- Apr 2, 2009
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On Tuesday and Wednesday (Oct 26 & 27) the FDA held a Public Workshop entitled Risks and Benefits of Long-Term Use of Nicotine Replacement Therapy (NRT) Products
Risks and Benefits of Long-Term Use of Nicotine Replacement Therapy (NRT) Products; Public Workshop
Agenda
http://www.fda.gov/downloads/Drugs/NewsEvents/UCM230910.pdf
At the workshop, a significant majority of the invited speakers endorsed the FDA approving NRT products for long term usage (i.e. beyond 10-12 weeks).
Regulations.gov
And ALL twelve public hearing speakers urged the FDA to approve the marketing of NRT for long term usage, including drug companies and drug industry funded groups that have urged the FDA to ban the sale of e-cigarettes and dissolvable tobacco products.
The FDA is accepting public comments on the issue until December 27, 2010
Regulations.gov
During the public comments, CASAA's Elaine Keller gave an excellent power point presentation. My presentation during the public comment period is below.
Im Bill Godshall, founder and executive director of Smokefree Pennsylvania, a nonprofit organization that since 1990 has been advocating local, state and federal policies to reduce indoor tobacco smoke pollution, reduce tobacco marketing to youth, hold cigarette companies accountable for their egregious past actions, preserve civil justice remedies for those injured by cigarettes, increase cigarette tax rates, fund tobacco education and smoking cessation services, and inform smokers that all smokefree tobacco/nicotine products are far less hazardous alternatives to cigarettes.
For disclosure, neither I nor Smokefree Pennsylvania have ever received any direct or indirect funding from any tobacco, drug or electronic cigarette company or trade association.
Im here to urge the FDA to stop protecting cigarettes from market competition by far less hazardous smokefree nicotine and tobacco products.
More than ninety nine percent of all tobacco attributable mortality and more than ninety nine percent of tobacco attributable health care costs in the US are caused by repeated inhalation of tobacco smoke, while <1% are caused by the use of noncombustible tobacco and nicotine products. Existing evidence also indicates that cigarettes are at least 100 times more hazardous than the smokefree nicotine and tobacco products marketed in the US, including smokeless tobacco products, electronic cigarettes and nicotine products marketed to treat tobacco dependence.
While quitting all tobacco/nicotine use may be the best way for smokers to improve their health, switching to smokefree tobacco/nicotine products reduces smokers health risks nearly as much as quitting all tobacco/nicotine use. Surveys indicate that more than a million smokers have quit smoking by switching to smokeless tobacco products, and sales reports indicate that nearly a half million smokers have switched to electronic cigarettes in just the past several years. Nonsmokers also benefit when smokers switch to or substitute smokefree alternatives, as they emit NO tobacco smoke.
As currently regulated by the FDA to treat tobacco dependence, nicotine products have had a 95% failure rate. But these products are deceptively promoted by drug companies, public health agencies and drug industry funded anti-tobacco organizations as the most effective way to quit smoking.
Although the FDA has only approved nicotine products for short term (10-12 weeks) usage to treat tobacco dependence, research and sales data indicate that a large percentage (probably a majority) of nicotine gum and lozenges are used for off label purposes as either long term or temporary nicotine maintenance alternatives to cigarettes.
But instead of taking actions to reduce current off label usage of nicotine products, the FDA should encourage and approve the marketing of nicotine products to smokers as long term and as temporary cigarette alternatives, similar to the way smokeless tobacco and electronic cigarettes are marketed to smokers.
Concurrently, the FDA should eliminate the current warning on nicotine products that urge consumers to discontinue use if they also use a tobacco product, and instead should encourage smokers to continue substituting nicotine products for cigarettes as often as possible.
The FDA also should allow the sale of $5-$10 packages of nicotine products, allow sales at all retail stores that sell cigarettes, and allow higher levels of nicotine in the products to satisfy the cravings of most smokers.
If the FDA doesnt take these long overdue actions to protect public health, the most effective way for companies to increase nicotine product usage by smokers would be to market their products as tobacco products under the FSPTCA.
The FDA also should stop trying to ban electronic cigarettes by misclassifying them as drug devices, which Federal Judge Richard Leon has already struck down, and instead the FDA should classify and reasonably regulate e-cigarettes as tobacco products in accordance with the FSPTCA.
Josh Sharsteins misleading fear mongering claims about e-cigarettes at a July 22, 2009 press conference also should be clarified and corrected by the agency. The FDA has an ethical duty to inform smokers that nicotine is addictive, but that all smokefree tobacco and nicotine products are far less hazardous long term and temporary alternatives to cigarettes.
Smokers have a human right to truthful health information and legal access to far less hazardous alternatives. The FDA should provide for that.
Risks and Benefits of Long-Term Use of Nicotine Replacement Therapy (NRT) Products; Public Workshop
Agenda
http://www.fda.gov/downloads/Drugs/NewsEvents/UCM230910.pdf
At the workshop, a significant majority of the invited speakers endorsed the FDA approving NRT products for long term usage (i.e. beyond 10-12 weeks).
Regulations.gov
And ALL twelve public hearing speakers urged the FDA to approve the marketing of NRT for long term usage, including drug companies and drug industry funded groups that have urged the FDA to ban the sale of e-cigarettes and dissolvable tobacco products.
The FDA is accepting public comments on the issue until December 27, 2010
Regulations.gov
During the public comments, CASAA's Elaine Keller gave an excellent power point presentation. My presentation during the public comment period is below.
Im Bill Godshall, founder and executive director of Smokefree Pennsylvania, a nonprofit organization that since 1990 has been advocating local, state and federal policies to reduce indoor tobacco smoke pollution, reduce tobacco marketing to youth, hold cigarette companies accountable for their egregious past actions, preserve civil justice remedies for those injured by cigarettes, increase cigarette tax rates, fund tobacco education and smoking cessation services, and inform smokers that all smokefree tobacco/nicotine products are far less hazardous alternatives to cigarettes.
For disclosure, neither I nor Smokefree Pennsylvania have ever received any direct or indirect funding from any tobacco, drug or electronic cigarette company or trade association.
Im here to urge the FDA to stop protecting cigarettes from market competition by far less hazardous smokefree nicotine and tobacco products.
More than ninety nine percent of all tobacco attributable mortality and more than ninety nine percent of tobacco attributable health care costs in the US are caused by repeated inhalation of tobacco smoke, while <1% are caused by the use of noncombustible tobacco and nicotine products. Existing evidence also indicates that cigarettes are at least 100 times more hazardous than the smokefree nicotine and tobacco products marketed in the US, including smokeless tobacco products, electronic cigarettes and nicotine products marketed to treat tobacco dependence.
While quitting all tobacco/nicotine use may be the best way for smokers to improve their health, switching to smokefree tobacco/nicotine products reduces smokers health risks nearly as much as quitting all tobacco/nicotine use. Surveys indicate that more than a million smokers have quit smoking by switching to smokeless tobacco products, and sales reports indicate that nearly a half million smokers have switched to electronic cigarettes in just the past several years. Nonsmokers also benefit when smokers switch to or substitute smokefree alternatives, as they emit NO tobacco smoke.
As currently regulated by the FDA to treat tobacco dependence, nicotine products have had a 95% failure rate. But these products are deceptively promoted by drug companies, public health agencies and drug industry funded anti-tobacco organizations as the most effective way to quit smoking.
Although the FDA has only approved nicotine products for short term (10-12 weeks) usage to treat tobacco dependence, research and sales data indicate that a large percentage (probably a majority) of nicotine gum and lozenges are used for off label purposes as either long term or temporary nicotine maintenance alternatives to cigarettes.
But instead of taking actions to reduce current off label usage of nicotine products, the FDA should encourage and approve the marketing of nicotine products to smokers as long term and as temporary cigarette alternatives, similar to the way smokeless tobacco and electronic cigarettes are marketed to smokers.
Concurrently, the FDA should eliminate the current warning on nicotine products that urge consumers to discontinue use if they also use a tobacco product, and instead should encourage smokers to continue substituting nicotine products for cigarettes as often as possible.
The FDA also should allow the sale of $5-$10 packages of nicotine products, allow sales at all retail stores that sell cigarettes, and allow higher levels of nicotine in the products to satisfy the cravings of most smokers.
If the FDA doesnt take these long overdue actions to protect public health, the most effective way for companies to increase nicotine product usage by smokers would be to market their products as tobacco products under the FSPTCA.
The FDA also should stop trying to ban electronic cigarettes by misclassifying them as drug devices, which Federal Judge Richard Leon has already struck down, and instead the FDA should classify and reasonably regulate e-cigarettes as tobacco products in accordance with the FSPTCA.
Josh Sharsteins misleading fear mongering claims about e-cigarettes at a July 22, 2009 press conference also should be clarified and corrected by the agency. The FDA has an ethical duty to inform smokers that nicotine is addictive, but that all smokefree tobacco and nicotine products are far less hazardous long term and temporary alternatives to cigarettes.
Smokers have a human right to truthful health information and legal access to far less hazardous alternatives. The FDA should provide for that.
