pipes to minors prohibited. 1. As used in this section:
(a) “A device capable of deciphering any electronically readable format” or “device” shall mean any commercial device or combination of devices used at a point of sale or entry that is capable of reading the information encoded on the bar code or magnetic strip of a driver’s license or non-driver identification card issued by the state commissioner of motor vehicles; (b) “Card holder” means any person presenting a driver’s license or non-driver identification card to a licensee, or to the agent or employee of such licensee under this chapter; [and] (c) “Transaction scan” means the process involving an automated bar code reader by which a licensee, or agent or employee of a licensee under this chapter reviews a driver’s license or non-driver identification card presented as a precondition for the purchase of a tobacco product or herbal cigarettes pursuant to subdivision three of this section; AND EXPLANATION–Matter in ITALICS (underscored) is new; matter in brackets [ ] is old law to be omitted. LBD15081-01-9
A. 9529 2 (D) “ELECTRONIC CIGARETTE” OR “E-CIGARETTE” MEANS A BATTERY-OPERATED DEVICE THAT CONTAINS CARTRIDGES FILLED WITH NICOTINE, FLAVOR AND OTHER CHEMICALS THAT ARE TURNED INTO VAPOR WHICH IS INHALED BY THE USER. 2. Any person operating a place of business wherein tobacco products [or], herbal cigarettes OR ELECTRONIC CIGARETTES are sold or offered for sale is prohibited from selling such products, herbal cigarettes, ELECTRONIC CIGARETTES, rolling papers or pipes to individuals under eighteen years of age, and shall post in a conspicuous place a sign upon which there shall be imprinted the following statement, “SALE OF CIGARETTES, CIGARS, CHEWING TOBACCO, POWDERED TOBACCO, OR OTHER TOBACCO PRODUCTS, HERBAL CIGARETTES, ELECTRONIC CIGARETTES, ROLLING PAPERS OR PIPES, TO PERSONS UNDER EIGHTEEN YEARS OF AGE IS PROHIBITED BY LAW.” Such sign shall be printed on a white card in red letters at least one-half inch in height. 3. Sale of tobacco products [or], herbal cigarettes, OR ELECTRONIC CIGARETTES in such places, other than by a vending machine, shall be made only to an individual who demonstrates, through (a) a valid driver’s license or non-driver’s identification card issued by the commissioner of motor vehicles, the federal government, any United States territory, commonwealth or possession, the District of Columbia, a state government within the United States or a provincial government of the dominion of Canada, or (b) a valid passport issued by the United States government or any other country, or (c) an identification card issued by the armed forces of the United States, indicating that the individual is at least eighteen years of age. Such identification need not be required of any individual who reasonably appears to be at least twenty-five years of age, provided, however, that such appearance shall not constitute a defence in any proceeding alleging the sale of a tobacco product [or], herbal cigarettes OR ELECTRONIC CIGARETTE to an individual under eighteen years of age. 4. (a) Any person operating a place of business wherein tobacco products [or], herbal cigarettes OR ELECTRONIC CIGARETTES are sold or offered for sale may perform a transaction scan as a precondition for such purchases. (b) In any instance where the information deciphered by the transaction scan fails to match the information printed on the driver’s license or non-driver identification card, or if the transaction scan indicates that the information is false or fraudulent, the attempted transaction shall be denied. (c) In any proceeding pursuant to section thirteen hundred-ninety nine of this article, it shall be an affirmative defence that such person had produced a driver’s license or non-driver identification card apparently issued by a governmental entity, successfully completed that transaction scan, and that the tobacco product [or], herbal cigarettes OR ELECTRONIC CIGARETTE had been sold, delivered or given to such person in reasonable reliance upon such identification and transaction scan. In evaluating the applicability of such affirmative defence the commissioner shall take into consideration any written policy adopted and implemented by the seller to effectuate the provisions of this chapter. Use of a transaction scan shall not excuse any person operating a place of business wherein tobacco products [or], herbal cigarettes OR ELECTRONIC CIGARETTES are sold, or the agent or employee of such person, from the exercise of reasonable diligence otherwise required by this chapter. Notwithstanding the above provisions, any such affirmative defence shall not be applicable in any civil or criminal proceeding, or in any other forum. A. 9529 3 5. A licensee or agent or employee of such licensee shall only use a device capable of deciphering any electronically readable format, and shall only use the information recorded and maintained through the use of such devices, for the purposes contained in subdivision four of this section. No licensee or agent or employee of a licensee shall resell or disseminate the information recorded during such a scan to any third person. Such prohibited resale or dissemination includes but is not limited to any advertising, marketing or promotional activities. Notwithstanding the restrictions imposed by this subdivision, such records may be released pursuant to a court ordered subpoena or pursuant to any other statute that specifically authorises the release of such information. Each violation of this subdivision shall be punishable by a civil penalty of not more than one thousand dollars. 6. A licensee or agent or employee of such a licensee may electronically or mechanically record and maintain only the information from a transaction scan necessary to effectuate this section. Such information shall be limited to the following: (a) name, (b) date of birth, (c) driver’s license or non-driver identification number, and (d) expiration date. The commissioner and state commissioner of motor vehicles shall jointly promulgate any regulations necessary to govern the recording and maintenance of these records by a licensee under this chapter. The commissioner and the state liquor authority shall jointly promulgate any regulation necessary to ensure quality control in the use of the transaction scan devices under this chapter and article five of the alcoholic beverage control law. 7. No person operating a place of business wherein tobacco products [or], herbal cigarettes OR ELECTRONIC CIGARETTES are sold or offered for sale shall sell, permit to be sold, offer for sale or display for sale any tobacco product [or], herbal cigarettes OR ELECTRONIC CIGARETTE in any manner, unless such products and cigarettes are stored for sale (a) behind a counter in an area accessible only to the personnel of such business, or (b) in a locked container; provided, however, such restriction shall not apply to tobacco businesses, as defined in subdivision eight of section thirteen hundred ninety-nine-aa of this article, and to places to which admission is restricted to persons eighteen years of age or older.

S 2. The public health law is amended by adding a new section 1399-mm-1 to read as follows:

S 1399-MM-1. PROHIBITION OF PRODUCTS NOT DEFINED AS TOBACCO PRODUCTS OR APPROVED BY THE UNITED STATES FOOD AND DRUG ADMINISTRATION. 1. PRODUCTS CONTAINING OR DELIVERING NICOTINE INTENDED OR EXPECTED FOR HUMAN CONSUMPTION THAT ARE NOT TOBACCO PRODUCTS, AS DEFINED IN SECTION THIRTEEN HUNDRED NINETY-NINE-AA OF THIS ARTICLE, SHALL NOT BE DISTRIBUTED OR SOLD UNLESS SUCH PRODUCTS HAVE BEEN APPROVED BY THE UNITED STATES FOOD AND DRUG ADMINISTRATION FOR SALE AS TOBACCO USE CESSATION OR HARM REDUCTION PRODUCTS OR FOR OTHER MEDICAL PURPOSES AND ARE BEING MARKETED AND SOLD SOLELY FOR THAT APPROVED PURPOSE. 2. IN ADDITION TO ENFORCEMENT ACTIONS AUTHORIZED IN SECTION THIRTEEN HUNDRED NINETY-NINE-EE OF THIS ARTICLE, THE ATTORNEY GENERAL MAY APPLY IN THE NAME OF THE PEOPLE OF THE STATE OF NEW YORK ON FIVE DAYS NOTICE, FOR AN ORDER COMPELLING COMPLIANCE WITH THIS SECTION. IN ANY SUCH PROCEEDING THE COURT MAY IMPOSE A CIVIL PENALTY IN AN AMOUNT NOT TO EXCEED TEN THOUSAND DOLLARS FOR EACH VIOLATION.

S 3. This act shall take effect immediately; provided however that section two of this act shall take effect on the sixtieth day after it shall have become a law.

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