I am not sure why they started the letter with dear Jacques Dupuis, since my name is Shane
Dear Jacques Dupuis,
Thank you for contacting the FDA. Your email has been forwarded to the Division of Drug Information in the FDA's Center for Drug Evaluation and Research for a direct reply.
However, at this time, we are not aware of any data establishing electronic cigarettes as safe and effective for their intended uses. Based upon our case by case review of a number of these products, they are drug/device combinations that require approval by FDA before they may be legally marketed in the United States.
None of these so-called electronic cigarettes or their components has been approved by FDA. Therefore, the marketing of the products FDA has reviewed is not legal in the United States. As a matter of policy, however, we limit communications about the regulatory status of specific marketed products to those responsible for them, and we do not discuss our enforcement actions except with the targets of those actions.
There may be a perception among some users that electronic cigarettes are a safe and effective means to quit smoking conventional forms of tobacco. However, FDA is not aware of any scientific data to support those perceptions. Since these products have not been submitted to the FDA for evaluation or approval, the agency has no way of knowing, except for the limited testing it has performed, the levels of nicotine or the kinds and amounts of other chemicals that the various brands of these products deliver to the user. The FDAs Division of Pharmaceutical Analysis analyzed the ingredients in a small sample of cartridges from two leading brands of electronic cigarettes. In one sample, the FDAs analyses detected diethylene glycol, a chemical used in antifreeze that is toxic to humans, and in several other samples, the FDA analyses detected carcinogens, including nitrosamines. FDA also found varying levels of nicotine in cartridges labeled as containing the same level of nicotine as well as the presence of nicotine in cartridges labeled as containing no nicotine. These test results indicate that these products are manufactured under inadequate or non-existent controls.
FDA is concerned that electronic cigarettes may introduce young people to nicotine use which may lead to an increase in the use of conventional tobacco products with well-known, adverse, health consequences. Additionally, it is unclear what health effects these products could have on users or if misuse or product failure could lead to nicotine poisoning or other serious adverse health consequences.
There are a number of proven safe and effective cessation aids that smokers can use to quit smoking. The U.S. Public Health Services, Treating tobacco Use and Dependence: 2008 Update recommends using a combination of proven cessation interventions including FDA-approved nicotine replacement therapy and/or non-nicotine medications and counseling to more than double a smokers chances of quitting successfully. Free help is available to smokers in all states by calling 1-800-QUIT-NOW or by visiting Smokefree.gov.
Again, we appreciate the time that you have taken to contact us.
Best regards,
Division of Drug Information LC
Center for Drug Evaluation and Research
Food and Drug Administration
For up-to-date drug information, follow the FDA's Division of Drug Information on Twitter at FDA_Drug_Info
This communication is consistent with 21CFR10.85(k) and constitutes an informal communication that represents our best judgment at this time but does not constitute an advisory opinion, does not necessarily represent the formal position of the FDA, and does not bind or otherwise obligate or commit the agency to the views expressed.
From: Shane Yardley [mailto:skyman21277@gmail.com]
Sent: Saturday, January 15, 2011 1:14 AM
To: OC Webmail
Subject: E cigarettes
My first email
Are you still holding up shipments of electronic e cigarettes? Didn't a judge rule against you? Are you ready for a class action law suit. You are great, in bed with tobacco companies but I can't use my e cig in peace. Ban cigarettes of your going to do this. My tax dollars pay your salary stop wasting my money. Stop trying to kill us.
Shane Yardley
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CDER DRUG INFO to me
show details 11:02 AM (10 hours ago)
Dear Shane Yardley,
- Show quoted text -
- Show quoted text -
Reply
Forward
Reply
Shane Yardley to CDER
show details 9:03 PM (0 minutes ago)
I just sent this in regards to their response at the top
I am not one took the time to write this. Thank you for getting back to me, but your reply is unsatisfactory. You say that none of these "so called electronic cigarettes or their components have been approved by the FDA". Well components are batteries, chargers, wires, and tubing. So you really can't regulate those if this is just a generated response or somese. Anyway, you allow cigarettes to kill millions of people each year. I don't know who these leading companies are you speak of, but the companies I use as vendors, do not make false claims, nor do they sale to minors or claim to help you stop. If you ban electronic cigarettes then does that mean you will ban tobacco also, or are you going to create a black market. You are so worried about the youth of the nation, yet you keep cigarettes here willingly, and knowingly. You know they cause cancer and this HAS been proven. So I don't think you are doing your job correctly. I understand you have done no tests, so get off your .... and do it. Tax the electronic cigarette industry like you do everyone else and leave us alone if this is what you need to do. I don't need tests. My blood pressure has gone down and allowed me to get off of medication, and I can breathe and exercise again. So take that to your scientists. I think tobacco companies may be paying you a little to much, to fight this hard to keep electronic cigarettes off of the market.
- Show quoted text -
--
Shane Yardley
-Life is not about the breaths you take, but the moments that take your breath away!
Dear Jacques Dupuis,
Thank you for contacting the FDA. Your email has been forwarded to the Division of Drug Information in the FDA's Center for Drug Evaluation and Research for a direct reply.
However, at this time, we are not aware of any data establishing electronic cigarettes as safe and effective for their intended uses. Based upon our case by case review of a number of these products, they are drug/device combinations that require approval by FDA before they may be legally marketed in the United States.
None of these so-called electronic cigarettes or their components has been approved by FDA. Therefore, the marketing of the products FDA has reviewed is not legal in the United States. As a matter of policy, however, we limit communications about the regulatory status of specific marketed products to those responsible for them, and we do not discuss our enforcement actions except with the targets of those actions.
There may be a perception among some users that electronic cigarettes are a safe and effective means to quit smoking conventional forms of tobacco. However, FDA is not aware of any scientific data to support those perceptions. Since these products have not been submitted to the FDA for evaluation or approval, the agency has no way of knowing, except for the limited testing it has performed, the levels of nicotine or the kinds and amounts of other chemicals that the various brands of these products deliver to the user. The FDAs Division of Pharmaceutical Analysis analyzed the ingredients in a small sample of cartridges from two leading brands of electronic cigarettes. In one sample, the FDAs analyses detected diethylene glycol, a chemical used in antifreeze that is toxic to humans, and in several other samples, the FDA analyses detected carcinogens, including nitrosamines. FDA also found varying levels of nicotine in cartridges labeled as containing the same level of nicotine as well as the presence of nicotine in cartridges labeled as containing no nicotine. These test results indicate that these products are manufactured under inadequate or non-existent controls.
FDA is concerned that electronic cigarettes may introduce young people to nicotine use which may lead to an increase in the use of conventional tobacco products with well-known, adverse, health consequences. Additionally, it is unclear what health effects these products could have on users or if misuse or product failure could lead to nicotine poisoning or other serious adverse health consequences.
There are a number of proven safe and effective cessation aids that smokers can use to quit smoking. The U.S. Public Health Services, Treating tobacco Use and Dependence: 2008 Update recommends using a combination of proven cessation interventions including FDA-approved nicotine replacement therapy and/or non-nicotine medications and counseling to more than double a smokers chances of quitting successfully. Free help is available to smokers in all states by calling 1-800-QUIT-NOW or by visiting Smokefree.gov.
Again, we appreciate the time that you have taken to contact us.
Best regards,
Division of Drug Information LC
Center for Drug Evaluation and Research
Food and Drug Administration
For up-to-date drug information, follow the FDA's Division of Drug Information on Twitter at FDA_Drug_Info
This communication is consistent with 21CFR10.85(k) and constitutes an informal communication that represents our best judgment at this time but does not constitute an advisory opinion, does not necessarily represent the formal position of the FDA, and does not bind or otherwise obligate or commit the agency to the views expressed.
From: Shane Yardley [mailto:skyman21277@gmail.com]
Sent: Saturday, January 15, 2011 1:14 AM
To: OC Webmail
Subject: E cigarettes
My first email
Are you still holding up shipments of electronic e cigarettes? Didn't a judge rule against you? Are you ready for a class action law suit. You are great, in bed with tobacco companies but I can't use my e cig in peace. Ban cigarettes of your going to do this. My tax dollars pay your salary stop wasting my money. Stop trying to kill us.
Shane Yardley
Reply
Forward
Reply
CDER DRUG INFO to me
show details 11:02 AM (10 hours ago)
Dear Shane Yardley,
- Show quoted text -
- Show quoted text -
Reply
Forward
Reply
Shane Yardley to CDER
show details 9:03 PM (0 minutes ago)
I just sent this in regards to their response at the top
I am not one took the time to write this. Thank you for getting back to me, but your reply is unsatisfactory. You say that none of these "so called electronic cigarettes or their components have been approved by the FDA". Well components are batteries, chargers, wires, and tubing. So you really can't regulate those if this is just a generated response or somese. Anyway, you allow cigarettes to kill millions of people each year. I don't know who these leading companies are you speak of, but the companies I use as vendors, do not make false claims, nor do they sale to minors or claim to help you stop. If you ban electronic cigarettes then does that mean you will ban tobacco also, or are you going to create a black market. You are so worried about the youth of the nation, yet you keep cigarettes here willingly, and knowingly. You know they cause cancer and this HAS been proven. So I don't think you are doing your job correctly. I understand you have done no tests, so get off your .... and do it. Tax the electronic cigarette industry like you do everyone else and leave us alone if this is what you need to do. I don't need tests. My blood pressure has gone down and allowed me to get off of medication, and I can breathe and exercise again. So take that to your scientists. I think tobacco companies may be paying you a little to much, to fight this hard to keep electronic cigarettes off of the market.
- Show quoted text -
--
Shane Yardley
-Life is not about the breaths you take, but the moments that take your breath away!
louis
