Submission complete (Thanks for the feedback!). Submitted as "Individual Consumer" (the LAST choice on the list of commenter types !!)
I made a change to the heading of item #3, replicated here, and also used a spellchecker, not replicated here.
Senior Systems Software Engineer
Grandmother, smoker, vaper
California
I am writing you in regards to the following notice:
Docket No. FDA-2012-N-1148: FDA Actions Related to Nicotine Replacement Therapies and Smoking Cessation Products; Report to Congress on Innovative Products and Treatments for tobacco Dependence.
I have been a smoker for 40 years, and am now transitioning to “vaping” as we call it when we use electronic cigarettes.
I am also a scientist's daughter and a nurse's granddaughter, raised to revere scientists, medical researchers, doctors, and others dedicated to the impartial search for truth.
I have 3 areas I wish to address related to Harm Reduction and the FDA.
1.To inform you of my struggle with smoking:
Beginning about 10 years after I began smoking, I started trying to quit. I have tried patches
many times, cold turkey many times, wellbutrin, hypnosis, support groups and classes.
The support-group method once worked for a 5-year period, no other methods have lasted
more than a week.
After a few years of wheezing, and being afraid of strenuous exercize because I can get to
where I can't catch my breath, I was feeling hopeless because I really need the mental clarity
I get from nicotine, and the sense of reward, but my breathing was starting to get frightening.
I told my daughter that I could tell I was going to be a smoker until I die. Probably
prematurely.
She suggested “Why don't you just give up tar?”
So I started investigating electronic cigarettes, and started trying them.
9 months later, I have cut from ~24 cigarettes a day to ~7, without struggle. My breathing
has improved noticeably, but not super-significantly. I have stopped wheezing in bed at night.
In order to get to this point, I had to experiment with many different flavors and devices, and
keep up with device improvements. I do not believe I would be smoking less than 15
cigarettes a day if I were limited to the devices available even 9 months ago, or the flavors I
tried first (flavors meant to try to imitate cigarettes.)
But I am well aware that I will probably NOT improve further unless I quit smoking, so I am
actively working on that, including by trying to always vape just before smoking so that the
cigarette will have less of a rewarding impact. I'm also thinking ahead to New Years
resolutions, Lent, etc.
2. To express my concern about the increasing prominence of statements made in an FDA press release in 2009.
I am seeing people in America and in other countries who have traditionally had the highest
respect for the U.S. CDC and the U.S. FDA beginning to ask “When did the FDA stop
being scientific?” This is especially of concern to people from Brazil, New Zealand,
Singapore, and Australia, whose governments are citing the FDA as the source for the
reason to limit or ban electronic cigarettes.
The stellar reputation of American medically-oriented science bodies has, until recently,
stood as a world model of trustworthiness and fierce independence from bias. A reputation
for using the strict discipline of the Scientific Method as a way to always find your way to
the truth despite political pressures or the inevitable natural human bias.
However, the continued proliferation of misinformation from that press release regarding
electronic cigarettes, which contradicts the actual published FDA scientific findings, is
spreading, and tarnishing an organization that has traditionally done better.
Is surviving with a slowly-diminishing level of respect the best hope? Is that the best
thing for arming yourselves for the next public health crisis where your credibility could
be crucial for a good public outcome? I think my grandchildren will be safer if you build
your reputation back up, rather than let it be legitimately doubted.
3. To request you do 'focus group reviews' for documents before they are published.
As an engineer, I have to write documents that express my findings, sometimes for public
consumption. Often, I am so wrapped up in the work after concentrating on it for weeks
or months that my expression, that seems right to me, is not always successful in
delivering the correct thoughts to my readers. Fortunately, we have a department that
provides detached editors to find and correct such things before publication.
This makes me wonder about FDA statements and requirements for statements. For
instance, when people are warned not to smoke AND use NRT, did you mean “Do not use a
full dose of NRT combined with a full dose of smoking, that creates a danger of raising your
nicotine needs long-term, and also a short-term danger of a mild nicotine overdose, which
can disrupt digestion, or mimic a mild panic attack.” ?
Or did you mean “Do not use NRT to cut down drastically on smoking, because smoking is
safer than half-smoking and half-NRT.” ?
I was recently at a literary convention, and went out to vape in the sun. While I was
vaping, a man approached me and told that me his wife, a long-term smoker, had just gotten
out of the hospital after a bout of pneumonia combined with athsma. He is experimenting
with electronic cigarettes and wanted his wife to try them, hoping to cut down on her
smoking.
She is still coughing horribly when she smokes. But she refuses to try them, because
electronic cigarettes are too dangerous. She's going to play it safe and just keep smoking.
Does the FDA really want to send that message?
Thank you for your time and attention.
I made a change to the heading of item #3, replicated here, and also used a spellchecker, not replicated here.
Senior Systems Software Engineer
Grandmother, smoker, vaper
California
I am writing you in regards to the following notice:
Docket No. FDA-2012-N-1148: FDA Actions Related to Nicotine Replacement Therapies and Smoking Cessation Products; Report to Congress on Innovative Products and Treatments for tobacco Dependence.
I have been a smoker for 40 years, and am now transitioning to “vaping” as we call it when we use electronic cigarettes.
I am also a scientist's daughter and a nurse's granddaughter, raised to revere scientists, medical researchers, doctors, and others dedicated to the impartial search for truth.
I have 3 areas I wish to address related to Harm Reduction and the FDA.
1.To inform you of my struggle with smoking:
Beginning about 10 years after I began smoking, I started trying to quit. I have tried patches
many times, cold turkey many times, wellbutrin, hypnosis, support groups and classes.
The support-group method once worked for a 5-year period, no other methods have lasted
more than a week.
After a few years of wheezing, and being afraid of strenuous exercize because I can get to
where I can't catch my breath, I was feeling hopeless because I really need the mental clarity
I get from nicotine, and the sense of reward, but my breathing was starting to get frightening.
I told my daughter that I could tell I was going to be a smoker until I die. Probably
prematurely.
She suggested “Why don't you just give up tar?”
So I started investigating electronic cigarettes, and started trying them.
9 months later, I have cut from ~24 cigarettes a day to ~7, without struggle. My breathing
has improved noticeably, but not super-significantly. I have stopped wheezing in bed at night.
In order to get to this point, I had to experiment with many different flavors and devices, and
keep up with device improvements. I do not believe I would be smoking less than 15
cigarettes a day if I were limited to the devices available even 9 months ago, or the flavors I
tried first (flavors meant to try to imitate cigarettes.)
But I am well aware that I will probably NOT improve further unless I quit smoking, so I am
actively working on that, including by trying to always vape just before smoking so that the
cigarette will have less of a rewarding impact. I'm also thinking ahead to New Years
resolutions, Lent, etc.
2. To express my concern about the increasing prominence of statements made in an FDA press release in 2009.
I am seeing people in America and in other countries who have traditionally had the highest
respect for the U.S. CDC and the U.S. FDA beginning to ask “When did the FDA stop
being scientific?” This is especially of concern to people from Brazil, New Zealand,
Singapore, and Australia, whose governments are citing the FDA as the source for the
reason to limit or ban electronic cigarettes.
The stellar reputation of American medically-oriented science bodies has, until recently,
stood as a world model of trustworthiness and fierce independence from bias. A reputation
for using the strict discipline of the Scientific Method as a way to always find your way to
the truth despite political pressures or the inevitable natural human bias.
However, the continued proliferation of misinformation from that press release regarding
electronic cigarettes, which contradicts the actual published FDA scientific findings, is
spreading, and tarnishing an organization that has traditionally done better.
Is surviving with a slowly-diminishing level of respect the best hope? Is that the best
thing for arming yourselves for the next public health crisis where your credibility could
be crucial for a good public outcome? I think my grandchildren will be safer if you build
your reputation back up, rather than let it be legitimately doubted.
3. To request you do 'focus group reviews' for documents before they are published.
As an engineer, I have to write documents that express my findings, sometimes for public
consumption. Often, I am so wrapped up in the work after concentrating on it for weeks
or months that my expression, that seems right to me, is not always successful in
delivering the correct thoughts to my readers. Fortunately, we have a department that
provides detached editors to find and correct such things before publication.
This makes me wonder about FDA statements and requirements for statements. For
instance, when people are warned not to smoke AND use NRT, did you mean “Do not use a
full dose of NRT combined with a full dose of smoking, that creates a danger of raising your
nicotine needs long-term, and also a short-term danger of a mild nicotine overdose, which
can disrupt digestion, or mimic a mild panic attack.” ?
Or did you mean “Do not use NRT to cut down drastically on smoking, because smoking is
safer than half-smoking and half-NRT.” ?
I was recently at a literary convention, and went out to vape in the sun. While I was
vaping, a man approached me and told that me his wife, a long-term smoker, had just gotten
out of the hospital after a bout of pneumonia combined with athsma. He is experimenting
with electronic cigarettes and wanted his wife to try them, hoping to cut down on her
smoking.
She is still coughing horribly when she smokes. But she refuses to try them, because
electronic cigarettes are too dangerous. She's going to play it safe and just keep smoking.
Does the FDA really want to send that message?
Thank you for your time and attention.
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