Fda news release
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Don't give the FDA any ideas. They may read that and actually do it.
Taleon - Here's an enlightening article regarding FDA funding: frontline: dangerous prescription: the fda: how independent is the fda? | PBS
Yes, I know and good point, but the FDA is in charge "to be trusted". We cannot change that.
We certainly can! Last year the FDA scientists screamed corruption noting that the FDA was ignoring them and following profit over scientific evaluation. Obama put together a task force to "investigate".
Over the past two years, the FDA has been responsible for ensuring that the food supply be free and clear of food borne illness, yet American made Peanut Butter was tested 12 times to contain salmonella and was still sold to the public.
What's happening is a large amount of FDA "oopsies" and when they are all pooled together, it is hard to not notice what is happening.
Hopefully, there are enough members here on the forum that take to heart the fact that not only are their freedoms being taken from them, but that an agency that hides under the guise of federally funded and public health is extremely under funded, under staffed and doing everything they can to stay alive... and the result, is the lack of oversight where it is needed most.
Hopefully, those same members are doing what they can to not let these injustices continue. It's going to take some time, but government agencies have been called out onto the carpet before and it's the people who have to call them out there.
Over the past two years, the FDA has been responsible for ensuring that the food supply be free and clear of food borne illness, yet American made Peanut Butter was tested 12 times to contain salmonella and was still sold to the public.
What's happening is a large amount of FDA "oopsies" and when they are all pooled together, it is hard to not notice what is happening.
Hopefully, there are enough members here on the forum that take to heart the fact that not only are their freedoms being taken from them, but that an agency that hides under the guise of federally funded and public health is extremely under funded, under staffed and doing everything they can to stay alive... and the result, is the lack of oversight where it is needed most.
Hopefully, those same members are doing what they can to not let these injustices continue. It's going to take some time, but government agencies have been called out onto the carpet before and it's the people who have to call them out there.
Ok, as far as I can read You are in favour that the FDA has insufficent data, so present Your own studies to Your lawyers and courts and let them rule 
We'll see then.
We'll see then.
Certainly would if I believed the FDA had control over nicotine... and even with the new tobacco bill, I still don't believe they do
Personally can't wait to see what Leon has to say about all of this. It will be an interesting read once he submits his decision.
Personally can't wait to see what Leon has to say about all of this. It will be an interesting read once he submits his decision.
Ok, as far as I can read You are in favour that the FDA has insufficent data, so present Your own studies to Your lawyers and courts and let them rule
Taelon--that is not what the case is all about--the case has nothing at all to do with the "Saftey" of e-cigs. The case is one of jurisdication and regulation. NJOY can submit studies all day long to the Court about its independent studies, but at the end of the day, Judge Leon will not base his ruling on any data submitted --- He will only apply the law and rule on the jurisdiction of the FDA with regards to its powers to embarko, and regulate.
Sun
Certainly would if I believed the FDA had control over nicotine... and even with the new tobacco bill, I still don't believe they do
Personally can't wait to see what Leon has to say about all of this. It will be an interesting read once he submits his decision.
I think it's pretty clear cut that the FDA has jurisdiction over nicotine. That's not really the issue. The issue is more whether the electronic cigarette is intended to prevent, cure, or treat a disease. If it is, it's a medical device delivering a drug and is to be regulated as such. If not, it's out of their hands. Since nicotine has long ago been classified as a drug, they most certainly have jurisdiction over it. If nicotine could be reclassified, it might be a different story. Unfortunately, no one (so far) has made an attempt to do so, so it remains a drug.
If this case has nothing to do with safety studies (and I'm not arguing with you that it does), then why the specific timing of the FDA report? Why would the FDA launch a smear campaign right about the same day Judge Leon was going to rule, using a 2.5 month old report directed strictly against the two parties involved in the lawsuit?? And why would the Judge delay everything another month "in light of this new information"?
Seems like the FDA's safety report/press conference had an awful lot of effect on the case.
You are correct that the issue lies with whether the ecig is intended to cure or treat... however, I can't find any legislation or rules governing nicotine. I can find it regarding lobelia inflata. It specifically notes that.
I think what happened is that in 94, Kessler went on a mission to make people think that nicotine was regulated by the FDA, when in fact it wasn't. Which ended the FDA up in court fighting the tobacco companies... where the FDA was told to piss off.
Since then, they have attacked every nicotine product on the market that has not been regulated by the FDA, and those products simply did not have the industry or the user base to fight back. Could the ecig end up in the pile? Yes. It could. However, I don't believe that any court has actually determined that NicoWater, the nicotine lollipop, et all... actually required regulation by the FDA.
But I can't find if nicotine is not sold/marketed as an NRT, the FDA has control over nicotine. In all references, it goes back to what you have noted and that if the product is marketed to cure, mitigate, or treat a disease, then it would need be FDA approved. This does not mean though that the FDA has control over all nicotine products.
EDIT: I should also note that it isn't that nicotine shouldn't be regulated because it should. However, it should not be regulated to the standards of the NRT's. It should either have the same standards as tobacco OR it's own category... and frankly, there are several products in the tobacco category like tobacco free snuff from Mountain ? that isn't technically a tobacco product but is being sold as such because it is far cheaper for the tobacco company to go that route than pharm.
I think what happened is that in 94, Kessler went on a mission to make people think that nicotine was regulated by the FDA, when in fact it wasn't. Which ended the FDA up in court fighting the tobacco companies... where the FDA was told to piss off.
Since then, they have attacked every nicotine product on the market that has not been regulated by the FDA, and those products simply did not have the industry or the user base to fight back. Could the ecig end up in the pile? Yes. It could. However, I don't believe that any court has actually determined that NicoWater, the nicotine lollipop, et all... actually required regulation by the FDA.
But I can't find if nicotine is not sold/marketed as an NRT, the FDA has control over nicotine. In all references, it goes back to what you have noted and that if the product is marketed to cure, mitigate, or treat a disease, then it would need be FDA approved. This does not mean though that the FDA has control over all nicotine products.
EDIT: I should also note that it isn't that nicotine shouldn't be regulated because it should. However, it should not be regulated to the standards of the NRT's. It should either have the same standards as tobacco OR it's own category... and frankly, there are several products in the tobacco category like tobacco free snuff from Mountain ? that isn't technically a tobacco product but is being sold as such because it is far cheaper for the tobacco company to go that route than pharm.
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Well, therein lies the problem. It's a semantics battle. If you look at what has been going on in the past few weeks, it's entirely possible that we all fell into a trap.
First the FDA releases a report saying that electronic cigarettes could be a health hazard. They contain carcinogens and a known toxin. We all get up in arms about it and say "Whoa! Hold on a minute there! Let's take a look at this report!" We determine that the report is definitely good news, since it pretty much proves that electronic cigarettes are a lot safer than tobacco smoking. Some vendors have their own testing done and released, and NJoy not only refutes the FDA test, but releases a survey proving that they market to adult smokers who wish to have an alternative. While they don't specifically say "a safer alternative" (and are actually very careful to NOT say that), their refuting of the aforementioned test results shows that they believe their product to be safe.
Therefore, the products are implicitly intended to prevent the diseases associated with smoking by substituting a device which simulates smoking and delivers nicotine, but has no harmful substances. This makes it a medical device, and subject to FDA regulation.
NOW! If there were no mention of safety whatsoever, and the vendors had looked at the FDA tests and said "So what?", and only marketed as a way to get around smoking bans on the technicality that it's not smoke... then the FDA might not have a point. Unfortunately, I think that we're past that point and that the vendors need to start looking at the very real possibility that things are going to go very wrong very soon.
-Nate
First the FDA releases a report saying that electronic cigarettes could be a health hazard. They contain carcinogens and a known toxin. We all get up in arms about it and say "Whoa! Hold on a minute there! Let's take a look at this report!" We determine that the report is definitely good news, since it pretty much proves that electronic cigarettes are a lot safer than tobacco smoking. Some vendors have their own testing done and released, and NJoy not only refutes the FDA test, but releases a survey proving that they market to adult smokers who wish to have an alternative. While they don't specifically say "a safer alternative" (and are actually very careful to NOT say that), their refuting of the aforementioned test results shows that they believe their product to be safe.
Therefore, the products are implicitly intended to prevent the diseases associated with smoking by substituting a device which simulates smoking and delivers nicotine, but has no harmful substances. This makes it a medical device, and subject to FDA regulation.
NOW! If there were no mention of safety whatsoever, and the vendors had looked at the FDA tests and said "So what?", and only marketed as a way to get around smoking bans on the technicality that it's not smoke... then the FDA might not have a point. Unfortunately, I think that we're past that point and that the vendors need to start looking at the very real possibility that things are going to go very wrong very soon.
-Nate
Our House--Judge Leon never had any intent of ruling on that day or any other day prior to the August 17th hearing that is upcoming---The Docket Sheet clearly shows Judge Leon desired to hear the parties again about the new legislation passed. The Judge can find for the FDA under one of two statutory schemes and is going to decide which one is the most applicable.
Sun
Okay cool. I remember (could be wrong, and I'm too lazy to look back) it going something like this:
Build-up in the docket thread about a ruling coming up in a day or two -> FDA comes out of left field and releases (old) report and holds press conference -> Judge Leon requests another month in light of new information.
And THANKS for the updates by the way! Never got a chance to thank you in that other thread, but you're doing a hell of a lot for the community.
No comment on the timing of the FDA report's release?
Our House--you are very correct that the timing of the FDA's release was suspect to say the least. I think what you have here is a full staff now assigned to the "E-cig matter". Before it was just some scant comments from Rita Chappelle of the FDA as a spokesperson. Now you have actual FDA agents on the the E-cig is full force. Agencies like the FDA do go into full throttle when they are sued.
I still have to say Our House that I find it troubling that the ECA never impleaded itself into this case, nor did NJOY ever release a report it said it had that showed that its e-lquid was "clean as a whistle" that was done prior to the FDA's report. I also am troubled that SE, who charges 150 dollars for an e-cig never funded a study.
Sun
You mentioned a few times in another thread that NJOY said this, yet I can't find the statement anywhere. Best I could come up with was from their Response To FDA Conference Call where they said:
(emphasis mine)NJOY said:
They stated that their cartridges were clear from DEG, but made no mention about tobacco specific impurities. Do you remember where they said "clean as a whistle" or anything to that effect?
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Our House--It is right in one of the threads and I got a confirmation of it as well. So much for the "Clean as a Whistle" my friend.
Sun
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