The Elephant in the Room
- Thread starter Plastic Shaman
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I thought the njoy v FDA case(whatever it's actually called) decided that e-cigarettes are not smoking cessation devices. iirc, they did not say "therefore e-cigarettes are tobacco products" but instead said "they do not fall under your jurisdiction as medical devices." So the FDA has to propose regulations bringing e-cigarettes under their control as tobacco products, they currently are NOT tobacco products. Someone please correct me if I'm wrong here.
This distinction is much more than semantics. Tobacco control legislation is based on the grounds that tobacco causes harm to the public. vaping, according to all but the most absurd research that I have seen, is 1000 times less harmful than smoking. So, restricting vaping based on the public face of tobacco control being for "public health," is ridiculous.
This distinction is much more than semantics. Tobacco control legislation is based on the grounds that tobacco causes harm to the public. vaping, according to all but the most absurd research that I have seen, is 1000 times less harmful than smoking. So, restricting vaping based on the public face of tobacco control being for "public health," is ridiculous.
Here's the ruling of Soretta, Inc. v. Food and Drug Admin.:
As we have already noted, the FDA has authority to regulate customarily marketed tobacco products—including e-cigarettes—under the Tobacco Act. It has authority to regulate therapeutically marketed tobacco products under the FDCA's drug/device provisions. And, as this decision is limited to tobacco products, it does not affect the FDA's ability to regulate other products under the “structure or any function” prong defining drugs and devices in 21 U.S.C. § 321(g) and (h), as to the scope of which—tobacco products aside—we express no opinion. Of course, in the event that Congress prefers that the FDA regulate e-cigarettes under the FDCA's drug/device provisions, it can always so decree.
So, no it didn't say that they are a not a smoking cessation device. It says that they can be regulated depending on how the FDA goes about it.
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Ok, so it said they can't regulate it as a drug/device unless there are therapeutic claims made.
Still, this point applies: Tobacco control legislation is based on the grounds that tobacco causes harm to the public. Vaping, according to all but the most absurd research that I have seen, is 1000 times less harmful than smoking. So, restricting vaping based on the public face of tobacco control being for "public health," is ridiculous.
Still, this point applies: Tobacco control legislation is based on the grounds that tobacco causes harm to the public. Vaping, according to all but the most absurd research that I have seen, is 1000 times less harmful than smoking. So, restricting vaping based on the public face of tobacco control being for "public health," is ridiculous.
That's the problem that the FDA runs into by trying to regulate it as a theraputic device, but the concurrence makes some interesting points about this.
Perhaps I should explain this a little better. There are two ways that the FDA could try to regulate it. One, under the tobacco control act, which is 21 USC 387. The other is under the FDCA, which is 21 USC 351. In this case, they said that they can regulate it under the FDCA if they do so in a way that would regulate it as a therapeutic device. Since there were no claims that e-cigs were such devices in this case, they could not do this. However, the Court clearly states that they can regulate it under the Tobacco Control Act. You should read it if you want to know more-
Sottera, Inc. v. Food & Drug Admin., 627 F.3d 891, (D.C. Cir. 2010)
Google that and you should be able to find it. Also, I had another thread about this last week where I made some more arguments that you might be interested in.
No, I get that, but CAN is not the same as SHOULD. My point is that the Tobacco Control Act, at least on the surface, regulates tobacco products because of how detrimental they are to public health. There is no evidence that currently suggest that vapor products are any where near as harmful as traditional tobacco products. IF some time down the road it turns out that vapor is harmful, it will be easy enough to tighten regulation at that point. IF regulations are enacted in the way that the FDA has proposed, we will never know, because the industry will be stifled to the point where the only players left in the game will be BT. So there needs to be a new set of rules to regulate vapor products, not an attempt to shoehorn them into regulations that truly don't apply.
Well, I guess this really depends on what a person's proprieties and views are. Also, what people consider a danger is probably pretty subjective. Of course, as vapers, we have a tendency to say that there isn't any evidence that e-cigs are harmful so it shouldn't be regulated. Other people with different agendas might think that there needs to be a lot more research conducted and it should be regulated in the meantime. I think I've said this a number of times, but when regulating something of which we don't know the long term effects, it is purely based off speculation. However, this speculation is deemed to outweigh the potential risks that come from not regulating.
You could have an argument about whether or not tobacco control policy is being properly implemented considering the purpose as opposed to the apparent safety of e-cigs. Still, courts give a lot deference to regulatory agencies instead of injecting their own opinions about what is the best course of action.
In all fairness to the FDA, and I think I say this a lot, all they are trying to do is bring e-cigs under their jurisdiction. Considering the definition that Congress has given of tobacco products, I think they would actually be deficient in their duty if they did not do this. At the present time, all this will do is make e-cigs open to study and requires the application process that was defined by Congress. I feel like I say this a lot lately, but I think that there is a lot of unnecessary hate towards the FDA based on perceptions of what they are doing. At this point, I think all they are doing is what they have been told to do by Congress. Also, this is what was deemed appropriate by a majority of Congress.
So, if the FDA should regulate all tobacco products, particlulary for the sake of the children, and congress only has our best interests in mind, why does the current deeming proposal exempt premium cigars?
Well, it kinda flips over with every revolution of the planet. Albeit with the rest of the planet so it's not that noticeable, except with going from night to day and all that
A more important question: When the FSPTCA of 2009 banned all flavored cigarettes, why was menthol exempted, when the majority of young and first time smokers start with menthol?
Except... They're cigarettes. Any movement and price and regulation is going to have a miniscule effect on consumption and / or addiction.
Sent from my device.
Here is the problem as I see it. Just my opinion. For a kid to buy cigarettes is illegal yet that doesnt stop kids from trying cigarettes or smoking. To want the government to make even more laws "to save the children" wont do a thing to stop any child from wanting to try vaping or becoming a vaporer but will open the door for more government control and regulations which we have far too much of already.
I look at this the same way that I look at things like gun control. It doesnt work, its pointless and will do far more harm than good. When you outlaw guns only oulaws will have guns and now you created a large pool of victims who cant defend themselves. Same with vaping. You invite the government in to make all these laws and regulations they are not going to stop there but make tons of stupid laws, tax the hell out of it and kids are still gonna try it and do it just like they do with smoking. Once again you did more harm than good.
The vaping community has done a great job of policing themselves. They are against sales to kids and also done things to make vaping safer for all like identifying juices and ingredients that can be harmful to people and pressured manufacturers to let people know if those ingredients are in their product. Its not a perfect system but far more effective than government control.
You may be right about that. More of the members should get to know their history of what they have done so they can form a true deep seeded hate for the FDA. Basing that hate on what might happen is completely unnecessary.
Sent from my device.
Part of the problem is trying to talk science to a politician. Appearance is everything to them. If it looks like smoking, it's smoking. Most have no interest in educating the general public. Easier to get elected by chiming in with the chorus. Try explaining the benefits of funding an ongoing manned space flight program to someone who thinks cavemen rode around on dinosaurs like Fred Flintstone, or who think wind is made by the leaves on trees moving around. God bless America. 
Menthol was the only thing that made cigarettes taste even remotely good, when I first started smoking at the age of 16.
Because those are what the big boys like to smoke when they've successfully chipped away at another bit of our freedom.
An issue that doesn't seem to be addressed much is it is possible that ecigs are a fad that teens try. Just as smoking was something that I tried but after I was ready to quit smoking, it was too late. I was truly hooked. It didn't take very long. I feel that it will be easier to stop vaping, when the novelty wears off, for those teens that do think it is a 'cool' thing to do.
I guess the bottom line for me is that it feels like a waste of time, money, and energy to create unenforceable laws. Rules for the sake of rules don't seem to be helpful. IMO, in a perfect world we'd have only well-crafted laws, that addressed real needs, and that could and would be consistently enforced.
And yep, i get the inherent problem of defining what a "real need" is. So, perhaps an easier to answer question is is the rule well-defined and consistently enforceable? If not, then perhaps it's not a good law.
And yep, i get the inherent problem of defining what a "real need" is. So, perhaps an easier to answer question is is the rule well-defined and consistently enforceable? If not, then perhaps it's not a good law.
lol @ the mental image of fat cat politicians sitting around chomping fat cigars and blowing clouds while passing anti-smoking and anti-vaping legislation. Would make a good editorial cartoon.
Always so nice to see threads like this that feed the ANTZ cause on here. Anything adults do kids will want to do, regardless of marketing.
Alcohol advertising is so youth oriented yet where is the political outcry? I mean the news here highlights local breweries and wineries all the time even though there is quite a few youth alcohol related deaths every year.
Alcohol advertising is so youth oriented yet where is the political outcry? I mean the news here highlights local breweries and wineries all the time even though there is quite a few youth alcohol related deaths every year.
menthol was the number one flavor choice for under age users.
all the other flavors combined i believe was less than 20%.
i am not sure of the exact %'s but as i recall menthol crushed
all the other flavors.
mike
its not that its the most important thing i our lives,it does however represent
how our lives are affected by the very government that's sworn to protect our
liberties
this whole debate is what is wrong and right about how government thinks and acts
as if it were the end all and be all in every little thing in the lives of the people
it supposedly represents
current political theory postulates government as nothing more than a means
of obtaining larger and ever increasing revenue streams so as to placate the
masses and maintain control, to maintain the status quo,(appeasing special interest groups)
and maintain the reins of power.(get re-elected)
we quite frankly are feed up with it.
regards
mike
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