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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...)

Monday, September 3, 2018

FDAs Orwellian Editing of Nicotine and Flavoring History


On Sunday, May 11, 2014 I wrote "Nicotine - Not Addictive" where I linked to an FDA web page linked at "http://www.fda.gov/forconsumers/consumerupdates/ucm345087.htm"

From the link I wrote (yes, I copied the text from the original link):

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."

Periodically I go back and check the links.

Recently I found that this and other links are broken.

Apropos I found this quote (from here) from George Orwell's 1984:

"As soon as Winston had dealt with each of the messages, he clipped his speakwritten corrections to the appropriate copy of ‘The Times’ and pushed them into the pneumatic tube. Then, with a movement which was as nearly as possible unconscious, he crumpled up the original message and any notes that he himself had made, and dropped them into the memory hole to be devoured by the flames."

On Saturday, May 10, 2014 I wrote "Diacetyl - What's the Real, Objective Danger?" about the scientific reality of diacetyl and "popcorn lung" in e-cigarettes.  The post linked to this FDA page:

http://www.fda.gov/ohrms/dockets/dockets/06p0379/06p-0379-cp00001-11-NIOSH-vol1.pdf

and this OSHA page

https://www.osha.gov/dsg/guidance/diacetyl-guidance.html

Following these links takes you to bupkis (404 Page Not Found for those with a modern education).

Why is this important?

Because what was once deemed "safe" and "acceptable" will now become "dangerous" as the FDA "cracks down" on "flavorings."

One really has to appreciate the prescience of Orwell's 1984.

One imagines "Winston" deep in the bowels of the FDA and CDC busily deleted inconvenient web pages that conflict with their current plans.

Liberal educators and the media also must be congratulated in removing critical thinking from decades of education, just as Orwell predicted in 1949.  Without this skill few will be able to read this blog post and understand what's happening.

After slamming the FDA "Deeming Regulations" in "Deeming Regs: A War on Science and Common Sense" where cell phones and software become "tobacco products" suddenly there is a "labeling change" and they aren't any longer (see this).

One has to believe that the FDA is proud of all this in the finest Orwellian sense:  Changing history to reflect the current political thinking.

Again, I call out @SGottliebFDA to address this wrong.

Fewer people will die if you, @SGottliebFDA, allow vaping to proceed naturally.

Restricting it will simply turn people back to smoking...

EDIT: Link to old FDA page here: https://archive.is/ejhfI


Sunday, September 2, 2018

From E-Cigs to Elphel: The Age of the Heroic Inventor is Not Over

From the article...
Here's something that's both sad and wrong by a "Robert W. Lucky..."

The Age of the Heroic Inventor Is Over
https://spectrum.ieee.org/at-work/innovation/the-age-of-the-heroic-inventor-is-over

The gist here is that no longer are there any heroic individuals sitting in their basements creating disruptive technologies - it's all high-end, committee drive stuff like GPS or the Internet.

This is just plain wrong.

Today's "disruptor" business world is focused on hype and drivel, not on anything real in terms of tech.

As an example, pdfExpress was created from a flash of insight in six weeks.  The "innovation" was to treat the content of the PDF file as a data stream instead of a sequence of graphic arts operations.  The result was a product that did things three (yes '3') orders of magnitude faster than anything else.  It generated literally billions of US dollars (yes 'billions') in revenue for its customers.  It's still in use today, twenty years later.

It was extremely disruptive.  What's been around longer that anyone might recognize? Linux, some GNU stuff, other similar things...

pdfExpress was conceived one evening while sitting in front of the TV thumbing through a PDF book.

Sure, this was software, but there are many cases of hardware as well.  Consider Elphel as an example: a couple of guys doing what NVIDIA does with twelve thousand.

And what about e-cigarettes?  Hon Lik created them in 2003, he was a pharmacist.  This will most likely be the greatest improvement to public health (fewer "combustion tobacco" deaths by far) of the last seventy five years.  Literally something you can build at home with minimal technology skill.

What's true today is there is a much stronger "herd" mentality.  Even during the creation of pdfExpress twenty years ago the "inertia" of the market couldn't really digest the concept much less the reality.  It was too foreign.  They simply didn't believe it.

Hon Lik's invention faces active regulatory attack from governments world wide.  Why?  Because it takes revenue away from existing products and it's frightening to people associated with those products - even though those products are less effective (and more will die if only they are used).

Great products are still developed and will continue to be developed.


Thursday, August 16, 2018

Vape Shop: Safer Than a Kitchen...

So the CDC published this report on Evaluation of Chemical Exposures at a Vape Shop.
From the report...

In part it says, beginning on page #13 (underlines mine): "None of the airborne concentrations of the specific flavoring chemicals we measured were above applicable OELs although we detected low levels of two flavoring chemicals, diacetyl and 2,3-pentanedione, in the personal and area air samples. NIOSH has an action level for diacetyl of 2.6 ppb [NIOSH 2016] but our sampling method (evacuated canisters) does not measure exposures at this level. Therefore, some of the personal air sampling results for diacetyl could have been above the NIOSH action level. When diacetyl exposures are above the action level, NIOSH recommends that employers develop a medical surveillance program and implement engineering and work practice controls to keep exposures below the REL [NIOSH 2016].

Formaldehyde is a breakdown product [see Note #1] of propylene glycol, which is present in the e-liquids used in e-cigarettes. Personal air sampling results for formaldehyde were well below the OSHA PEL and OSHA action level. They were also below the NIOSH REL, which is much lower than the OSHA PEL. Area sampling results showed that background formaldehyde concentrations were similar to the personal sampling results. Low concentrations of formaldehyde exist in many indoor environments because of off gassing from furnishings, clothing, and other materials.

In addition to the specific flavoring chemicals we looked for in the air samples (diacetyl, 2,3-pentanedione, 2,3-hexanedione, acetoin, and acetaldehyde), we also identified other flavoring chemicals and VOCs in the air of the vape shop. Results from the area air samples we collected using thermal desorption tubes showed very low concentrations of 102 chemicals. These included chemicals found in cleaning products used in the shop (limonene, isopropanol), chemicals that are common ingredients in personal care products (decamethylcyclopentasiloxane), and other chemicals that could be classified as flavoring chemicals. Background concentrations of airborne nicotine, propylene glycol, and VOCs in the air of the shop were also very low.

Over the 2 days of our evaluation, we observed that very few customers vaped inside the shop. In contrast, we found that employees vaped throughout the day. Therefore, most of an employee’s exposure to vaping-related chemicals inside this vape shop was due to direct inhalation of vaping-related chemicals from their personal e-cigarette, as well as secondhand emissions from coworkers’ e-cigarettes. Our air sampling only measured vaping chemicals present in the air from the emissions of e-cigarettes and exhaled breath. ..."

Note #1: Google "propylene glycol breakdown products" and various variations.  You don't see much about formaldehyde (see this Dow publication as an example).  It probably happens but its unclear from reading through a number of similar articles and publications how or when.

In general from reading this it would seem that anything dangerous in the vape shop is there for non-vaping reasons, e.g., outgassing of furniture, cleaning products, etc.

I would say a kitchen is far, far more "dangerous" than a vape shop (see Diacetyl - What's the Real, Objective Danger?) as far as the airborne chemicals they are looking for...

Monday, August 6, 2018

Scott Gottlieb: Muddled Milk, Nicotine and Hypocrisy

I like to spend a little time over at Ars Technica now and then.

Today I found this article (What is Milk? Answer Muddled after Almond Milk Mixes with Cow Milk).  In the article FDA Commission Scott Gottleib (image left from this FDA web page) is said to note: "Just last month, Food and Drug Administration commissioner Scott Gottlieb noted that current agency standards indeed identify milk products specifically as those derived from lactating animals—which would exclude non-mammary liquids wrung from nuts, soy beans, rice, coconuts etc. from being called “milk.” Gottlieb said the agency would review the situation and soon issue a new regulatory guidance on how beverage makers should use the term in product marketing and labeling..." [ underline mine ].

So it would appear Commission Gottlieb doesn't like things to called what they are not, i.e., "milk" from almonds is not actually milk as from lactating animals.

The full FDA commentary appears to be here.

In we see Gottlieb saying: "... One area that needs greater clarity – and which has been the subject of much discussion of late – is the wide variety of plant-based foods that are being positioned in the marketplace as substitutes for standardized dairy products. Many of these plant-based foods use traditional dairy terms (e.g., milk, yogurt, cheese) in the name of the product. For instance, we’ve seen a proliferation of products made from soy, almond or rice calling themselves milk. ..."

I wonder if this also applies to calling "nicotine" a "tobacco product?"

What hypocrisy!!!

C'mon Scott...  What do you mean here?  Clearly nicotine is a chemical compound found many places in nature, not just tobacco.

The article title also makes the same point I did in this post (Schrodinger's Nicotine: Not Derived From Tobacco) about how mixing "tobacco nicotine" and "non-tobacco nicotine" wreaks havoc on your CTP's  scientifically nonsensical ideas.

Thoroughly mixing one liter of nicotine from another, non-tobacco source into a 100 liters of nicotine from tobacco by the most basic of science makes the resulting nicotine "not derived from tobacco." (Of course, at the atomic level all nicotine is just that, nicotine.  You can pretend all day long that somehow a molecule from one plant, like tobacco, is different from a molecule of the same compound from another but that would simply be false...) 

So to me it looks like even you don't believe the silly non-scientific bullshit your Center for Tobacco Products (CTP) is pushing.

Trump put you in charge of the FDA and the general consensus was you had, at least at one point, owned stock in a vaping company.  This gave us all hope you would set things straight for the vaping world.

Up until now I (and many others) have been disappointed.  Sure you extended the doomsday clock a few more years but nothing came of addressing the true nonsense.  (Doomsday is still doomsday.)

But perhaps your press release on milk means there is hope.

From my reading of the tea leaves your boss doesn't like nonsense and bullshit regulations.

Yet hear you are - directly contradicting the CTP with what I think makes perfect sense.

C'mon Scott, apply your thinking across the board.

(Oh, and BTW, your high tech pals at Juul aren't trying to poison children.  It's your lax state tobacco programs and parents of smoking children that are undermining you monthly stats.)