I will be watching and already on a prayer chain for this meet. thank you for all you guys do!!
Link to webcast of Dec. 17 FDA Public Hearing on NRT & Innovative Products
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Good luck & Thank you for your efforts. I only wish Congress would look at more pressing matters, like government spending, campaign contributions or corporate (pharmaceutical) corruption. Ya know, instead of weather some jock took steroids to be better @ a game.
Thank you for your efforts. I will not be able to watch or contribute much being in the part of the world that I am, however my thoughts will be with those at the front line at the time. This is such important work that you are doing and is appreciated - give it all you've got! Cheers.
I am glad to know we have members of the Medical community fighting with us. I find it ironic that the FDA is down on E Cigs because of lack of knowledge on their part, yet they enthusiastically support chantix to help quit smoking. Knowing that chantix is a black label pharmaceutical responsible for many suicides. I will do whatever i can to help fight the FDA.
Ok I read into this further and all it is is them inviting e cigarette manufacturers to work with them and ensure that it is safe for all users in the u.s. and that it is actually a replacement to nicotine because all companies say that it is but it must be FDA approved to replace nicotine before the companies are able to advertise it. Really the companies asked for it because they sent 5 letters to 5 companies in 2010 saying this but companies still manufactured it as a cigarette alternative. On a lighter note it will be great that the FDA will work in accordance with e cigarette manufacturers so we can ensure that we are consuming a safe and effective product with no unwanted side effects!
To respond to the questions previously asked:
1. What can I do to help?
You can submit a written comment. The original deadline was Jan. 2, but they have extended this to Jan 16. The CASAA Call to Awareness page contains the link to take you to the item on Regulations.gov. Click the "Comment Now" button on the right side of the page, near the top.
If your comment will be longer than 2,000 characters, we suggest that you prepare a document and submit that as an attachment. When you get to the Comment page, Section 3 (right under the comment field) there are buttons to upload a file from your computer. In the comment field, you can type, "See attachment."
Here's the link to the CASAA Call to Awareness: CASAA: Call to Awareness - FDA Public Hearing on Nicotine Reduction Therapy Products
2. What's going to happen after this meeting?
Understand that the purpose of the meeting is for the FDA to gather information to write a report to congress, as required in Section 918 of the Family Smoking Prevention and Tobacco Control Act.
They are gathering information for the report. They already held a workshop on Risks and Benefits of Long-Term Use of NRTs back in 2010. Bill Godshall and I spoke at that meeting as well.
More information will be collected from the speakers and the questions and answers at this meeting, and then from the written comments are are submitted for this meeting, and that were collected in 2010 for the first meeting.
Those who write the report are supposed to review all of this information and then write the report to Congress making recommendations on how the FDA should regulate long-term use of NRT's and Innovative Products and Therapies for Treatment of Tobacco Dependence. Over half of the speakers we have lined up are going to be recommending that instead of treating "tobacco dependence" as an addiction that requires complete abstinence from nicotine, the FDA should pursue Tobacco Harm Reduction (THR). THR is the practice of substituting low risk products that deliver nicotine such as snus, dissolvables, and e-cigarettes in place of taking in nicotine via smoking cigarettes.
The tricky thing is that two different divisions regulate these products. The Center for Drug Research and Evaluation (CDER) regulate NRTs, Zyban, and Chantix -- the products that are considered treatment for a disease. This is the division charged with producing the required report.
The FDA's Center for Tobacco Products (CTP) currently regulates tobacco cigarettes and smokeless tobacco. But smokeless tobacco refers to chewing tobacco, snuff, and snus. The newer dissolvable tobacco orbs -- which are essentially the same thing as Nicorette lozenges -- may not be regulated as of yet. The FDA has announced that it will issue a "deeming" regulation that brings all other products made of or derived from tobacco under the auspices of the CTP (except for the products regulated by CDER as "smoking cessation" (actually really nicotine cessation) products.)
For more information on the questions that FDA seeks answers for during this meeting and in the written comments, see:
http://www.fda.gov/downloads/Drugs/NewsEvents/UCM329739.pdf
Under the heading
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
21 CFR Part 15
[Docket No. FDA–2012–N–1148]
See the SUPPLEMENTARY INFORMATION section.
We feel that this question opens the door for our discussion of THR:
Even though theoretically it will be the Center for Tobacco Products, not CDER, that will regulate e-cigarettes, the division is capricious and arbitrary, in my opinion. I have this to say about the separation of regulation w/i FDA, as the commentary for a slide that displays a table with the Lung Cancer Mortality Rates for Sweden and the US. In Sweden, many smokers have switched to snus, and the smoking rate for males is now something like 12%. The mortality rates for the US are more than double those of Sweden.
P.S. The CASAA Call to Awareness page (see link above) has a section that provides help for what to say in written comments. You have to scroll down a ways to find it. The section title is "What you can say."
1. What can I do to help?
You can submit a written comment. The original deadline was Jan. 2, but they have extended this to Jan 16. The CASAA Call to Awareness page contains the link to take you to the item on Regulations.gov. Click the "Comment Now" button on the right side of the page, near the top.
If your comment will be longer than 2,000 characters, we suggest that you prepare a document and submit that as an attachment. When you get to the Comment page, Section 3 (right under the comment field) there are buttons to upload a file from your computer. In the comment field, you can type, "See attachment."
Here's the link to the CASAA Call to Awareness: CASAA: Call to Awareness - FDA Public Hearing on Nicotine Reduction Therapy Products
2. What's going to happen after this meeting?
Understand that the purpose of the meeting is for the FDA to gather information to write a report to congress, as required in Section 918 of the Family Smoking Prevention and Tobacco Control Act.
They are gathering information for the report. They already held a workshop on Risks and Benefits of Long-Term Use of NRTs back in 2010. Bill Godshall and I spoke at that meeting as well.
More information will be collected from the speakers and the questions and answers at this meeting, and then from the written comments are are submitted for this meeting, and that were collected in 2010 for the first meeting.
Those who write the report are supposed to review all of this information and then write the report to Congress making recommendations on how the FDA should regulate long-term use of NRT's and Innovative Products and Therapies for Treatment of Tobacco Dependence. Over half of the speakers we have lined up are going to be recommending that instead of treating "tobacco dependence" as an addiction that requires complete abstinence from nicotine, the FDA should pursue Tobacco Harm Reduction (THR). THR is the practice of substituting low risk products that deliver nicotine such as snus, dissolvables, and e-cigarettes in place of taking in nicotine via smoking cigarettes.
The tricky thing is that two different divisions regulate these products. The Center for Drug Research and Evaluation (CDER) regulate NRTs, Zyban, and Chantix -- the products that are considered treatment for a disease. This is the division charged with producing the required report.
The FDA's Center for Tobacco Products (CTP) currently regulates tobacco cigarettes and smokeless tobacco. But smokeless tobacco refers to chewing tobacco, snuff, and snus. The newer dissolvable tobacco orbs -- which are essentially the same thing as Nicorette lozenges -- may not be regulated as of yet. The FDA has announced that it will issue a "deeming" regulation that brings all other products made of or derived from tobacco under the auspices of the CTP (except for the products regulated by CDER as "smoking cessation" (actually really nicotine cessation) products.)
For more information on the questions that FDA seeks answers for during this meeting and in the written comments, see:
http://www.fda.gov/downloads/Drugs/NewsEvents/UCM329739.pdf
Under the heading
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
21 CFR Part 15
[Docket No. FDA–2012–N–1148]
See the SUPPLEMENTARY INFORMATION section.
We feel that this question opens the door for our discussion of THR:
Even though theoretically it will be the Center for Tobacco Products, not CDER, that will regulate e-cigarettes, the division is capricious and arbitrary, in my opinion. I have this to say about the separation of regulation w/i FDA, as the commentary for a slide that displays a table with the Lung Cancer Mortality Rates for Sweden and the US. In Sweden, many smokers have switched to snus, and the smoking rate for males is now something like 12%. The mortality rates for the US are more than double those of Sweden.
P.S. The CASAA Call to Awareness page (see link above) has a section that provides help for what to say in written comments. You have to scroll down a ways to find it. The section title is "What you can say."
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Good thing I have craploads of batteries and gallons of juice and millions of CE4's.......
I'll be set till the day I die.
Thanks for looking out for us, CASAA folks.
And the vaping community holds it's breath..
And the vaping community holds it's breath..
Same here, unless I can vape up/give away 5 quarts of 100 mg/ml unflavored nic liquid (diluted to around 6 gallons of mixed juice) plus 24 feet of coil wire plus several feet of wicking material before I die. 
No, I'm not a vendor.
No, I'm not a vendor.
Howdy Folks,
The double edged sword comes in to play here, either way I suspect that regulations will be put in to play. I do know that if the vaping community as a whole weighed in on this one that it would shift the tide in retrospect.
Lack of education on the product has heavily weighed in on the issues at hand, also that sever members of congress get their pockets greased by the tobacco industry which will be some serious road blocks.
I will tune in to the webcast and write in to the FDA as well, God speed all those who represent us at the ECF. We can win this battle and come out victorious
I myself have been through the gum and patch...neither worked, the E-Cig has kept me off them with ease, I really don't wish to loose this and go back.
The double edged sword comes in to play here, either way I suspect that regulations will be put in to play. I do know that if the vaping community as a whole weighed in on this one that it would shift the tide in retrospect.
Lack of education on the product has heavily weighed in on the issues at hand, also that sever members of congress get their pockets greased by the tobacco industry which will be some serious road blocks.
I will tune in to the webcast and write in to the FDA as well, God speed all those who represent us at the ECF. We can win this battle and come out victorious
I myself have been through the gum and patch...neither worked, the E-Cig has kept me off them with ease, I really don't wish to loose this and go back.
Damit! I wish I had seen and known about this sooner. I could have taken off work and been there. I'm in Silver Spring! Bless you all that put so much hard work and effort into helping us!
I will go and write my comments.
Will there be a way (link posted please) to watch this webcast afterwards?
Thank you all!!!!!
I will go and write my comments.
Will there be a way (link posted please) to watch this webcast afterwards?
Thank you all!!!!!
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