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Sunday, November 18, 2018

FOIA Request for Nicotine Statements...

Requested:

All scientific articles, research, web links, documents, emails and other information used to document the statement in the last paragraph (see PDF) "... decades of research [by the FDA] and use have shown that NRT [nicotine replacement therapy, i.e., vaping] do not appear to have significant potential for abuse or dependence" with FDA web page "https://www.fda.gov/forconsumers/consumerupdates/ucm345087.htm"  (now removed).


Scott Gottlieb: JUUL is Now Your Bitch

So for the last say fifty years or so the message from the FDA has been very simple: SMOKING KILLS


My children, their children, all know this.

The fact that smoking is bad is engrained in their DNA almost from birth (while this may seem like a good idea it's in fact not because you lose your critical thinking skill as I describe below).

Originally at https://www.fda.gov/forconsumers/consumerupdates/ucm345087.htm we now find a HTTP 404 Not Found error.  (Preserved in this blog is the original though now even the saved https://archive.is/ejhfI is gone...):


Nicotine was a side show for the FDA: "... decades of research [by the FDA] and use have shown that NRT [nicotine replacement therapy, i.e., vaping] do not appear to have significant potential for abuse or dependence."  (Be nice or I'll file another FOIA request to get the research and publish it... or maybe I just will anyway.)

Not really addictive after all.

And so on as I write in older posts (for example this).

I have spoken to various "vaping" children.

I ask: "Is smoking bad?"

"Of course...!!" they cry, "We are not stupid!"

Some even know that the "smoke" itself is bad as opposed to just "smoking."

They reason, not unreasonably, that "JUULing" is not smoking.

And they are right.

Today, naked and afraid, I can still find tobacco, dry the plants, ignite them with flint, and smoke.  Nothing has changed in millennia.  Modern society has added convenient delivery to the corner store, chemical-laced paper wrappers and treatment of the tobacco but that's just marketing - people still (or would) buy plain old tobacco and smoke it.

On the other hand, about 10,000 years of technological advancement is required to build a modern JUUL.  No scavenging USB connectors in the bush.  No building lithium ion batteries from salt scavenged from the flats.

Then there is the nicotine.  Not much interesting there according to decades of FDA research.

But there is the problem of appearances.

Can't have little Johnny down at the corner JUULing, can we (as in the above picture).  It looks bad.  It looks, in fact, like smoking.

So there are two real problems.

Kids know better than to smoke so they don't.  YOU taught them this.

The FDA, to a point, has done their job there.

Unfortunately for the FDA JUULing is not smoking.

People vaping are not smoking.

So now the FDA defines away smoking (literally airborne ash from fire) and converts it to what "looks" like smoking, namely JUULing, to save the children.

They do this by redefining "nicotine vapor" or even just "vapor" into "smoking", plastic USB lithium ion batteries into "burning", and so on.

All so they can save us and the children from "not smoking" which they aren't anyway.

So if adults use JUUL to stop smoking and JUUL and/or the FDA make flavors that help people stop smoking unavailable to in 90,000 convenience stores across the USA won't both youth and adult be more inclined to actually smoke?

Of course.

You see, "public health" as a job cannot deal with the normal course of disruptive change brought on by technology.

The FDA was caught flat-footed by vaping.

Their "SMOKING KILLS" message has backfired: kids don't want to smoke so they don't.

You, Scott, just didn't think there was any alternative for them but the FDA and big pharma.

What you didn't think of was that some poor Chinese guy would solve the smoking problem with a disruptive technological solution.

So now YOU want to give more people of all ages incentive to smoking instead of vape.

(Quite honestly Scott, based on my research, the whole "vice" model is based on faulty science.  Groups of humans like to sit around and do things together, smoke, eat, drink.  They do this because it's a human trait: we are social animals and these things help to bind the society together.  Cell phones, on the other hand, make you depressed and isolate you and your children.  But don't worry, there are much larger companies than convenience stores selling those...)

Scott Gottlieb, you own this.  JUUL is now your bitch.

Maybe your latest actions can convince the kiddies to JUUL "tobacco flavors" or "plain" instead of cucumber and what not...

Oh wait, JUUL is removing only "kiddie friendly" flavors and leaving their older brother or who ever to buy them "tobacco" flavors???

Hmmm....

That seems like YOU are actually trying to indoctrinate the kiddies back into the flavor of "tobacco."

You see, Scott, if you were smart you'd realize that disruptive technologies like vaping are exactly that, disruptive.  Old ideas no longer work.

Maybe you should think long term and come up with a real plan instead of this "status quo" knee-jerk response.

You can pretend that decades of your own addiction research show that nicotine isn't really the problem.

You can pretend that youth vaping is the real 800 pound gorilla.

But YOU, and the FDA, over decades have taught these kids SMOKING KILLS.

Why wouldn't you expect them to JUUL?

Now you slap them in the face and say, no, we LIED, it's really the nicotine that's bad.

It's not, it's the SMOKE.

You own this...


Sunday, November 11, 2018

LG Chem: 18650 Death Knell

About a year ago I wrote Vaping On a Plane Redux about the danger of lithium ion batteries, i.e., 18650's et al.  I've also written about sources of 18650 batteries (Sony 30A - Wherefore Art Thou...).

Yet for the many years I have been writing about vaping not once was I able to actually relate an actual "18650" to any particular company.  Yes, I believe that large companies make them, and that there are only a very few large companies that make them, but never have I seen any actual facts, i.e., Chinese battery companies say them make 18650's but everyone really knows this is not true.

So the FDA has been busily working in the background (I think) to stir up battery safety issues for vaping (as I predicted).

Low and behold this arrived yesterday:


What this says is A) me, as a "seller supplier" of LG Chem need to be aware of the "safety issues," B) the "four industry trade associations" and "leading manufacturers" of "18650 cells" recently launched a safety campaign at be-cigarettesafe.org.

(Lawyer's ears perking up to the sound of ambulances...)

And whose fingerprints are on this, why the FDA's of course.

While I personally believe this is the right approach I think the problem is not here in the US.

If you look at the letterhead we see that LG Chem is located in Soeul, Korea. 

Seems like the FDA's reach is quite far...

Somehow these batteries, without real LG labels (though occasionally batteries are actually marked as such), turn up in vaping sporting a variety of Chinese battery logos, e.g., eFest and others.

So I am told, in the letter, to "immediately" cease celling 18650's and tell my customers to stop using them.

Hmmm...

I also have a charger for 18650's and a bunch of 18650 flashlights.

Based on the rest of the paperwork these warnings are for vaping and not flashlight usage.

However, one has to wonder what exactly is different between the two types of usage? (None)

Clearly carrying an 18650 for a flashlight in my pocket with coins and keys is just as dangerous as carrying it for vaping.

Yet the letter does not indicate an issue with other 18650 usages.

How remarkable is that?

So, Mr. LG Chem, what if I use an 18650 for my flashlight and only after I take it out of my pocket and decide to put it in my vape?  Is that okay?

Perhaps these letters should go to the Chinese 18650 re-packagers?

After all, my flashlights are perfectly safe and, at least as indicated by these letters, not a problem.

(I warned you, CASAA, that this would start...)

Where will it go?

Soon loose 18650's will be "too dangerous" to take on a plane...

Why, because some Korean company says so (because the FDA told them too).

Interestingly, in Pennsylvania at least, vape shops sell 18650's for non-vaping uses because of taxes.

So perhaps taxing 18650's makes them safe?

Good thing people are dumb and buy this nonsense.  As well as buy the nonsense that lithium ion batteries are generally safe (which they are not).

(Make sure you always carry a flashlight for you 18650s...)

On the other hand, gasoline is dangerous too.  So is a car or truck or plane.

Me thinks the FDA's fingerprints are here for a purpose.   Specifically these notices will come next from the FDA to vape shops saying, of course, that since we killed off JUUL for you you vape shops can't use 18650's any more because the manufacturer says they are a miss use of their highly dangerous product.

So first good bye JUUL, next good bye 18650.

No one should be surprised.

No one will care for the most part.

Most vapers are too busy hating Trump or believing in fantastical self-deceptive nonsense to notice their health rights being stripped away.

But fear not - soon enough you'll only be enjoying JUUL faux tobacco flavors exclusively at a 7/11 near you.

CASAA: you were explicitly warned about this back in April of 2016.  But no, in the interest of the industry I am just a trouble maker.  What do I know...?

Nothing except to predict what is now happening.

All I can say is the bridge of the Titanic offers an excellent view...

Enjoy!




Thursday, November 1, 2018

FDA: Obesity Trumps Smoking

It's fascinating to relate the decline in smoking in the US with the rise of obesity (from: http://www.resetyourbody.com/6-charts-to-remind-americans-what-normal-healthy-bodies-look-like/)...



with the decline in smoking (from: https://www.ahrq.gov/professionals/education/curriculum-tools/population-health/abrams.html):

Note that the obesity chart above starts roughly
at the peak of this chart in 1960...
According to this site (https://www.milkeninstitute.org/publications/view/944) obesity costs about 9.3% of the US gross domestic product.  Smoking accounts for a mere 8.7% of the GDP.  Obesity costs range into the one and a half trillion (with a "T") US dollars a year.  Smoking a paltry $170 billion (see this site: https://ash.org/u-s-taxpayers-bear-cost-of-smoking/).

Yes there are many charts out there but the bottom line is the same.

Is there a causal relationship here?

It's hard to say.

Other's have postulated a relationship (see: https://www.statnews.com/2016/02/05/are-fewer-smokers-obesity-rate-linked/).  This article attributes a gain of 11-12 pounds to quitting smoking.

One has to wonder if instead of hitting the JUUL or Winston little Jr. is happily slurping up donuts, pop tarts, and all the rest of the processed delights offered by busy mom and the local vending and convenience outlets.

Imagine that a technology like vaping could reduce the 18% or so that stinky cigs and pop tarts cost the GDP every year.


What's different in the US from, say, Japan where smoking is far less evil?

Why the FDA of course, and big tobacco and big food.

Think about it.

No wonder vaping is evil.

Imagine if little Jr. just sat around and vaped instead of eating all the chocolate donuts and twinkies - why he wouldn't be contributing to the economy at all!

Sunday, September 23, 2018

FDA FOIA: Vaping Leadership FAIL

So this is quite interesting...  I received a second set of FOIA data from the FDA:



The corresponding FOIA PDF docs are here:

https://github.com/OpenSourceVaping/FDA_FOIA_2

The specific request was for "all scientific evidence, emails, scientific evidence, expert information and all validating documents ... 'Not all nicotine-free e-liquids (NFLs) are subject to the deeming rule."

The interesting document is the "Brief" which contains the following (from the brief):

1. “[W]hat is it exactly that a manufacturer of a nicotine-free liquid is required to do to comply with the Rule . . . at this time?” 

Perhaps nothing. Not all nicotine-free e-liquids (“NFLs”) are subject to the deeming rule. Assuming an NFL is not made or derived from tobacco, it is subject to the rule only if it meets the definition of a “component or part”—that is, if it is “intended or reasonably expected” either “(1) To alter or affect [a] tobacco product’s performance, composition, constituents, or characteristics; or (2) To be used with or for the human consumption of a tobacco product,” and is not an accessory. 21 C.F.R. § 1100.3. An NFL that is intended or reasonably expected to be mixed with liquid nicotine would qualify as a “component or part.” 81 Fed. Reg. at 29,017.

Apparently there is no scientific evidence at all for the FDA's position.  What a surprise.  Just a bunch of huffing and puffing (no pun intended) on how, just as in the days of the NICOWater (see FOIA #1 docs), they resort to thuggery in order to bludgeon folks into compliance.  But they know their limits and they don't like to be challenged and lose hence they know when to stop. 

So since "non-tobacco nicotine" (regardless of the scientific nonsense such a thing involves) is not a "tobacco product" it's effectively not possible for the FDA to regulate it (even though there is no way to determine "where" a given nicotine molecule came from).

What does this mean?

Clearly mods, tanks and so forth contain no actual tobacco.

FDA derives its power from the fact that "nicotine" is a tobacco product even though it isn't by somehow pointing to the tobacco plant as the source.  So a mod, tank or coil "become" tobacco products by association (as in "component or part" above) as they move the "tobacco product" (nicotine) from the e-liquid to the human body.

Now if I had a batch of, say 0mg flavoring (like King Arthur's Coconut Flavoring) what would make this a "component or part" as above?

Intent.

King Authur makes flavoring for cupcakes and doesn't "intend or reasonably intend" you to literally put it in your pipe and smoke it...

So TFN from Next Generation Labs is not a "tobacco product" because A) somehow the nicotine molecules in it have nothing to do with tobacco nicotine molecules and B) it's not intended to be mixed with nicotine derived from tobacco.  They list the a portion of the quote "Brief" on their website.

It's interesting that "intent" seems to only come into play when a final consumer is involved.  For example, 100mg nicotine base is available in a free and unregulated fashion from dozens of sources.

It would seem the only way to regulate TFN or it's friends would be to sell a kit with both "tobacco nicotine" e-liquids and TFN e-liquids together.  In which case the FDA might argue that both are now potential "component or part" of a "tobacco product."  Though this seems a significant stretch.

(Note that Sottera prevents the FDA from relating any type of "tobacco product" as a drug unless it's marketed as for "therapeutic purposes.")

It's also important to note that state law, in Pennsylvania for example, is quite different in that it calls out "nicotine" explicitly as part of an e-cigarette.  So while TFN can't be regulated by the FDA it is regulated (taxed in this case) at the state level (see: PA HB 682, page 4) explicitly when part of an e-cigarette.  The only interesting element to the PA law is that the device is regulated only when the vapor it generates involves "... inhalation of which simulates smoking."

As I have argued here extensively the "vaping community" is barking up the wrong tree entirely.

There is ample precedent that enables vaping to be unregulated:

1) Using synthetic nicotine disable FDA regulation as described above.  Yes, the nicotine is about 10x the cost but result is freedom.

2) The myriad of state laws all have either significant flaws or involve unenforceable elements which need to be challenged (this has been done here in PA: http://lwgat.blogspot.com/2018/06/kingdom-vapor-wins-against-state-of.html for "component or part" and I believe "... inhalation of which simulates smoking" will not stand up as it regulates free speech).

3) You have a federal right to treat your own disease (see: http://lwgat.blogspot.com/2015/01/the-right-not-to-smoke.html).

4) "Dual use" devices (as outlined here: http://lwgat.blogspot.com/2017/09/thoughts-on-dual-use-regulation-and.html) make regulation impossible (a USB charger cannot be a tobacco product).

There is enough here to make vaping free of all regulation.

The reason there is failure is because most, unlike Kingdom Vapor, are unwilling to challenge the status quo.  In fact here's what I see leadership doing (corresponding to the above):

1) "Leadership" wants regulation so aren't really interested in challenging it.

2) "Leadership" has no balls.  Kingdom Vapor does and they won.  Think David and Goliath.  But if you don't try then you'll just get #1 (regulation) which is, as I said, what they want.

3) "Leadership" again has no balls.  No one even attempts to make these arguments though the Supreme Court has granted this in numerous cases I outline.  Again, look at #2 above.  Kingdom is not large but they are tough and relentless.  Can't say that for too many others in this business.

4) "King Arthur Coconut" can't be regulated because of it's "intent?"  More hogwash - it's simple to construct cases where this BS breaks down (again - Kingdom Vapor and USB chargers).

JUUL will is just rolling over for the FDA - they are no help but represent 70% of the market at the time of this writing.

The FDA knows what it can and can't do.

Apparently most in the "vaping leadership" either don't care, are unwilling or are in league with the FDA as far as allowing the vaping public to be shut down.

For the FDA, they are expert at the "legal threat" model as I describe above.  What they can't handle is death by a thousand cuts: repeated, small successes based on the law.

Thursday, September 20, 2018

FDA FOIA Success...

I was rather surprised yesterday when I received the following document in response to my original FDA FOIA request (http://lwgat.blogspot.com/2018/01/fda-foia-request.html and the electronic request here: http://lwgat.blogspot.com/2018/02/foia-re-request-via-web.html) on the decision to treat e-cigs as "drugs":


Attached was a CD (gotta love "modern" technology) with three .PDF files.

I had paid my $25.00 US for the search a few months ago thinking the weird emails I got would yield nothing (none-the-less I didn't want to owe the government any money so I paid).

I put the PDFs here: https://github.com/OpenSourceVaping/FDA_FOIA_01 (you can click on the PDFs and view them there or choose the green "Clone or Download" button and then "Download ZIP." (I used github.com to keep this with the Open Source Vaping materials.)

A quick scan through reveals some interesting nuggets...

The trick here would seem to be to ask for very specific things in the correct way.  The FDA was quite polite and helpful via email at the initiation of this and you have to listen to them.  Though I didn't get everything I thought I had asked for I plan to file more detailed requests going forward.

So it would seem that the stories of the FDA "failing to comply" are merely aberrations. They can and do.

As I promised the FDA I am a "news" organization and here is the original material without partisan comment.

I am also surprised that I have not seen anyone else succeed with this (though they may have and I don't know about it).

Friday, September 14, 2018

FDA: The JUUL of Denial

FDA Commissioner Scott Gottlieb recently posted this discussion of the FDA's attack on the stampede of children run amuck clutching their JUULs.  While I'm sure Scott means well it's hard to pin the the exact source of his concerns related to youth and vaping, for example (from this link):


What the actual truth is on the matter is hard to say but my guess is that the above graphic is true.

For one thing, the vaping market is growing rapidly and now owned at the level of some 70% by JUUL (see juul.com) where we find this interesting information:



Seems old JUUL has figured out what the Marlboro Man knew all along (see this on making Marlboro more addictive fun) - diddling the product (in this case with Benzoic acid - not necessarily the best thing to vape) makes it, er, shall we say, more addictive fun.  Vaping's been around for some time now, in our house some eight years.  No more smokers (unless that pesky FDA punishes people like Mrs. Wolf because of JUUL).

Little wonder everyone and their brother is hitting the JUUL, what with the high-tech, chemlab formulation targeting the most expedient rise in blood/nicotine they could find.

(Or perhaps it's this lawsuit against the FDA claiming the FDA is not regulating vaping products fast enough that's twisting Mr. Gottlieb's knickers...)

No, Scott, I think you've got it all wrong...

Vaping isn't really all the exciting when you take JUUL away.  Mom and dad, and even some big businesses, making plain old USP nicotine (POUN) e-liquids didn't really get the growth that JUUL did.

Don't you wonder about this (hint: Barry Bond on steroids)?

Nobody had this kind of market share before JUUL.

Now, just like that, kaboom!

See what a little industrial chemistry can do to juice up something that's boring and not much fun?

Nicotine salts versus POUN - guess who looses?

My wife and family.

Now the threat in your manifesto is to take away life saving products in the name of public health...

Hmmm...  Not really helping public health to slow down a drop in smoking, is it?

Especially if people go back to smoking because of FDA's actions.

Scott, I'm sure you've seen this video of James Monsees at TechCrunch:

https://techcrunch.com/2018/09/05/juul-says-it-will-use-technology-to-help-you-quit-e-cigarettes-too/

Why, they've solved the problem they've created by "tobacco education."

Sure...

Smoking is declining because of vaping - JUUL is making it faster, but in a bad way - their doing it too fast.

On the other hand I guess you like JUUL because it's a one stop regulation shopping deal - no messy mom and pop's to regulate.  Just let JUUL get really big in the market and bam all they sell is taste-frree vape that sends people flocking to cigarettes (oops!)

You've got a lot of high and mighty talk in your manifesto...

But it really sounds like you are selling out (or at best threatening to sell out) smoke free adults for a problem that you can fix by stamping out JUUL... er, wait, that won't work either because the happy little JUULers like the host in the Monsees video will go back to smoking...

(And one more thing Scott - listen how she talks about the damn thing?  Like it's an opium pipe or something.  There's like a dozen people in my family who vape - and I know many more - who don't JUUL and they don't talk like her either...)