Search This Blog

Loading...

Sunday, May 25, 2014

In the Consideration of "The Children" with Regard to Vaping...

“The state must declare the child to be the most precious treasure of the people. As long as the government is perceived as working for the benefit of the children, the people will happily endure almost any curtailment of liberty and almost any deprivation.”


― Adolf Hitler, Mein Kampf

"USP" Nicotine

There is yet more to this story.

The term "USP" has meaning in and of itself. There is a scale from seven (7) to one (1) for purity. One (1) being the most pure, seven (7) the least.

USP is number three (3): "A chemical grade of sufficient purity to meet or exceed requirements of the U.S. Pharmacopeia (USP); acceptable for food, drug, or medicinal use; may be used for most laboratory purposes."

Hence any nicotine that is of "USP" purity would be considered by established science to be a product usable in any context for which that chemical is appropriate. By this I mean that it is considered "pure nicotine" and not some FDA-defined mish-mash of tobacco alkaloids.

These are scientific standards that apply to all manner of chemicals covered by the US Formulary, not just nicotine. (Look up the USP formulary web sites.)

Now if one inspects a site such as nicSelect we see this claim "NicSelect doesn’t just meet – it exceeds U.S. Pharmacopeia standards."  Below you'll see a list of chemicals, the maximum specific level of impurity required by the standard, and how nicSelect exceeds them (has fewer impurities).

I will argue that while the FDA could attempt to argue that, for example, nicSelect nicotine is "derived from tobacco" such an interpretation would imply that any USP-grade chemical that was sufficiently pure for a USP designation would not be what it was but in fact what it was derived from.

More absolute nonsense as I originally postulated.

So while one can argue nano- and micro-gram amounts of nicotine in second hand smoke or vapor, for example, these standards are simply not applicable here.

Effectively the FDA would have to single out nicotine as somehow "magical" in the sense that only it remained a tobacco product once it was sufficiently pure to receive a "USP" designation.

More importantly bypassing the intent of the legislature which specifically identifies the formularly.

I find it hard to imagine, and in fact in the legislation linked above it is not present, there would be any special meaning for nicotine outside the actual statutes.

So while the FDA and Mr. Zeller can say whatever they like they would have to undo a lot of established science to create the fiction that USP nicotine was somehow a tobacco product.

So, as they say, stick that in your pipe and smoke it...

Tuesday, May 20, 2014

Family Smoking Prevention and Tobacco Control Act/Food Drug and Cosmetic Act can not Regulate Nictone

As it turns out, upon reading the various acts you see the following:

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.

Wednesday, May 14, 2014

Reductio ad absurdum - Nictone cannot be "derived" from Tobacco

So in the context of proposed FDA regulation of electronic cigarettes we see that bad old nicotine is probably a significant target.  After all, it, in a legal sense under, say the "The Family Smoking Prevention and Tobacco Control Act of 2009" (FSPTCA), is "... any product made or derived from tobacco that is intended for ..."

And, in the context of vaping, the intention of "deeming" regulations is to include nicotine.

So let's think carefully about this.

Tobacco is a plant to so by definition it contains chlorophyll and water as well as many other things, like alkaloids, amino acids, proteins, carbohydrates, starches, and pigments.   There are many lists and discussions of this (for example here and here) - this is not rocket science and the understanding of what constitutes of plant is hopefully not in question.

So if I were to "grind up" a tobacco leaf what might I find?

Things like water, chlorophyll, dextrose, ammonia, and pectin (from the second link).

Are these things addictive?

No.

Are these things unique to tobacco in the sense that they can be derived from no other source?

No.

I can derive these things (water, chlorophyll, dextrose, ammonia, and pectin), as well as many others, from tobacco.

I can also buy them at Walmart.

So I think we can also agree that the authors of the FSPTCA did not intend the FDA nor anyone else to "regulate" these items.

It would be absurd.

Now there are many alkaloids such as anabasine which are present only in tobacco.

Hence to obtain this alkaloid I would be required to derive it specifically from a tobacco plant.

This chemical is a pyridine (cyclical organic compound) and is relatively poisonous.

But this chemical, derived from tobacco, is unregulated by the FDA though I think it is clear that, by "derived," the authors of the FSPTCA would intend the FDA to regulate this chemical.

But they do not.

So if we divide up what we find in tobacco we have three classes of constituent: the first I will call a common constituent, something like water, which occurs naturally outside tobacco.  The second I will call a "derivative" which is something which is a constituent but, unlike the first class, can only be derived from tobacco.

And then there is nicotine, alone in its own class.

Nicotine as I have written previously in this blog is available from many sources besides tobacco such as peppers, tomatoes, and potatoes.

Like water and chlorophyll nicotine can be derived from tobacco.

Unlike anabasine it can also derived from peppers, tomatoes, and potatoes.

Nicotine's sin regarding regulation, then, must be its addictive properties?

Well, the FDA does not believe that nicotine is addictive (see their own web site),  where they say "although any nicotine-containing product is potentially addictive, decades of research and use have shown that NRT products sold OTC do not appear to have significant potential for abuse or dependence. [underline mine]"

Dextrose, which is sugar, is potentially addicting too (at least WebMD thinks so).

So under what logic, or specifically how from the perspective of the FSPTCA, can nicotine be singled out for regulation.

It is both logically and legal inconsistent.

The only reason would appear to be that historically nicotine was "thought" to be addictive.

The FDA's new "deeming" apparently fails to reflect the FDAs own thinking - more or less analogous to keeping laws regarding slavery on the books because your thinking on slavery hasn't changed since the passing of the 14th amendment.

If we look at copyright law, for example, its clear what a derivative work is, i.e., what it means to derive.  Congress passed both copyright law and the FSPTCA.

Basically a clear link between an original work and the derivative - something that retains the unique aspects of the original, analogous to anabasine being only found in tobacco.

Tobacco is the "original work" and "anabasine" is the derivative - it is in some sense a subset of tobacco and uniquely derivable from it.

Nicotine, water and chlorophyll are not derivatives in this sense.  They can be derived from anything that contains them, e.g., potatoes.

They are effectively constituents of tobacco but not derivatives.

So we are now faced with an absurdity:

Since I can derive water and pectin from tobacco they must be, by definition because they can be derived from tobacco, regulated under the FSPTCA.

After all pectin is found in jams and jellies - and "intended for human consumption."

So is water.

And finally: Is the water derived from tobacco somehow different that water from other sources?

Yet another absurdity.

Of course not.

Water is water - regardless of the source.

Water squeezed out of a tobacco plant is just like water from any other source.

If we believe that the FSPTCA is intended to regulate the constituents of tobacco then by definition virtually the entire planet would be regulated by this law.

But that's not what the law says.

It says "tobacco" and clearly there exists a class of things which are uniquely derivable from tobacco.

Since tobacco contains virtually all amino acids did the FSPTCA intend to include those as well?

The animals we eat all contain the same amino acids, hence the FDA would be required to regulate all animals that humans might consume as well.

But in fact there are other laws, such as laws related to supplements, to address those constituents.

So if the FSPTCA did not intend to regulate water or chlorophyll how can it regulate nicotine, a chemical with the same properties as water or chlorophyll?

The Congress clearly differentiates between "derivatives" and "constituents" in many areas.

The FDA is taking the law into their own hands and creating a magical new class of tobacco "constituent" - nicotine.
 

Monday, May 12, 2014

Discriminating Against Smokers/Vapers is in fact Racism...


From this.

From my read of the linked article what's going on with smoking and electronic cigarettes is very simple.

Nicotine metabolizes into cotinine - available, by the way, from Santa Cruz Biotechnology.

The process is basically applying either UV light or hydrogen peroxide to nicotine.

Cotinine was once supposed to be marketed as an antidepressant called "Scotine." (See this link - image from link at the right.)

So Cotinine is

  - a cognitive enhancer;

  - something that reduces anxiety and fear in at least the mouse model of PTSD;

  - something that extinguishes fear; and

  - positively affects mental illness such as depression or schizophrenia.

More here.

Basically it does much of what cigarette smokers claim cigarettes in fact do.

Your reaction to cotinine is very likely genetic and can be influenced by ethnicity.

There are specific genes and variations of those genes that determine your reaction to cotinine (see the linked article at the top of the page).

Which makes smoking or vaping, at least in my book, a genetic disorder, i.e., people with certain genes are predisposed to become smokers.

Would you discriminate against a woman with the breast cancer gene BRCA?
Hence singling out smoker is an act of racism.

So the FDA singles out smokers as an ethnic group - a group with specific genes - an discriminates against them.

How is this different than any other form of racism?

I have posted more detail here on the ECF.

Sunday, May 11, 2014

Nicotine - Not Addictive

So I have been vaping nicotine professionally for sometime (over six months, in fact).

I haven't had a single issue of addiction - no desire to vape compulsively, no urges to pick up the vape, nothing.

So I started to wonder why I was not falling victim to the "great satan nicotine."  After all, at least according to the NY Times (see this) and Wikipedia, nicotine is more addictive than cocaine or heroin.

I've seen the consequences of these other drugs - not much fun.

But no addiction - no withdrawal when I leave the vape home, even for days.

Nothing...

So what's up with this?

First off I found this link at Discover Magazine. (EDIT: I have contacted the author for specific references to these studies.)

Its kind of an interesting article where you find things like this "In 2005, for instance, researchers at the University of California, Irvine, found that animals self-administer a combination of nicotine and acetaldehyde, an organic chemical found in tobacco, significantly more often than either chemical alone. In 2009, a French team found that combining nicotine with a cocktail of five other chemicals found in tobacco — anabasine, nornicotine, anatabine, cotinine and myosmine — significantly increased rats’ hyperactivity and self-administration of the mix compared with nicotine alone. "

And "...it’s almost impossible to get laboratory animals hooked on pure nicotine..."

So alone (and its alone in your vape because anabasine and friends are not present there) the nicotine your vape probably produces no addictive effect unless mixed with other chemicals.

This is not the only article.

Another, here,  which says “Studies have shown that none of the nicotine replacement therapies — chewing gum, inhalers, patches — none of those are addictive.”

What?  No addiction?

In fact, the professor who the article was about “I presented this position to 20 of the world’s experts,” he said. “And though some were shocked and insulted, no one could argue that my case was untrue.”

How interesting is this?  Sounds like the same crap the discoverers of H. Pylori (the bacetria the create stomach uclers) when through.  No one believed that the bacteria could live in the stomach of a human, much less cause ulcers.

As I recall and perhaps have written about in one of my posts, they had to resort to infecting themselves with H. Pylori to cause themselves to get ulcers and then curing themselves because no one would believe them.

Ultimately, in 2005, they won the Nobel Prize for their discovery.

Sounds like the same bogus science model - start with a forgone conclusion, e.g., nicotine is addictive, and conduct a study that shows you are correct.

ADDITIONAL STUDIES:  Here is a Nation Institute of Health document with many detailed references to studies showing that its not nicotine alone (as found in vaping relative to other whole tobacco alkaloids) that is addictive.

Another study from Israel (Dr. Reuven Dar) showing that smoking is a habit and not a nicotine-related addiction (Reference here.).

An earlier study from 2005 by Dr. Dar showing similar results.

Another study from New Zealand implicating whole tobacco alkaloids as an important element when combined with nicotine: "The conclusions were that non-nicotinic components have a role in tobacco dependence and that some tobacco products could have higher abuse liability, irrespective of nicotine levels."

UPDATE: The FDA says here, regarding its approved patches and gums, that "although any nicotine-containing product is potentially addictive, decades of research and use have shown that NRT products sold OTC do not appear to have significant potential for abuse or dependence."

Some Clarification on the Prize Process

So let's think about the cost of raising tobacco - we need a farm, equipment, good weather, fertilizer, labor, a means to dry out the tobacco, and so on just to get the basic tobacco leaves ready for processing.

If we were to splice a nicotine-generating DNA strand into something like algae the process might look more like this:  fill a large tank with water and some fertilizer, throw in some nicotine algae, apply light for some number of days, pour off the water, dry the algae sludge.
On the order of grow pot in a "grow house."

Now since the post-production process extracts the nicotine and purifies it we are not really changing anything from the point of harvest/drying on.

Of course, microbiologists might have better ways to do this, I certainly don't know.  But if I were trying to do this this would seem like one of the better routes.

Alternatively I suppose you could insert the DNA sequence into something like a yeast and do the same thing - basically brewing nicotine instead of beer.

Its hard to imagine that separating nicotine from tobacco leaves/plants would be any more or less difficult than separating nicotine from the resulting brew sludge.

(NOTE: I didn't offer the prize for making nicotine in a chemical reactor.  Plenty of information exists with regard to that such as this patent application going well back into the 1960s.  This issue there is what's left mixed with the nicotine at the end.)

The solution to regulation is that nicotine is not a product of only tobacco plants.

(Caffeine, for example, is not a product of only the coffee plant, i.e, it also comes from tea.)

Here is a list of plants containing nicotine in relatively - though small compared to tobacco - amounts: http://www.nejm.org/doi/full/10.1056/NEJM199308053290619.

Under the Dietary Supplement Health and Education Act of 1994 its clear that I could, for example, grind up eggplant and make a "flavor" for vaping that was a "dietary supplement."  Its simply a "botanical" - like elderberry or anything else you can buy at amazon for $10 a bottle.

All the infrastructure, e.g., the NicSelect's and other companies like them, exists converting plant material to nicotine.

The goal of the prize is to make an "artificial" plant material that's not tobacco based.

And because much less infrastructure is required to produce it the cost, particularly considering it would be a unregulated dietary supplement, would make the cost competitive with existing products.