Posted on 29th Dec 2009 @ 6:43 PM

Published With Permission.

The following are in addition to comments previously submitted by William Godshall and Smokefree Pennsylvania (on September 29, comment tracking number 80a2e4ef) on FDA tobacco regulation.

 The FDA should STOP protecting cigarettes from market competition by far less hazardous smokefree tobacco/nicotine products (including the electronic cigarette).

As delineated in Smokefree Pennsylvania’s letters and testimony to U.S. Congress during the past five years, the recently enacted Family Smoking Prevention and Tobacco Control Act protects the deadliest consumer product (i.e. cigarettes) from market competition by far less hazardous smokefree tobacco products.

http://www.smokefree.net/bg-announce/messages/248038.html

http://www.smokefree.net/bg-announce/messages/247929.html

http://www.smokefree.net/bg-announce/messages/247915.html

http://www.smokefree.net/bg-announce/messages/247774.html

http://www.smokefree.net/bg-announce/messages/247583.html

http://www.smokefree.net/bg-announce/messages/247151.html

Meanwhile, existing FDA policies for electronic cigarettes and nicotine gums, lozenges, skin patches and inhalers also protect cigarettes from many aspects of market competition by these far less hazardous smokefree nicotine alternatives.

Since switching from cigarettes to smokefree tobacco/nicotine products reduces morbidity and mortality risks by nearly as much as quitting all tobacco/nicotine use, the FDA should adopt policies to inform/encourage smokers who are unwilling or not ready to quit using tobacco to switch to smokefree tobacco/nicotine products until they are willing and ready to quit using tobacco.

Based upon published calculations by Karl Fagerstrom, Smokefree Pennsylvania has estimated that the percentage of nicotine consumed in the US from smokefree tobacco/nicotine products has increased from about 10% a decade ago to about 20% in 2009, while the percentage of nicotine consumed from cigarettes has declined from about 90% a decade ago to about 80% in 2009. 

The nicotine market: An attempt to estimate the nicotine intake from various sources and the total nicotine consumption in some countries, Karl Fagerstrom, Nicotine & Tobacco Research, Vol. 7, Number 3, pp 343-350, June 2005.

Furthermore, about 90% of the nicotine consumed from smokefree tobacco/nicotine products in the US is now obtained from smokeless tobacco products, while about 10% is now obtained from nicotine gums, lozenges, patches, and electronic cigarettes. 

Just as less than half of all nicotine consumed in Sweden is now obtained from smokefree tobacco/nicotine products (primarily snus), less than half of all nicotine consumed in the U.S. could be obtained from smokefree tobacco/nicotine products within the next decade if the FDA adopted policies to truthfully inform smokers that smokefree tobacco/nicotine products are far less hazardous alternatives to cigarettes, to allow manufacturers and marketers to truthfully inform smokers that smokefree tobacco/nicotine products are far less hazardous alternatives to cigarettes, and to provide other incentives to encourage manufacturers to develop and market smokefree tobacco/nicotine product to smokers as far less hazardous alternatives to cigarettes.

The FDA should propose reasonable and responsible regulations for Electronic Cigarettes and for Electronic Cigarette Liquid to ensure that these products remain legally accessible and less expensive than cigarettes.

 Based upon my communications with dozens of electronic cigarette vendors in recent months, it appears that there are now about 200,000 e-cigarette consumers in the U.S., virtually all of whom are either exsmokers or are dual users in the process of switching.  E-cigarettes also now appear to be a $200 million dollar per year industry in this country, similar to current sales of nicotine gums, lozenges and patches. 

It is crucial that the FDA recognize that every dollar spent on e-cigarettes would otherwise be spent on tobacco cigarettes, and that every dose of nicotine obtained from an e-cigarettes would otherwise be obtained from inhaling hazardous tobacco smoke.

That is why the FDA’s ongoing opposition to e-cigarettes primarily protects cigarette markets at the expense of smokers and public health.

 The FDA should take seriously statements by e-cigarette users, including the following.

 Petition to US FDA with testimonials by thousands of e-cigarette users 

http://www.thepetitionsite.com/1/keep-life-saving-electronic-cigarettes-available

 Surveys of e-cigarette users

http://www.tobaccoharmreduction.org/wpapers/011v1.pdf

http://www.e-cigarette-forum.com/forum/quitting/6470-e-cig-success-rate.html
http://www.e-cigarette-forum.com/forum/general-e-smoking-discussion/50594-update-analogs-vs-vaping-poll.html
http://www.e-cigarette-forum.com/forum/general-e-smoking-discussion/45062-how-long-have-you-been-using-electronic-cigarette.html 
http://www.e-cigarette-forum.com/forum/general-e-smoking-discussion/50464-poll-how-long-have-you-been-vaping.html
http://www.e-cigarette-forum.com/forum/campaigning-discussions/42778-myth-e-cigarettes-aimed-non-smokers.html
http://www.e-cigarette-forum.com/forum/nicotine/48862-does-nicotine-abstinence-screw-up-your-life-4.html
http://www.e-cigarette-forum.com/forum/health-safety-e-smoking/31195-did-your-lungs-clear-up.html

While Smokefree Pennsylvania’s previously submitted comments encouraged the FDA to propose redefining electronic cigarettes as tobacco products and to reasonably regulate them as such, another option available to the FDA is to propose reasonable and responsible regulations for electronic cigarettes (and electronic cigarette liquid) as drug delivery devices. 

It is critically important to note that when then Commissioner David Kessler proposed FDA regulations for tobacco products as drug delivery devices in 1995, he insisted that the FDA had no intention of removing tobacco products from the market (even though the agency has the legal authority to do so for unapproved drug delivery devices) because doing so would be a societal disaster by creating a black market for tobacco products. 

Instead of proposing to remove tobacco products from the market in 1995, the FDA wisely proposed reasonable and responsible regulations to reduce tobacco industry marketing and sales to youth.  Although the US Supreme Court struck down the tobacco regulations approved by the FDA in 1996 (citing Congressional failure to grant FDA authority to regulate tobacco products), David Kessler’s rationale opposing removal of tobacco products (as drug delivery devices) from the market is even more cogent as it pertains to electronic cigarettes.   If it made no sense for the FDA to remove the deadliest consumer products (i.e. cigarettes) from the market, it is absurd for the FDA to now claim that far less hazardous smokefree alternatives to cigarettes (i.e. electronic cigarettes) should be removed from the market simply because the agency has recently declared them to be drug delivery devices.

That is yet another reason why the FDA should propose reasonable and responsible regulations for electronic cigarettes and electronic cigarette liquid (as either drug delivery devices or as tobacco products) to prevent their marketing and sales to youth, to ensure product safety and proper labeling via standards for manufacturers and/or importers, and to display a warning indicating that the products contain nicotine and can be addictive.

Although there is no evidence that electronic cigarettes have been or are marketed to youth (despite claims to contrary by several government officials and other tobacco harm reduction opponents), it would be wise for the FDA to prohibit the sale of electronic cigarettes and electronic cigarette liquid to minors under 18 years, to require the products be kept behind-the-counter at retail stores accessible to youth, to prohibit their advertising in publications with significant youth readership, and to prohibit their promotions via sports sponsorships.  But since there is no evidence that flavored e-cigarettes are marketed to or appeal to youth, there is no justification for the FDA to ban flavorings in e-cigarettes or e-cigarette liquid (just as there is no justification for the FDA to ban flavorings in nicotine gums or lozenges). 

To ensure product safety and proper labeling of electronic cigarettes and electronic cigarette liquid, the FDA should require product testing by manufacturers and/or importers (similar to those required for tobacco products by the new FDA tobacco law).

Since the nicotine in electronic cigarettes and electronic cigarette liquid can be addictive (which is one of the reasons many smokers have found the products to be desirable substitutes for cigarettes), the FDA should require a warning on e-cigarettes and e-cigarette liquid that informs consumers that the products contain nicotine and can be addictive.

It is critically important for the FDA to understand that the agency’s ongoing efforts to block shipments of e-cigarettes from entering the country have affected only a small percentage of product shipments, nearly all of which have been subsequently reshipped back into the country.  

It is also critically important for the FDA to understand that future attempts by the agency to remove e-cigarettes from the market will:

- protect and preserve cigarette markets, revenues and profits,

- encourage thousands of e-cigarette users to switch back to deadly cigarettes,

- discourage millions of smokers from reducing health risks by switching to e-cigarettes,  

- create a black market for e-cigarettes, and

- demonstrate that the FDA is more interested in protecting cigarettes than public health.

Feel free to contact me anytime for additional information, clarification, or collaboration in reducing this nation’s leading cause of disease, disability and death.

Since 1990, Smokefree Pennsylvania has advocated policies to reduce tobacco smoke pollution indoors, increase cigarette taxes, reduce tobacco marketing to youth, preserve civil justice remedies for those injured by cigarettes, expand smoking cessation services, and inform smokers that smokefree tobacco/nicotine products are far less hazardous alternatives to cigarettes.

William T. Godshall, MPH
Founder and Executive Director
Smokefree Pennsylvania
1926 Monongahela Avenue
Pittsburgh, PA 15218
412-351-5880
FAX 351-5881
smokefree@compuserve.com