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Saturday, December 1, 2018

Chlorophyll and Billirubin Fluorescence at 460nm

Chlorophyll and billirubin fluoresce with blue light with a frequency of about 460nm.

There is an interesting link here showing the structure of heme (blood from which billirubin is derived) and chlorophyll (image from the link):


You can see how an unwound (my term) heme create the billirubin structure:

The fluorescence is described here and can be triggered with common plant lights:


Thursday, November 29, 2018

Scott Gottlieb: FDA FOIA #3: Bolliger Study

I found this study from 2000 in the latest FOIA response:  https://www.bmj.com/content/bmj/321/7257/329.full.pdf.  Hopefully this is not old news.

Study Objective: To determine whether use of an oral nicotine inhaler can result in long term reduction in smoking and whether concomitant use of nicotine replacement and smoking is safe.

The study describes something remarkable similar to vaping: "The active treatment comprised nicotine replacement through an inhalation device (Nicorette Inhaler, Pharmacia and Upjohn).12 13 The inhaler consists of a plastic mouthpiece into which a disposable cartridge containing 10 mg nicotine and 1 mg menthol is inserted. At room temperature the total available nicotine content is 4-5 mg per cartridge. The inhaler delivers about 13 ìg of nicotine per puff (average puff volume of 50 ml), which means that about 80 puffs are required to obtain 1 mg nicotine. [My description of the Nicorette Inhaler relative to vaping was published here.]"

The result: "In summary, our study shows that sustained, long term reduction in smoking with the nicotine inhaler can be achieved and maintained. Smoking reduction seems a feasible first step towards improved health and may ultimately lead to complete smoking cessation in people unable or unwilling to stop smoking abruptly."

Scott: I wonder why the FDA CTP would take this down off their web site?

FDA: FOIA Response #3

I recently wrote "Scott Gottlieb: JUUL is Now Your Bitch" and "Scott Gottlieb: JUUL's Industrial Revolution Runs Away" (where I talk about this FOIA request).



As part of the latter I filed another FOIA request related to "The changes that FDA is allowing to these labels reflect the fact 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.

The changes being recommended by FDA include a removal of the warning that consumers should not use an NRT product if they are still smoking, chewing tobacco, using snuff or any other product that contains nicotine—including another NRT."

This statement used to be present on the FDA web site but was recently removed: see this.

I began interacting with the FDA FOIA people (interestingly this request went directly to a fellow with "JD" after his title who was relatively aggressive in responding).

In the end here's where it ended up: "Good Morning Todd,

Thanks for having a look at what’s been located thus far and clarifying the request for me.

I think I’ve located exactly what you’re asking for.

The consumer updates announcements are the consequence of the Federal Register announcements, like a news headline. They are usually based upon permanent agency notices. In this case the notice was this: “Modifications to labeling of Nicotine Replacement Therapy Products for Over-the-Counter Use,” 78 FR 19718, published on April 2, 2013. Please navigate to this link: https://www.regulations.gov/document?D=FDA-2013-N-0341-0001 , and scroll down to section IV, “published Literature Supporting Proposed Labeling Revisions.” You will find the complete list of references for the labeling changes. 

I will call in a few minutes to confirm that this is what you’ve been looking for.

Many thanks,
..."

(NOTE: The FDA FOIA responder made clear NRT does not include vaping.)

Following the link (https://www.regulations.gov/document?D=FDA-2013-N-0341-0001) you see section IV.

I have underlined several items related to, for example, nicotine inhalers and flavoring, that seem quite interesting.

The next step will be to track down these actual documents.

(From FOIA the link...)

IV. Published Literature Supporting Proposed Labeling Revisions

The published literature we have relied on in making the determinations contained in this notice is listed in this section of the document. Copies of the published literature will be on display in the Division of Dockets Management (see ADDRESSES) and may be seen by interested persons between 9 a.m. and 4 p.m., Monday through Friday, and are available electronically at http://www.regulations.gov.

1. Batra, A., et al., “Smoking Reduction Treatment With 4-Mg Nicotine Gum: A Double-Blind, Randomized, Placebo-Controlled Study,” Clinical 78(6):689-96, 2005.

2. Benowitz, N.L., et al., “Suppression of Nicotine Intake During Ad Libitum Cigarette Smoking by High-Dose Transdermal Nicotine,” Journal of Pharmacology and Experimental Therapeutics, 287(3):958-62, 1998.

3. Blondal, T., et al., “Nicotine Nasal Spray With Nicotine Patch for Smoking Cessation: Randomised Trial With Six Year Follow Up,” BMJ, 318(7179):285-8, 1999.

4. Bohadana, A., et al., “Nicotine Inhaler and Nicotine Patch as a Combination Therapy for Smoking Cessation,” Archives of Internal Medicine, 160(20):3128-34, 2000.

5. Bolliger, C.T., et al, “Smoking Reduction With Oral Nicotine Inhalers: Double Blind, Randomised Clinical Trial of Efficacy And Safety,” BMJ, 321(7257):329-33, 2000.

6. Bullen, C., et al., “Precessation Nicotine Replacement Therapy: Pragmatic Randomized Trial,” Addiction, 105(8):1474-83, 2010.

7. Dale, L.C., et al., “High-Dose Nicotine Patch Therapy. Percentage of Replacement and Smoking Cessation,” JAMA, 274(17):1353-58, 1995.

8. Etter, J.F., et al., “Nicotine Replacement to Reduce Cigarette Consumption in Smokers Who Are Unwilling to Quit: A Randomized Trial,” Journal of Clinical Psychopharmacology, 22(5):487-95, 2002.

9. Etter, J.F., et al., “Post intervention Effect of Nicotine Replacement Therapy on Smoking Reduction in Smokers Who Are Unwilling to Quit: A Randomized Trial,” Journal of Clinical Psychopharmacology, 24(2):174-79, 2004.

10. Etter, J.F., et al., “Nicotine Gum Treatment Before Smoking Cessation—A Randomized Trial,” Archives of Internal Medicine, 169(11):1028-34, 2009.

11. Hajek, P., et al., “Dependence Potential of Nicotine Replacement Treatments: Effects of Product Type, Patient Characteristics, and Cost to User,” Preventive Medicine, 44(3):230-34, 2007.

12. Hall, S.M., et al., “Extended Treatment of Older Cigarette Smokers,” Addiction, 104(6):1043-52, 2009.

13. Hatsukami, D., et al., “Effects of High Dose Transdermal Nicotine Replacement in Cigarette Smokers,” Pharmacology, Biochemistry, and Behavior, 86(1):132-39, 2007.

14. Horst, W.D., et al., “Extended Use of Nicotine Replacement Therapy to Maintain Smoking Cessation in Persons With Schizophrenia,” Neuropsychiatric Disease and Treatment, 1(4):349-55, 2005.

15. Houtsmuller, E.J., et al., “Flavor Improvement Does Not Increase Abuse Liability of Nicotine Chewing Gum,” Pharmacology, Biochemistry, and Behavior, 72(3):559-68, 2002.

16. Hughes, J.R., et al., “A Randomized, Controlled Trial of NRT-Aided Gradual Vs. Abrupt Cessation in Smokers Actively Trying to Quit,” Drug and Alcohol Dependence, 111(1-2):105-13, 2010.

17. Joseph, A.M., et al., “Chronic Disease Management for Tobacco Dependence,” Archives of Internal Medicine, 171(21):1894-1900, 2011.

18. Lerman, C., et al., “Genetic Variation in Nicotine Metabolism Predicts the Efficacy of Extended-Duration Transdermal Nicotine Therapy,” Clinical Pharmacology and Therapeutics, 87(5):553-57, 2010.

19. Lindson, N. and Aveyard, P., “An Updated Meta-Analysis of Nicotine Preloading for Smoking Cessation: Investigating Mediators of the Effect,” Psychopharmacology, 214(3):579-92, 2011.

20. Murray, R.P., et al., “Safety of Nicotine Polacrilex Gum Used by 3,094 Participants in the Lung Health Study. Lung Health Study Research Group,” CHEST, 109(2):438-45, 1996.

21. Murray, R.P., et al., “Does Nicotine Replacement Therapy Cause Cancer? Evidence From the Lung Health Study,” Nicotine & Tobacco Research, 11(9):1076-82, 2009.

22. Newhouse, P., et al., “Nicotine Treatment of Mild Cognitive Impairment: A 6-Month Double-Blind Pilot Clinical Trial,” Neurology, 78(2):91-101, 2012.

23. Piper, M.E., et al., “A Randomized Placebo-Controlled Clinical Trial of 5 Smoking Cessation Pharmacotherapies,” Archives of General Psychiatry, 66(11):1253-62, 2009.

24. Rennard, S.I., et al., “Efficacy of the Nicotine Inhaler in Smoking Reduction: A Double-Blind, Randomized Trial,” Nicotine & Tobacco Research, 8(4):555-64, 2006.

25. Rose, J.E., et al., “Mecamylamine Combined With Nicotine Skin Patch Facilitates Smoking Cessation Beyond Nicotine Patch Treatment Alone,” Clinical Pharmacology and Therapeutics, 56(1):86-99, 1994.

26. Rose, J.E., et al., “Nicotine-mecamylamine Treatment for Smoking Cessation: The Role of Precessation Therapy,” Experimental and Clinical Psychopharmacology, 6(3):331-43, 1998.

27. Rose, J.E., et al., “Precessation Treatment With Nicotine Skin Patch Facilitates Smoking Cessation,” Nicotine & Tobacco Research, 8(1):89-101, 2006.

28. Rose, J.E., et al., “Precessation Treatment With Nicotine Patch Significantly Increases Abstinence Rates Relative to Conventional Treatment,” Nicotine & Tobacco Research, 11(9):1067-75, 2009.

29. Schuurmans, M.M., et al., “Effect of Pretreatment With Nicotine Patch on Withdrawal Symptoms and Abstinence Rates in Smokers Subsequently Quitting With the Nicotine Patch: A Randomized Controlled Trial,” Addiction, 99(5):634-40, 2004.

30. Tønnesen, P., et al., “Higher Dosage Nicotine Patches Increase One-Year Smoking Cessation Rates: Results From the European CEASE Trial,” European Respiratory Journal, 13(2):238-46, 1999.

31. Wang, D., et al., ” `Cut Down to Quit' With Nicotine Replacement Therapies in Smoking Cessation: A Systematic Review of Effectiveness and Economic Analysis,” Health Technology Assessment, 12(2):iii-iv, ix-xi, 1-135, 2008.

32. Wennike, P., et al., “Smoking Reduction Promotes Smoking Cessation: Results From a Double Blind, Randomized, Placebo-Controlled Trial of Nicotine Gum With 2-Year Follow-Up,” Addiction, 98(10):1395-402, 2003.

33. West, R., et al, “A Comparison of the Abuse Liability and Dependence Potential of Nicotine Patch, Gum, Spray and Inhaler,” Psychopharmacology, 149(3):198-202, 2000.

34. Zevin, S., et al, “Dose-Related Cardiovascular and Endocrine Effects of Transdermal Nicotine,” Clinical Pharmacology and Therapeutics, 64(1):87-95, 1998.

Saturday, November 24, 2018

The Ice Age Cometh (Again)...

In July of 2017 I wrote "The Ice Age Cometh..." describing how actual astrophysical science was potentially pointing in a much different direction that "Climate Change" Science.

We are again heading into a significant solar minima (2019 to 2020).  This means few if any sun spots and a reduced solar energy output.  For those with a modern education this means less energy from the sun to warm the earth.

NASA satellites have shown for some time (2002 - 2009) that the thermosphere (outermost layer of atmosphere) is cooling and shrinking (see this and this).  Does this mean we are headed into a new ice age?


Of course, there are skeptics (this for example, though written in 2013 before the minima and seems to exclude NASA satellite data).

In any case there's a lot to show no one really knows: hypothesizing is fine as is measuring actual data.  But so far, at least, there's not a lot of reconciliation between the sciences.

And let's not forget about Mars and it's now measured effect on our planet...

Friday, November 23, 2018

1970's ION Propulsion

An article An Airplane With No Moving Parts appeared over at IEEE Spectrum: MIT researchers have used ion drive—until now a purely space-based system—to fly a model plane a short distance indoors.

There's quite a lengthy video about the invention of this device here featuring Steven Barrett, associate professor of aeronautics and astronautics at MIT:



The article also says "... Ion drive was first demonstrated 101 years ago by famed rocketeer Robert Goddard, and it’s now routinely used in space, for instance to reposition satellites." 

Here's the dubious link for that

Goddard's rockets never reached outer space (he died in 1945).

As it turns out US Patent 3,130,945 describes exactly the device shown at IEEE Spectrum.  Here's the single claim from this 1964 patent:

"1. IN COMBINATION WITH FLYING APPARATUS COMPOSED OF A STRUCTURE SUPPORTING DISCHARGE ELECTRODES FOR CAUSING ADJACENT AIR MODULES TO BECOME ELECTRICALLY CHARGED SPACED FROM A GRID OF ELECTRICAL CONDUCTING MEANS FOR NEUTRALIZING THE CHARGE ON ELECTRICALLY CHARGED MOLECULES WHOSE CHARGE WAS CAUSED BY SAID DISCHARGE ELECTRODE AND MEANS FOR APPLYING A HIGH D.C. POTENTIAL BTWEEN SAID ELECTRODES AND SAID GRID TO CAUSE AIR TO MOVE FROM SAID ELECTRODES TOWARD SAID GRIDS TO PROVIDE A PROPULSION FORCE FOR SAID FLYING APPARATUS, AND ANTENNA MEANS FOR USE WITH RADIO FREQUENCY ENERGY SIGNALS, SAID ANTENNA COMPRISING A PLURALITY OF ELEMENTS WHICH SERVE ALSO AS PART OF SAID STRUCTURE FOR THE FLYING APPARATUS BY BEING CONNECTED ELECTRICALLY TO ONE TERMINAL OF SAID HIGH D.C. POTENTIAL TO ASSIST IN PROVIDING PROPULSION FORCE FOR SID APPARATUS."

I was intrigued by this article because I actually know quite a bit about this.

You see, about 47 or so years ago building ion-powered mechanical devices wasn't that uncommon.

I couldn't say where I got the idea from exactly, perhaps some variant of this Popular Mechanics article (I was not a fan, I read Radio Electronics and Popular Electronics and followed "Carl & Jerry quite closely).  I did not think it up myself, of that I am sure, the details are apparently lost to time.

(Lest you think I am kidding look up the Badger State Science Fair from the early 1970's - if you can find it.  Voice activated locks,  Plasma.  Lasers. Computers. All manner of things taken as "modern" today.)

Being 12 years old and living in rural Wisconsin didn't leave much room for entertainment.  Grandpa had an endless supply of electronics mags so that's what I turned to.

Unlike the IEEE article there weren't any well-to-do donors to fund the project so creativity was required.

First off a high-voltage power supply was required, at least 20kV.

The best source for this were abandoned TVs by the side of the road.  I specifically remember a DuMont TV I picked up one day while driving somewhere with my dad.  Something along these lines:



In the olden days TV's often had schematics pasted onto the inside back cover.  This made it easy to see if it contained all the parts you needed.

Before you could build a 20kV power supply out of tubes you needed aa 250vDC power supply to run the tubes.  This was easy because all TV's at the time contained such a DC power supply.  All you had to do was strip down the TV to remove the chassis.  Then strip the chassis down to remove the parts you didn't need leaving the 250vDC supply (usually a couple of transformers, a couple of rectifier tubes (5U4's), a couple of big caps and miscellaneous parts.

Next step was to convert the horizontal sync portion of the circuitry into a free-running multivibrator.  Something along these lines:



I used two distinct tubes and had to learn RC math to calculate the frequency needed.  Then you extracted the "flyback" transformer and tapped off the 20kV line:


Next you attach a pin pointing up off the tap.  Of course, you insulate things well: I used acrylic plastic my father brought home from job sites or clients.

When fired up, aside from the screaming flyback (no doubt because my frequency calculations were off), there is the distinct sound of ionization and a definite "wind."

Finally you bend up some wire like this:

Set it on the pin (the pin stuck through the loop) and watch it spin!

The whole apparatus probably weighed 25 pounds and plugged into a wall outlett so there was no chance of flight but the principles were there (it would take another 40 years for batteries to catch up).

It this weren't fun enough I learned how to build capacitors out of tin foil and acrylic.  The tin foil would convulse on discharge.

Thursday, November 22, 2018

Scott Gottlieb: JUUL's Industrial Revolution Runs Away...

My father spoke about this book (http://www.steinerag.com/flw/Books/a0328.htm#BoxCover) when I was young.  He studied under Wright...


I always found the statement "The Industrial Revolution Runs Away" a very interesting take on  disruptive technologies (like vaping).  Government can't control everything.  Wright figured this out in 1932.

Today, some 85 years later FDA is cracking down on JUUL; wrestling JUUL down by the horns to prevent "the children" from vaping.

Unfortunately for the FDA the industrial revolution (in this case JUUL tech) is running away.  The horse is out of the barn.  To wit from "Not Blowing Smoke" on Facebook we have


Note the second line "Santa Cruz will allow youth to possess and use cigarettes but not vapor."

Hmmm...

I've met the guy that runs this.  I really don't think he is making this up.

I've written extensively about what would happen when the FDA "steps in" to save us all from vaping: Opioids vs E-Liquids: How the FDA Harms Children, Withholding THR from Children is Abuse and FDA: The JUUL of Denial as examples.

People will be encouraged to smoke.

Now it seems to be coming true, at least in California.

Adding fuel to this fire is the concept of JUUL "modding" as outlined in this Motherboard article:



Seems like JUUL has seeded the US with millions of recycle-enabled JUUL "pods" - (no, no says JUUL, they can't be refilled).

Ha, Ha, Ha says Motherboad.

Seems like the kiddies that wrote the article have rediscovered the origins of vaping:


Stuff that's freely available anywhere to anyone (see what I wrote on King Arthur baking flavoring).

Now there's no doubt millions of JUUL pods circulating that can be easily refilled via common hacking and maker techniques.  Enterprising kids can rifle through the garbage and sell their pals refilled JUUL pods.  Given JUULs reach there's virtually an unlimited supply of materials. If I were in high school this would be a big money maker: refilling JUULs and helping kids NOT SMOKE.

Imagine what will happen when these kiddies figure out they don't just need to use Mango...

Given you now own this problem where do you go next Scott?

Ban PG and VG?

Freeze sales of flavoring?

Maybe the SS should step in and rifle through everyones lockers, cars and homes for vaping supplies.

YOU have the kiddies heading back toward smoking, at least in Santa Cruz, instead of vaping... (Well, maybe just the loons in CA have done this but they are taking their directions from your anti-smoking minions.)

So what's next,  Scott?

Personally I think the FDA's attempts to put the Genie back in the bottle needs to end.

It's not working.

There is no real statistical basis for the under age vaping "emergency" except it looks bad relative to the status quo.

And I get that.

But wouldn't it be better if kids in CA couldn't possess cigarettes instead of vapes?

The collective "you" know (or at least you used to) that nicotine isn't the problem.

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...)

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...