The Elephant in the Room

[Lessifer]

I respect your opinion and I won't argue whether the FDA is being biased in what research it looks at because I don't have the background to weigh the validity of the research presented. I also don't disagree that there may be undue influence from a lot of sources in government. However, I don't know why you think the FDA has handed the industry over to BT. All the proposed rules do is bring e-cigs within their jurisdiction, ask for more research, and apply the existing applications statutes to the industry. This is something that I would expect to see happen since it is required by statute.

Even though it may not be something great for us, I don't really see anything they are doing that is abnormal or particularly hostile.

The only research the FDA ever cites is it's own study in 2009, which consisted of an incredibly limited sample, and excluding the single instance of a cartridge containing a chemical that none of the others had, the data shows that while toxins were present they were at such low levels as to be unmeasurable. Of course, they don't say that, they just say that the toxins were found. We can ignore the scientific data for now though.

You are right in that all that the proposed regulations do is attempt to bring the vaping industry in line with current tobacco control policy. My opinion is that the current policy would all but kill the vaping industry. The tobacco companies can afford, and have mechanisms in place to spend thousands of man hours and millions of dollars to submit their product applications. Most of the vaping industry does not. They won't have to do anything to hand vaping over to BT, the application process will do it for them. Since vaping has an entirely different risk level, it deserves an entirely different regulatory process. I'm not saying vaping is risk free, but at this point in time it appears to be at least 90% less harmful than smoking.

 

[Robino1]

The only research the FDA ever cites is it's own study in 2009, which consisted of an incredibly limited sample, and excluding the single instance of a cartridge containing a chemical that none of the others had, the data shows that while toxins were present they were at such low levels as to be unmeasurable. Of course, they don't say that, they just say that the toxins were found. We can ignore the scientific data for now though.

You are right in that all that the proposed regulations do is attempt to bring the vaping industry in line with current tobacco control policy. My opinion is that the current policy would all but kill the vaping industry. The tobacco companies can afford, and have mechanisms in place to spend thousands of man hours and millions of dollars to submit their product applications. Most of the vaping industry does not. They won't have to do anything to hand vaping over to BT, the application process will do it for them. Since vaping has an entirely different risk level, it deserves an entirely different regulatory process. I'm not saying vaping is risk free, but at this point in time it appears to be at least 90% less harmful than smoking.

Actually, the FDA don't conduct their own studies. They used a study by a well known ANTZ using a device that no longer is on the market. The results were skewed simply by testing the ecig by using it like a cigarette. We all know not to run an ecig dry and can tell when it is, running dry, by the flavor (or lack thereof).

If you want to check out the FDA forum, you will find threads discussing who the FDA are paying, with grant money, to study ecigs. Hint: Most are already predisposed to be against ecigs. Their hands are stuck firmly in the pocket of BP.

 

[Plastic Shaman]

If you don't disagree with 12 U.S. Code § 411 - Issuance to reserve banks; nature of obligation; redemption | LII / Legal Information Institute which simply states in one short paragraph:

"Federal reserve notes, to be issued at the discretion of the Board of Governors of the Federal Reserve System for the purpose of making advances to Federal reserve banks through the Federal reserve agents as hereinafter set forth and for no other purpose, are authorized. The said notes shall be obligations of the United States and shall be receivable by all national and member banks and Federal reserve banks and for all taxes, customs, and other public dues. They shall be redeemed in lawful money on demand at the Treasury Department of the United States, in the city of Washington, District of Columbia, or at any Federal Reserve bank."

Now you must agree that you are either a Federal Reserve bank or a Federal Reserve agent and the currency is not lawful money. So we are surprised then when we are all willfully operating outside the scope of the framework and corruption like campaign finance occurs?

Is the Federal Reserve the federal government?

Agreed it is a governments supreme prerogative to issue Money. So the example from 12USC411 I gave you is Money then? What about the stated purpose? I assume the campaign finance corruption is paid in Fed Notes, no?

So if I am RJR and contribute to a campaign how is that not collusion between government, bank and corporation? Who controls what competition with RJR there is? Why is Congress able to interfere with Major League Baseball?

Sorry, main point is how is unlimited funding not the source of corruption on any level? Of course lets not touch on "unlimited" but when a million here and a billion there literally goes unnoticed every single day it is the same difference.

So this statute allows the Federal Reserve to issue notes, basically loans to the government, that can then be redeemed for legal currency later.

Are you suggesting that the Federal Reserve is issuing unlimited notes to companies which then give them to politicians for favors?

When I say campaign finance reform, I mean caps on the amount of money that private interests can donate to politicians to run for office.

 

[Plastic Shaman]

Shaman, I know you are a law student. My father taught law and we've had a few lawyers in the family, think it's a recessive gene thing. You need to look at this with a little wider scope than just as a lawyer. If person A kills person B and Person A's lawyer does a lot of backroom wheeling and dealing to get A found not guilty, that doesn't mean A is not a murderer even if in the eyes of the law he is not. There is a lot more going on than just the FDA mulling deeming regulations.

Sure, I acknowledge that corruption exists. In the future, if further regulations are proposed, I don't doubt that there will be a lot of outside influence and a lot of people will disagree with the evidence on both sides. All I'm saying is that the research presented right now doesn't have a lot to do with the proposed rules. It's laying the groundwork for any possible rules in the future, but all they are doing right now is enacting their powers under the statute that grants it. I don't see how they have proposed anything unreasonable at the time being.

I agree with your analogy, but can you apply it to the current situation? Can you point to anything that the FDA is trying to enact in the proposed rules that is particularity corrupt or is outside of the scope of the statute? As I've expressed in the past, there may be some arguments that deal with interpretation and scope, but I don't see anything that would take effect in the final rule that is shady.

Additionally, I would like to point out that the FDA did acknowledge some of the possible benefits to e-cigs. Just saying.

 

[Plastic Shaman]

The only research the FDA ever cites is it's own study in 2009, which consisted of an incredibly limited sample, and excluding the single instance of a cartridge containing a chemical that none of the others had, the data shows that while toxins were present they were at such low levels as to be unmeasurable. Of course, they don't say that, they just say that the toxins were found. We can ignore the scientific data for now though.

You are right in that all that the proposed regulations do is attempt to bring the vaping industry in line with current tobacco control policy. My opinion is that the current policy would all but kill the vaping industry. The tobacco companies can afford, and have mechanisms in place to spend thousands of man hours and millions of dollars to submit their product applications. Most of the vaping industry does not. They won't have to do anything to hand vaping over to BT, the application process will do it for them. Since vaping has an entirely different risk level, it deserves an entirely different regulatory process. I'm not saying vaping is risk free, but at this point in time it appears to be at least 90% less harmful than smoking.

So people on here would disagree with your assessment of it killing the industry as I've been told that there e-cig companies that can afford it and could make it through the application process.

Regardless, I don't deny that a large part of the community would be crushed by the application process. In the comments submitted by SFATA, they proposed some exemptions, which I hope the FDA allows. Now, there's no guarantee that they will, but we don't know. They are supposed to take all evidence presented to them into account to some extent. I have not looked into it or really thought about it too much, but maybe there's grounds for an appeal if they don't consider these options. So, maybe they don't need a totally different process, they just need the FDA to take into account the special concerns of the industry.

 

[Lessifer]

Actually, the FDA don't conduct their own studies. They used a study by a well known ANTZ using a device that no longer is on the market. The results were skewed simply by testing the ecig by using it like a cigarette. We all know not to run an ecig dry and can tell when it is, running dry, by the flavor (or lack thereof).

If you want to check out the FDA forum, you will find threads discussing who the FDA are paying, with grant money, to study ecigs. Hint: Most are already predisposed to be against ecigs. Their hands are stuck firmly in the pocket of BP.

I was referring to this one: http://www.fda.gov/downloads/drugs/scienceresearch/ucm173250.pdf which was commissioned(?) by the FDA, or at least is the one that has been cited multiple times.

 

[Lessifer]

So people on here would disagree with your assessment of it killing the industry as I've been told that there e-cig companies that can afford it and could make it through the application process.

Regardless, I don't deny that a large part of the community would be crushed by the application process. In the comments submitted by SFATA, they proposed some exemptions, which I hope the FDA allows. Now, there's no guarantee that they will, but we don't know. They are supposed to take all evidence presented to them into account to some extent. I have not looked into it or really thought about it too much, but maybe there's grounds for an appeal if they don't consider these options. So, maybe they don't need a totally different process, they just need the FDA to take into account the special concerns of the industry.

Ok, perhaps kill is a strong word. I'll use decimate instead, it's more in line with what would most likely happen. Although, instead of 1 in every 10 not surviving the process, I'd say maybe 1 in every 10 would survive. Could vaping limp along with only 10% of the current e-liquid/hardware manufacturers, probably, but it would be a much different industry. I would argue that lack of competition stifles innovation. Also, when it comes to e-liquid, as the sub forum dedicated to it can attest, the wide range of available choices are key to the success of vapers.

I can't comment on the SFATA proposed options, I haven't read their comments yet, but what would the exemptions be based on?

 

[Plastic Shaman]

Ok, perhaps kill is a strong word. I'll use decimate instead, it's more in line with what would most likely happen. Although, instead of 1 in every 10 not surviving the process, I'd say maybe 1 in every 10 would survive. Could vaping limp along with only 10% of the current e-liquid/hardware manufacturers, probably, but it would be a much different industry. I would argue that lack of competition stifles innovation. Also, when it comes to e-liquid, as the sub forum dedicated to it can attest, the wide range of available choices are key to the success of vapers.

I can't comment on the SFATA proposed options, I haven't read their comments yet, but what would the exemptions be based on?

You should read them. They are really good.

http://sfata.org/wp-content/uploads/2014/08/FDA_2014_N_0189_SFATA_Comments.pdf

I talked a lot about some of these points in my other thread, but they state them a hell of a lot better. They suggest an investigational use exception and an extension of the application period.

As a note, when I cited the case that all this was based on, I cited the ruling. They point out this is not the holding. However, I maintain that this supports the FDA position that it has the ability under the tobacco control act. Although, this gives some really interesting arguments about other issues.

 

[Lessifer]

You should read them. They are really good.

http://sfata.org/wp-content/uploads/2014/08/FDA_2014_N_0189_SFATA_Comments.pdf

I talked a lot about some of these points in my other thread, but they state them a hell of a lot better. They suggest an investigational use exception and an extension of the application period.

As a note, when I cited the case that all this was based on, I cited the ruling. They point out this is not the holding. However, I maintain that this supports the FDA position that it has the ability under the tobacco control act. Although, this gives some really interesting arguments about other issues.

Ok, now I have to ask, did you actually read the comment? My mind might be wandering a bit, but I don't think I've posted anything in this thread that does not fall in line with that comment.

1. E-cigarettes are not currently under the jurisdiction of the FDA as Tobacco Products, and should not fall under the same regulation as current Tobacco products because they are wholly different.

2. Imposing the current regulatory framework on e-cigarettes would violate fairness principles.

 

[Plastic Shaman]

Ok, now I have to ask, did you actually read the comment? My mind might be wandering a bit, but I don't think I've posted anything in this thread that does not fall in line with that comment.

1. E-cigarettes are not currently under the jurisdiction of the FDA as Tobacco Products, and should not fall under the same regulation as current Tobacco products because they are wholly different.

2. Imposing the current regulatory framework on e-cigarettes would violate fairness principles.

Yes. If you read my other thread, I talked a lot about these things before I read SFATA comments

http://www.e-cigarette-forum.com/fo...on/620297-fdas-proposed-rules-unworkable.html

I've said a few times throughout this thread that there will be some room for challenges in court. However, this won't stop the rules from being imposed, but they may be successfully challenged later. I think their arguments are interesting, but I don't think they will hold up. As always, I can be wrong, but courts give a great deal of deference to regulatory agencies. Yes, SFATA is making these arguments, but they also have the alternative proposals in there for a reasons.

As far as the 1st argument goes, I talked about some ways I was thinking about this in my other thread. The problem is that you would have to show evidence that Congress did not intend for the FDA to have the power to do this type of thing or did not intend for it to have this power to this extent. I can see that as a common sense argument since e-cigs were not out at that time. However, the question is, will the Court? I doubt it. The plain language of the statute is pretty clear.

As for the second point. Eh...
I don't know how the court would look at this, but generally just because something is bad for an industry or business, doesn't mean that it is invalid.

Anyways, what do I know? Probably very little. If you see anything that I'm misunderstanding, either in that or in my other post, I'd love to hear it!

 

[sub4me]

Fairness principles?? Lmao.

 

[Plastic Shaman]

I have not done any research on this, so this is just my initial thought on the issue.

In looking at the fairness argument, SFATA cites two cases. One has to do with consistency. The case they cite says that a regulatory agency cannot make inconsistent decisions that conflict with its own precedents in identical situations. I would question how the proposed rules do this. First, the situations are not identical so I would expect a good deal of deference to be granted. Also, I don't know what they are doing here that would cause major conflict with previous precedent.

As for the second point, which is basically a cost benefit analysis, SFATA claims that they would have to show that quantifiable benefits outweigh the quantifiable costs and burdens. However, in the absence of adequate study, the agency has to offer a "rational connection between the facts found and choice made." SAFTA makes a good argument quoting the part about a lack of research... maybe that's a really good argument. However, what you have to consider is this rational connection. Anytime you hear a phrase like that relating to a government decision, you are facing a really high standard that gives tons of deference to the government. I don't see it, but I could be wrong.

Regardless, it will be a while before we see any of these arguments.

 

[sub4me]

Exactly, which is why I don't understand why so many are freaking out over proposed regulations. Its called proposed for a reason. Nothing has been set in stone yet except the fact that the FDA will have control over e cigs as a related tobacco product. The way I see it is we will know what's in these liquids, bottles will be clearly marked with ingredients labels and warning and taxes will be paid. The government gets their taxes we get safer liquid that has to have consumer safety regulations. Sure I don't want to pay more taxes, no one does, but I wouldn't mind some oversight to be sure what I'm buying is actually what I think it is.

I'm tired of all the gloom from some posters who think the world is coming to an end. Alcohol, tobacco, and firearms are all regulated and guess what all of them are easily available. E liquid will be no different. The only real difference will be some oversight of what's being sold as E liquid. Its called consumer safety.

 

[Lessifer]

Eh, I try to balance my doom and gloom with being active in trying to keep the worst from happening. On a personal level, I'm pretty set to vape how I want until I'm ready to stop even if the industry changes over night.

 

[Rossum]

we get safer liquid

Really? In what way is it unsafe now?

 

[Ryedan]

You should read them. They are really good.

http://sfata.org/wp-content/uploads/2014/08/FDA_2014_N_0189_SFATA_Comments.pdf

A very good read. Thanks Plastic

 

[Plastic Shaman]

Really? In what way is it unsafe now?

Well, suppliers will have standards that they have to comply with. I don't think that that's something that's undesirable.

 

[sub4me]

Really? In what way is it unsafe now?

If I have to answer that for you then you have a lot to learn about liquids, where they are made, and some of things that are being sold as party liquids.

I will agree that some are made to high standards but we have to take the companies word for that which leaves a lot of room for assumptions and I'm not even gonna go into all the possibilities of liquids anyone can buy on the web that contain who knows what. Just do reading in more then one place. I think its easy to find if your looking for unbiased facts on the dangers of unregulated liquids. Or perhaps contact your local law enforcement and ask about what they've been seeing being sold in the open in some stores.

 

[FlamingoTutu]

Sure, I acknowledge that corruption exists. In the future, if further regulations are proposed, I don't doubt that there will be a lot of outside influence and a lot of people will disagree with the evidence on both sides. All I'm saying is that the research presented right now doesn't have a lot to do with the proposed rules. It's laying the groundwork for any possible rules in the future, but all they are doing right now is enacting their powers under the statute that grants it. I don't see how they have proposed anything unreasonable at the time being.

I agree with your analogy, but can you apply it to the current situation? Can you point to anything that the FDA is trying to enact in the proposed rules that is particularity corrupt or is outside of the scope of the statute? As I've expressed in the past, there may be some arguments that deal with interpretation and scope, but I don't see anything that would take effect in the final rule that is shady.

Additionally, I would like to point out that the FDA did acknowledge some of the possible benefits to e-cigs. Just saying.

Lessifer pretty much said what I would have said in this post. http://www.e-cigarette-forum.com/fo...ion/621724-elephant-room-25.html#post14561333 You and a few others think regulation would be a good thing and not much will change, many of us think otherwise. I sincerely hope you guys are right because I believe we are going to have regulation crammed down our throats.

 

[sub4me]

No your just over reacting to what ifs, all will be fine. Just relax and vape.