FDA Nicotine - "Derived From Tobacco" Implies Logical Absurdity

[toddkuen]

On another thread Rodger Lafayette makes the following point:

...

I would like to address your point about the "doubts" you suggest may exist concerning the FDA's authority under FSPTCA. First of all, although it wasn't a critical part of the Soterra decision, a three-judge panel in the DC Cicruit unanimously agreed that Congress' use of the language "derived from" clearly indicated an intent to include products that are ... well, how should I put this ... derived from tobacco Recently, the FDA's former Chief Counsel (who now advises clients who are regulated by the FDA) said just at the Smoke-Free Alternatives Trade ...'n conference in Chicago. I have yet to read or hear of any analysis from a legal expert who takes the position you mentioned (this is the first time for me). But then I don't claim to be the best-informed person in the world on the question.
...

So I from a common sense perspective I found your quote troubling.

The word "derived" must mean exactly what in the FSPTCA context?

That any constituent of tobacco (that I might get from, say grinding it up and assaying the result) is governed by FSPTCA?

Does this include water, amino acids, pectin, starches, sugar, chlorophyll, etc. etc.?

These chemicals exist independently of tobacco in earths biosphere, i.e., if tobacco no longer existed these would still exist.

Does anyone think the legislative intention of the FSPTCA is to regulate them?

Water from a tobacco plant (as in H20 molecules) cannot be distinguished from H2O molecules form other sources.

Neither can nicotine.

There is a spectrum here from patently absurd (using the FSPTCA to regulate water and amino acids) to legislative intention (regulating anabasine or tobacco itself).

There is, I think, a bright line that limits the FSPTCA from regulating the entirety of life on earth.

I would argue that the proposed FDA regulation of nicotine crosses the bright line into absurdity as nicotine is more like water than anabasine - particularly since the only attribute that might have separated it from water and chlorophyll, namely its ability to addict, is by their own words no longer anything but an imagined potential.

{MODERATED} .

 

[stevegmu]

Nicotine is widely and now legally recognized as a tobacco product. End of story. Doesn't matter what other substances there are which can be extracted from tobacco; nicotine is the issue here...

 

[MorpheusPA]

Logically, yes. Cellulose, derived from the tobacco plant, would therefore be a tobacco derivative. As would water.

There's no way anybody would bother doing that (we have better sources of both), and the FDA probably wouldn't bother regulating said items as they have alternate sources that are...well, as I said, better. Nor are either particularly neurologically active, assuming the extraction was close to pure.

But theoretically, if the FDA wished to regulate tobacco-derived cellulose, it could.

I'd tend to agree with you that it's absurd, but I also don't think anybody saw the popularity of vaping on the horizon when this was enacted.

 

[TheProphet]

But if e-juice manufacturers switched to a non-tobacco derived nicotine, such as that extracted from eggplants, potatos, and papaya, then they would not be able to regulate it as a tobacco product correct?

 

[toddkuen]

I bring this up because judges can and do use "legislative intent" when deciding cases.

I am arguing "derived" is ambiguous in the context of nicotine and the FSPTCA and that the intent of the legislature was to limit tobacco and not the constituents of all plants on the planet.

 

[stevegmu]

But if e-juice manufacturers switched to a non-tobacco derived nicotine, such as that extracted from eggplants, potatos, and papaya, then they would not be able to regulate it as a tobacco product correct?

They would then regulate nicotine, which could actually be worse than regulating it as a tobacco product...

 

[toddkuen]

Nicotine is widely and now legally recognized as a tobacco product. End of story. Doesn't matter what other substances there are which can be extracted from tobacco; nicotine is the issue here...

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.

 

[Dave_in_OK]

Is Nicotine derived from tobacco? Yes. Is nicotine currently regulated as a tobacco product? No. IMO this is all just smoke and mirrors as the FDA is not moving to deem Nicotine a tobacco product they're trying to deem ecigs a tobacco product which may or may not contain nicotine. The real question should be why doesn't the FDA just move to increase their regulation over nicotine. Ecigs are not clearly a tobacco product but they are clearly a substitute for a tobacco product, one that is safer to those vaping & those around them and as such shouldn't be regulated in the same manner as tobacco products.

 

[Roger_Lafayette]

I'm not sure what we're discussing here.

If the goal is to try to read the "tea leaves" of Congressional intent in this exercise in what I can only charitably describe as "airmchair lawyering," perhaps one good place to start is in the preamble to the enabling statute: http://www.fda.gov/downloads/tobaccoproducts/guidancecomplianceregulatoryinformation/ucm237080.pdf

Note the repeated references to "tobacco products" and the specific references to nicotine in particular.

I have repeatedly suggested on this forum that reading statutes and regulations "from first principles" (AKA "armchair lawyering") is a bad idea because it leads to wild goose chases, but if we're going to do that, then I tend to suspect that a little Googling would clearly reveal the backround legislative history behind this statute, and am willing to risk suggesting that there can be very little doubt among reasonable and fair-minded folks that Congress intended to regulate (at least) all tobacco products that contain nicotine.

Anyone who wishes to dispute that should confront the text of the statute (including the preamble) as well as the legislative history, instead of having this discussion in a some kind of philosophical vaccuum.

If you think that this Congressional intent and the FSPTCA reflect dreadful public policy, that's another matter. I agree with you there.

EDIT: By "all tobacco products that contain nicotine," I mean those sold for consumer ingestion, etc. Please don't play word games here and bring up insecticide or NRT. The scope of the statute is described on p.10 at the top.

 

[TomCatt]

Roger!

 

[toddkuen]

...

We can argue all day long about what's sensible, reasonable, etc. But the background to this statute and the words of the preamble itself provide some very strong indications that Congress intended to regulate nicotine derived from tobacco.

I have repeatedly suggested on this forum that reading statutes and regulations "from first principles" (AKA "armchair lawyering") is a bad idea because it leads to wild goose chases, but if we're going to do that, then I tend to suspect that a little Googling would clearly reveal the backround legislative history behind this statute, and am willing to risk suggesting that there can be very little doubt among reasonable and fair-minded folks that Congress intended to regulate (at least) all tobacco products that contain nicotine.

...

From what I see you seem to be confusing the fact that tobacco contains nicotine and is regulated as if it does with my questioning of the limits of the meaning of "derived" as used on page 10.

For at least 15 years before this legislation nicotine was known to be present in other plants.

I would be interested in any pre-2009 links you have to the intent to regulate nicotine as a "stand alone" item not in any way "derived" from tobacco.

 

[Roger_Lafayette]

From what I see you seem to be confusing the fact that tobacco contains nicotine and is regulated as if it does with my questioning of the limits of the meaning of "derived" as used on page 10.

For at least 15 years before this legislation nicotine was known to be present in other plants.

I would be interested in any pre-2009 links you have to the intent to regulate nicotine as a "stand alone" item not in any way "derived" from tobacco.

So your point is that if Congress didn't intend to regulate nicotine derived from eggplant, then they couldn't possibly have intended to regulate tobacco products containing nicotine?

Or are you saying that at some point in the process of deriving nicotine from tobacco, then the FSPTCA no longer applies? At what point is that? I've seen one COA - there are still some impurities. Is it covered as a tobacco product?

What if I've just begun the derivation process? Does the fact that I've even started to isolate some nicotine, mean that the results are now free from regulation as a "tobacco product" - because nicotine derived from eggplant is not covered?

 

[toddkuen]

So your point is that if Congress didn't intend to regulate nicotine derived from eggplant, then they couldn't possibly have intended to regulate tobacco products containing nicotine?

No.

Or are you saying that at some point in the process of deriving nicotine from tobacco, then the FSPTCA no longer applies? At what point is that? I've seen one COA - the nicotine isn't 100% pure. There are still some impurities. Is it covered as a tobacco product?

What if I've just begun the derivation process? Does the fact that I've even started to isolate some nicotine, mean that the results are now free from regulation as a "tobacco product" - because nicotine derived from eggplant is not covered?

No. I wasn't talking about the derivation process at all. Let's review the original premise one point at a time.

Is the water in the tobacco plant covered by the FSPTCA, i.e., does it regulate that water itself or the whole leaf or plant?

We can imagine that the plant is made up of constituents, starch, amino acids, water, chloropyll.

The FSPTCA seems to anticipates the idea of constituents of tobacco because it describes the notion of something being "made" or "derived" from it.

I can bake brownies containing the leaves and I think we can agree that would be something "made."

So what about "derived?" Can I extract components from the leaves?

Are you saying that there is some residue left that makes the extract tobacco?

What would that residue be?

 

[TomCatt]

But if e-juice manufacturers switched to a non-tobacco derived nicotine, such as that extracted from eggplants, potatos, and papaya, then they would not be able to regulate it as a tobacco product correct?

The level of nicotine in plants other than tobacco is EXTREMELY LOW.

You would need 100 pounds of eggplant to get 4.5mg of nicotine - put that in 1 mL of eLiquid and you have "4.5MG" (4.5mg/mL) of nicotine eLiquid

 

[Roger_Lafayette]

This is the last time I'll address your point on this thiread:

1) Congress was clearly concerned about the addictive properties of tobacco products that contain nicotine. This is obvious from the preamble to the statute, and I'd almost be ready to offer to eat my trackball if the legislative history didn't bear this out. So now we have the preamble, we have the legislative history and of course we have (on p.10) the clear language of the law.

2) Do my points about the legislative history and the preamble apply to your brownies that might contain no nicotine (let's assume they don't), or to a shirt fabricated somehow from the tobacco plant which also either contains no nicotine, or which has no physiological and no psychoactive effects (to the extent that the two can be separated)? Nope. But as soon as you have a tobacco product that contains nicotine, the preamble and the legislative history look a whole lot more relevant.

3) However in other respects, the legislative history and the preamble do not match the evidence available for vaping. No one has yet shown that vaping is addictive (to my knowledge) or that is causes the kind of medical carnage that combustible tobacco cigarette smoking (and perhaps other combustible OTPs) do. In fact, vaping addresses this medical mayhem via THR. Fair enough. I can't predict what a well-funded legal effort on behalf of a vaping manufacturer against the FDA might entail, but perhaps it would include a general claim that vaping should be exempt, based on the very concerns cited by Congress in the statute itself, as well as the legislative history.

[ If it matters, my is that this may actually be a more compelling point than your broader argument that nicotine derived from tobacco is completely free-and-clear of the statute. After all, someone could take that nicotine and put it in combustible 100% clove cigarettes, which as I understand it are fairly bad for the user - for much the same reasons as combustible tobacco cigarettes. ]

4) Do I think the FSTPCA is good public policy? No. Should it be rewritten to clarify that nicotine derived from tobacco, as used in the vaping context, might be regulated under some other system, other than one which is clearly designed to discourage the introduction of tobacco products into the US marketplace (specifically: we should have a system which recognizes the vastly reduced health risks and cessation benefits of vaping)? Absolutely.

***

That said, Counselor, you're still "armchair lawyering," in that you're quibbling with the plain meaning of the statutory language, and much of the preamble, if not the legislative history.

Not to mention the fact that I have yet to see any legal expert who has published an argument similar to yours, i.e. one that would exempt tobacco-derived nicotine from the statute. I'd love to see such a link, if anyone has it.

No.



No. I wasn't talking about the derivation process at all. Let's review the original premise one point at a time.

Is the water in the tobacco plant covered by the FSPTCA, i.e., does it regulate that water itself or the whole leaf or plant?

We can imagine that the plant is made up of constituents, starch, amino acids, water, chloropyll.

The FSPTCA seems to anticipates the idea of constituents of tobacco because it describes the notion of something being "made" or "derived" from it.

I can bake brownies containing the leaves and I think we can agree that would be something "made."

So what about "derived?" Can I extract components from the leaves?

Are you saying that there is some residue left that makes the extract tobacco?

What would that residue be?

 

[Stosh]

Right on Roger...
Just because the law mentions nicotine 40 times, it's a pretty clear the intent is to regulate it as the "devil drug" associated with smoking.
http://www.fda.gov/downloads/tobaccoproducts/guidancecomplianceregulatoryinformation/ucm237080.pdf
To argue otherwise is as similar to the "The Income Tax Amendment was never passed legally" crowd ...

 

[Fitzie]

Actually, all you have to do is look at the FSPTCA to learn what Congress meant by "nicotine."

CHAPTER IX--TOBACCO PRODUCTS

"Sec. 900. DEFINITIONS.

"In this chapter:

12) Nicotine.-- The term 'nicotine' means the chemical substance named 3-(1-Methyl-2-pyrrolidinyl) pyridine or C[10]H[14]N[2], including any salt or complex of nicotine."

Actually, the definition doesn't say anything about where the nicotine is derived from, so I suppose it could include nicotine from any source, natural or man-made.

 

[Stosh]

This is what the current FDA deeming proposal is written to make vaping and personal vaporizers part of, deeming them to be the same as cigarettes.........Join CASAA Now!!

Actually, all you have to do is look at the FSPTCA to learn what Congress meant by "nicotine."

CHAPTER IX--TOBACCO PRODUCTS

"Sec. 900. DEFINITIONS.

"In this chapter:

12) Nicotine.-- The term 'nicotine' means the chemical substance named 3-(1-Methyl-2-pyrrolidinyl) pyridine or C[10]H[14]N[2], including any salt or complex of nicotine."

Actually, the definition doesn't say anything about where the nicotine is derived from, so I suppose it could include nicotine from any source, natural or man-made.

 

[toddkuen]

This is the last time I'll address your point on this thiread:

...
That said, Counselor, you're still "armchair lawyering," in that you're quibbling with the plain meaning of the statutory language, and much of the preamble, if not the legislative history.

Not to mention the fact that I have yet to see any legal expert who has published an argument similar to yours, i.e. one that would exempt tobacco-derived nicotine from the statute. I'd love to see such a link, if anyone has it.

How many legal "experts" do you think really understand vaping as well as FDA Food and Tobacco law?

And not just "about" vaping and the law but the technology, biochemistry, the electronics, the industrial issues the differences between nicotine and tobacco, and all the rest.

My guess is probably very close to zero - at least that don't work for the FDA.

Clever lawyers can only do a good job if they have good information and good strategy.

Dogma provides neither.

But the constant implied message here is "don't worry - its all under control" - just sit back and let those who manage the "dogma" sail us home to an easy victory.

My wife's health is at stake so don't mind me if don't get the pop corn out and stay to watch "Bambi vs. Godzilla"

I might be lawyering from my arm chair but at least my wife knows I've put in my best effort.

 

[Roger_Lafayette]

We're done talking about the original point you raised, but let's finish this discussion by delving into some of the other stuff.

I can appreciate your concern about your wife's life. So, first things's first - let's help her out: http://www.e-cigarette-forum.com/fo...ttle-help-freezing-nic-juice.html#post2126610

Next, let's consider what can be done for the rest of the smokers who may not have the same chance to quit as she did, as I have, and as many other denizens of ECF (as well as a total of 1M American vapers, if the UK proportions apply over here). Perhaps your wife will appreciate these efforts as well, since you indicated in another post that she owns a vaping B&M.

1) Your profile identifies you as living in PA. How about spending a minute or two contacting Sen. Casey, as per this thread: http://www.e-cigarette-forum.com/fo...e-contact-us-senate-help-committee-today.html ?

2) Why not formulate your argument about the statute into a question that might be asked in the upcoming Sen hearings? (You got nothing to lose, right?) People are suggesting questions here: http://www.e-cigarette-forum.com/fo...us-senate-help-committee-thursday-2-30pm.html Hey, wouldn't it be fun to stymie Mitch Zeller (JD)? If he doesn't have a good answer for your analysis, then you could change the game in just one day, without even having your points raised in court. It would be all over the news, I'm sure. Imagine him sitting there in front of a sen. cmte on nat'l TV ... utterly dumbfounded. (After all, I don't think he's a vaper. So maybe he's never thought of your idea, as per the point you make about non-vaper lawyers.)

3) I beg to differ with your point about the dearth of vaping attorneys. The new head of the American Vaping Assn. is ECF user Placebo Effect, known to us as Greg Conley. Trust me, he's a vaper, and an attorney: Greg Conley to lead American Vaping Association - ECF InfoZone

4) I don't know of any sensible person here on this forum who thinks the situation is "under control" vis-a-vis the FDA, or myriad battles that vapers are fighting at the state and local levels (not to mention what will be happening across the pond as the TPD is implemented by 28 EU member states). By all means do whatever you think works best, everyone is trying to help in whatever way they can. If you think you've come up with (another) game changer - this time in the form of a unique point of view about the statute - then by all means let some members of the legal community know about it. Maybe some will slap their foreheads and say "ah ha! ... I never thought of that!" No one here is stopping you. (BTW I offered you a slightly different argument directed against the FDA's interpretation of the FSTPCA in my last post. My suggestion focuses on vaping and THR instead of nicotine, and incorporates some of Congress' explcitly expressed concerns about the harms of combustible tobacco product use - but evidently you didn't care for it. That's your call, and I'm by no means offended

5) You've got "20,000 members" (to quote one of your other posts) here at ECF who will listen advidly do any suggestion that you can post here which is compatible with the forum rules. In that regard, the sky's (almost) the limit. Have at it. ECF is also not the only vaping forum on the net, there are plenty of other places where you can blog and post. We vapers will need all the help that we can get. Besides, your wife is going to have a tough time running her B&M if the FDA reg.s have the effect that most of us think they will have. So, welcome aboard!

How many legal "experts" do you think really understand vaping as well as FDA Food and Tobacco law?

And not just "about" vaping and the law but the technology, biochemistry, the electronics, the industrial issues the differences between nicotine and tobacco, and all the rest.

My guess is probably very close to zero - at least that don't work for the FDA.

Clever lawyers can only do a good job if they have good information and good strategy.

Dogma provides neither.

But the constant implied message here is "don't worry - its all under control" - just sit back and let those who manage the "dogma" sail us home to an easy victory.

My wife's health is at stake so don't mind me if don't get the pop corn out and stay to watch "Bambi vs. Godzilla"

I might be lawyering from my arm chair but at least my wife knows I've put in my best effort.