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Tuesday, May 24, 2016

Hoosier Vapers, Common Sense and Simple Science

I have to say that I like the Hoosier challenge to the Indiana anti-vaping law.  This is not just a "you didn't do your homework lawsuit."  It seems to reach further into the more substantive issues.

(The link above is to a drop box containing both the suit as well as the arguments of the defendants - in this case the State of Indiana.  So far I don't see the state refuting the basic science put forth.  There is, of course, argument about the application of the law which is harder to discern at this point.)

This suit contemplates a difference between tobacco and nicotine, a difference between e-liquid containing nicotine and one that does not, a difference between a "tobacco product" and things not made of tobacco.  Seems like common sense.

It also addresses an important notion of basic science: nicotine is not tobacco.  One which various advocacy people think cannot be won.

In Count III we here customer's won't be able to discern between "tobacco nicotine" and synthetic nicotine (98).  Similar to this post I wrote two years ago.  Of course, if it fails I accept my failure as well.  None-the-less its good to see there is a place for common sense and science.


Next we see this:


Here they argue that the new law creates standards that are stricter for e-liquid than for food or tobacco.  I think this applies in the case of the FDA "deeming regulations" as well.

Finally:


Here the argument is simple: nicotine is a "naturally occurring substance" to which the state magically applies special properties if its used in e-liquid and magically makes e-liquid without nicotine an item to be regulated.

Of course there are substantive legal elements here if you read the various back and forth between the parties in the drop box.

But these types of arguments are what's required to keep vaping free.

Arguments to delay the FDA, for example, don't really make vaping free.  These arguments do.




Saturday, May 21, 2016

Maybe the Enemy isn't the FDA...

"We have met the enemy and it is us." - Pogo

I have been involved in vaping advocacy for some time.  Not as a "Greg Conley" or other famous vaping personage but as a grunt using what I know to try and advance an agenda of "less risk" (to quote the FDA) with regard to vaping and combustion smoking (mostly technology stuff).

In 2011 most of my family were smokers...  today there are none.

I am writing this column today because there is no leadership of the "pro vaping" forces.  No discernible over-arching strategy (financial, technological, political, etc.).

Yes, there are a number of individual people who are at the "top of the food chain" in the sense are very involved and active within their personal sphere.  But the real question that needs to be asked is "involved in what?" exactly.  

Everyone throwing rocks and sticks at the dragon while our homes are incinerated.

Vapers want vaping to be "left alone;" the vile FDA has created deeming regulations so that all of vaping can now look like this according to vice.motherboard:



A canonical "big tobacco" package.  Vetted, taxed, approved and FDA cleared (just like Vioxx).  Properly labeled (er, maybe or maybe not), and ready for Joe Six Pack to consume during the game.

The regs from the FDA have been a long time in coming and I have posted about them for several years.  They are no surprise.

What has been surprising to me, though, is the level of "resistance" to addressing the regulations as they were pending.

I recall fondly posts being thrown out of the CASAA Facebook page and the e-cigarette forum for trying to spur financial advocacy, e.g., a variety of contests (the first non-tobacco nicotine for which I offered a $10,000.00 USD cash price - since withdrawn).  The reason for this?  Its a "contest."  No, it was supposed to be like the fucking "X Prize" for space exploration!  Was that a "contest?"

I could go on but the bottom line is there seems to be very little interest in leading consumers to actually do things about the regulations other than complain and "call your congressman."

How's that working out?

I've been calling mine for two years - he doesn't care, as far as I can see, to touch this political "third rail." 

There is no leadership.

There is no plan other than to let others, e.g., Nicopure or Lost Arts, sue.  As to what this will bring I am not sure but at best it will take years - years of additional uncertainty about a lifesaving product.  What if they sue and win a bad victory for the rest of us - line their pockets and we get shit? 

When I started writing about this there wasn't nearly the positive vaping medical science there is now.  (I went on the words of my daughter and wife who had researched the various chemicals and technologies on the internet around 2011 when it first started in my house: a housewife and fantasy author spent a month digging and ended up five years ahead of the Royal College of Physicians.)

Today we know its safer (or in terms of the FDA deeming regs page #30 - "less risk") - than combustion tobacco.

But as vapers (I vape but never smoked, I've also vaped nicotine for a year but was unable to create a heroin-like addiction promised by the ANTZ) we are utter failures in terms of advancing our cause.  (Truth: I have the mutant gene that makes me not need nicotine; is it an addiction if its genetic?)

I think there are a several reasons for our leadership fail:

First, smokers (and vapers) are by and large cheap - hence all the "givaways" at trade shows, contests online, and so on.  So donating a $1.00 a month to save vaping is far too much to consider or ask. 

Consider there are now about 10,000 vape shops.  Imagine if each shop simply donated $10/week to a legal fund.

$10.00 a week per shop.

10,000 x $10 = $100,000 x 52 = $5,200,000 US dollars for lawyers, suing the FDA, and media time.

All shops spend more than that on soft drinks, energy drinks and junk food.

Only one problem - no one in charge - no place for the money to go.

(Hell, even the pot guy's have NORML...)

Sure we have CASAA - but they are only a "consumer advocacy" organization - they tell you to "call your legislator "(with some success) and what petitions to sign.

We have SFATA, VTA and a few others, but they are for "commercial" businesses - they pay lobbyists (I don't think these organizations will sue).

So here we sit - with nothing clutching holding our underwear at the side of the road.  

Next problem with defending ourselves is this.  Say you create a legal entity to collect this money and hire lawyers.  Now, let's go tell people about it in a CASAA or (an/the) e-cigarette forum...

[ Nasty buzzer sound ] - STOP!!!

You're advertising, i.e., looking for money.

You're promoting... You're EVIL...

We can't have this!  Go a way - your post is deleted!

So what do you do?  You're out the legal fees to set it up and no one can find out about it.

Yep - can't compete with the ads running or the vested interests of God knows who...

BTW - I tried this two years ago - long before http://www.seviausa.org/.  


I took my own money, time, etc. and went around trying to garner interest in getting out front of the deeming regs.  I didn't have enough dollars to close the full deal on my own.  I spent a whole trade show going around to drum up support.  

The result?

Zero interest... (as recently as February of this year there was still a lack of interest in SEVIA USA).

NOTE: Apparently since May 5th (Cinco de Mayo no less) there's been might be a change of attitude.

Another reason we fail to defend ourselves is that there is a great effort afoot to deprive vapers of their Constitutional rights conducted by non-other than vapers.  

Yes, we are our own worst enemy.

"Oh no - you'd don't have the right to vape anywhere its not wanted..."

I have to smell perfume, deodorant, cleaning spray, diacytel-filled cooking odors I don't want to smell but God-forbid not vape!

And such.  Trumpeted by those in charge of CASAA from my perspective at least.

So, er, why not just roll over for the FDA then?  How's the FDA different, say, than a business like Chili's (one of my favorite examples).

We fail because we have no media presence.  

On guy gets on some sub-optimal CNN report for the deeming regs.

Yet there are millions of vapers spending billions of dollars - hey, but we're less than a junkie in societies eyes...

I was thinking: Let's kick that $10/week up to $30/week (oops, maybe no free pizza one week) and get out on the internet and air waves and make some noise...  but there's no where to send the $30 each week.

There's no where to send the check.

And finally we fail on the technology aspect.  

Oh no - vapes banned from planes!

Er, there are standards for battery powered devices and aircraft THAT VIRTUALLY NO ONE IN VAPING PAYS ATTENTION TOO.

In point of fact battery explosions on aircraft are a very bad thing.

Doesn't anyone think we need to pay some bit of attention to this?  If we think things are bad now image if someone with a vape turns out to be the cause of a crash (or even in a car, bus or boat...)?

We need to attend to the actual OBJECTIVE dangers involved and not pretend we don't all know somebody who built a zero-ohm coil, left their mechanical on the car seat with the button pressed, or whatever...

Again - no leadership.

If we want recognition in the world of technical things we need some responsibility for ourselves.  I don't want some unregulated (no pun intended) sex toy in the baggage to take down a plane any more than a vape.

If you haven't guess by now I am somewhat bitter and sad.  It doesn't have to be this way.  I'm a tech guy and I live in the land of self driving cars, cars that will kill people, but we're going to get those whether they do or not, and we don't even need them...  But don't vape sonny... its dangerous!

I don't know how to change things but, as things are, I don't really see much real hope.

(Now the dragon has taken to the air, he's pissed, so he's circling around for a hot fly-over.  We're still standing in the field clutching our wooden spears and staring into the sky...)

How about this:  

It's time for well funded organization.  I don't care who runs it.  I don't care who owns it.  But it must be run for vapers by vapers and must act like we are in this to save our own collective asses lives.

I like many others have (and are) spending a lot of personal resources on this.  Eventually it will run out.

"We have met the enemy and it is us." - Pogo






Friday, May 20, 2016

Family Smoking Prevention and Tobacco Control Act: FDA "Misbranding" Vaping

To quote the Family Smoking Prevention and Tobacco Control Act (2009):

"Section (903): 
    "(a) In General.--A tobacco product shall be deemed to be misbranded--
   "(1) if its labeling is false or misleading in any particular;
   "(2) if in package form unless it bears a label containing--
     "(A) the name and place of business of the tobacco product manufacturer, packer, or distributor;
     "(B) an accurate statement of the quantity of the contents in terms of weight, measure, or numerical count;
     "(C) an accurate statement of the percentage of the tobacco used in the product that is domestically grown tobacco and the percentage that is foreign grown tobacco; and
     "(D) the statement required under section 920(a),"

The deeming regs say "programmable software" must be labeled as a "tobacco product."

It's also interesting me that the we must put the percentage (underlined by me in the above quote) of US and foreign tobacco used in "programmable software" (or eliquid for that matter - which is the chemical compound nicotine, not tobacco).

Somehow the FDA escapes the need to follow Section 903 in the deeming regs - software isn't a "tobacco product" nor does it contain physical tobacco.

Software is actually made up of electrons.

It would surely seem that this labeling of software would be "false."

New FDA "Tobacco Products" - USB Cables, cotton, ohm meters...

As the lawyers descend on the FDA and its "deeming" regulation we see the new suit by Lost Art Liquid including this list of potential "regulated" tobacco products (in addition to software and digital displays):



Unfortunately this is not in text form but we now see "USB cables," "cotton," and "Ohm meters." 

Sunday, May 15, 2016

On the topic of FDA: "Programmable Software" is a "tobacco product..."

So let's look at what the FDA says about software for medical devices.

This says in part:

"2.1

This guidance applies to:

  • Software used as a component, part, or accessory of a medical device;
  • Software that is itself a medical device (e.g., blood establishment software);
  • Software used in the production of a device (e.g., programmable logic controllers in manufacturing equipment); and
  • Software used in implementation of the device manufacturer's quality system (e.g., software that records and maintains the device history record).

This document is based on generally recognized software validation principles and, therefore, can be applied to any software. For FDA purposes, this guidance applies to any software related to a regulated medical device, as defined by Section 201(h) of the Federal Food, Drug, and Cosmetic Act (the Act) and by current FDA software and regulatory policy. This document does not specifically identify which software is or is not regulated."

Which from my perspective as someone with 40+ years of software experience seems reasonable.  You also find this in FAA regulations for things like airplanes (and probably drones real soon).

I have numerous family members involved with and investments in things which this potentially applies to and, if you read the rest of the linked section above, seems reasonably well thought out.  Software development is a complex process and they try to rationalize how someone who makes, say a defibrillator, would go about the process to ensure that it works reliably and doesn't harm people.

On the other hand in the deeming regs we see this (page #8):

"FDA may clarify the distinctions between ‘component’ and ‘part’ in the future. Specifically, "Component or Part" means "any software or assembly of materials intended or reasonably expected: 1) to alter or affect the tobacco product’s performance, composition, constituents or characteristics; or 2) to be used with or for the human consumption of a tobacco product. The term excludes anything that is an accessory of a tobacco product." Components and parts of the newly deemed tobacco products, but not their related accessories, are included in the scope of this final rule. The following is a nonexhaustive list of examples of components and parts used with electronic nicotine delivery systems (ENDS) (including ecigarettes): e-liquids; atomizers; batteries (with or without variable voltage); cartomizers (atomizer plus replaceable fluid-filled cartridge); digital display/lights to adjust settings; clearomisers, tank systems, flavors, vials that contain e-liquids, and programmable software."

Now reading a bit before this we see that the FDA is deeming anything it decides is a "tobacco product" into a "component" or "part" of a "tobacco product" - including batteries, software and digital displays.

This is quite a distinction from the medical software described above.

After some thought it seems to me that this is because of the Soterra decision (also this) that prevented the FDA from treating vaping and e-cigs as medical devices (which they lost in 2010).  So they can't really apply the "software for medical devices" stuff for vaping because they can't call them "medical devices."

So I guess rather than coming up with something reasonable (or because they are unhappy about Soterra) the choice was to make software (or anything else listed in the regs) a "component" of a "tobacco product."

Now a "medical device" is a sensible term when discussing software.  Most modern "devices" these days have some sort of computer in them, even if its just to "debounce" a power switch.  "Software" in this context means the code running some bit of electronic computer hardware inside the "medical device."  The discussion also makes perfect sense in their section "2.1" above when discussing how to develop said software.

On the other hand the new "deeming" regulations seem to lump e-liquid, bottles, flavors and software into the same "component" part model and lash them to the Electronic Nicotine Delivery System (ENDS) device such that these things are all in fact "tobacco products."

This seems a significant stretch because clearly software cannot be "derived from tobacco" primarily because its composed of electrons and does not have a physical embodiment.

Rationally it would seem that over the long haul you would want software regulations, such as the medical ones listed above, to apply to ENDS to ensure that the ENDS don't catch fire, burn someone, cause the batteries to explode, etc. to the extent reasonably possible.

Most devices today use standard chips of various sorts to perform these functions so I don't see a huge need - but I readily admit that there need to be some standards in place.  After all, these devices do output heat at a significant wattage level. Unfortunately for vaping there seems to be zero interest in this type of regulation - save for the Chinese who build most devices.  From disassembling Chinese devices it would seem that they are all using a relatively small subset of technologies which by this point should be properly vetted for safety.

So my thought is that we are being punished, as vapers, for the Soterra decision.

No one could reasonably argue if the FDA suggested the medical device process be applied to ENDS design and manufacture.  (Though with the number of devices already in the field and the extremely small number of recorded "incidents" its seems the industry is doing a very good job policing itself in this area.  Additionally, to acquire insurance when building and selling these devices there is significant impetus to "do the right thing" relative to testing and development.)

But that doesn't appear to be what's been done for ENDS.

Instead they've created a new notion: software as a tobacco product under a different set of rules.

Best Vaping Battery Discussion I Have Seen...

Friday, May 13, 2016

Message to Developers (FDA Deeming...)

NOTE: This cannot be posted directly on Apple's site because it contained the word "tobacco" in the heading.

We license a software-based, multi-platform controller software and hardware that is used, among other things, to control electronic cigarettes we manufacture.  It involves a variety of both proprietary and GPL-based components (used only on the e-cigarette as open source).  Specifically the software I am writing about here uses an iPhone (GRX Controller 1.0), Android, Windows or OS X via Bluetooth or Wifi web page to control the e-cigarettes.  This includes both a display (power levels, etc.) and a controleller (setting power levels).  (Other versions of this run on Windows, Mac, and Android to do the same.)

The FDA recently released these "deeming" regulations that govern this:


and


These regulations, which did not previously as far as I know include these items, now include "Programmable software" and "Digital display or lights to adjust settings."

They make the software (and perhaps hardware) components involved with "Programmable software" and "Digital display or lights to adjust settings" such as our products and potentially iOS, OS X, Windows, Android, etc. "tobacco products."

It would seem that since the phone or computer are the "digital display" there would be a requirement to follow the above regulations.

It would also seem that some portion of my code and perhaps some or all of iOS, Linux, Windows or Mac OS would now qualify as "programmable software" under these regulations.

We will have to comply ourselves but its unclear to me what the FDA will say about other things it now "deems" to be components of tobacco products.

This potentially means that Linux, iOS, Mac OSX, Windows, and who knows what else will be impacted in unimaginable ways.  "Tobacco products" cannot, as examples, be given away or sold to children.

The deadline for this to begin is August 8th, 2016.

This would be funny if it weren't so serious.