The final countdown to August 8th - your FDA comments NEEDED
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I forgot to add that banning all flavors would cure diabetes and obesity too.
Aaahh less than 3 hours left!!! What to say, what to say...
Oh, I got it! Just let me put down my brand new black nemesis clone for a sec and write another comment...
Oh, I got it! Just let me put down my brand new black nemesis clone for a sec and write another comment...
Heres what I submitted:
After smoking for 15 years, I was able to give up cigarettes overnight thanks to my advanced personal vaporizer and a flavored e-liquid I enjoyed.
I am deeply opposed to regulation beyond age restriction as I feel it would serve no legitimate purpose aside from protecting the interests of those invested in tobacco, pharmaceuticals, and other interests that benefit financially from regulatory action.
Regulation will create unnecessary burden on the consumer, vendors, manufacturers and taxpayers. This country was founded on the principles of Freedom. Unless hardened scientific research suggests that e-cigarettes cause harm to others, we should remain free to choose the devices and consumables we desire without limitations or interference by government.
-sj
After smoking for 15 years, I was able to give up cigarettes overnight thanks to my advanced personal vaporizer and a flavored e-liquid I enjoyed.
I am deeply opposed to regulation beyond age restriction as I feel it would serve no legitimate purpose aside from protecting the interests of those invested in tobacco, pharmaceuticals, and other interests that benefit financially from regulatory action.
Regulation will create unnecessary burden on the consumer, vendors, manufacturers and taxpayers. This country was founded on the principles of Freedom. Unless hardened scientific research suggests that e-cigarettes cause harm to others, we should remain free to choose the devices and consumables we desire without limitations or interference by government.
-sj
This was my mom's comment:
I am a 58 year old female exsmoker who was only able to quit smoking when I purchased a vaping device. I tried several times over the years to quit with all the methods available (patches, gum, zyban, cold turkey etc). Nothing worked until I went to a new shop that opened in my town and bought a vaping kit.
I can finally breathe again after almost 40 years of smoking a pack a day. If you ban these devices, you will be dooming not only me but millions of people to die a slow extremely painful death.
I enjoy vaping and I would like to continue to be an exsmoker. I enjoy the wide range of flavors from tobacco to bubble gum to fruits to chocolate. Yes, I'm 58 and my favorite gum is still bubble gum. I don't mind safety regulations but do not take away the only thing that helped me get rid of smoking for good.
My mom is awesome I like the slow painful death part she sure doesn't mince words!
I am a 58 year old female exsmoker who was only able to quit smoking when I purchased a vaping device. I tried several times over the years to quit with all the methods available (patches, gum, zyban, cold turkey etc). Nothing worked until I went to a new shop that opened in my town and bought a vaping kit.
I can finally breathe again after almost 40 years of smoking a pack a day. If you ban these devices, you will be dooming not only me but millions of people to die a slow extremely painful death.
I enjoy vaping and I would like to continue to be an exsmoker. I enjoy the wide range of flavors from tobacco to bubble gum to fruits to chocolate. Yes, I'm 58 and my favorite gum is still bubble gum. I don't mind safety regulations but do not take away the only thing that helped me get rid of smoking for good.
My mom is awesome
I like the slow painful death part she sure doesn't mince words!
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So very sorry for my sloppy imprecision. I shall offer a correction to say that death is the only scientifically proven way to avoid carcinogens.
My beautiful, non-vaping, never-smoked wife just submitted a wonderful comment from the perspective of a person with severe allergies who enjoys the aromas from my vaping rig and whose difficulties have improved with my e-cig use. She also admonished the perspective of manufacturers using flavors to entice kids, as The Fed would have to pull a myriad of products from shelves that are flavored, so they must be marketed to kids, but remain, anyway.
I love my wife, and you should, too. But mind your manners.
I love my wife, and you should, too. But mind your manners.
One hour and fifteen minutes left!! I want to make one more comment... but I feel like I've touched on everything already and I don't know what else to say... so...
Any special requests? Is there anything in particular anyone here wants me to write to the FDA about? I will write to them on the topic you choose, on the condition that you submit a comment on the same topic as well
Any special requests?
Is there anything in particular anyone here wants me to write to the FDA about? I will write to them on the topic you choose, on the condition that you submit a comment on the same topic as well 
"I would rather be exposed to the inconveniences attending too much liberty than those attending too small a degree of it." Thomas Jefferson
"FDA is aware of new product category entrants into the market after the February 15, 2007, reference date and that the SE pathway may not be available to these newer products. Because this date is written into the statute, we do not believe that we have the authority to amend it with respect to e-cigarettes or other products." (1)
"FDA is specifically seeking comment on whether and, if so, how FDA should consider a different regulatory mechanism for newer proposed deemed tobacco products that cannot, as a practical matter, use the SE pathway." (1)
“The core responsibility of FDA is to protect consumers by applying the best possible science to its regulatory activities.” (2)
"Advances in science and technology are moving forward rapidly and have created
unprecedented challenges and opportunities in U.S. and global health. FDA plays a
critical role in protecting and promoting the nation’s health and regulates industries
that are among the most successful and innovative in the world. Critical responsibilities
across the products FDA regulates require application of the best available science to
keep pace with these advances and make decisions and take actions that both support
innovation and protect and promote the public health." (2)
I realize the FDA is under pressure by groups that would rather the FDA act first based on bias, emotion, and the current political ideology of hatred instead of "the best available science".
The groups that would have you act first contend that e-cigarettes are dangerous since we do not have evidence of the contents of the emitted vapor. A study of the current body of evidence (3) by Igor Bursytn, PhD of Drexel University's School of Public Health which surveyed data from over 9,000 measurements showed that the contents were well within safe exposure thresholds and rarely exceded 1% of the safe exposure limits. These same chemicals are present in FDA approved patches (4)
The groups that would have you act first contend that e-cigarettes are a gateway to smoking. A survey (5) of 1300 college students found only 1 that transitioned from e-cigarettes to cigarettes.
The groups that would have you act first contend that e-cigarettes are flavored to attract youth. Dr. Howard Marsh the chief medical officer for GlaxoSmithKline Consumer Healthcare has given evidence to the FDA to the contrary as to why flavoring is important in nicotine replacement therapy. "The availability of other forms and various flavors of oral nicotine replacement therapy can lead to an increased interest in quitting, and therefore has significant public health benefits." (6) The FDA has subsequently approved flavored NRT's such as White Ice Mint, Cinnamon Surge, and Fruit Chill for use over the counter.
The FDA needs to act only after "applying the best possible science" in keeping with its own statement. E-cigarettes offer the best possibility for the most effective harm reduction to date in regards to tobacco related illness and death. Acting without the best possible science could cause irreparable harm and should be avoided.
In the event the FDA is pressured to act without the best possible science, FDA should ask Congress for a new reference date and suggest that the date should be based on the effective date of regulation since these products were not intended by Congress to be regulated by the reference date.
Thank you.
(1) Deeming Tobacco Products To Be Subject to the Federal Food, Drug, and Cosmetic Act, as Amended by the Family Smoking Prevention and Tobacco Control Act; Regulations on the Sale and Distribution of Tobacco Products and Required Warning Statements for Tobacco Products FDA-2014-N-0189-20870.pdf
(2) Strategic Plan for Regulatory Science Advancing Regulatory Science at FDA: A Strategic Plan (August 2011) http://www.fda.gov/downloads/ScienceResearch/SpecialTopics/RegulatoryScience/UCM268225.pdf
(3) Burstyn, I (2013), Peering through the mist: What does the chemistry of contaminants in electronic cigarettes tell us about health risks? Drexel University School of Public Health, Philadelphia, PA - http://publichealth.drexel.edu/~/media/Files/publichealth/ms08.pdf
(4) Siegel, M (2009), Comparison of Carcinogen Levels Shows that Electronic Cigarettes are Much Safer Than Conventional Ones, The Rest of the Story - http://tobaccoanalysis.blogspot.co.uk/2009/07/comparison.html
(5) Goodman, B. (2013) E-Cigarettes May Not be Gateway to Smoking: Study, Health - E-Cigarettes May Not Be Gateway to Smoking: Study - Health News and Views - Health.com
(6) FDA ACTIONS RELATED TO NICOTINE REPLACEMENT THERAPIES AND SMOKING-CESSATION PRODUCTS REPORT TO CONGRESS ON INNOVATIVE PRODUCTS AND
TREATMENTS FOR TOBACCO DEPENDENCE Part 15 Public Hearing Monday, December 17, 2012 http://www.fda.gov/downloads/drugs/newsevents/ucm336652.pdf
"FDA is aware of new product category entrants into the market after the February 15, 2007, reference date and that the SE pathway may not be available to these newer products. Because this date is written into the statute, we do not believe that we have the authority to amend it with respect to e-cigarettes or other products." (1)
"FDA is specifically seeking comment on whether and, if so, how FDA should consider a different regulatory mechanism for newer proposed deemed tobacco products that cannot, as a practical matter, use the SE pathway." (1)
“The core responsibility of FDA is to protect consumers by applying the best possible science to its regulatory activities.” (2)
"Advances in science and technology are moving forward rapidly and have created
unprecedented challenges and opportunities in U.S. and global health. FDA plays a
critical role in protecting and promoting the nation’s health and regulates industries
that are among the most successful and innovative in the world. Critical responsibilities
across the products FDA regulates require application of the best available science to
keep pace with these advances and make decisions and take actions that both support
innovation and protect and promote the public health." (2)
I realize the FDA is under pressure by groups that would rather the FDA act first based on bias, emotion, and the current political ideology of hatred instead of "the best available science".
The groups that would have you act first contend that e-cigarettes are dangerous since we do not have evidence of the contents of the emitted vapor. A study of the current body of evidence (3) by Igor Bursytn, PhD of Drexel University's School of Public Health which surveyed data from over 9,000 measurements showed that the contents were well within safe exposure thresholds and rarely exceded 1% of the safe exposure limits. These same chemicals are present in FDA approved patches (4)
The groups that would have you act first contend that e-cigarettes are a gateway to smoking. A survey (5) of 1300 college students found only 1 that transitioned from e-cigarettes to cigarettes.
The groups that would have you act first contend that e-cigarettes are flavored to attract youth. Dr. Howard Marsh the chief medical officer for GlaxoSmithKline Consumer Healthcare has given evidence to the FDA to the contrary as to why flavoring is important in nicotine replacement therapy. "The availability of other forms and various flavors of oral nicotine replacement therapy can lead to an increased interest in quitting, and therefore has significant public health benefits." (6) The FDA has subsequently approved flavored NRT's such as White Ice Mint, Cinnamon Surge, and Fruit Chill for use over the counter.
The FDA needs to act only after "applying the best possible science" in keeping with its own statement. E-cigarettes offer the best possibility for the most effective harm reduction to date in regards to tobacco related illness and death. Acting without the best possible science could cause irreparable harm and should be avoided.
In the event the FDA is pressured to act without the best possible science, FDA should ask Congress for a new reference date and suggest that the date should be based on the effective date of regulation since these products were not intended by Congress to be regulated by the reference date.
Thank you.
(1) Deeming Tobacco Products To Be Subject to the Federal Food, Drug, and Cosmetic Act, as Amended by the Family Smoking Prevention and Tobacco Control Act; Regulations on the Sale and Distribution of Tobacco Products and Required Warning Statements for Tobacco Products FDA-2014-N-0189-20870.pdf
(2) Strategic Plan for Regulatory Science Advancing Regulatory Science at FDA: A Strategic Plan (August 2011) http://www.fda.gov/downloads/ScienceResearch/SpecialTopics/RegulatoryScience/UCM268225.pdf
(3) Burstyn, I (2013), Peering through the mist: What does the chemistry of contaminants in electronic cigarettes tell us about health risks? Drexel University School of Public Health, Philadelphia, PA - http://publichealth.drexel.edu/~/media/Files/publichealth/ms08.pdf
(4) Siegel, M (2009), Comparison of Carcinogen Levels Shows that Electronic Cigarettes are Much Safer Than Conventional Ones, The Rest of the Story - http://tobaccoanalysis.blogspot.co.uk/2009/07/comparison.html
(5) Goodman, B. (2013) E-Cigarettes May Not be Gateway to Smoking: Study, Health - E-Cigarettes May Not Be Gateway to Smoking: Study - Health News and Views - Health.com
(6) FDA ACTIONS RELATED TO NICOTINE REPLACEMENT THERAPIES AND SMOKING-CESSATION PRODUCTS REPORT TO CONGRESS ON INNOVATIVE PRODUCTS AND
TREATMENTS FOR TOBACCO DEPENDENCE Part 15 Public Hearing Monday, December 17, 2012 http://www.fda.gov/downloads/drugs/newsevents/ucm336652.pdf
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Comments received: 75,735 - as of 11:59 pm yesterday. Wish I was seeing more than that. Have to wait and see what the final total is when they update the total after today.
Git 'er done! Still have a bit over an hour to get your comments in!
Have to wait and see what the final total is when they update the total after today.Git 'er done! Still have a bit over an hour to get your comments in!
Aug. 17 is my birthday. That date is vastly more meaningful for you.There were some moments a few years ago when I figured there probably wouldn't be too many more birthday celebrations for me. Thanks to e-cigarettes, I'm fairly certain I'll survive a bit longer and my doctor agrees. Let's celebrate!
One hour and fifteen minutes left!! I want to make one more comment... but I feel like I've touched on everything already and I don't know what else to say... so...
Any special requests?
Go tp the site and pick an ANTZ comment and rebutt that.
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