gbalkam
Postman
- Joined
- Jul 2, 2016
- Messages
- 356
Write your own Ombudsman in your local area.
So being as how I am very timid, shy, and hesitate to speak my mind.. lest I offend anybody or cause hurt feelings...
I hear you trying to choke back that snort @Crewella and the fits of laughter that follow.. (I got good esp)
Anyway....
Response from a previous email contact..
From: CTPOmbudsman <[email protected]>
Sent: August 22, 2016 9:20 AM
To: [email protected]
Subject: RE: FDA is overstepping its boundaries with e-cigarettes and fluid
Good morning Gary,
Thank you for your email. It matters to us to hear how our regulations affect everyone and your comments are important in providing another perspective. It seems like you have several questions about FDA’s new regulations and I hope that I can be of some assistance.
You may be interested to know that the FDA Center for Tobacco Products (CTP) is responsible for carrying out the Family Smoking Prevention and Tobacco Control Act, which Congress passed in 2009. This law—commonly called the Tobacco Control Act—gives us broad authority to regulate the manufacturing, distribution, and marketing of tobacco products. The FDA’s mandate is to protect Americans from tobacco-related disease and death. Ultimately, we hope that regulating all tobacco products will have a positive impact on public health. That is the motivation for finalizing the deeming regulations.
You mentioned that nicotine may come from different sources. The definition of ‘‘tobacco product’’ includes any product made or derived from tobacco, including any component, part, or accessory of a tobacco product. E-liquids that do not contain nicotine or other substances made or derived from tobacco may still be components or parts and, therefore, subject to FDA’s tobacco control authorities. FDA will review these products on a case-by-case basis. The FDA has also recognized that some tobacco products have the potential to be less harmful than others are. In turn, the FDA has built a robust regulatory science program to help inform the agency’s tobacco policy through interagency collaborations and FDA-directed research here in the United States. Now that the FDA regulates these additional tobacco products, the agency can apply the science toward actions that will further reduce the disease and death associated with all tobacco products.
You also mention nicotine patches and gum, which are cessation therapies. Those products and other drugs are regulated by the FDA Center for Drug Evaluation and Research (CDER) and you can reach out to the CDER Ombudsman by visiting their website here: http://www.fda.gov/AboutFDA/Centers...co/CDER/ContactCDER/CDEROmbudsman/default.htm
We appreciate every comment that we receive and hope that you find this information useful. Thanks again for taking the time to share your opinion with us.
Best,
Allison C. Monyei, J.D.
Associate Ombudsman
Office of the Center Director
FDA Center for Tobacco Products
[email protected]
********************************************************************
And my reply....
o.. eggplant has to be sold behind the counter and not on display, and can not be sold in any supermarket with a pharmacy, right? Forcing your child to eat his eggplant is a federal offense, correct?
Here's the thing, if the FDA were so concerned about tobacco products, and the Family Smoking Prevention and Tobacco Control Act, they would put a ban on actual tobacco products. Like cigarettes and cigars, etc. Nicotine, on its own, is not that dangerous or addictive. In fact, it is less harmful than caffeine. Now, there are over 4000 other chemicals present in tobacco. Are products containing these chemicals also being regulated? OR is it just a vendetta against any products that will reduce the income from tobacco to tobacco companies and GSK for nicorette products?
Now as for 0 nicotine e-juice.. is the FDA regulating vegetable glycerine, the PG and food flavorings also? Frankly, those are pretty much the only other ingredients consumers will accept, and some sweeteners. Vapers are far more cautious than the fda, even at its most paranoid. We demand to know every molecule in our ejuice. Therefore the manufacturers are down right fanatical about what goes into their products, or they can't sell them, nobody will buy them.
Sure, I agree, no vape products sold to anyone under 18. Even the vendors agree with this. They don't mind abiding by existing tobacco laws. That isn't the problem. The problem is.. I can go to any store and buy cigarettes but I can't get e-liquid to use as a harm reduction method. By the way.. I am 6 months tobacco free. I have cut my nicotine down from 18mg to 3 and cutting down even further to 1.5 or 0mg, but it would be a lot easier if i could get pure pharma grade nicotine from the pharmacist and coaching on how to use it, rather than looking it up on the web. Isn't that why they talk to you when you start a new prescription?
There has already been charges of racketeering and a multi billion dollar fine given to the FDA and some higher level execs. Who is getting the $$$$ one THIS deal? What is more upsetting, is these $$$$ aren't just being made by something like manipulating stock prices, they are being made at the expense of human lives. In your case.. Big tobacco, the FDA, Pharma, and politicians are getting fat off these billions of dollars of blood money.
Even if pure nicotine, in limited amounts.. say 30 or 60 grams, was available by prescription, that would be a plus. The only people that could get the prescription would be smokers, and Doctors have been nagging ppl to quit smoking tobacco for years.
The REAL problem is.. vaping devices and products are taking money out of the tobacco industry. If Pharma were smart.. they could take the entire industry over,
What is also happened here.. is the FDA is driving the vaping industry under ground. Just like prohibition did with alcohol, and just like is happening with marijuana. I don't know about in the US, but in Canada, marijuana has been illegal for 93, that is NINTY THREE years. I can still go out and buy a joint faster than I can get a pack of cigarettes or ejuice. Seriously.. I live in an apartment building.. I wouldn't even have to go outside.
I'm hoping you can see where advocates of vaping (I refuse to use the term e-cigarette) are coming from. From where I am sitting, and others, the FDA has a stock pile of life preservers and are sitting on a deck watching the titanic sink and snacking on water crackers and caviar while doing it.
Ombudsman-an official appointed to investigate individuals' complaints against maladministration, especially that of public authorities.
This means.. that to your fellow citizens, YOU are the white knight, in shining armor, guarding and protecting them from monsters like Big Tobacco, Pharma, and corruption in politics and within the FDA. So take your Vorpal sword in hand and slay those Jabberwockys. Or at least give them a few good pokes in some tender places..
I also invite you to view and or join
https://www.e-cigarette-forum.com/forum/
https://www.e-cigarette-forum.com/forum/
E-Cigarette Forum
www.e-cigarette-forum.com
E-Cigarette Forum is the world's largest ecigarette website. ECF is global vaping central - start here.
This is a US based site, but is also world wide. Any questions you have can either be answered there or someone will find the answer for you. Consider it a huge research team.
If you want to know what percentage of people vaping has helped quit tobacco.. ask there. If you want to know what goes into ejuice, ask there. If you want to know about device safety, ask there. There are vape users there and vendors there.. any question you can think of, they will try their best to answer.
Yeah, I am a Canadian. But if you have ever had to watch one or more loved ones waste away, slowing dying from tobacco related cancer, you will understand why I come out with guns a blazing.
You should see what I have said to Health Canada and the FDA here.. Such as were can I get the magical non-addictive nicotine they use in gum and patches? Or is it just regular old nicotine, and they get paid to say that? I am by no means subtle.
Thanks for replying to my query. Hope you will consider joining that forum and talking to vapers and that you don't shy away from the fight to get these harm reduction products to smokers that need them. The way I see it, if vaping kills me in 20 years, I am ahead of the game, I already know tobacco will kill me.. it is my life, and I'll take that chance! People in the US should have the right to choose.
*********************************************************************************
*EFC is a US based forum, since this was the office for the US ombudsman.. i sent him there. I think they are actually bigger than this group, but I find them a bit to uptight. LMAO.. in fact.. i can pretty close to telling the site admin that he had no man parts... when it came to questioning the FDA and holding them accountable.
************************************************************************************
So being as how I am very timid, shy, and hesitate to speak my mind.. lest I offend anybody or cause hurt feelings...
I hear you trying to choke back that snort @Crewella and the fits of laughter that follow.. (I got good esp)
Anyway....
Response from a previous email contact..
From: CTPOmbudsman <[email protected]>
Sent: August 22, 2016 9:20 AM
To: [email protected]
Subject: RE: FDA is overstepping its boundaries with e-cigarettes and fluid
Good morning Gary,
Thank you for your email. It matters to us to hear how our regulations affect everyone and your comments are important in providing another perspective. It seems like you have several questions about FDA’s new regulations and I hope that I can be of some assistance.
You may be interested to know that the FDA Center for Tobacco Products (CTP) is responsible for carrying out the Family Smoking Prevention and Tobacco Control Act, which Congress passed in 2009. This law—commonly called the Tobacco Control Act—gives us broad authority to regulate the manufacturing, distribution, and marketing of tobacco products. The FDA’s mandate is to protect Americans from tobacco-related disease and death. Ultimately, we hope that regulating all tobacco products will have a positive impact on public health. That is the motivation for finalizing the deeming regulations.
You mentioned that nicotine may come from different sources. The definition of ‘‘tobacco product’’ includes any product made or derived from tobacco, including any component, part, or accessory of a tobacco product. E-liquids that do not contain nicotine or other substances made or derived from tobacco may still be components or parts and, therefore, subject to FDA’s tobacco control authorities. FDA will review these products on a case-by-case basis. The FDA has also recognized that some tobacco products have the potential to be less harmful than others are. In turn, the FDA has built a robust regulatory science program to help inform the agency’s tobacco policy through interagency collaborations and FDA-directed research here in the United States. Now that the FDA regulates these additional tobacco products, the agency can apply the science toward actions that will further reduce the disease and death associated with all tobacco products.
You also mention nicotine patches and gum, which are cessation therapies. Those products and other drugs are regulated by the FDA Center for Drug Evaluation and Research (CDER) and you can reach out to the CDER Ombudsman by visiting their website here: http://www.fda.gov/AboutFDA/Centers...co/CDER/ContactCDER/CDEROmbudsman/default.htm
We appreciate every comment that we receive and hope that you find this information useful. Thanks again for taking the time to share your opinion with us.
Best,
Allison C. Monyei, J.D.
Associate Ombudsman
Office of the Center Director
FDA Center for Tobacco Products
[email protected]
********************************************************************
And my reply....
o.. eggplant has to be sold behind the counter and not on display, and can not be sold in any supermarket with a pharmacy, right? Forcing your child to eat his eggplant is a federal offense, correct?
Here's the thing, if the FDA were so concerned about tobacco products, and the Family Smoking Prevention and Tobacco Control Act, they would put a ban on actual tobacco products. Like cigarettes and cigars, etc. Nicotine, on its own, is not that dangerous or addictive. In fact, it is less harmful than caffeine. Now, there are over 4000 other chemicals present in tobacco. Are products containing these chemicals also being regulated? OR is it just a vendetta against any products that will reduce the income from tobacco to tobacco companies and GSK for nicorette products?
Now as for 0 nicotine e-juice.. is the FDA regulating vegetable glycerine, the PG and food flavorings also? Frankly, those are pretty much the only other ingredients consumers will accept, and some sweeteners. Vapers are far more cautious than the fda, even at its most paranoid. We demand to know every molecule in our ejuice. Therefore the manufacturers are down right fanatical about what goes into their products, or they can't sell them, nobody will buy them.
Sure, I agree, no vape products sold to anyone under 18. Even the vendors agree with this. They don't mind abiding by existing tobacco laws. That isn't the problem. The problem is.. I can go to any store and buy cigarettes but I can't get e-liquid to use as a harm reduction method. By the way.. I am 6 months tobacco free. I have cut my nicotine down from 18mg to 3 and cutting down even further to 1.5 or 0mg, but it would be a lot easier if i could get pure pharma grade nicotine from the pharmacist and coaching on how to use it, rather than looking it up on the web. Isn't that why they talk to you when you start a new prescription?
There has already been charges of racketeering and a multi billion dollar fine given to the FDA and some higher level execs. Who is getting the $$$$ one THIS deal? What is more upsetting, is these $$$$ aren't just being made by something like manipulating stock prices, they are being made at the expense of human lives. In your case.. Big tobacco, the FDA, Pharma, and politicians are getting fat off these billions of dollars of blood money.
Even if pure nicotine, in limited amounts.. say 30 or 60 grams, was available by prescription, that would be a plus. The only people that could get the prescription would be smokers, and Doctors have been nagging ppl to quit smoking tobacco for years.
The REAL problem is.. vaping devices and products are taking money out of the tobacco industry. If Pharma were smart.. they could take the entire industry over,
What is also happened here.. is the FDA is driving the vaping industry under ground. Just like prohibition did with alcohol, and just like is happening with marijuana. I don't know about in the US, but in Canada, marijuana has been illegal for 93, that is NINTY THREE years. I can still go out and buy a joint faster than I can get a pack of cigarettes or ejuice. Seriously.. I live in an apartment building.. I wouldn't even have to go outside.
I'm hoping you can see where advocates of vaping (I refuse to use the term e-cigarette) are coming from. From where I am sitting, and others, the FDA has a stock pile of life preservers and are sitting on a deck watching the titanic sink and snacking on water crackers and caviar while doing it.
Ombudsman-an official appointed to investigate individuals' complaints against maladministration, especially that of public authorities.
This means.. that to your fellow citizens, YOU are the white knight, in shining armor, guarding and protecting them from monsters like Big Tobacco, Pharma, and corruption in politics and within the FDA. So take your Vorpal sword in hand and slay those Jabberwockys. Or at least give them a few good pokes in some tender places..
I also invite you to view and or join
https://www.e-cigarette-forum.com/forum/
https://www.e-cigarette-forum.com/forum/
E-Cigarette Forum
www.e-cigarette-forum.com
E-Cigarette Forum is the world's largest ecigarette website. ECF is global vaping central - start here.
This is a US based site, but is also world wide. Any questions you have can either be answered there or someone will find the answer for you. Consider it a huge research team.
If you want to know what percentage of people vaping has helped quit tobacco.. ask there. If you want to know what goes into ejuice, ask there. If you want to know about device safety, ask there. There are vape users there and vendors there.. any question you can think of, they will try their best to answer.
Yeah, I am a Canadian. But if you have ever had to watch one or more loved ones waste away, slowing dying from tobacco related cancer, you will understand why I come out with guns a blazing.
You should see what I have said to Health Canada and the FDA here.. Such as were can I get the magical non-addictive nicotine they use in gum and patches? Or is it just regular old nicotine, and they get paid to say that? I am by no means subtle.
Thanks for replying to my query. Hope you will consider joining that forum and talking to vapers and that you don't shy away from the fight to get these harm reduction products to smokers that need them. The way I see it, if vaping kills me in 20 years, I am ahead of the game, I already know tobacco will kill me.. it is my life, and I'll take that chance! People in the US should have the right to choose.
*********************************************************************************
*EFC is a US based forum, since this was the office for the US ombudsman.. i sent him there. I think they are actually bigger than this group, but I find them a bit to uptight. LMAO.. in fact.. i can pretty close to telling the site admin that he had no man parts... when it came to questioning the FDA and holding them accountable.
************************************************************************************
