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Regulating tobacco: Q&A with FDA's Mitch Zeller
Regulating Tobacco: Q&A with FDA's Mitch Zeller - Robert Wood Johnson Foundation
I was surprised that my lengthy comment was posted. But since that may not last, I'm reposting it below.
In April 2009, FDA's Rita Chappelle revealed the agency's policy to defend the agency's unlawful ban on e-cigs and deceive the public about e-cigs
“We don’t want the public to perceive them as a safer alternative to cigarettes.”
E-Cigarettes Under Fire
In July 2009, Obama appointee (and former Waxman staffer) FDA Deputy Director Josh Sharfstein held a press conference (also in defense of the agency's unlawful ban on e-cigs) to claim that e-cigs are addicting children, can be gateways to cigarette smoking, are target marketed to children, contain carcinogens and toxic chemical DEG, haven't been proven as less hazardous than cigarettes, haven't been proven to help smokers quit, and are marketed as smoking cessation aids.
Concerns Voiced by the Public Health Experts About Electronic Cigarettes
http://www.fda.gov/downloads/NewsEvents/Newsroom/MediaTranscripts/UCM173405.pdf
But since then, the growing mountain of scientific and empirical evidence consistently indicates that e-cigarettes:
- are 99% (+/-1%) less hazardous than cigarettes,
- have never been found to create nicotine dependence in any nonsmoker (youth or adult),
- have never been found to precede cigarette smoking in any daily smoker (youth or adult),
- emit similar trace levels of constituents as FDA approved nicotine inhalers,
posing no risks to nonusers,
- are consumed almost exclusively (i.e. 99%) by smokers and former smokers who quit by switching to e-cigs,
- have helped several million smokers quit and/or sharply reduce cigarette
consumption,
- have replaced (reduced consumption of) nearly 1 Billion packs of cigarettes in the US in the past five years,
- are more effective than FDA approved nicotine gums, lozenges, patches and inhalers for smoking cessation and reducing cigarette consumption, and
- pose fewer risks than FDA approved Verenicline (Champix) and Wellbutrin.
Unfortunately, the FDA has refused to correct or clarify any of its many false and misleading fear mongering claims about e-cigs, which have been repeated by many public health officials and thousands of news stories in the past four and a half years.
But thankfully for public health, civil liberties, market competition and common sense, all 13 federal judges (who adjudicated litigation filed against FDA by two e-cig companies) struck down FDA e-cig ban as unlawful in 2010.
In response, on April 25, 2011 the FDA stated its intent to regulate e-cigarettes as tobacco products by imposing the "deeming" regulation and by imposing additional regulations on e-cigarettes (despite the agency's repeated claims that it bases all of its regulatory policies on scientific evidence).
Regulation of E-Cigarettes and Other Tobacco Products
In the fall of 2011, more than 5,000 people signed a Petition to the White House to “Recognize electronic cigarettes as an effective alternative to smoking and support job creation in this new industry”
https://wwws.whitehouse.gov/petitio...d-support-job-creation-new-industry/57vtB0QK?
In response to the 2011 White House Petition, FDA’s then Director of the Center for Tobacco Products Lawrence Deyton responded by claiming:
“E-cigarette may contain ingredients that are known to be toxic to humans or otherwise harm public health – for example, if they are attractive to young people and lead kids to try other tobacco products, including conventional cigarettes, which are known to cause disease and lead to premature death. Because clinical studies of these products have not been submitted to the Food and Drug Administration (FDA), consumers currently have no way of knowing what types or concentrations of potentially harmful chemical are found in these products, or how much nicotine people inhale when they use these products.”
In December 2012, more than a dozen e-cig consumers and supporters testify at a FDA public hearing about the many benefits of e-cigs, how FDA approved drugs didn’t help them quit smoking, and pointing out that the FDA "deeming" regulation would ban all e-cigarettes
FDA Actions Related to Nicotine Replacement Therapies and Smoking-Cessation Products; Report to Congress on Innovative Products and Treatments for Tobacco Dependence; Public Hearing
https://collaboration.fda.gov/p98191651/?launcher=false&fcsContent=true&pbMode=normal
https://collaboration.fda.gov/p95861884/?launcher=false&fcsContent=true&pbMode=normal
https://collaboration.fda.gov/p36279658/?launcher=false&fcsContent=true&pbMode=normal
https://collaboration.fda.gov/p20988129/?launcher=false&fcsContent=true&pbMode=normal
In January 2013, more than 5,200 e-cig consumers submitted comments to the FDA’s Docket on Section 918 (accounting for >99% of docket submissions) informing the agency of the benefits of e-cigs, and urging the agency to not ban or unjustifiably regulate the products. But the FDA has only made 99 of these comments available to the public.
Regulations.gov
http://www.e-cigarette-forum.com/fo...-fda-e-cigarettes-your-action-needed-now.html
Then in April 2013 (shortly after Mitch Zeller became Director of FDA's Center for Tobacco Products), the FDA submitted a Report to Congress per Section 918 of TCA that contradicted and misrepresented the evidence provided to agency at December's hearing and submitted to the agency's docket on Section 918 regarding the health benefits for smokers who switch to e-cigarettes or smokefree tobacco products, and about the ineffectiveness of NRT for smoking cessation and less that safe Chantix.
The FDA's Report to Congress also contradicted and misrepresented evidence submitted to the agency about NRT’s dismal success rate for smoking and nicotine cessation at the agency's 2/3/11 IOM MRTP
meeting, the agency's 8/25/11 MRTP conference, at numerous TPSAC meetings, and in public comments submitted to agency’s respective dockets.
http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/UCM348930.pdf
FDA Actions Related to Nicotine Replacement Therapies and Smoking-Cessation Products; Report to Congress on Innovative Products and Treatments for Tobacco Dependence; Public Hearing
Public Workshop: Scientific Evaluation of Modified Risk Tobacco Product (MRTP) Applications
http://www.e-cigarette-forum.com/fo...ds-studies-reduced-risk-tobacco-products.html
In February 2013, more than 28,000 people submitted a Petition to White House to "Prevent the FDA from regulating or banning the sale and use of electronic cigarettes, accessories and associated liquids", but the White House still hasn’t responded.
https://petitions.whitehouse.gov/pe...igarettes-accessories-and-associated/RQLBYRsd
To date, the FDA (and the news media) have refused to acknowledge that the "deeming" regulation (per Section 905(j) and Section 910 of the Tobacco Control Act) would once again ban ALL e-cigarettes.
Even if the FDA exempts e-cigarettes from the prohibition clauses in Sections 905 and 910, imposing the "deeming" regulation and additional regulations on e-cigarettes would likely ban 99% of the several thousand e-cigarette products now on the market, eliminate 98% of the approximately 500 e-cig manufacturers and importers, and basically give the entire fledgling e-cigarette industry to Big Tobacco (and perhaps several of the largest e-cigarette companies).
Then two months ago, to lobby for the FDA "deeming" regulation, CDC Director Tom Frieden and OSH Director Tim McAfee not only lied about the scientific evidence on e-cigs (by falsely claiming nicotine damages the brain, e-cigarettes are addictive, and are a gateway to cigarette smoking), but also intentionally misrepresented their own NYTS survey findings (i.e. finding that "past-month" use of an e-cig by teens increased from 1% in 2011 to 2% in 2012)
Notes from the Field: Electronic Cigarette Use Among Middle and High School Students — United States, 2011–2012
CDC Online Newsroom | Press Release | E-cigarette use more than doubles among U.S. middle and high school students from 2011-2012
The two most important findings by far of the NYTS survey were that teen smokers were >40 times more likely to have used an e-cig than nonsmokers (24% of smokers vs .5% of nonsmokers), and that teen smokers were even more likely than nonsmokers to have used an e-cig in 2012 than in 2011.
CDC's intentional misrepresentation of the scientific evidence and their own survey data is unethical public health malpractice.
Later In September 2013, the FDA announced it will give $273 million to many Tobacco Harm Reduction opponents and FDA regulation advocates, and will call them "Tobacco Centers for Regulatory Science"
FDA and NIH create first-of-kind Tobacco Centers of Regulatory Science
Tobacco Centers of Regulatory Science (TCORS)
Centers Research Portfolio
FDA and NIH create first-of-kind Tobacco Centers of Regulatory Science
A more appropriate name for these FDA funding recipients would be "Centers for Tobacco Propaganda"
Everyone agrees that it is sound public policy to ban e-cig sales to minors. But states can enact and enforce these laws far more rapidly than FDA (as it will take several years to finalize any regs that are proposed by FDA) and 25 states have already done so.
Ironically (or not), many more states would have banned e-cig sales to minors if those proposals weren't opposed by drug industry funded CTFK, ACS, AHA, ALA and other e-cigarette prohibitionists that urged FDA to unlawfully ban and seize e-cigarettes in 2009, that have lobbied state and local governments to ban the sale and use of e-cigarettes, that have made many false and misleading fear mongering claims about e-cigarettes, and that have refused to disclose that they've been paid off by Big Pharma to promote their products and to oppose competitive (but more effective) smokefree tobacco/nicotine alternatives.
The best thing the FDA can do to further reduce cigarette smoking is to allow the largely free market for e-cigarettes to continue flourishing without any federal regulations.
FDA regulation of e-cigs will protect cigarettes from market competition by far less hazardous e-cigs, will threaten the lives of vapers and smokers, and will give the e-cig industry to the three largest tobacco companies (none of which benefit public health).
For disclosure, neither I nor Smokefree Pennsylvania has ever received funding from any tobacco, drug or e-cigarette company.
In sharp contrast, Mitch Zeller worked as a lobbyist for GlaxoSmithKline (via Pinney Associates) for the past decade advocating public policies to promote GSK's ineffective NRT products, while demonizing and lobbing to ban or severely restrict the marketing of and truthful claims about smokeless tobacco products, dissolvables, e-cigs and other far less hazardous alternatives to cigarettes.
Bill Godshall
Executive Director
Smokefree Pennsylvania
1926 Monongahela Avenue
Pittsburgh, PA 15218
412-351-5880
smokefree@compuserve.com
Regulating Tobacco: Q&A with FDA's Mitch Zeller - Robert Wood Johnson Foundation
I was surprised that my lengthy comment was posted. But since that may not last, I'm reposting it below.
In April 2009, FDA's Rita Chappelle revealed the agency's policy to defend the agency's unlawful ban on e-cigs and deceive the public about e-cigs
“We don’t want the public to perceive them as a safer alternative to cigarettes.”
E-Cigarettes Under Fire
In July 2009, Obama appointee (and former Waxman staffer) FDA Deputy Director Josh Sharfstein held a press conference (also in defense of the agency's unlawful ban on e-cigs) to claim that e-cigs are addicting children, can be gateways to cigarette smoking, are target marketed to children, contain carcinogens and toxic chemical DEG, haven't been proven as less hazardous than cigarettes, haven't been proven to help smokers quit, and are marketed as smoking cessation aids.
Concerns Voiced by the Public Health Experts About Electronic Cigarettes
http://www.fda.gov/downloads/NewsEvents/Newsroom/MediaTranscripts/UCM173405.pdf
But since then, the growing mountain of scientific and empirical evidence consistently indicates that e-cigarettes:
- are 99% (+/-1%) less hazardous than cigarettes,
- have never been found to create nicotine dependence in any nonsmoker (youth or adult),
- have never been found to precede cigarette smoking in any daily smoker (youth or adult),
- emit similar trace levels of constituents as FDA approved nicotine inhalers,
posing no risks to nonusers,
- are consumed almost exclusively (i.e. 99%) by smokers and former smokers who quit by switching to e-cigs,
- have helped several million smokers quit and/or sharply reduce cigarette
consumption,
- have replaced (reduced consumption of) nearly 1 Billion packs of cigarettes in the US in the past five years,
- are more effective than FDA approved nicotine gums, lozenges, patches and inhalers for smoking cessation and reducing cigarette consumption, and
- pose fewer risks than FDA approved Verenicline (Champix) and Wellbutrin.
Unfortunately, the FDA has refused to correct or clarify any of its many false and misleading fear mongering claims about e-cigs, which have been repeated by many public health officials and thousands of news stories in the past four and a half years.
But thankfully for public health, civil liberties, market competition and common sense, all 13 federal judges (who adjudicated litigation filed against FDA by two e-cig companies) struck down FDA e-cig ban as unlawful in 2010.
In response, on April 25, 2011 the FDA stated its intent to regulate e-cigarettes as tobacco products by imposing the "deeming" regulation and by imposing additional regulations on e-cigarettes (despite the agency's repeated claims that it bases all of its regulatory policies on scientific evidence).
Regulation of E-Cigarettes and Other Tobacco Products
In the fall of 2011, more than 5,000 people signed a Petition to the White House to “Recognize electronic cigarettes as an effective alternative to smoking and support job creation in this new industry”
https://wwws.whitehouse.gov/petitio...d-support-job-creation-new-industry/57vtB0QK?
In response to the 2011 White House Petition, FDA’s then Director of the Center for Tobacco Products Lawrence Deyton responded by claiming:
“E-cigarette may contain ingredients that are known to be toxic to humans or otherwise harm public health – for example, if they are attractive to young people and lead kids to try other tobacco products, including conventional cigarettes, which are known to cause disease and lead to premature death. Because clinical studies of these products have not been submitted to the Food and Drug Administration (FDA), consumers currently have no way of knowing what types or concentrations of potentially harmful chemical are found in these products, or how much nicotine people inhale when they use these products.”
In December 2012, more than a dozen e-cig consumers and supporters testify at a FDA public hearing about the many benefits of e-cigs, how FDA approved drugs didn’t help them quit smoking, and pointing out that the FDA "deeming" regulation would ban all e-cigarettes
FDA Actions Related to Nicotine Replacement Therapies and Smoking-Cessation Products; Report to Congress on Innovative Products and Treatments for Tobacco Dependence; Public Hearing
https://collaboration.fda.gov/p98191651/?launcher=false&fcsContent=true&pbMode=normal
https://collaboration.fda.gov/p95861884/?launcher=false&fcsContent=true&pbMode=normal
https://collaboration.fda.gov/p36279658/?launcher=false&fcsContent=true&pbMode=normal
https://collaboration.fda.gov/p20988129/?launcher=false&fcsContent=true&pbMode=normal
In January 2013, more than 5,200 e-cig consumers submitted comments to the FDA’s Docket on Section 918 (accounting for >99% of docket submissions) informing the agency of the benefits of e-cigs, and urging the agency to not ban or unjustifiably regulate the products. But the FDA has only made 99 of these comments available to the public.
Regulations.gov
http://www.e-cigarette-forum.com/fo...-fda-e-cigarettes-your-action-needed-now.html
Then in April 2013 (shortly after Mitch Zeller became Director of FDA's Center for Tobacco Products), the FDA submitted a Report to Congress per Section 918 of TCA that contradicted and misrepresented the evidence provided to agency at December's hearing and submitted to the agency's docket on Section 918 regarding the health benefits for smokers who switch to e-cigarettes or smokefree tobacco products, and about the ineffectiveness of NRT for smoking cessation and less that safe Chantix.
The FDA's Report to Congress also contradicted and misrepresented evidence submitted to the agency about NRT’s dismal success rate for smoking and nicotine cessation at the agency's 2/3/11 IOM MRTP
meeting, the agency's 8/25/11 MRTP conference, at numerous TPSAC meetings, and in public comments submitted to agency’s respective dockets.
http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/UCM348930.pdf
FDA Actions Related to Nicotine Replacement Therapies and Smoking-Cessation Products; Report to Congress on Innovative Products and Treatments for Tobacco Dependence; Public Hearing
Public Workshop: Scientific Evaluation of Modified Risk Tobacco Product (MRTP) Applications
http://www.e-cigarette-forum.com/fo...ds-studies-reduced-risk-tobacco-products.html
In February 2013, more than 28,000 people submitted a Petition to White House to "Prevent the FDA from regulating or banning the sale and use of electronic cigarettes, accessories and associated liquids", but the White House still hasn’t responded.
https://petitions.whitehouse.gov/pe...igarettes-accessories-and-associated/RQLBYRsd
To date, the FDA (and the news media) have refused to acknowledge that the "deeming" regulation (per Section 905(j) and Section 910 of the Tobacco Control Act) would once again ban ALL e-cigarettes.
Even if the FDA exempts e-cigarettes from the prohibition clauses in Sections 905 and 910, imposing the "deeming" regulation and additional regulations on e-cigarettes would likely ban 99% of the several thousand e-cigarette products now on the market, eliminate 98% of the approximately 500 e-cig manufacturers and importers, and basically give the entire fledgling e-cigarette industry to Big Tobacco (and perhaps several of the largest e-cigarette companies).
Then two months ago, to lobby for the FDA "deeming" regulation, CDC Director Tom Frieden and OSH Director Tim McAfee not only lied about the scientific evidence on e-cigs (by falsely claiming nicotine damages the brain, e-cigarettes are addictive, and are a gateway to cigarette smoking), but also intentionally misrepresented their own NYTS survey findings (i.e. finding that "past-month" use of an e-cig by teens increased from 1% in 2011 to 2% in 2012)
Notes from the Field: Electronic Cigarette Use Among Middle and High School Students — United States, 2011–2012
CDC Online Newsroom | Press Release | E-cigarette use more than doubles among U.S. middle and high school students from 2011-2012
The two most important findings by far of the NYTS survey were that teen smokers were >40 times more likely to have used an e-cig than nonsmokers (24% of smokers vs .5% of nonsmokers), and that teen smokers were even more likely than nonsmokers to have used an e-cig in 2012 than in 2011.
CDC's intentional misrepresentation of the scientific evidence and their own survey data is unethical public health malpractice.
Later In September 2013, the FDA announced it will give $273 million to many Tobacco Harm Reduction opponents and FDA regulation advocates, and will call them "Tobacco Centers for Regulatory Science"
FDA and NIH create first-of-kind Tobacco Centers of Regulatory Science
Tobacco Centers of Regulatory Science (TCORS)
Centers Research Portfolio
FDA and NIH create first-of-kind Tobacco Centers of Regulatory Science
A more appropriate name for these FDA funding recipients would be "Centers for Tobacco Propaganda"
Everyone agrees that it is sound public policy to ban e-cig sales to minors. But states can enact and enforce these laws far more rapidly than FDA (as it will take several years to finalize any regs that are proposed by FDA) and 25 states have already done so.
Ironically (or not), many more states would have banned e-cig sales to minors if those proposals weren't opposed by drug industry funded CTFK, ACS, AHA, ALA and other e-cigarette prohibitionists that urged FDA to unlawfully ban and seize e-cigarettes in 2009, that have lobbied state and local governments to ban the sale and use of e-cigarettes, that have made many false and misleading fear mongering claims about e-cigarettes, and that have refused to disclose that they've been paid off by Big Pharma to promote their products and to oppose competitive (but more effective) smokefree tobacco/nicotine alternatives.
The best thing the FDA can do to further reduce cigarette smoking is to allow the largely free market for e-cigarettes to continue flourishing without any federal regulations.
FDA regulation of e-cigs will protect cigarettes from market competition by far less hazardous e-cigs, will threaten the lives of vapers and smokers, and will give the e-cig industry to the three largest tobacco companies (none of which benefit public health).
For disclosure, neither I nor Smokefree Pennsylvania has ever received funding from any tobacco, drug or e-cigarette company.
In sharp contrast, Mitch Zeller worked as a lobbyist for GlaxoSmithKline (via Pinney Associates) for the past decade advocating public policies to promote GSK's ineffective NRT products, while demonizing and lobbing to ban or severely restrict the marketing of and truthful claims about smokeless tobacco products, dissolvables, e-cigs and other far less hazardous alternatives to cigarettes.
Bill Godshall
Executive Director
Smokefree Pennsylvania
1926 Monongahela Avenue
Pittsburgh, PA 15218
412-351-5880
smokefree@compuserve.com
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