FDA Nicotine - "Derived From Tobacco" Implies Logical Absurdity

[Vaslovik]

Isn't that what we call capitalism?

No, it's a perversion of capitalism, and a power trip. You may have confused the two. In capitalism individuals have the right to produce a product and sell it for a profit. In the perverse power trip they crave the power to force others to buy their product and wipe out all others producing it, while controlling the former customer as their subject.

It is to this end that the FDA has become the tool of the corporations and serves as little else.

 

[toddkuen]

Smokers are victims of bullying from many sources.

The consensus model to me looks very much like "smoker psychology" - we're all doomed to have our rights taken, no sense in fighting, lets just give up and hope for the best.

I know it well and it shows in these posts.

But I am not a smoker (though I vape) and I come from a technology background.

I am very familiar with disruptive technologies - which vaping is - the internet is one, cell phones, many other modern conveyances.

I have created my own and I lived through the transitions of many others.

"Consensus" is always the enemy of any disruptive technology and in my view consensus posters are in fact the "best enemy" of vaping that I or anyone else could ever imagine.

What's their point here other than to dispense dogma, discourage, delay, and whip up hope for a "white knight?"

If I owned a tobacco company I would certainly want to employ these kinds of folks as "ringers" based on the comments I see here.

It is always the job "of very smart people" to appear to provide "consensus" understanding as to why things like buggy whips will still be needed in the age of the automobile.

Why not shut down the forum and stop wasting everyone's time with the illusions of hope?

 

[Sarin]

I've made nicotine from scratch in a lab at considerably less cost and time than extracting it from a plant. Therefore it is was not a tobacco product!

 

[Nermal]

The consensus model to me looks very much like "smoker psychology" - we're all doomed to have our rights taken, no sense in fighting, lets just give up and hope for the best.

It doesn't really sound like you've spent much time outside your own threads.

 

[Roger_Lafayette]

<snip>
Why not shut down the forum and stop wasting everyone's time with the illusions of hope?

Because if I lived in OR, MN, or MD I'd be very glad that ECF served as one organizing hub for helping to stop proposed statewide legislation to ban indoor vaping in all public places - regardless of who owns them. (And public parks, etc. to boot.)

If I lived in WA, I'd be happy that I'm not paying a 75% wholesale tax on vaping supplies purchased from local B&Ms - also a victory organized in part via efforts here on ECF.

If I lived in UT, I'd be happy that I can still purchase vaping supplies via the 'net.

(etc. - there are at least two dozen or so other states that I didn't mention.)

And if/when there's a state and local vaping rights issue that directly affects me, I'll be even more grateful for the existence of CASAA and ECF.

There are a number of senators who might've appeared at that hearing yesterday in order to take cheap political shots at vaping. None of those who are potentially running for re-election in the future did. I don't know why that is. But it's possible that reactions from vapers all over the country - including many of those here - made a difference.

These are all pretty good reasons for keeping the forum going, over and above the excellent advice and support provided to thousands of vapers and would-be ex-smokers who come here every week, many for the first time. We're talking about saving people's lives in many of these cases.

***

Incidently, no one is required to join CASAA or give money to either CASAA or ECF.

But I'm glad that both exist, and by no means regret contributing to each. I'll continue to do so.

I'm also happy that I've posted here, because I've learned a great deal. I hope to keep doing that, too.

You are most certainly free to do - or refrain from doing - any of the above.

 

[Nermal]

That's interesting, Sarin. Can the process be scaled up?

 

[Traver]

That's interesting, Sarin. Can the process be scaled up?

Why would you want it scaled up? It would cost even more than synthetic nicotine and that is already being made.

 

[turner.curtis]

toddkuen - I am not sure if you are a member of the local Steel City Vapers' Club, but we have a meet this Sunday where Bill Godshall and a number of the vendors will likely be present. Bill has come out a few times in the past to talk to the club, and we have invited him yet again since this will be our last planned meet before the current end of comment period. If you are not aware of us please consider looking us up on Facebook and coming out this Sunday we can use more people in the region helping.

 

[Roger_Lafayette]

toddkuen - I am not sure if you are a member of the local Steel City Vapers' Club, but we have a meet this Sunday where Bill Godshall and a number of the vendors will likely be present. Bill has come out a few times in the past to talk to the club, and we have invited him yet again since this will be our last planned meet before the current end of comment period. If you are not aware of us please consider looking us up on Facebook and coming out this Sunday we can use more people in the region helping.

Wow, that's great. If I lived nearby, I'd definitely take the opportunity to meet him in person. Bill has been fighting the good fight for a long time. He seems to have tremendous insight into how these processes work.

 

[toddkuen]

I've had enough contact from various forum members to believe that I am not alone in my opinions.

Be that as it may CASAA is doing well legislatively and I do understand why and how that's happening - but it doesn't always win.

If you think of "strategy" as stool I think you'll agree that most people would not buy a one or two legged stool.

I am critical because I don't see other legs for the stool: strong media (to compete with the dogma-filled conventional media), various protests and organizing, strong science, tie ins with other groups, the civil and human rights aspects, disruptive thinking in general.

I perceive this (and I do get detailed input from others and other threads from this forum) as the "hero" model - the hero will save us.

I like science and technology and disruptive thinking so I tend to rely on it instead - principally because it tends to work well against dogma.

(Dogmatists have a hard time imagining something that's, well, outside of the dogma, so they tend not to anticipate unexpected approaches.)

I also don't like relying only on one plan so I don't.

As I see it the FDA has far more options than just ejuice/tobacco/nicotine even if totally defeated on that front for regulating e-cigarettes.

They are presently busy regulating in unique and wonderful ways outside their jurisdiction (the attack on small lasers, as I brought up in another thread, form the basis for my beliefs).

I apologize if any feel offended but I have learned the hard way to always have more than one solid option and I just don't see it here.

(Again I am scolded from attempting to talk about anything outside the spectrum of approved "thought" here - another sign of strong dogma.)

I do plan on being at the Steel City meeting Sunday - perhaps I will meet some of you - I believe it starts at 12:30?

 

[Nermal]

Why would you want it scaled up? It would cost even more than synthetic nicotine and that is already being made.

I give you this for context, Traver:

I've made nicotine from scratch in a lab at considerably less cost and time than extracting it from a plant. Therefore it is was not a tobacco product!

That should answer the question of why I wonder if it can be scaled up - perhaps into commercial quantities.

 

[turner.curtis]

@Roger I wish you were closer as well we would love to have you come out also.

@ToddKuen yes 12:30 - 5 at the least. https://www.facebook.com/events/632467233482921/

 

[Nermal]

Thanks Curtis, but yeah, that would be quite a drive.

 

[Traver]

Nermal, I should read more carefully and think more before posting. I thought Sarin was extracting nicotine from eggplants or some other plant.

I would like to know more about this if Sarin actually was able to make nicotine for less than the cost of extraction. Dow chemical makes synthetic nicotine but it more expensive the the extracted product. It could be because Dow makes purer product with less contaminants.

That should answer the question of why I wonder if it can be scaled up - perhaps into commercial quantities.

Quote Originally Posted by Sarin View Post
I've made nicotine from scratch in a lab at considerably less cost and time than extracting it from a plant. Therefore it is was not a tobacco product!

 

[toddkuen]

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]

and

(rr)
(1) The term “tobacco product” means any product made or derived from tobacco that is intended for human consumption, including any component, part, or accessory of a tobacco product (except for raw materials other than tobacco used in manufacturing a component, part, or accessory of a tobacco product).

(2) The term “tobacco product” does not mean [ my underline ] an article that is a drug under subsection (g)(1), a device under subsection (h), or a combination product described in section 353 (g) of this title.

The Family Act amends (1) and (2) as

TITLE I—AUTHORITY OF THE FOOD
AND DRUG ADMINISTRATION
SEC. 101. AMENDMENT OF FEDERAL FOOD, DRUG, AND COSMETIC ACT.
(a) DEFINITION OF TOBACCO PRODUCTS
.—Section 201 of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321) is amended
by adding at the end the following:
‘‘(rr)(1) The term ‘tobacco product’ means any product made
or derived from tobacco that is intended for human consumption,
including any component, part, or accessory of a tobacco product
(except for raw materials other than tobacco used in manufacturing
a component, part, or accessory of a tobacco product).
‘‘(2) The term ‘tobacco product’ does not mean an article that
is a drug under subsection (g)(1), a device under subsection (h),
or a combination product described in section 503(g).

So, as I originally postulated and as is confirmed here the "Family Smoking Prevention and Tobacco Control Act" would not seem to include the regulation of nicotine "derived" from tobacco because nicotine is something that already exists outside of the tobacco plant, i.e., just like water or chloropyll.

Of course in the normal course of events I WOULD LINK TO EACH ITEM but that would violate the standards of this forum.

Quite honestly that (linking to the actual pages) seems to me to discourage any sort of thinking, critical or otherwise, what-so-ever - particularly odd in a forum regarding such dire consequences as the FDA "deeming" regulations.

(If you could read the subtitle: "Basically just stay dumb and listen to what we tell you...")

Finding this convinces me, for now and pending further missing or obscured information, that while everyone "talks loudly" about what they know they apparently DON'T KNOW as much as they thought.

Originally...

... 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.
...

--Roger

Seems clearly spelled out and that Congress was clear about what parts of tobacco ought be regulated: the parts that are in fact unique to tobacco.

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.

 

[Bobbilly]

Their definition is their interpretation. Nicotine is nicotine nothing more. If they found a substance in tobacco that was extremely successful in curing disease would it still fall under the tobacco act?

 

[toddkuen]

Their definition is their interpretation. Nicotine is nicotine nothing more. If they found a substance in tobacco that was extremely successful in curing disease would it still fall under the tobacco act?

If that "article" was unique to tobacco then absolutely - they are simply spelling out that the tobacco act covers things unique to tobacco.

It really makes perfect logical sense - otherwise you'd have the FDA claiming to regulate water as I postulated in the OP.

The USP contains probably thousands of chemicals - without this constraint the various tobacco acts would probably cover them all - leading to even more nonsense.

 

[Nermal]

Traver, I too would like for Sarin to come back with more information.

 

[toddkuen]

...

{MODERATED} .

From the now edited first post...

Not that I am a conspiracy theorist or but really...

 

[Fitzie]

Just some additional food for thought in this discussion (from the FSPTCA):

Sec. 2. FINDINGS.

The Congress finds the following:

(3) Nicotine is an addictive drug.

Sec. 3. PURPOSE.

The purposes of this division are--

(5) to vest the Food and Drug Administration with the authority to regulate the levels of tar, nicotine, and other harmful components of tobacco products;

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.

I just cherry picked a few sections from the statute related to nicotine as I'm trying to educate myself as to where FDA (and Congress) are coming from when seeking to regulate e-cigs (there may be others, I didn't read the entire statute). As of now, I'm in the camp that the FDA can and will regulate nicotine as a tobacco product. But I also respect that others can and do have a contrary opinion (and I hope they're correct). Ultimately, I will defer to CASAA's interpretation (they're the experts, not me).

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?