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Sunday, July 15, 2018

#WalkAway from FDA Lies About Vaping

I wrote this little piece in response to spending the last week or two reading and watching #WalkAway threads on Facebook.  It's been a challenge to get it posted there as, like the early days of CASAA, etc. there are too many things going on for admin's to keep up.  So I am putting this here as well.

There are some interesting parallels in #WalkAway to how I grew to accept vaping. Though I never smoked most everyone of my family (wife, children, grandchildren) did or would be likely too.  Today no one smokes "Combustion Tobacco."

You always would like to think that the FDA and "public health" are about making people healthy - until you realize that the FDA, despite numerous studies showing the opposite, want to stop its advancement.

In any case:


As someone who "walked away" more than thirty years ago I have a thought I'd like to share.

You need to “#WalkAway" from much more than politics.

You are being fed a similar line of BS about healthcare, about food and diet, about science, about religion, and just about everything else.  You are simply “demographics” at which measurable, clickable content is focused in order to make money.  You aren’t told anything that’s actually “good” for you.  It began the moment you first saw a TV commercial and continued through your high school text books and onto your phones to your social network sock puppet “feeds” today.

The reason I am writing this post is vaping (Nicotine KIlls!!!, ...) It is well documented that vaping is perhaps one of the most significant public health improvements to ever come along (I’ll provide a link at the end for this).  

Yet it is demonized just like Trump because of its impact on taxes collected by states, revenue for "Big Pharma," etc...

Combustion tobacco products (cigarettes) are known to the FDA to be higher risk than vapor-based products yet there is an enormous effort underway to prevent people from using them.  The consequence? People continue to smoke.  

Your demographic is kept the victim in order to generate tobacco revenue: http://lwgat.blogspot.com/2011/06/hows-that-tobacco-settlement-coming.html



Sampling of vaping studies showing the relative danger to “combustion tobacco”: http://vaping360.com/positive-vaping-studies/

Politics is just the tip of the iceberg…

Wednesday, July 11, 2018

FDA Free Speech Regulation

Think about this for a moment...  Could this be "free speech" and afforded all the liberties associated with free speech?


Now consider this  activity (image from https://thepoliticalinsider.com/trump-flag-burning-liberals-hypocrites/):


As per the Constitution burning a flag is a "protected" activity: Texas v. Johnson (No. 88-155) argued before the Supreme Court March 21, 1989, and decided in favor of this Constitutionally protected activity June 21, 1989.  In particular, burning a US flag is considered free speech and therefore is afforded all the protections the Constitution provide any other form of "free speech." (More details below.)

So if burning a flag is "free speech" why wouldn't this be?


Is this then not also free speech?



Clearly each of the two non-flag cases above are protected "political speech."

However, these later forms of speech are currently highly "regulated" by both the FDA and various state and local laws.

Consider that in Bernstein v. Dept. of Justice the restrictions against publishing computer source code for encryption algorithms (considered a"munition" at the time) was also struck down in a similar fashion.

Similarly, publishing DIY 3D printing instructions to make guns was also found an unfair restriction on free speech (the US Justice department settled in favor of the gun publisher).

Why can't I boil propylene glycol and natural flavorings and exhale the extract while extolling my political beliefs?

Can the FDA really regulate "free speech?"

Johnson says that even the US Congress cannot make laws limiting free speech.

Restraining "vape speech" therefore seems is wrong, especially considering that Texas v. Johnson (No. 88-155) Held: Johnson's conviction for flag desecration smoking vaping is inconsistent with the First Amendment. Pp. 402-420 (adornments my own):

(a) Under the circumstances, Johnson's burning of the flag smoking vaping constituted expressive conduct, permitting him to invoke the First Amendment. The State conceded that the conduct was expressive. Occurring as it did at the end of a demonstration coinciding with the Republican National Convention, the expressive, overtly political nature of the conduct was both intentional and overwhelmingly apparent. Pp. 402-406.

(b) Texas has not asserted an interest in support of Johnson's conviction that is unrelated to the suppression of expression and would therefore permit application of the test set forth in United States v. O'Brien, 391 U.S. 367, whereby an important governmental interest in regulating nonspeech can justify incidental limitations on First Amendment freedoms when speech and nonspeech elements are combined in the same course of conduct. An interest in preventing breaches of the peace is not implicated on this record. Expression may not be prohibited [p398] on the basis that an audience that takes serious offense to the expression may disturb the peace, since the Government cannot assume that every expression of a provocative idea will incite a riot, but must look to the actual circumstances surrounding the expression. Johnson's expression of dissatisfaction with the Federal Government's policies also does not fall within the class of "fighting words" likely to be seen as a direct personal insult or an invitation to exchange fisticuffs. This Court's holding does not forbid a State to prevent "imminent lawless action" and, in fact, Texas has a law specifically prohibiting breaches of the peace. Texas' interest in preserving the flag as a symbol of nationhood and national unity is related to expression in this case and, thus, falls outside the O'Brien test. Pp. 406-410.

(c) The latter interest does not justify Johnson's conviction. The restriction on Johnson's political expression is content based, since the Texas statute is not aimed at protecting the physical integrity of the flag in all circumstances, but is designed to protect it from intentional and knowing abuse that causes serious offense to others. It is therefore subject to "the most exacting scrutiny." Boos v. Barry, 485 U.S. 312. The Government may not prohibit the verbal or nonverbal expression of an idea merely because society finds the idea offensive or disagreeable, even where our flag is involved. Nor may a State foster its own view of the flag by prohibiting expressive conduct relating to it, since the Government may not permit designated symbols to be used to communicate a limited set of messages. Moreover, this Court will not create an exception to these principles protected by the First Amendment for the American flag alone. Pp. 410-422.

755 S.W.2d 92, affirmed.



Friday, June 22, 2018

Kingdom Vapor Wins Against the State of Pennsylvania

I wrote this post in April showing how the FDA backed down on labelling things that were not tobacco as "Tobacco Products."

Now Kingdom Vapor has won there lawsuit against the state of Pennsylvania (from the link):

"Jun 22nd 2018
630 days or 1 year, 8 months, and 21 days: This is the duration of time that it has taken to Fight and WIN in Pennsylvania. What have small businesses and retail customers across Pennsylvania won as of today, June 22nd, 2018? 40% less tax on many Vapor Products.
Unfortunately, in June of 2016 during a heated budget battle in Pennsylvania, the Vaping Industry came under attack. Vaping was labeled by the State of Pennsylvania as a "Tobacco" product and ultimately handed a 40% tax on E-Liquid and Hardware.
The letter of the law was unfortunately very tight when it came to E-Liquid and it's taxable standing; however, Hardware was very cut and dry requiring that to be taxable the product "must contain a heating element and battery, or circuit". Tax laws must be strictly construed, meaning no room for interpretation.
As time came closer to the October 1st enactment date of the Tobacco Products Tax Act or TPTA, numerous Vape Shops and Kingdom Vapor Wholesale had been bombarding the PA Department of Revenue with questions regarding Hardware Categories and whether these Categories and Types would be taxed. In a decision which seems to have been made out of frustration and lack of product knowledge, the DOR choose to tax all hardware at 40%, essentially smearing the Strictly Construed definition of the TPTA into a state of Gray.
As an answer, the PA DOR released many updates on their interpretation of taxable status of Hardware Components. At this time the PA DOR began using the term "Integral" to provide reason behind their expanded list of taxable items; however, Integral does not appear in the original TPTA law when discussing Hardware. This is where Pennsylvania shop owners and the public became burdened and wrongfully taxed.
Kingdom Vapor Wholesale, being a PA based Hardware and E-liquid Distribution Company working in the Industry since 2013, realized that the PA DOR had in fact wrongfully interpreted the TPTA law of 2016, and approached a local law firm. Through meeting with Lindsay Law Firm of Butler Pennsylvania, and getting their interpretation of the TPTA 2016 law, it was agreed that the PA DOR was wrongfully taxing Businesses in PA as well as PA consumers of these products and Suit was filed on December 20th, 2016
Over the next year there were numerous heated Question and Responses back and forth between Kingdom Vapor and PA DOR Attorneys. This ultimately led to Kingdom Vapor's Lawsuit being moved from State Court to Federal Court, only to be kicked back down to Pennsylvania State Court. Kingdom Vapor's first court appearance was slated for late December of 2017 but was pushed back to January 10, 2018.
After the January 10th hearing, the request for preliminary injunction was granted in part. This prevented the DOR from pursuing administrative and criminal penalties during the pendency of this litigation if Kingdom Vapor continues to file its monthly reports and pay the 40% tax on the same items on which it has been collecting and paying the tax. A final decision on what products would remain taxable would ultimately be made in a separate hearing scheduled in April.
On April 11th, Kingdom Vapor had their second court date in front of 7 judges. Closing arguments were heard from both sides. After hearing closing statements, the Judges were able to ask questions of both parties, focusing most of their attention on PA DOR Attorney Gallagher. Questions came at the DOR hot and heavy, leaving Kingdom Vapor Wholesale with a feeling of success.
Today (6/22/2018) that feeling of success is a reality. Through litigation against the State of Pennsylvania, Kingdom Vapor has WON. This win will drastically help Pennsylvanian Retailers better compete on Hardware against bordering states and online retailers who haven't been affected by the TPTA 40% tax. Through the ruling provided by these Honorable Judges, only Complete ready to use Kits will be taxed at 40%, as is written in the letter of the law.
This has been a long and arduous roller coaster for the Ownership and Team here at Kingdom Vapor Wholesale. Kingdom Vapor would like to extend a very sincere thanks to all Pennsylvania Retailers who have shown support over the last 18 months. The support of out of state Retailers has also been extremely appreciated as well and is a testament to the Community that exists in the Vaping Industry.
Kingdom Vapor Wholesale would also like to thank Lindsay Law Firm for providing exceptional Legal Support, and Specifically Andrew Salemme for his dedication to their case. Also, thanks to East Coast Vapor for their related lawsuit. Thanks to the Honorable Mary Hannah Leavitt, President Judge; Honorable Renee Cohn Jubelirer, Judge; Honorable Robert Simpson, Judge; Honorable Patricia A. McCullough, Judge; Honorable Michael H. Wojcik, Judge; Honorable Christine Fiazzano Cannon, Judge; Honorable Ellen Ceisler, Judge
To read the court's full decision, click the link below."

Saturday, June 16, 2018

The Disparate Impact of Vaping "Flavor Bans" on Minorities

Disparate impact in United States labor law refers to practices in employment, housing, and other areas that adversely affect one group of people of a protected characteristic more than another, even though rules applied by employers or landlords are formally neutral (from Wikipedia).

"Flavor bans" target minorities (everyone that is a "non-white male") by reducing the opportunity for them to have "less risk" choices beyond "combustion tobacco."  This includes vaping and/or flavor bans in housing as well as other areas (see this for example).

According to the CDC (this website):


and



3. Jamal A, Phillips E, Gentzke AS, et al. Current Cigarette Smoking Among Adults—United States, 2016. Morbidity and Mortality Weekly Report 2018;67:53-59. DOI: https://www.cdc.gov/mmwr/volumes/67/wr/mm6702a1.htm [accessed 2018 Jan 30].

This would seem to indicate that about 81% of smokers are non-white and about 65% don't have a high school education.

There is also more than adequate information indicating that gender and race account for tobacco flavor choices, e.g., this study.

Interestingly there is little in the way of similar e-cig usage by race.  This study, though, provides a tiny bit of insight, e.g., "African Americans/Blacks were significantly less likely to report ever-use compared to Whites and Hispanics (50% vs. 71% and 71%, respectively; p < 0.001). "

Even the FDA CTP admits the potential risk reduction opportunities, e.g.,   "It is not the nicotine that kills half of all long-term cigarette smokers," said Zeller. "The nicotine creates and sustains the addictions, but it's not the nicotine that kills people." and “We are also optimistic that this could have positive implications for eventual modified risk claims by non-combustible nicotine delivery products such as e-cigs and smokeless products.”

But it would seem that all of the e-cigarette activity relates to what amounts to "white people." For example see this.



Looking at pages like this we notice that "youth" is the only criteria for the statistics.  However, given the vast disparity between white and non-white tobacco use documented by the CDC one can only conclude most youthful smokers are non-white and that there is a similar disparity for e-cigarettes.

As I wrote in Genocide by Regulation combustion tobacco targets poor minorities because they are the heaviest users.  Changing the risk for these users is a win: "The regs say on page #30: “FDA believes that the inhalation of nicotine (i.e., nicotine without the products of combustion) is of less risk to the user than the inhalation of nicotine delivered by smoke from combusted tobacco products.” (Of course there's some expected maybe's and "limited data" caveat's...) Then: "... nicotine exposure by inhalation without combustion are likely NOT responsible for the high prevalence of tobacco-related death and disease in this country" (my emphasis)."

Flavor bans target minorities (everyone that is a non-white male) by reducing the opportunity for them to have choices beyond "combustion tobacco."

I believe that all ethnic groups deserve a fair and equal chance under the law to make their own health decisions regardless of where they work or live.

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.