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Recommendations to FDA’s TPSAC on
Modified Risk tobacco Product Applications
April 30, 2013
by
William T. Godshall, MPH
Executive Director
Smokefree Pennsylvania
1926 Monongahela Avenue
Pittsburgh, PA 15218
412-351-5880
smokefree@compuserve.com
I’m Bill Godshall, founder and executive director of Smokefree Pennsylvania, a nonprofit organization that since 1990 has been advocating local, state and federal policies to ban smoking in workplaces, reduce tobacco marketing to youth, hold cigarette companies accountable in civil litigation, increase cigarette tax rates, fund tobacco education and smoking cessation services, inform smokers that smokefree tobacco/ nicotine products are less hazardous alternatives to cigarettes, and ensure that smokefree alternatives remain legal and affordable to smokers.
In 2007, I convinced Sen. Mike Enzi to amend to TCA to require graphic warnings on cigarette packs, which was vehemently opposed at the time by the Campaign for Tobacco Free Kids, American Cancer Society, American Heart Association and American Lung Association. In 2009, we urged FDA to keep electronic cigarettes legal, and in 2010 we filed an amicus brief with the DC Court of Appeals in support of njoy’s lawsuit against FDA’s unlawful e-cigarette import ban.
For disclosure, neither I nor Smokefree Pennsylvania have ever received any funding from any tobacco, drug or electronic cigarette company or trade association.
I’m pleased to report that cigarette sales volume declined a whopping 6.2% in the first quarter of 2013, with Wall Street tobacco stock analysts agreeing that the key reason was skyrocketing e-cigarette sales to smokers. And smokeless tobacco sales continue their decade long sales increase, as more white male cigarette smokers in rural areas switch to moist snuff.
Scientific evidence indicates that >99% of all tobacco attributable morbidity, mortality and health care costs in the US are caused by daily inhalation of tobacco smoke, while <1% are caused by the use of noncombustible tobacco and nicotine products. The evidence also indicates that cigarettes are at least 100 times more hazardous than smokeless tobacco products marketed in the US.
While daily cigarette smoking causes an estimated 438,000 deaths annually in the US, epidemiological studies indicate that smokeless tobacco causes no more than several dozen oral cancer deaths.
In fact, smokefree tobacco products have very similar health risk/benefit profiles as FDA approved NRT. On a continuum of risk from 1 to 100 on which FDA approved NRT products are 1 and cigarettes are 100, all noncombustible tobacco/nicotine products are below 2.
Scientific evidence also indicates that switching from cigarettes to smokeless tobacco products reduces a smoker’s disease risks nearly as much as quitting all tobacco and nicotine use. Survey and sales data indicate that several million cigarette smokers in the US have switched to smokeless tobacco products. Nonsmokers also benefit when smokers substitute smokefree tobacco products for cigarettes due to reduced secondhand smoke exposure.
Since Chapter IX of the TCA only applies to cigarettes, cigarette tobacco, RYO tobacco and smokeless tobacco products, there appear to be three different types of MRTP applications that tobacco companies might consider submitting to the FDA:
- comparing a smokeless tobacco product to cigarettes,
- comparing a cigarette to other cigarettes, and
- comparing a smokeless tobacco product to other smokeless products.
Since there is no scientific evidence indicating that any type of cigarette is less hazardous than other cigarettes, and since there is insufficient scientific evidence indicating that any type of smokeless tobacco product is less hazardous than other smokeless tobacco products used in the US, I urge this Committee and the FDA to very critically scrutinize any MRTP application seeking to claim that one brand of cigarette is less hazardous than other brands, or that one smokeless tobacco brand is less hazardous than other brands.
In sharp contrast, I strongly encourage this Committee to endorse, and FDA to approve, any MRTP application seeking to truthfully claim that a smokeless tobacco brand is less hazardous than smoking cigarettes. It very likely that the only MRTP applications tobacco companies will submit to FDA in the foreseeable future are those seeking to claim a smokeless product is less harmful than cigarettes.
Unfortunately for scientific integrity and public health, Lawrence Deyton instructed the IOM MRTP Committee to ignore the huge differences in risks between different categories of tobacco products, and David Ashley never asked FDA’s invited participants at the 2011 MRTP conference to consider the differences in risks between different types of tobacco products.
And yet, the majority of public speakers at those meetings urged the FDA to consider and acknowledge these differences of risks, and submitted lots of scientific evidence consistently finding that smokeless tobacco products are far less hazardous than cigarettes.
So it was no surprise that the vast differences in tobacco product risks were never mentioned in the IOM Committee’s report on MRTP, or in FDA’s Draft Guidance for MRTP Applications, which was issued last year just one week after this Scientific Committee truthfully acknowledged in its report that “dissolvable” tobacco products are less hazardous than cigarettes.
Meanwhile, since 2011 the FDA’s MRTP webpage has falsely stated in bold letters “To date, no tobacco products have been scientifically proven to reduce risk of tobacco-related disease, improve safety or cause less harm than other tobacco products."
I’ve repeatedly urged the FDA to correct or clarify that false statement, and I encourage this Committee to urge the FDA do so as well. Although the FDA has repeatedly claimed its regulatory policies are based upon the scientific evidence, in reality the FDA has continued misrepresenting scientific evidence to help attain its counterproductive abstinence-only and prohibition policy goals.
Since cigarettes are 100 times more harmful than cigarettes, and since population surveys have found that several million smokers already quit smoking by switching to smokeless tobacco products, it is mathematically impossible for any increase in smokeless tobacco use to offset those public health benefits at the population level, even if everybody in America began to using smokeless tobacco, which is NOT going to happen. Besides, the 2009 TCA, the 1992 Synar Law, laws in all 50 states and the 1998 MSA already prohibit marketing of smokeless tobacco products to youth.
In sum, there is no justification for this Committee or FDA to demand additional research from a company so it can truthfully inform smokers that a smokeless tobacco product is less hazardous than cigarettes.
Smokers have a human right to be truthfully informed that smokeless tobacco products are far less hazardous alternatives to cigarettes, and public health agencies have an ethical duty to truthfully inform tobacco consumers that smokeless tobacco is far less hazardous than cigarettes.
Since 1986 when Congress enacted the Comprehensive Smokeless Tobacco Education Act, federal health agencies have intentionally deceived the public to believe that smokeless tobacco is just as hazardous as smoking cigarettes, which has deceived 85% of smokers and the public to believe that smokeless tobacco is as hazardous as cigarettes, discouraged tens of millions of smokers from switching to smokeless tobacco, and encouraged some smokeless users to switch to far more hazardous cigarettes.
It was wrong for cigarette companies to mislead the public about the health risks of cigarettes for decades. But it is far worse for the FDA, health agencies, organizations and/or professionals to intentionally deceive smokers and the public about the comparable health risks of cigarettes and noncombustible tobacco and nicotine products.
During the past two decades, Johnson & Johnson, GlaxoSmithKline, Pfizer and other drug companies have given more than a hundred million dollars to the Campaign for Tobacco Free Kids, American Cancer Society, American Heart Association, American Lung Association, Pinney Associates, American Medical Association, American Academy of Pediatrics, Legacy and others to promote NRT products (which have a 95% failure rate for smoking cessation) and less than safe Chantix as the safest and most effective ways to quit smoking, and to grossly exaggerate the risks and deny the benefits smokefree tobacco products provide smokers, lobbying to enact the TCA and to unfairly tax smokeless tobacco products at the same rate as cigarettes, and urging the FDA to ban e-cigarettes.
Instead of improving public health, those actions have protected cigarette markets and harmed millions of smokers who would have otherwise reduced their disease risks by switching to smokefree tobacco alternatives.
Now is the time for this Committee to help the FDA reestablish its scientific credibility and improve public health by endorsing and approving all MRTP applications for smokeless products seeking to claim they are less hazardous alternatives to cigarettes.
Thank you,
Modified Risk tobacco Product Applications
April 30, 2013
by
William T. Godshall, MPH
Executive Director
Smokefree Pennsylvania
1926 Monongahela Avenue
Pittsburgh, PA 15218
412-351-5880
smokefree@compuserve.com
I’m Bill Godshall, founder and executive director of Smokefree Pennsylvania, a nonprofit organization that since 1990 has been advocating local, state and federal policies to ban smoking in workplaces, reduce tobacco marketing to youth, hold cigarette companies accountable in civil litigation, increase cigarette tax rates, fund tobacco education and smoking cessation services, inform smokers that smokefree tobacco/ nicotine products are less hazardous alternatives to cigarettes, and ensure that smokefree alternatives remain legal and affordable to smokers.
In 2007, I convinced Sen. Mike Enzi to amend to TCA to require graphic warnings on cigarette packs, which was vehemently opposed at the time by the Campaign for Tobacco Free Kids, American Cancer Society, American Heart Association and American Lung Association. In 2009, we urged FDA to keep electronic cigarettes legal, and in 2010 we filed an amicus brief with the DC Court of Appeals in support of njoy’s lawsuit against FDA’s unlawful e-cigarette import ban.
For disclosure, neither I nor Smokefree Pennsylvania have ever received any funding from any tobacco, drug or electronic cigarette company or trade association.
I’m pleased to report that cigarette sales volume declined a whopping 6.2% in the first quarter of 2013, with Wall Street tobacco stock analysts agreeing that the key reason was skyrocketing e-cigarette sales to smokers. And smokeless tobacco sales continue their decade long sales increase, as more white male cigarette smokers in rural areas switch to moist snuff.
Scientific evidence indicates that >99% of all tobacco attributable morbidity, mortality and health care costs in the US are caused by daily inhalation of tobacco smoke, while <1% are caused by the use of noncombustible tobacco and nicotine products. The evidence also indicates that cigarettes are at least 100 times more hazardous than smokeless tobacco products marketed in the US.
While daily cigarette smoking causes an estimated 438,000 deaths annually in the US, epidemiological studies indicate that smokeless tobacco causes no more than several dozen oral cancer deaths.
In fact, smokefree tobacco products have very similar health risk/benefit profiles as FDA approved NRT. On a continuum of risk from 1 to 100 on which FDA approved NRT products are 1 and cigarettes are 100, all noncombustible tobacco/nicotine products are below 2.
Scientific evidence also indicates that switching from cigarettes to smokeless tobacco products reduces a smoker’s disease risks nearly as much as quitting all tobacco and nicotine use. Survey and sales data indicate that several million cigarette smokers in the US have switched to smokeless tobacco products. Nonsmokers also benefit when smokers substitute smokefree tobacco products for cigarettes due to reduced secondhand smoke exposure.
Since Chapter IX of the TCA only applies to cigarettes, cigarette tobacco, RYO tobacco and smokeless tobacco products, there appear to be three different types of MRTP applications that tobacco companies might consider submitting to the FDA:
- comparing a smokeless tobacco product to cigarettes,
- comparing a cigarette to other cigarettes, and
- comparing a smokeless tobacco product to other smokeless products.
Since there is no scientific evidence indicating that any type of cigarette is less hazardous than other cigarettes, and since there is insufficient scientific evidence indicating that any type of smokeless tobacco product is less hazardous than other smokeless tobacco products used in the US, I urge this Committee and the FDA to very critically scrutinize any MRTP application seeking to claim that one brand of cigarette is less hazardous than other brands, or that one smokeless tobacco brand is less hazardous than other brands.
In sharp contrast, I strongly encourage this Committee to endorse, and FDA to approve, any MRTP application seeking to truthfully claim that a smokeless tobacco brand is less hazardous than smoking cigarettes. It very likely that the only MRTP applications tobacco companies will submit to FDA in the foreseeable future are those seeking to claim a smokeless product is less harmful than cigarettes.
Unfortunately for scientific integrity and public health, Lawrence Deyton instructed the IOM MRTP Committee to ignore the huge differences in risks between different categories of tobacco products, and David Ashley never asked FDA’s invited participants at the 2011 MRTP conference to consider the differences in risks between different types of tobacco products.
And yet, the majority of public speakers at those meetings urged the FDA to consider and acknowledge these differences of risks, and submitted lots of scientific evidence consistently finding that smokeless tobacco products are far less hazardous than cigarettes.
So it was no surprise that the vast differences in tobacco product risks were never mentioned in the IOM Committee’s report on MRTP, or in FDA’s Draft Guidance for MRTP Applications, which was issued last year just one week after this Scientific Committee truthfully acknowledged in its report that “dissolvable” tobacco products are less hazardous than cigarettes.
Meanwhile, since 2011 the FDA’s MRTP webpage has falsely stated in bold letters “To date, no tobacco products have been scientifically proven to reduce risk of tobacco-related disease, improve safety or cause less harm than other tobacco products."
I’ve repeatedly urged the FDA to correct or clarify that false statement, and I encourage this Committee to urge the FDA do so as well. Although the FDA has repeatedly claimed its regulatory policies are based upon the scientific evidence, in reality the FDA has continued misrepresenting scientific evidence to help attain its counterproductive abstinence-only and prohibition policy goals.
Since cigarettes are 100 times more harmful than cigarettes, and since population surveys have found that several million smokers already quit smoking by switching to smokeless tobacco products, it is mathematically impossible for any increase in smokeless tobacco use to offset those public health benefits at the population level, even if everybody in America began to using smokeless tobacco, which is NOT going to happen. Besides, the 2009 TCA, the 1992 Synar Law, laws in all 50 states and the 1998 MSA already prohibit marketing of smokeless tobacco products to youth.
In sum, there is no justification for this Committee or FDA to demand additional research from a company so it can truthfully inform smokers that a smokeless tobacco product is less hazardous than cigarettes.
Smokers have a human right to be truthfully informed that smokeless tobacco products are far less hazardous alternatives to cigarettes, and public health agencies have an ethical duty to truthfully inform tobacco consumers that smokeless tobacco is far less hazardous than cigarettes.
Since 1986 when Congress enacted the Comprehensive Smokeless Tobacco Education Act, federal health agencies have intentionally deceived the public to believe that smokeless tobacco is just as hazardous as smoking cigarettes, which has deceived 85% of smokers and the public to believe that smokeless tobacco is as hazardous as cigarettes, discouraged tens of millions of smokers from switching to smokeless tobacco, and encouraged some smokeless users to switch to far more hazardous cigarettes.
It was wrong for cigarette companies to mislead the public about the health risks of cigarettes for decades. But it is far worse for the FDA, health agencies, organizations and/or professionals to intentionally deceive smokers and the public about the comparable health risks of cigarettes and noncombustible tobacco and nicotine products.
During the past two decades, Johnson & Johnson, GlaxoSmithKline, Pfizer and other drug companies have given more than a hundred million dollars to the Campaign for Tobacco Free Kids, American Cancer Society, American Heart Association, American Lung Association, Pinney Associates, American Medical Association, American Academy of Pediatrics, Legacy and others to promote NRT products (which have a 95% failure rate for smoking cessation) and less than safe Chantix as the safest and most effective ways to quit smoking, and to grossly exaggerate the risks and deny the benefits smokefree tobacco products provide smokers, lobbying to enact the TCA and to unfairly tax smokeless tobacco products at the same rate as cigarettes, and urging the FDA to ban e-cigarettes.
Instead of improving public health, those actions have protected cigarette markets and harmed millions of smokers who would have otherwise reduced their disease risks by switching to smokefree tobacco alternatives.
Now is the time for this Committee to help the FDA reestablish its scientific credibility and improve public health by endorsing and approving all MRTP applications for smokeless products seeking to claim they are less hazardous alternatives to cigarettes.
Thank you,
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