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Saturday, May 19, 2018

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:


Friday, May 18, 2018

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…

/mäləˌkyol/
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/enNicotine 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.")

Wednesday, April 18, 2018

Science Backs the FDA Down (Vaping is Free)...

The FDA recently posted some non-binding guidance here.  In part it says on page #6:

"Examples of components or parts for which FDA does not intend to enforce the ingredient listing
submission requirement of section 904(a)(1) at this time include, but are not limited to, the
following:

  • Electrical components including, but not limited to, batteries, charging systems, circuit
  • boards, wiring, and connectors
  • System software
  • Digital display, lights, and buttons to adjust settings
  • Connection adapters
  • Cartomizers
  • Coils
  • Wicks"
Now this is really a kind of interesting.

The original deeming regs say in part that "e-liquids; atomizers; batteries (with or without variable voltage); cartomizers (atomizer plus replaceable fluid-filled cartridge); digital display/lights to adjust settings; clearomisers, tank systems, flavors, vials that contain e-liquids, and programmable software" are components/parts of e-cigs.
 
On December 30th, 2017 I wrote the following here on this blog relative to this nonsensical gibberish passed off as science:

"...Lights (devices which emit photons) and digital display's (devices which emit patterns of photons) convey information to a user's eye or a camera or other photo receptive device, i.e., they indicate a value of something (through shape or color or arrangement of these photons) typically contained in software or electronic hardware to a "user." 

Secondly, "lights" and "digital displays" only pass information from within a device to a user.  You would need a "control system" of some type, a physical element which translates the actions of a user, e.g. a switch or button, into a value inside the device.  These lights are not directly connect to a "tobacco product," of course, either."

I wrote "Your Child's iPhone is a Tobacco Product" about how the deeming regs make any software device indirectly involved in an e-cig a tobacco product (more insane nonsense).

On December 30th I also wrote: "At best the "voltage" and "software" are affecting this "atomizer" and not the "tobacco product" itself.

Even if I put the "tobacco product" into a tank on an atomizer and apply power via "lights" through "software" etc. etc. nothing happens..."

The list and non-science goes on.

There are far, far too much similarities here for this to be any kind of coincidence.

Another interesting coincidence has been the extremely high volume of blog views recently:


The peak here occurring from December of 2017 through March 26th.

From the beginning (about seven years ago) I have maintained that these "deeming regs" and the ideas behind them consist solely of scientific nonsense.

This guidance would seem to prove this assertion.

I think that the backing down of the FDA on non-tobacco nicotine (for which I am still awaiting my FOIA information) is related as well.

The path is clear for the right products.

Vaping is now free.


Wednesday, February 21, 2018

FDA FOIA Update 02-21-18...

Electronic correspondence over the last week or so...


Monday, February 19, 2018

Facebook: Russian Meddling vs. Vaping...

Supposedly Russian's spent some $100,000 USD with Facebook meddling in the US 2016 election:

https://www.washingtonpost.com/outlook/why-russias-facebook-ad-campaign-wasnt-such-a-success/2017/11/03/b8efacca-bffa-11e7-8444-a0d4f04b89eb_story.html?utm_term=.3fbb382615c6

This begs the question:

Why does Facebook allow Russian's meddling in our elections to purchase ads but not vape shops?

Seems like Facebook values the business of Russian meddlers far more than the lives of smokers.

Russian ads from the WaPo... via Google Image Search
Surprisingly the Russian's are merely (top center) repeating what Sanders actually said as reported The Hill (for example):

"Do I have a problem when a sitting secretary of State and a foundation run by her husband collects many, many dollars from foreign governments — governments which are dictatorships?

"Yeah, I do have a problem with that. Yeah, I do," Sanders said on CNN's "State of the Union."

Yet vaping cannot be advertised despite the growing scientific evidence demonstrating it's safety relative to smoking (for example, from the Guardian):

https://www.theguardian.com/science/sifting-the-evidence/2017/dec/29/e-cigarettes-vaping-safer-than-smoking

I think the judgement of Facebook really needs to be questioned.

(Still waiting for data from the FDA FOIA requests...)

Wednesday, February 14, 2018

FOIA Replies (Second Time...) $250.00?

Here they are below.  Apparently "... charges may be incurred once processing of your request has begun.

According to https://www.fda.gov/RegulatoryInformation/FOI/FOIAFees/default.htm "Noncommercial Use Requestors, Such as Representatives of the News Media, Public Interest Groups, and Educational and Noncommercial Scientific Institutions: Duplication charges at the same rates listed above with no charge for first 100 pages of duplication." and "Requestors are generally billed for fees after their requests have been processed; however, if total fees are expected to exceed $250.00 FDA may require payment in advance of processing."

So I guess I am in for a max of $250.00 USD for each request.

So I wonder how this works for electronic requests? 

No charge for "media" on searches (up to $83.00/hour).

We'll see what turns up I guess.

As state before I will set up a kickstarter if more funds are required and share the results with all who contribute.



and



Wednesday, February 7, 2018

FOIA Re-Request via Web...

So apparently writing a FOIA letter (kiss my $12 to the USPS goodbye) isn't appropriate as I am part of the news media here (11,000 views last month):


So I went here (https://www.accessdata.fda.gov/scripts/foi/FOIRequest/index.cfm) and filed these slightly modified requests: