FDA Nicotine - "Derived From Tobacco" Implies Logical Absurdity

[Roger_Lafayette]

1) If you think you've got a game-changer here which has been overlooked by the FDA, and everyone else under the sun, then you might want to e-mail some folks who can give you an authoritative opinion on the matter. My own humble suggestion would be this guy: Keller Heckman | Azim Chowdhury to Speak at the ECC Electronic Cigarette Expo

2) If my opinion counts (and it most certainly doesn't), what I'd say is that the statute refers to a derivated product of tobacco - not to a drug. Nicotine derived in some other way is free and clear, at least from the tobacco act. You may also have to deal with the purity issue that I raised in post #12.

But again - my opinion is of no relevance.

I hope you'll have the courage of your convictions, and take this to an expert.

And I hope you're right! (Not about it being a "logical absurdity" - which is philosophical point - but rather about the FDA's legal authority under the FSPTCA.)

See:

U.S. Code › Title 21 › Chapter 9 › Subchapter II › § 321
21 U.S. Code § 321 - section (g)1 -
(g)
(1) The term “drug” means
(A) articles recognized in the official United States Pharmacopoeia, official Homoeopathic Pharmacopoeia of the United States, or official National Formulary, or any supplement to any of them; and [nicotine is listed in the National Formulary]
<snip>

 

[toddkuen]

1) If you think you've got a game-changer here which has been overlooked by the FDA, and everyone else under the sun, then you might want to e-mail some folks who can give you an authoritative opinion on the matter. My own humble suggestion would be this guy: Keller Heckman | Azim Chowdhury to Speak at the ECC Electronic Cigarette Expo

...

Emailed him last week - did not ask this specific question but asked to join his "group" - never heard back.

I assume he's busy.

There are lots of Tobacco lawyers - you'd think at least one would vape...

Perhaps some have minions to transmit information like this to them.

Questioning basic assumptions is no longer taught to anyone (it tends to dampen the enthusiasm for dogma - think global warming, etc.)

But its always the best place to start with these matters because rabid dogma, at least in my experience, is always symptomatic of the fact that no one has really done their homework.

Beyond what I have posted I can now do nothing - so I will await a learned opinion (by someone who has done more homework than I) about why its wrong...

It would be a shame if I was right and no one with sufficient "juice" found out about it.

Kind of why I am concerned over all...

 

[aubergine]

I googled Chowdhury at some point and came up with this - it's dated, though. He's well informed, don't know how to read his assertion that the industry should welcome regulation... it wasn't clear where this was going in 2011. Anyway: http://www.khlaw.com/Files/10084_The Evolution of the Electronic Cigarette.pdf

And re "nicotine derivative", for what it's worth and IMHO (my father was an inside-the-beltway lawyer for the federal government [HUD], mostly performing analysis and drafting - a legal writer) lawyers are impatient with and and dismissive of efforts to introduce tricky ambiguities or seize upon unforeseen oversights in order to obscure or compromise the "intended meaning" of a legal document.
Unless there's a case to be made that the language in question was actually intended to specifically exclude non-tobacco nicotine used for the same purpose as tobacco-derived nicotine, this interesting project would not be taken seriously, I think. I believe that an opposing lawyer who argued it would be regarded as frivolous and told that when and if such a product became relevant it would be addressed. At which point some amendment like "or synthetic or otherwise derived identical product" would be added without much dispute, as the intention of the regulation is pretty clear.

Not that I have any legal expertise myself, and I might be mistaken in that.

 

[Roger_Lafayette]

Send Chowdhury a snail-mail letter via return receipt. It won't even cost you $10 - and you'll get his attention pretty quickly, I suspect. And/or try Jule Woessner of CASAA, Greg Conley, anyone else you want.

Posting here will not get you any closer to bringing this to the attention of anyone who might be able to act on it.

Which means you'll walk around thinking that only you have this game-changing eqivalent of a (real, working) perpetual motion machine (at least in this context), no one is paying attention to you, and perhaps thousands of smokers will lose the chance to quit as a result.

Surely this is not a result that you'd prefer.

Emailed him last week - did not ask this specific question but asked to join his "group" - never heard back.

I assume he's busy.

There are lots of Tobacco lawyers - you'd think at least one would vape...

Perhaps some have minions to transmit information like this to them.

Questioning basic assumptions is no longer taught to anyone (it tends to dampen the enthusiasm for dogma - think global warming, etc.)

But its always the best place to start with these matters because rabid dogma, at least in my experience, is always symptomatic of the fact that no one has really done their homework.

Beyond what I have posted I can now do nothing - so I will await a learned opinion (by someone who has done more homework than I) about why its wrong...

It would be a shame if I was right and no one with sufficient "juice" found out about it.

Kind of why I am concerned over all...

 

[Fitzie]

I suspect Chowdhury is looking for paying clients in the vaping industry (rather than someone to join his "group" per se or some sort of pro bono assistance). Given his expertise, I can only imagine his hourly rates for assistance in crafting comments to the proposed regs. Unless he was trying to say, "if a group of small vaping businesses get together and pool their resources ($$$$), I'm available for hire."

 

[Roger_Lafayette]

Just some additional food for thought in this discussion (from the FSPTCA):
<snip>
And, reading the definition of "nicotine" in the statute, oddly enough, it says nothing about it being derived from tobacco. Was Congress anticipating that synthetic nicotine or nicotine derived from other plants should be regulated as well?

My is that touchstone of the law is 'tobacco products' - the preamble talks about the addictive nature of nicotine, but only in the context of tobacco products. The legislative history might help to clear up intent.

That said, when we go into intent, we run into Ralph Tyler's argument, which I alluded to in #15. (For anyone who wants to hear his comments at the SFATA conference, google VP Live - Kev played a 'bootleg' recording of them a couple weeks ago. Tyler is the fmr. Chief Counsel at FDA.)

Tyler's point is that Congress was only interested in the tobacco products that it was acquainted with, and didn't intend to regulate vaping. Not because nicotine-derived-from-tobacco isn't a tobacco product, but rather because the activity-in-Q has none of the public health issues which undergird the entire context of the FSPTCA. (I'm not sure if Tyler thinks this is such a great argument or even believes it himself. He was simply suggesting that it be made.)

Which ultimately goes back to what Cynthia Cabrera of SFATA said - the tobacco act wasn't designed to regulate vaping, and could hardly be a more awkward tool for doing it. And that might be true, regardless of whether you're a vaper who thinks that vaping is the best thing to happen to public health since pennicilin, or Stanton Glantz who apparently views it as the looming medical crisis of our time.

Although on balance, I think applying the law to vaping is more favorable to Glantz

 

[Bobbilly]

IMHO The control over nicotine in the context of tobacco products was to regulate the addictive nature that kept people smoking. I believe Canada and the UK is looking at Recreational Nicotine use is not use of a tobacco product. Once nicotine is extracted it becomes nicotine. Tobacco is irrelevant after that.

 

[toddkuen]

...

And re "nicotine derivative", for what it's worth and IMHO (my father was an inside-the-beltway lawyer for the federal government [HUD], mostly performing analysis and drafting - a legal writer) lawyers are impatient with and and dismissive of efforts to introduce tricky ambiguities or seize upon unforeseen oversights in order to obscure or compromise the "intended meaning" of a legal document.
Unless there's a case to be made that the language in question was actually intended to specifically exclude non-tobacco nicotine used for the same purpose as tobacco-derived nicotine, this interesting project would not be taken seriously, I think. I believe that an opposing lawyer who argued it would be regarded as frivolous and told that when and if such a product became relevant it would be addressed. At which point some amendment like "or synthetic or otherwise derived identical product" would be added without much dispute, as the intention of the regulation is pretty clear.

Not that I have any legal expertise myself, and I might be mistaken in that.

That's how it works. The regulation would have to affect someone with "standing" to sue, i.e, be in a position to be directly affected by the law or regulation.

For example, I can't sue just because I thought this up - I have no standing.

On the other hand, if such regs passed and the FDA sent a letter to me saying I had to stop making ejuice, I could sue because it now directly affects me.

Usually these are "test" cases contrived to force a decision for a very specific topic, e.g., is nicotine derived from tobacco allowed.

I would argue it was and that the FDA unjustly blocked from using it.

Note that such a case would decide only one issue, not, for example, another like is synthetic nicotine allowed.

This would have to be another similar case.

 

[Roger_Lafayette]

If no one listened to you via any other means, placing ads in major newspapers is one way to get attention: http://nytmediakit.com/

(It's not cheap. But seems as if I recall a figure of $10,000 from some blog somewhere.)

I mean, considering the fact that you may be the only person in the world to have figured this out, and given how many lives are at stake, maybe it's worth a shot.

I would hate to see the secret be buried with you (and the readers of this thread).

That's how it works. The regulation would have to affect someone with "standing" to sue, i.e, be in a position to be directly affected by the law or regulation.

For example, I can't sue just because I thought this up - I have no standing.

On the other hand, if such regs passed and the FDA sent a letter to me saying I had to stop making ejuice, I could sue because it now directly affects me.

Usually these are "test" cases contrived to force a decision for a very specific topic, e.g., is nicotine derived from tobacco allowed.

I would argue it was and that the FDA unjustly blocked from using it.

Note that such a case would decide only one issue, not, for example, another like is synthetic nicotine allowed.

This would have to be another similar case.

 

[Talyon]

I disagree with this perspective. History is full of things that are WRONG being eliminated from society, e.g, the 14th amendment.

Its only if we believe that WRONG is okay for the status quo do we fail to change things.

Just because one group, like the FDA, interprets a word like "derived" one way doesn't mean someone else, like a judge, might not interpret another, particular if a strong argument is made.

I don't know how strong my argument is but its better than simply accepting regulation without a fight.

Dice and Slice it, agree or disagree, it DON'T matter, the FDA will regulate Nicotine like it or not.

Also we are fighting, maybe that hasn't been made clear here on ECF,

 

[Jman8]

Dice and Slice it, agree or disagree, it DON'T matter, the FDA will regulate Nicotine like it or not.

Dice and slice it, agree or disagree, it DON'T matter, the black market will produce lots and lots of Nicotine, like it or not.

 

[stevegmu]

I thought the same for a while, until I re-read the Controlled Substance ACT. Diluted nicotine would never pass muster as a controlled substance...

 

[iowajosh]

Dice and Slice it, agree or disagree, it DON'T matter, the FDA will regulate Nicotine like it or not.

Also we are fighting, maybe that hasn't been made clear here on ECF,

Yes but regulating it without the engine of burning tobacco is sort of a black hole. They haven't even indicated what they would do so far. That is what is making all of us daydream and complain and fight and get cranky. If they try to restrict diluted nic base more than caffeine, it is outright wrong as far as I see it. Sure there should be and age limit and childproof caps and a warning or whatever. Can't disagree with that, personally. Gotta write them to extend the comment period first. I gotta get that done.

 

[Stosh]

I'm not sure this should be described as a Logical Absurdity so much as a Legal Absurdity, given the apparent contradiction cited in the above posts defining tobacco products excluding nicotine as it is a drug. Here's another data point in the mess that is tobacco law.

In the Sottera decision the appeals court (citing the Supreme Court Brown & Williamson) - held...

But Brown & Williamson is not the end of the story. In 2009, Congress passed the Tobacco Control Act, which states:
“Tobacco products . . . shall be regulated by the Secretary under this [Act] and shall not be subject to the provisions of [the drug/device subchapter of the FDCA].” 21 U.S.C. § 387a(a). Moreover, unlike Brown & Williamson, which used the term “tobacco products” without defining it, the Tobacco Control Act includes a definition: “The term ‘tobacco product’ means any product made or derived from tobacco that is intended for human consumption.” 21 U.S.C. § 321(rr)(1) (emphasis added). Because the nicotine in NJOY’s electronic cigarettes is “derived from” natural tobacco, NJOY Compl. ¶ 1, it appears that the FDA may regulate it only pursuant to the provisions of the Tobacco Control Act.

The definitions, regulations, and final determination of what can be regulated and how restrictive it can be will very likely be determined by court cases sometime in the future. Given that NJOY is also likely to be a participant in the lawsuit and mentioned directly in Sottera. Given that the lower courts are unlikely to hand down a ruling contradicting the Appeals court and certainly not contradicting the Supreme court this appears to be a long and costly case to pursue. That said, NJOY did just that once already.

It would appear that the laws and regulations as written combined with court precedents don't seem to mesh together in any coherent way. Also it's very likely there are many other laws and court cases we are missing here, that the lawyers might use on either side of the case. What this may mean for the future of vaping, tobacco harm reduction, I can't even begin to guess.

Oh what a tangled web we weave when first we practice to deceive law....

 

[Bobbilly]

Id like it if some could interpret GARLAND, Circuit Judge comments about supporting the findings however under different reasons. Starts at page 16 of the report. I tried but my brain hurts.

 

[Talyon]

Dice and slice it, agree or disagree, it DON'T matter, the black market will produce lots and lots of Nicotine, like it or not.

Only If im willing to go outside my comfort zone, and I'm NOT. You suggesting I become a petty criminal? How does that help, sheesh!

As always your view on these maters disturbs me greatly, and I find them offensive....

 

[Talyon]

Yes but regulating it without the engine of burning tobacco is sort of a black hole. They haven't even indicated what they would do so far. That is what is making all of us daydream and complain and fight and get cranky. If they try to restrict diluted nic base more than caffeine, it is outright wrong as far as I see it. Sure there should be and age limit and childproof caps and a warning or whatever. Can't disagree with that, personally. Gotta write them to extend the comment period first. I gotta get that done.

Ive stated many many times that regulating by the FDA is actually a crime, and until they abolish Smoking I won't change my mind. They cant but will have it both ways. That's a sad way for a country to run in this day and age.

 

[tombaker]

Chowdhury is the most public and available lawyer and legal scholar on Vaping and the E-cigarette industry today. Emphasis on Scholar.
Azim has published many well thought out, and fully footnoted publications on E-Cig Regulations over years. And these are not behind pay firewalls either. Each well worth the time.

Azim has been available at various events, and is a regular on VapersPlace , and plenty of Youtube interviews also. None of which his commentary has been pay for play.

He is also the lawyer involved with the American E-liquid Manufacturing Standards Association (AEMSA)

I have listened to Azim's assessments of the Deeming, he gave on interviews to Vapers Place as recently as last week. If there was any other lawyer so supportive of Vaping I would love to be able to listen to them, but I can not say I have heard them interviewed.

If you are familiar with the movie Old School, Azim would be the guy who handles the paperwork. "We tried, but they are surprisingly very good at paperwork"

I suspect Chowdhury is looking for paying clients in the vaping industry (rather than someone to join his "group" per se or some sort of pro bono assistance). Given his expertise, I can only imagine his hourly rates for assistance in crafting comments to the proposed regs. Unless he was trying to say, "if a group of small vaping businesses get together and pool their resources ($$$$), I'm available for hire."

 

[tombaker]

Questioning basic assumptions is no longer taught to anyone (it tends to dampen the enthusiasm for dogma - think global warming, etc.)

But its always the best place to start with these matters because rabid dogma, at least in my experience, is always symptomatic of the fact that no one has really done their homework.

Beyond what I have posted I can now do nothing - so I will await a learned opinion (by someone who has done more homework than I) about why its wrong...

It would be a shame if I was right and no one with sufficient "juice" found out about it.

Unless someone else can point to a more clear (or better thought out) analysis I am unfortunately going to have to remain a "flat earther" in that I do not believe the FDA can regulate nicotine as a product "derived" from tobacco.

It was called "critical thinking" when I was taught it.....and yes, that class was likely dissolved in favor of a Masters of hyphenated-studies du jour curriculums. The question Why? throws the generation of Politically Correctness into a tizzy.

I believe that legally you are correct, that Nicotine is legally outside of the tobacco control act of 2009, but the court point the FDA to it. I also agree with the poster that because it could be legally inserted via various means, and that the lawyers will not rest on using it as means of an out....of the Regulations. The text of the documents you posted read fairly clearly.

If the FDA was to completely go nuts and try to ban everything, which they have already publicly said they are not, IF THEN, I would think the nicotine is its own Molecule outside of Tobacco would be brought up hard.

So yeah, they can fix it to so it can work, might as just well give it to them.....is likely the outcome to be dealt with.

excellent posts

 

[toddkuen]

To my other comments regarding an "more complete" strategy.

I see this kind of thing as "just another arrow" in a quiver of potentially successful options (which include voting more Republicans into the Senate, the UK study mentioned in another thread that show ecigs work for quitting, other legal or scientific approaches like this, etc., etc.)

You can also think of it like a scale you present Zeller: on the one side are all arrows in our quiver and on the other is what he has to do by law as his job.

In a "discussion" about the scale you demonstrate that its not worth the FDA's time (or lives, or distraction from combustion smoking, etc.) to fight with us by show how the scale is likely to tip in our favor.

The more likely it looks like we can and will succeed the less likely to fight he will become because I think he sincerely wants to stop combustion tobacco.

Its a political calculus and Zeller, in a larger political sense, makes sense falling in with vaping as allies against big combustion tobacco because we both win if "they" lose.

And there is value to that on the scale as well.

But without a single, united front across vendors, China, science, legal, etc. etc. it will never be possible to have this discussion because there will be no single voice to articulate it.

The biggest danger is too many small, disorganized voices crying separately in the wind: CASAA, SFATA, ... and Zeller never sees the larger picture.

That's my fear.