FDA FOIA Finality #1...

So in February, as I wrote here, I made a FOIA request (Freedom of Information Act) to the FDA for

“All FDA scientific records, evidence, emails, and expert data related to the decision to block NJOY (April 15, 2009) and other e-cigarette importers as detailed in SOTTERRA INC NJOY V. FOOD DRUG Administration.”

Remarkably no such records exist.

Apparently the FDA engaged in this process without so much as a single sentence of documentation.

Recall the FDA made the claim at the time that e-cigs were "medical devices."

There are many interesting inferences here:

• No such records do exist.
  
• They are withholding them.
  
• They can't find them.

Of course we know that there are court filings so those must exist.  But apparently not any more...

Here is part of the response:

Schrodinger's Nicotine: Not Derived From Tobacco

Schrodinger's Cat

A while back I wrote “Science Backs the FDA Down (Vaping is Free)…” describing how software will no longer be labeled as a “tobacco product.”  Simple science showed how ridiculous the “deeming regulation” claims were in that regard. Software was not and never will be a “tobacco product” nor will it ever directly affect “tobacco.”

Be that as it may we can now turn our attention to the idea that vaping e-liquid is a “tobacco product.”  

Here the FDA uses the slight of hand by defining nicotine to be either “made from tobacco” or “derived from tobacco.”   While nicotine is found in tobacco plants so are many other things.  All plants, including tobacco, contain chemical compounds such as water, starch, various sugars, vitamins, amino acids, and minerals.

Specific chemical compounds such as nicotine or capsaicin are unique to specific types of plants.  For example nicotine is present in egg plant and tobacco, capsaicin in certain types of peppers.

Certain other chemicals such as cotinine (https://en.wikipedia.org/wiki/Cotinine) are unique only to tobacco, capsaicin to peppers and so on.

So now we are going to show how an simple and inexpensive scientific alteration of nicotine renders it into a state that both keeps it nicotine yet makes it "underivable" from tobacco (much like Schrodinger's cat which is both alive and dead at the same time: http://invigorate.royalsociety.org/ks5/the-best-things-come-in-small-packages/why-is-quantum-physics-important.aspx).

For those ignorant of science…

mol·e·cule  (http://www.dictionary.com/browse/molecule)

/mäləˌkyo͞ol/

noun 

1. a group of atoms bonded together, representing the smallest fundamental unit of a chemical compound that can take part in a chemical reaction.

All compounds in plants outside of the photosynthesis process are molecules or atoms, e.g., water, sugar, and so on.

So let’s look specifically at what the FDA says is a tobacco product (https://www.fda.gov/ForIndustry/ImportProgram/ImportBasics/RegulatedProducts/ucm511517.htm).

What is a tobacco product?

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)”.

Firstly, nicotine is not and cannot be made from tobacco.  Nicotine is part of the tobacco plant, but no one, to my knowledge, makes nicotine from tobacco (however the plant makes its as do others).  (Here's a mechanism to "make" nicotine: https://patents.google.com/patent/US9556142B2/en) Nicotine might be extracted from tobacco, but not made from it.  (This as opposed to say, grinding up physical tobacco plants and rolling them in paper, i.e., making a cigarette.)

So let’s now consider if this is a rational, scientific statement:  Water molecules that escape from tobacco processing into the environment and make their way into, say, bottled water, make bottled water (for human consumption) a “tobacco product.”

From a scientific perspective, at least, this is utter nonsense.

First, molecules are not identifiable beyond their chemical compound and structure.  Thus one water molecule (H2O) is no different from another and cannot be distinguished uniquely.  Further, the source of a molecule is not identifiable so water generated by the space shuttle engines from combustion of hydrogen and oxygen is not distinguishable from water in the ocean. 

Second, since there is no way to trace individual molecules uniquely water molecules from tobacco plants have already mixed into our ground water, rivers, lakes, aquifers, and so on for millennia.  There is no way tell where water comes from.  And humans are already consuming it.

Now let’s think for a moment about what a derivation is.

der·i·va·tion /derəˈvāSH(ə)n/ (http://www.dictionary.com/browse/derivation)

noun 

1. the obtaining or developing of something from a source or origin.

Note here that derivation is always from a source.  In a scientific or mathematical sense this means that there is a connection between a derivation and what the derivation is from.  In calculus, for example, we derive the rate of change at a point on a curve.

In physics Einstein derived the equation: The inertia (or mass) of an object at rest is equal to where E is the energy content of the object.

In all cases a derivation must be bidirectional in the sense that it defines a relationship between the source of the derivation and the derived result.  Changing the source or derivation breaks the connection.

It is also clear that there are limits to derivations.  If I squeeze water out of a plant into a cup the water in the cup was derived from the plant.

If entropy or time could be reversed than I could, at least theoretically, “unsqueeze” the water back into a reconstructed plant.  

However, if I substitute different water molecules into the cup the reconstruction of the plant would end up both the same and not the same.

It would be the “same” in the sense that water (in a general sense) is back in the plant and “not the same” in that what was derived from the the plant is no longer part of the plant.

However, a mixture of water cannot, by definition, have been derived from the plant as different water molecules are now involved.

So “derived from tobacco” only is meaningful if we don’t alter the extracts at a molecular level so that there is a clear connection from the derivation to the source.

So now we turn our attention to nicotine.

Nicotine, like the water in the example above, can only be “derived from tobacco” if it’s molecules are not adulterated with other nicotine, i.e., there is a clear path from the nicotine back to its source.

So replacing nicotine or altering nicotine molecules from that was derived from tobacco ensures that the resulting nicotine can no longer be described as “derived from tobacco.”

Though the mixture contains nicotine from tobacco the nicotine molecules are not distinguishable as such because all nicotine is equivalent and interchangeable and not identifiable as to its source; hence the original derivational arrangement of nicotine to the tobacco is broken.

Note that here we rely on the scientific principles used in quantum mechanics (https://en.wikipedia.org/wiki/Particle_statistics#Quantum_statistics) that state all atoms and molecules are indistinguishable.

Thus mixing non-tobacco nicotine with “derived from tobacco” nicotine creates a result which could not be derived from tobacco yet at a quantum level are indistinguishable from the original nicotine.

SO, for example, mixing TFN Nicotine from Next Generation Labs (http://www.nextgenerationlabs.com/fda-confirms-tfn-nicotine-is-not-a-tobacco-product/) with nicotine produced in the usual ways makes it, at least in my opinion, no longer “derived from tobacco” and thus immune from regulation.

To deny this is to deny physics, quantum mechanics, mathematics and science in general.

Note here too that the act of mixing the two, rather than the specific amounts, is what renders it no longer “derivable.”

EDIT: While one can, I suppose, argue that their might be "other tobacco things" somehow left in "nicotine" as impurities one must also understand that typical "USP" nicotine is specifically identified as suitable for, among other things, medical and food applications (see: http://www.usp.org/reference-standards).  What's interesting here is that TFN is also identified as "USP" grade (see patent above re: "synthesis of pharmaceutically pure, USP grade, (R,S) Nicotine").

Somehow the FDA engages in magical think relating to the purity of nicotine.  Quite a bit is available on the purity of chemicals in general.  "USP" is medical grade and very, very low in "impurities."  Also, it's important to note, no chemical compound is free of impurities, even the highest grade (which has the lowest number of impurities as opposed to none).

To believe the FDA is to not believe in science. 

Everything used by humans contains a certain amount of impurities and to create a special category just of "tobacco products," i.e., exceeding USP just because it's tobacco, goes against all of science.

(Imagine, for example, if lawyers began suing based on the fact that USP is not "pure.")