FDA Let's talk legal theory. (Section 910, in particular)

[Stubby]

" plaintiffs Sottera (doing business as njoy) and Smoking Everywhere argued that Congress intended for tobacco products, including their own, to be subject to the tobacco Control Act and not to the drug and device provisions of the FD&C Act. The district court described plaintiffs' position as follows: "In FDA v. Brown and Williamson Tobacco Corp., the Supreme Court held that tobacco products, like traditional cigarettes, are not subject to FDA regulation as a drug or device. [529 U.S. 120 (2000).] "

So, care to restate?

No. The above is pretty much taken out of context. During the original trial (I believe towards the end of it) the tobacco control act was passed. It was certainly not part of the original argument that ecigs be regulated under the tobacco control act. How could it as it didn't exist yet.

Not being a lawyer I didn't keep up with the details, but I believe it was Judge Leon that told the FDA that it was possible they could regulate ecigs under the then new tobacco control act of 2009. It looks as if NJOY simply went along with the ruling. Judge Leon was of course correct and that is just what has happened.

What you appear to be trying to claim is that the reason for the current situation is because the FDA lost in 2009 (though I guess that could be true because if they had won ecigs would have been illegal so there would be no reason for the deeming), and that Judge Leon suggested the FDA could regulate ecigs under the TCA. It is a silly assumption. As if the FDA would not have figured out they could regulate ecigs under the TCA on their own. Laying blame on the 2009 case completely ignores the reality of the tobacco control act.

One of the problems with this is that many in the vaping community are pretty naive as to what the actual problem is and have little understanding of intended use, which is what the case was entirely centered on, and what gives the FDA authority to deem ecigs as a tobacco product. I can just about guarantee that if someone tries to go to court claiming that we are not tobacco, they will lose. The intended use of ecigs is exactly the same as other tobacco products, as the recreational use of nicotine.

 

[StormFinch]

Those are CLEARLY associated with tobacco though, the issue here is that you don't have to get nicotine in vapor products, just like you don't have to put tobacco in a pipe. Not to mention, Juicy Jays makes flavored rolling papers specifically stating they are NOT to be used for tobacco, exempting them as well. I think the court is going to find that the more you can do with it yourself the less like a cigarette filter it is and the more like a pipe it is.

And pipes are now included as regulated in the same document as e-cigarettes. You think we have it bad? There goes the expensive, handmade pipes and pretty much all pipe tobacco, since the tobacco is blended and changes from year to year. I'd pull up the pertinent sections but my stupid PDF viewer decided to freeze. I think the deeming gave it a stroke.

I don't know, I personally think they don't make a whole lot of sense, but it's going to be up to the legal professionals to decide ultimately. I lost a lot of ability to pour over legal and research double speak years ago.

 

[sqirl1]

Wait what? Pipes themselves are considered tobacco products? Last I checked the FDA said pipes couldn't be tobacco products and they had no intention of doing so? What the hell?

 

[StormFinch]

Wait what? Pipes themselves are considered tobacco products? Last I checked the FDA said pipes couldn't be tobacco products and they had no intention of doing so? What the hell?

As usual, they lied. Here's the main stuff listed in the new deeming, (I resurrected my viewer) it's by no means an exhaustive list, since even pipe tobacco tins are now listed as a component because they can be expected to alter or effect the tobacco. Lovely, yes? Congress currently has matching bills in the Senate and House to help out premium cigars, but as far as I know, pipe smokers are a pretty small group, maybe smaller than us.

"While FDA currently has authority to regulate cigarettes, cigarette tobacco, roll-your-own
tobacco, and smokeless tobacco under chapter IX of the FD&C Act, under the final rule, all
additional tobacco products that meet the statutory definition, except accessories of those newly
deemed tobacco products, will be subject to chapter IX of the FD&C Act and its implementing
regulations. 16 These products include cigars, pipe tobacco, waterpipe tobacco, ENDS (including
e-cigarettes), and other novel tobacco products such as certain dissolvable products and gels.
These products further include components and parts of the newly deemed products, including
pipes, e-liquids, atomizers, batteries, cartomizers (atomizer plus replaceable fluid-filled
cartridge), tank systems, flavors for e-liquids, vials that contain e-liquids, programmable
software, flavor enhancers for waterpipe tobacco, waterpipe cooling attachments, water filtration
base additives, flavored waterpipe tobacco charcoals, and waterpipe bowls, valves, hoses, and
heads."

 

[sqirl1]

Wow, litterally everything. I guess speculation about legal theory isn't going to do much good at this point then. Worst case scenario is I'm going to be importing a lot of snus.
The FDA can't really be blamed here though, they really are just doing what the law says to do, we really can't do anything but hit the statute itself and only time will tell if that works.

EDIT: and how the hell are they going to regulate the firmware for e-cigs (I'm assuming thats what they mean by "Programmable software")? Some kid could probably write that in their basement....

 

[Harbinger82]

I was thinking about what I was reading, and something that I don't see a lot of people talking about became very apparent to me. Why aren't the other forms of nicotine also having to fall under this deeming( such as Nicorette gum/patch/lozenges)? They contain nicotine. That comes from a tobacco plant.... Shouldn't they also have to conform with these regulations? Granted, they were available before 2007 so they can easily go the SE route, but it would be a nice little jab at BP to make them go through the process anyways.

 

[Harbinger82]

And pipes are now included as regulated in the same document as e-cigarettes. You think we have it bad? There goes the expensive, handmade pipes and pretty much all pipe tobacco, since the tobacco is blended and changes from year to year. I'd pull up the pertinent sections but my stupid PDF viewer decided to freeze. I think the deeming gave it a stroke.

I don't know, I personally think they don't make a whole lot of sense, but it's going to be up to the legal professionals to decide ultimately. I lost a lot of ability to pour over legal and research double speak years ago.

IMHO, they just threw "pipes" into the rule to save some face. All of the pipe companies will be able to go the SE route as the technology for them has been around for a few centuries.

 

[Katmar]

I was thinking about what I was reading, and something that I don't see a lot of people talking about became very apparent to me. Why aren't the other forms of nicotine also having to fall under this deeming( such as Nicorette gum/patch/lozenges)? They contain nicotine. That comes from a tobacco plant.... Shouldn't they also have to conform with these regulations? Granted, they were available before 2007 so they can easily go the SE route, but it would be a nice little jab at BP to make them go through the process anyways.

I think because they are already regulated as a drug device.

 

[sqirl1]

I was thinking about what I was reading, and something that I don't see a lot of people talking about became very apparent to me. Why aren't the other forms of nicotine also having to fall under this deeming( such as Nicorette gum/patch/lozenges)? They contain nicotine. That comes from a tobacco plant.... Shouldn't they also have to conform with these regulations? Granted, they were available before 2007 so they can easily go the SE route, but it would be a nice little jab at BP to make them go through the process anyways.

Nicotine is either a drug or a tobacco product, if nicorette theoretically wanted their products to be regulated as tobacco products they have the option to do so, but instead they have as a drug.

 

[Stubby]

I was thinking about what I was reading, and something that I don't see a lot of people talking about became very apparent to me. Why aren't the other forms of nicotine also having to fall under this deeming( such as Nicorette gum/patch/lozenges)? They contain nicotine. That comes from a tobacco plant.... Shouldn't they also have to conform with these regulations? Granted, they were available before 2007 so they can easily go the SE route, but it would be a nice little jab at BP to make them go through the process anyways.

It goes back to the question of intended use. The intended use of NRT's is a smoking/tobacco cessation product. The drug companies spent millions of dollars going through the clinical trials and where approved by the FDA as a smoking cessation product, which classifies them as a drug. The intended use of ecigs is a recreational product (simply an alternative to cigarettes) which puts them in an entirely different legal category.

 

[Kent C]

Including pipe tobacco may be a new in road in regulating RYO tobacco which is now considered 'pipe tobacco' - which was the case just as I went from RYO to vaping 7 years ago.

 

[zoiDman]

...

3.) Has section 910 been challenged by any tobacco companies thusfar regarding cigarettes and smokeless tobacco? If so, what is the case name and bluebook citation?

Does BT have a desire to Challenge Section 910?

When Both the sale of Combustible Tobacco and sale of e-Cigarettes in a Regulated Market are consider in Totality, does BT benefit More or Less from something like Section 910?

 

[StormFinch]

IMHO, they just threw "pipes" into the rule to save some face. All of the pipe companies will be able to go the SE route as the technology for them has been around for a few centuries.

Not exactly. The FDA is really big on Substantial Equivalence, which to them pretty much means identical. A cigarette is a cigarette is a cigarette after all. The pipe culture is all about hand carved pipes and small runs of natural, blended tobacco. Yes, there are some mass producing of both items, but an aficionado wouldn't be caught dead utilizing either one. It compares more to custom built mods and limited run premium juices versus Chinese made stuff in our world. And, it would be nigh on impossible to prove SE when you hand carve a single pipe at a time or the PH and nicotine content of the tobacco blend changes from year to year. There's notes about some of the arguments in the front section of the deeming, I'm just currently to lazy to go look them up.

 

[sqirl1]

Does BT have a desire to Challenge Section 910?

When Both the sale of Combustible Tobacco and sale of e-Cigarettes in a Regulated Market are consider in Totality, does BT benefit More or Less from something like Section 910?

A few of their products did get
applications rejected as far as I know, forget what it was though. Of course when you're RJ Renoylds you're probably better off just letting the new variety of camels get rejected instead of fighting for something you were just kind of experimenting with and don't even know if it's going to sell or not.

 

[zoiDman]

A few of their products did get
applications rejected as far as I know, forget what it was though. Of course when you're RJ Renoylds you're probably better off just letting the new variety of camels get rejected instead of fighting for something you were just kind of experimenting with and don't even know if it's going to sell or not.

True.

But forget about Cigarettes for a second. What about e-Cigarettes?

The Big 3 Tobacco Groups want to sell e-Cigarettes. But Darn, seems like there is a Lot of Competition in that Market.

Would something like a 2007 Cut-Off Date that would Force Everyone to go down a Ginormous Expensive and Complex PMTA Route be a Good thing for BT?

 

[sqirl1]

True.

But forget about Cigarettes for a second. What about e-Cigarettes?

The Big 3 Tobacco Groups want to sell e-Cigarettes. But Darn, seems like there is a Lot of Competition in that Market.

Would something like a 2007 Cut-Off Date that would Force Everyone to go down a Ginormous Expensive and Complex PMTA Route be a Good thing for BT?

Well sure it would, they wouldn't challenge it for that purpose onviously. I guess I should have asked if medium-sized tobacco (like Swedish Match or the makers of a few discount cigarettes for example) has ever gotten screwed and fought it then and if so what the court said about it.

 

[Robert Cromwell]

"Section 910(c)(1)(A)(ii) of theFD&C Act requires that FDA deny a PMTA and issue an order that the product may not be introduced or delivered for introduction into interstate commerce where FDA finds that:

You have not shown that the product is appropriate for the protection of the public health"

 

[skoony]

Read the entire regulations carefully. What the actual components are is irrelevant.
The regulations are written to effectively regulate not only products on the market
now but,any possible product that may come on the market in the future no mater
what form the new product takes or what process is used to replace,mimic,be used
instead etc.,etc., the predicate finished tobacco product,a cigarette.

The FDA reserves the right through these new regulation to determine what is and
is not a tobacco product now and forever into the future. Some parts of the regulations
appear vague because they are vague. The FDA will argue (and quite successfully I might ad)
that this is needed to act quickly in order to effectively regulate and control these products
to protect the health and welfare and or ensure the health and welfare of the population
is protected as they have been mandated by Congress to do. And of course lets not
forget,"The Chillin'".

The ability to protect the health and welfare and or insure the health and welfare +
the chillin' negates most if not all legal challenges.

Regards
Mike

 

[sqirl1]

The ability to protect the health and welfare and or insure the health and welfare +
the chillin' negates most if not all legal challenges.

A lot of judges don't see it that way though. Take judge Leon for example. He blocked the cigarette warning labels from taking effect and if the above statement were true I don't think that would have happened. Judges aren't like congress, they aren't going to buy into those ideas for political reasons so easily.

 

[skoony]

A lot of judges don't see it that way though. Take judge Leon for example. He blocked the cigarette warning labels from taking effect and if the above statement were true I don't think that would have happened. Judges aren't like congress, they aren't going to buy into those ideas for political reasons so easily.

I wouldn't bet on it. We are not talking about cigarettes or warning labels.
We are talking about a whole class of new tobacco products.
Granted there might be a set back or two but, Idoubt it would be enough to affect the over
all result.

Then again who know's. I won't be holding my breath.
regards
Mike