- Apr 2, 2009
- 5,171
- 13,288
- 67
Action Alert: FDA public comment deadline tonight (Nov 25) at 11:59PM on Swedish Match's snus MRTP application for TPSAC review
Regulations.gov
Comment Opportunities?
Smokefree Pennsylvania submitted the following comments:
Public Comments to FDA on Modified Reduced tobacco Product Application submitted by Swedish Match North America for ten brands of snus
November 25, 2014
by
William T. Godshall, MPH
Executive Director
Smokefree Pennsylvania
1926 Monongahela Avenue
Pittsburgh, PA 15218
412-351-5880
billgodshall@verizon.net
Smokefree Pennsylvania strongly encourages the FDA to swiftly approve the Modified Risk tobacco Product Application submitted by Swedish Match North America for ten of its snus brands because smokeless tobacco products are far less hazardous alternatives to cigarettes, because hundreds of thousands of smokers in Sweden and Norway have quit smoking by switching to snus, and because the 1986 Comprehensive Smokeless Tobacco Education Act and the US DHHS have been deceiving the public to inaccurately believe that smokeless tobacco products are as hazardous as cigarettes for nearly three decades.
Since FDA’s former director of CTP Lawrence Deyton deceitfully ordered the agency’s contracted IOM committee to ignore the scientific consensus and evidence that smokeless tobacco products are far less hazardous than cigarettes at its February 3, 2011 meeting, and since the FDA either ignored or rejected the same scientific evidence that was presented at the agency’s August 25, 2011 public workshop on MRTP and that was submitted to FDA’s MRTP workshop public docket, and at FDA’s subsequent 2012 public docket on MRTP Application Draft Guidance, Smokefree Pennsylvania is resubmitting the following excerpts of our oral testimonies and public docket comments.
Excerpts from Smokefree Pennsylvania’s 2012 comments submitted to FDA’s docket on MRTP Application Draft Guidance.
“After I and others provided hundreds of scientific studies to the FDA during the past three years documenting that smokefree tobacco products are far less hazardous than cigarettes, that millions of smokers have already quit smoking and/or significantly reduced cigarette consumption by substituting smokefree tobacco alternatives for cigarettes, and that smokefree tobacco products are not a gateway to cigarette use, the agency’s Draft Guidance for MRTP Applications falsely and deceitfully presumes that all smokeless tobacco products (and perhaps all unregulated smokefree tobacco products) are just as hazardous as cigarettes.
Using the research protocol proposed in the FDA’s MRTP Application Draft Guidance, it would cost any smokeless tobacco manufacturer (or any manufacturer of a dissolvable, e-cigarette, or other unregulated smokefree tobacco product if/when the agency "deems" them to be regulated by Chapter IX of the FSPTCA) at least $10 million to conduct totally unnecessary research before it could apply to the FDA to truthfully claim that any of its smokefree tobacco products is less hazardous than cigarettes. As such, the MRTP Application Draft Guidance amounts to an arbitrary, capricious and punitive “$10 million tax” that protects cigarette markets and threatens consumer and public health.
Unless the FDA significantly changes its MRTP Application Draft Guidance, only several large tobacco companies could even afford to conduct this unnecessary research, and even that would be a very risky investment since the FDA continues to falsely claim "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," and "Claiming less harm or reduced risk of disease from using tobacco products misleads consumers to think that these products are safe to use," at the agency's ironically titled "Health Fraud" website on Section 911 and MRTP at Health Fraud
Under FDA's MRTP Application Draft Guidance, tens of millions of American smokers will continue smoking cigarettes, getting sick and dying simply because President Obama's appointees at DHHS and the FDA don't want smokers or the public to know that smokefree tobacco products are far less hazardous alternatives to cigarettes.
On a scale of harm/risk from 1 to 100, on which FDA approved NRT products are 1 and cigarettes are 100, existing scientific and empirical evidence indicate that ALL noncombustible tobacco products marketed in the US are below 2, as all have very similar health/safety risk/benefit profiles as NRT products.
Although the research protocol in FDA’s Draft Guidance for MRTP Applications would be appropriate for making cigarette-to-cigarette health claims, and may be appropriate for making smokeless-to-smokeless health claims, the FDA proposed research protocol is totally inappropriate for making a smokeless-to-cigarette health claim since it is a well established fact that smokeless tobacco products are far less hazardous than cigarettes.
Therefore, the FDA should establish an entirely different MRTP Application Guidance for manufacturers that desire to truthfully claim that a smokeless (or noncombustible) tobacco product is less hazardous than cigarettes.
By trying to prevent tobacco companies from truthfully informing smokers that smokefree alternatives are less hazardous than cigarettes, and by falsely claiming that all tobacco products are just as hazardous as cigarettes, the FDA continues to threaten the health and lives of tens of millions of smokers, which violates the human rights of smokers, is immoral and unethical, and is public health malpractice.
Please note that Section 911 and other provisions of Chapter IX of the FSPTCA only apply to: cigarettes, cigarette tobacco, RYO tobacco and smokeless tobacco products. Although the FDA has stated that it intends to propose a “deeming” regulation to apply Chapter IX to all currently unregulated tobacco products, Section 911 does not apply to small cigars, large cigars, pipe tobacco, hookah/shisha tobacco, electronic cigarettes, e-liquid, tobacco skin cream, tobacco water and at least two dissolvable tobacco products.
As such, there are three different types of MRTP applications that tobacco manufacturers might submit to the FDA:
- comparing a smokeless tobacco product to cigarettes,
- comparing a cigarette to other cigarettes, and
- comparing a smokeless product to other smokeless products.
Since there no scientific evidence indicating that any type of cigarette is less hazardous than other cigarettes, and since there is insufficient evidence indicating that any type of smokeless tobacco product is less hazardous than other smokeless tobacco products used in the US, the FDA should require additional studies for MRTP applications seeking to claim that one cigarette is less hazardous than another and for those seeking to claim that one smokeless product is less hazardous than another.
But in sharp contrast, a growing body of scientific evidence has found that daily use of smokefree tobacco products marketed in the US and Sweden pose about 99% fewer mortality risks than cigarettes, and that switching to a smokefree tobacco product reduces a smoker’s mortality risks nearly as much as quitting all tobacco/nicotine. Nonsmokers are also exposed to less tobacco smoke when smokers switch to smokeless tobacco. In fact, NRT and smokeless tobacco products have very similar health risk and benefit profiles.
Since >99% of all tobacco attributable deaths and healthcare costs in the US are caused by the repeated inhalation of tobacco smoke, and that <1% are caused by smokeless tobacco products, it is vitally important for the FDA to publicly acknowledge the exponential differences of risk between cigarettes and smokeless tobacco, and to take this into account when considering criteria for evaluating MRTP applications.
Even in the absence of reduced risk marketing claims, population surveys found that several million smokers have already switched to smokeless tobacco products, despite numerous surveys finding that most smokers inaccurately believe smokeless products are as hazardous as cigarettes. So smokeless tobacco products have already saved more lives (of smokers) than could be offset even if every American non tobacco user begins to use smokeless tobacco. Besides, laws in all 50 states, the FSPTCA, and the 1998 MSA already prohibit the marketing of smokeless tobacco products to youth.
If the FDA desires further evidence that the marketing of smokeless tobacco to smokers as less hazardous alternatives won’t harm public health, the agency should consider that e-cigarettes have been marketed to smokers as less hazardous alternatives for several years. As a result, smokers and former smokers account for the vast majority of e-cigarette consumers, while there is no evidence that youth or non tobacco users have become addicted to e-cigarettes. Surveys of e-cigarette consumers have found that nearly all perceive significant health benefits from switching to e-cigarettes, and that most had previously failed to quit smoking by using FDA approved smoking cessation products.
There is no rationale justification for FDA to require new studies for the approval of MRTP applications seeking to claim that a smokeless tobacco product is less hazardous than cigarettes.
Just as ...... addicts and the public have a right to be truthfully informed that methadone, clean needles and condoms can reduce risks of transmitting and contracting HIV, hepatitis and other diseases, tobacco consumers (and the public) have a human right to be truthfully informed that smokeless tobacco products are far less hazardous alternatives to cigarettes.
Just as the US Public Health Service had an ethical duty to inform black syphilis patients in the infamous Tuskeegee Study that effective syphilis treatments were available, the FDA and public health agencies have an ethical duty to truthfully inform tobacco consumers that smokeless tobacco is far less hazardous than cigarettes.
But since 1986 when Congress enacted the Comprehensive Smokeless Tobacco Education Act, public health agencies have intentionally mislead the public to believe that smokeless tobacco is just as hazardous as smoking cigarettes, which has discouraged tens of millions of smokers from switching to smokeless products, and has encouraged some smokeless users to switch to far more hazardous cigarettes.
Although the FDA has stated that it would comply with Judge Richard Leon’s ruling that electronic cigarettes are tobacco products, the FDA hasn’t clarified or corrected any of former Deputy Commissioner Josh Sharfstein’s false and misleading fear mongering propaganda about e-cigarettes back in July, 2009 at FDA and Public Health Experts Warn About Electronic Cigarettes and
http://www.fda.gov/downloads/NewsEvents/Newsroom/MediaTranscripts/UCM173405.pdf
in the agency’s desperate attempt to win a lawsuit by deceiving the public.
In October, 2011, the FDA posted even more inaccurate and misleading fear mongering claims about e-cigarettes at
Electronic Cigarettes (e-Cigarettes)
that deceptively state “e-Cigarettes may contain ingredients that are known to be toxic to humans, and may contain other ingredients that may not be safe. Additionally, these products may be attractive to young people and may lead kids to try other tobacco products, including conventional cigarettes, which are known to cause disease and lead to premature death.“
Further, FDA officials instructed the FDA contracted IOM Committee to NOT consider different research protocols for MRTP Applications making cross category comparisons (e.g. smokeless-to-cigarettes), which is why the IOM Committee failed to make that recommendation, and why the FDA should have ignored (instead of embracing) the IOM Committee’s report recommendations.
The FDA also invited many abstinence-only tobacco prohibitionists to its staff, its TPSAC and to present at its MRTP workshop, while inviting very few, if any, harm reduction advocates or tobacco consumers.
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 and other federal health agencies to deceive the public about the comparable health risks of cigarettes and noncombustible tobacco products.
As long as the FDA continues to post and maintain inaccurate and misleading information about electronic cigarettes, smokeless tobacco and other smokefree tobacco products, the agency cannot be trusted to make any objective decisions about MRTP Applications, any other tobacco regulations, or any other public health issue.
Only about half of the estimated 70 million tobacco users in the US (i.e. the 34 million daily smokers) face significant disease risks by their tobacco use. Meanwhile, the other half of America’s tobacco users (i.e. 10 million smokeless tobacco users, 13 million occassional cigar smokers, 2 million e-cigarette users, and 12 million occasional cigarette smokers) face far lower if any disease risks. Instead of falsely claiming that all tobacco products are as hazardous as cigarettes, the FDA must distinguish between these vastly different types of tobacco products and users.
Public health benefits every time a cigarette smoker substitutes a smokefree tobacco product for a cigarette, and the FDA needs to acknowledge this important fact.
Thus, the FDA also should correct or clarify ALL of the many inaccurate and misleading information about the health risks of different tobacco products.
Regulations.gov
Comment Opportunities?
Smokefree Pennsylvania submitted the following comments:
Public Comments to FDA on Modified Reduced tobacco Product Application submitted by Swedish Match North America for ten brands of snus
November 25, 2014
by
William T. Godshall, MPH
Executive Director
Smokefree Pennsylvania
1926 Monongahela Avenue
Pittsburgh, PA 15218
412-351-5880
billgodshall@verizon.net
Smokefree Pennsylvania strongly encourages the FDA to swiftly approve the Modified Risk tobacco Product Application submitted by Swedish Match North America for ten of its snus brands because smokeless tobacco products are far less hazardous alternatives to cigarettes, because hundreds of thousands of smokers in Sweden and Norway have quit smoking by switching to snus, and because the 1986 Comprehensive Smokeless Tobacco Education Act and the US DHHS have been deceiving the public to inaccurately believe that smokeless tobacco products are as hazardous as cigarettes for nearly three decades.
Since FDA’s former director of CTP Lawrence Deyton deceitfully ordered the agency’s contracted IOM committee to ignore the scientific consensus and evidence that smokeless tobacco products are far less hazardous than cigarettes at its February 3, 2011 meeting, and since the FDA either ignored or rejected the same scientific evidence that was presented at the agency’s August 25, 2011 public workshop on MRTP and that was submitted to FDA’s MRTP workshop public docket, and at FDA’s subsequent 2012 public docket on MRTP Application Draft Guidance, Smokefree Pennsylvania is resubmitting the following excerpts of our oral testimonies and public docket comments.
Excerpts from Smokefree Pennsylvania’s 2012 comments submitted to FDA’s docket on MRTP Application Draft Guidance.
“After I and others provided hundreds of scientific studies to the FDA during the past three years documenting that smokefree tobacco products are far less hazardous than cigarettes, that millions of smokers have already quit smoking and/or significantly reduced cigarette consumption by substituting smokefree tobacco alternatives for cigarettes, and that smokefree tobacco products are not a gateway to cigarette use, the agency’s Draft Guidance for MRTP Applications falsely and deceitfully presumes that all smokeless tobacco products (and perhaps all unregulated smokefree tobacco products) are just as hazardous as cigarettes.
Using the research protocol proposed in the FDA’s MRTP Application Draft Guidance, it would cost any smokeless tobacco manufacturer (or any manufacturer of a dissolvable, e-cigarette, or other unregulated smokefree tobacco product if/when the agency "deems" them to be regulated by Chapter IX of the FSPTCA) at least $10 million to conduct totally unnecessary research before it could apply to the FDA to truthfully claim that any of its smokefree tobacco products is less hazardous than cigarettes. As such, the MRTP Application Draft Guidance amounts to an arbitrary, capricious and punitive “$10 million tax” that protects cigarette markets and threatens consumer and public health.
Unless the FDA significantly changes its MRTP Application Draft Guidance, only several large tobacco companies could even afford to conduct this unnecessary research, and even that would be a very risky investment since the FDA continues to falsely claim "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," and "Claiming less harm or reduced risk of disease from using tobacco products misleads consumers to think that these products are safe to use," at the agency's ironically titled "Health Fraud" website on Section 911 and MRTP at Health Fraud
Under FDA's MRTP Application Draft Guidance, tens of millions of American smokers will continue smoking cigarettes, getting sick and dying simply because President Obama's appointees at DHHS and the FDA don't want smokers or the public to know that smokefree tobacco products are far less hazardous alternatives to cigarettes.
On a scale of harm/risk from 1 to 100, on which FDA approved NRT products are 1 and cigarettes are 100, existing scientific and empirical evidence indicate that ALL noncombustible tobacco products marketed in the US are below 2, as all have very similar health/safety risk/benefit profiles as NRT products.
Although the research protocol in FDA’s Draft Guidance for MRTP Applications would be appropriate for making cigarette-to-cigarette health claims, and may be appropriate for making smokeless-to-smokeless health claims, the FDA proposed research protocol is totally inappropriate for making a smokeless-to-cigarette health claim since it is a well established fact that smokeless tobacco products are far less hazardous than cigarettes.
Therefore, the FDA should establish an entirely different MRTP Application Guidance for manufacturers that desire to truthfully claim that a smokeless (or noncombustible) tobacco product is less hazardous than cigarettes.
By trying to prevent tobacco companies from truthfully informing smokers that smokefree alternatives are less hazardous than cigarettes, and by falsely claiming that all tobacco products are just as hazardous as cigarettes, the FDA continues to threaten the health and lives of tens of millions of smokers, which violates the human rights of smokers, is immoral and unethical, and is public health malpractice.
Please note that Section 911 and other provisions of Chapter IX of the FSPTCA only apply to: cigarettes, cigarette tobacco, RYO tobacco and smokeless tobacco products. Although the FDA has stated that it intends to propose a “deeming” regulation to apply Chapter IX to all currently unregulated tobacco products, Section 911 does not apply to small cigars, large cigars, pipe tobacco, hookah/shisha tobacco, electronic cigarettes, e-liquid, tobacco skin cream, tobacco water and at least two dissolvable tobacco products.
As such, there are three different types of MRTP applications that tobacco manufacturers might submit to the FDA:
- comparing a smokeless tobacco product to cigarettes,
- comparing a cigarette to other cigarettes, and
- comparing a smokeless product to other smokeless products.
Since there no scientific evidence indicating that any type of cigarette is less hazardous than other cigarettes, and since there is insufficient evidence indicating that any type of smokeless tobacco product is less hazardous than other smokeless tobacco products used in the US, the FDA should require additional studies for MRTP applications seeking to claim that one cigarette is less hazardous than another and for those seeking to claim that one smokeless product is less hazardous than another.
But in sharp contrast, a growing body of scientific evidence has found that daily use of smokefree tobacco products marketed in the US and Sweden pose about 99% fewer mortality risks than cigarettes, and that switching to a smokefree tobacco product reduces a smoker’s mortality risks nearly as much as quitting all tobacco/nicotine. Nonsmokers are also exposed to less tobacco smoke when smokers switch to smokeless tobacco. In fact, NRT and smokeless tobacco products have very similar health risk and benefit profiles.
Since >99% of all tobacco attributable deaths and healthcare costs in the US are caused by the repeated inhalation of tobacco smoke, and that <1% are caused by smokeless tobacco products, it is vitally important for the FDA to publicly acknowledge the exponential differences of risk between cigarettes and smokeless tobacco, and to take this into account when considering criteria for evaluating MRTP applications.
Even in the absence of reduced risk marketing claims, population surveys found that several million smokers have already switched to smokeless tobacco products, despite numerous surveys finding that most smokers inaccurately believe smokeless products are as hazardous as cigarettes. So smokeless tobacco products have already saved more lives (of smokers) than could be offset even if every American non tobacco user begins to use smokeless tobacco. Besides, laws in all 50 states, the FSPTCA, and the 1998 MSA already prohibit the marketing of smokeless tobacco products to youth.
If the FDA desires further evidence that the marketing of smokeless tobacco to smokers as less hazardous alternatives won’t harm public health, the agency should consider that e-cigarettes have been marketed to smokers as less hazardous alternatives for several years. As a result, smokers and former smokers account for the vast majority of e-cigarette consumers, while there is no evidence that youth or non tobacco users have become addicted to e-cigarettes. Surveys of e-cigarette consumers have found that nearly all perceive significant health benefits from switching to e-cigarettes, and that most had previously failed to quit smoking by using FDA approved smoking cessation products.
There is no rationale justification for FDA to require new studies for the approval of MRTP applications seeking to claim that a smokeless tobacco product is less hazardous than cigarettes.
Just as ...... addicts and the public have a right to be truthfully informed that methadone, clean needles and condoms can reduce risks of transmitting and contracting HIV, hepatitis and other diseases, tobacco consumers (and the public) have a human right to be truthfully informed that smokeless tobacco products are far less hazardous alternatives to cigarettes.
Just as the US Public Health Service had an ethical duty to inform black syphilis patients in the infamous Tuskeegee Study that effective syphilis treatments were available, the FDA and public health agencies have an ethical duty to truthfully inform tobacco consumers that smokeless tobacco is far less hazardous than cigarettes.
But since 1986 when Congress enacted the Comprehensive Smokeless Tobacco Education Act, public health agencies have intentionally mislead the public to believe that smokeless tobacco is just as hazardous as smoking cigarettes, which has discouraged tens of millions of smokers from switching to smokeless products, and has encouraged some smokeless users to switch to far more hazardous cigarettes.
Although the FDA has stated that it would comply with Judge Richard Leon’s ruling that electronic cigarettes are tobacco products, the FDA hasn’t clarified or corrected any of former Deputy Commissioner Josh Sharfstein’s false and misleading fear mongering propaganda about e-cigarettes back in July, 2009 at FDA and Public Health Experts Warn About Electronic Cigarettes and
http://www.fda.gov/downloads/NewsEvents/Newsroom/MediaTranscripts/UCM173405.pdf
in the agency’s desperate attempt to win a lawsuit by deceiving the public.
In October, 2011, the FDA posted even more inaccurate and misleading fear mongering claims about e-cigarettes at
Electronic Cigarettes (e-Cigarettes)
that deceptively state “e-Cigarettes may contain ingredients that are known to be toxic to humans, and may contain other ingredients that may not be safe. Additionally, these products may be attractive to young people and may lead kids to try other tobacco products, including conventional cigarettes, which are known to cause disease and lead to premature death.“
Further, FDA officials instructed the FDA contracted IOM Committee to NOT consider different research protocols for MRTP Applications making cross category comparisons (e.g. smokeless-to-cigarettes), which is why the IOM Committee failed to make that recommendation, and why the FDA should have ignored (instead of embracing) the IOM Committee’s report recommendations.
The FDA also invited many abstinence-only tobacco prohibitionists to its staff, its TPSAC and to present at its MRTP workshop, while inviting very few, if any, harm reduction advocates or tobacco consumers.
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 and other federal health agencies to deceive the public about the comparable health risks of cigarettes and noncombustible tobacco products.
As long as the FDA continues to post and maintain inaccurate and misleading information about electronic cigarettes, smokeless tobacco and other smokefree tobacco products, the agency cannot be trusted to make any objective decisions about MRTP Applications, any other tobacco regulations, or any other public health issue.
Only about half of the estimated 70 million tobacco users in the US (i.e. the 34 million daily smokers) face significant disease risks by their tobacco use. Meanwhile, the other half of America’s tobacco users (i.e. 10 million smokeless tobacco users, 13 million occassional cigar smokers, 2 million e-cigarette users, and 12 million occasional cigarette smokers) face far lower if any disease risks. Instead of falsely claiming that all tobacco products are as hazardous as cigarettes, the FDA must distinguish between these vastly different types of tobacco products and users.
Public health benefits every time a cigarette smoker substitutes a smokefree tobacco product for a cigarette, and the FDA needs to acknowledge this important fact.
Thus, the FDA also should correct or clarify ALL of the many inaccurate and misleading information about the health risks of different tobacco products.
Last edited:
