Yes, all drugs. Some drugs are also food, and are primarily that. What other purposes do humans have for nicotine, that are primary?
We need a bigger boat.
- Thread starter skoony
- Start date
- th_trl_thread_readers 0
- Status
Yes, all drugs. Some drugs are also food, and are primarily that. What other purposes do humans have for nicotine, that are primary?
It's been a Long Time since I have read any Rulings.
Do you have a Link to the Actual Text that Judge Garland wrote?
I don't know how Accurate the Quotes are below...
"...
The Appeals Court decision was rendered by a three-judge panel. Interesting, one of the three judges, while concurring in the ultimate decision, did so for different reasons. Judge Garland opined that Brown & Williamson does apply only to cigarettes and smokeless tobacco products, not to all nicotine-containing products. However, he goes on to argue that under the Tobacco Act, electronic cigarettes are clearly defined as tobacco products because they are derived from tobacco.
As Judge Garland states: "Because the nicotine in njoy's electronic cigarettes is "derived from" natural tobacco, it appears that the FDA may regulate it only pursuant to the provisions of the Tobacco Control Act."
Judge Garland concludes: "I conclude that, unless a product derived from tobacco is marketed for therapeutic purposes, the FDA may regulate it only under the provisions of the Tobacco Control Act."
..."
The Rest of the Story: Tobacco News Analysis and Commentary: Appeals Court Upholds Injunction Against FDA: Agency Cannot Regulate Electronic Cigarettes as Drugs/Devices Under Food, Drug, & Cosmetic Act
What, exactly, makes walnuts, oats, and onions drugs? What is your definition of drug?
Thank you Lessifer.
When it comes to Fundamental Issues like this, I like to Read the Unabridged Text whenever Possible.
Everyone seems to have some amount of Spin they would like to put on things like a Judge's Decision. And many times the Paragraph Before or directly After are just as Meaningful as the one that an Author chooses to Quote.
Definition: a medicine or other substance which has a physiological effect when ingested or otherwise introduced into the body
Yup, which is why I didn't post any quotes to go with my interpretation. People can read for themselves and do with it what they will. To me, he seems pretty clear on the fact that e-cigs do not contain tobacco, but legally the definition of tobacco product in the FSPTCA includes the "derived from" which can apply to the nicotine in e-cigs.
Conceivably, yes. But food has a purpose other than medicinal. Clearly, the way vapers use nicotine (even if it's not to cease smoking) is medicinal. But because of what FSPTCA provides (a way around the whole drug claim), it can't be regulated as such unless vendors (are stupid enough to) market it with therapeutic claims.
Because FSPTCA provides a legal workaround, this (I reckon) is why Godshall saw the ruling as incredibly wonderful for vapers/vaping industry.
It's Funny how Two Words... "Derived From" can effect the Outcome of a 8 Billion Dollar Industry. And can effect the Lives of More that 15% of the Entire Population in one way or Another.
And can be the Make (or the Break) in the way that Policies are Crafted on Federal, State and Local Level.
Amazing when you Think About it in Symbolic Terms.
It's not the legal authority, under existing law, that I question. It's whether vapor products SHOULD be regulated under that framework. It doesn't make any sense. None of the same health concerns. Not the same economic concerns as cigarettes and ST. Not medicinal.
Recreational product that may or may not contain a mild stimulant. It just doesn't fit.
IMO, the over arching point is that regulators are going to regulate. People (many vapers) act all upset that it is being regulated under FSPTCA, and seemingly ignorant of history (that it almost got regulated as a drug) or in denial, that it would be regulated at all.
A third classification, unique to eCigs would be wonderful if (and really only if) the regulators were going to be reasonable. As the regulators in this case are FDA, then it seems they will be not all that reasonable. Or if they are reasonable, it would be on par with however one feels FSPTCA is conveyed. A third classification could mean some other body regulates instead.
While I am firm on the opinion of eCigs (with nic) are tobacco products, I highly favor the idea of going with a third classification. Not because I think things will get better (I actually think they could get a lot worse), but because it would serve as yet another delay mechanism. Could be a whole other 5 years before FDA nails that regulatory scheme down.
Currently we are stuck with FSPTCA, and I agree that Act sucks. It sucks for BT and sucks for all other industries having to follow that Act and all the umpteen million dollars of cost that come with it.
But there are 2 fairly larger slivers of hope. Foremost is that court challenges could greatly curtail any steps FDA takes to specialize regulations for eCigs. Secondly, the black market. If FDA is over reaching in its aim or does price out a whole lot of businesses, then they are responsible for that underground market. Surely they will deny this, but unless you are not paying close attention to what it takes to get product to the open market, you would be foolish / irresponsible to go along with such a denial. However convenient that might be.
A third classification, unique to eCigs would be wonderful if (and really only if) the regulators were going to be reasonable. As the regulators in this case are FDA, then it seems they will be not all that reasonable. Or if they are reasonable, it would be on par with however one feels FSPTCA is conveyed. A third classification could mean some other body regulates instead.
While I am firm on the opinion of eCigs (with nic) are tobacco products, I highly favor the idea of going with a third classification. Not because I think things will get better (I actually think they could get a lot worse), but because it would serve as yet another delay mechanism. Could be a whole other 5 years before FDA nails that regulatory scheme down.
Currently we are stuck with FSPTCA, and I agree that Act sucks. It sucks for BT and sucks for all other industries having to follow that Act and all the umpteen million dollars of cost that come with it.
But there are 2 fairly larger slivers of hope. Foremost is that court challenges could greatly curtail any steps FDA takes to specialize regulations for eCigs. Secondly, the black market. If FDA is over reaching in its aim or does price out a whole lot of businesses, then they are responsible for that underground market. Surely they will deny this, but unless you are not paying close attention to what it takes to get product to the open market, you would be foolish / irresponsible to go along with such a denial. However convenient that might be.
But it is not tobacco. We all didn't smoke cigarettes because we all were addicted to the big N.
Only 30% of smokers will develop a dependency to smoking. Roughly half will quit on there own
between 30 to 40 years of age. 50 % will keep smoking for whatever reason. That means 20%
with no dependency will continue smoking. I maintain we are not so much addicted to nicotine
as we are addicted to the smoke or smoking in and of itself. The demonization of nicotine which
over the last two years has reached a feverish pitch is deafening. Nicotine is not the problem.
Any one who understand the placebo effect will understand why it works so well for us. Some
fewer require WTA's. Most of us switched to vaping to quit smoking. Smoking requires tobacco
vaping does not. Ergo vapor products are not tobacco products.
I know the court said they could regulate e-cigarettes as a tobacco product but, they never said
they should. It's not a mandate with force of law is it?
Because they are highly trained professionals With ISO level 5854 certified labs with trained
technicians and specialists and Uber harmless juice and 100% safe and tested ENDS and
we are not.
Regards
Mike
All this depends on how you are defining tobacco products. If only counting the leaf, then no. If counting nicotine derived from the plant, then (clearly) yes.
@Stubby already addressed this.
It clearly wasn't a mandate, hence the reason it was treated by politically aware vapers at the time as great news. Go read the older posts on this. You'll see for yourselves that ECF'ers were doing cartwheels over this ruling.
The concluding paragraph of the Leon ruling says:
To me, it reads like a huge slap in the FDA's face on the initial lawsuit while placing a big ol' welcome mat for the FDA to regulate it still. Written in 2010, it is treated as, "we'll cross that bridge when we get to it." Here in 2015, we are fretting over how idiotic will that bridge be constructed.
Just to clarify, that's actually Judge Garland's concurring opinion.
I read that opinion as "Without therapeutic claims it is not a drug or drug device, and since the FSPTCA includes an actual definition of tobacco product which includes the words 'derived from' that is the regulation that should apply, since there are no other applicable regulations."
Perhaps he would have actually preferred they be regulated as drug devices.
To me, neither makes sense. A third category could be worse, or it could be better. This is where my idealistic optimism kicks in. If you don't apply decades of hate campaigning that applies to tobacco, perhaps there could be meaningful regulation that would not degrade the industry to only a few participants. In any event, applying regulations that appear to be written with the sole intent of preventing innovation, is counter intuitive to a growing industry. The FDA could choose not to apply all of that cigarette specific regulation to vapor products, but they don't seem to be inclined to do so.
I'm not sure under what Framework that e-Liquids that contain Nicotine could be Regulated that a Majority of Vapers would agree on?
I look at something like AEMSA. I see Views over the Entire Spectrum. From People who think that AEMSA's Standards are Great. To People who think that AEMSA is Evil Incarnate. And everything in between.
And AEMSA Doesn't Address all of the Parameters of the e-Cigarette Market. Only a Narrow segment of them.
I define a tobacco product as some thing made out of the whole leaf not an extract
of one of the thousands of compounds in it. A plastic bag is derived from oil but
you will get zero protection for your engine if you used it for lubricant.
A ICBM is derived from gun powder. Just a bigger bang. It's a generational derivative.
This means if not for this we wouldn't have the later. This by the way how they get
around to equating e-cigs as tobacco products. It's not the nicotine per say,it's
where the new thing got its origins from. Take away the nicotine we're still tobacco
in their eyes. Not in mine.
Regards
Mike
I know what I would prefer. I would prefer that any regulation be subjected to a measure of necessity and efficacy. Of course who would determine necessary and effective could be problematic.
I don't have an issue with AEMSA as a trade group. I also don't believe that all of their standards are necessary or effective, but I'm not required to purchase from AEMSA member vendors.
- Status
Similar threads
- Locked
- Locked
- Locked
