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...

https://www.e-cigarette-forum.com/forum/blog-entry/9-battery-basics-for-mods-the-ultimate-battery-guide.4848/

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:

http://www.fda.gov/TobaccoProducts/Labeling/ProductsIngredientsComponents/ucm456610.htm

and

https://s3.amazonaws.com/public-inspection.federalregister.gov/2016-10685.pdf

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.

FDA - All Software On Earth is a "Tobacco Product"

The "Bluetooth" Laisimo Mod

The latest FDA deeming regulations (see pages 7-8 at https://s3.amazonaws.com/public-inspection.federalregister.gov/2016-10685.pdf) include the following language: 

FDA may put in place "restrictions on the sale and distribution of a tobacco product," 

and

This final rule has two purposes: (1) To deem all products that meet the definition of "tobacco product" under the law, except accessories of a newly deemed tobacco product, and subject them to the tobacco control authorities in chapter IX of the FD&C Act and FDA's implementing regulations; and (2) to establish specific restrictions that are appropriate for the protection of the public health for the newly deemed tobacco products. In accordance with section 5 of the Tobacco Control Act, we consider and intend the extension of our authorities over tobacco products and the various requirements and prohibitions established by this rule to be severable.

and

The final rule defines "component or part" and "accessory" to provide additional clarity as to which products are subject to FDA’s tobacco product authority.

and finally

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. Similarly, the following is a nonexhaustive list of examples of components and parts used with waterpipe tobacco: flavor enhancers and the vials in which they are contained; hose cooling attachments; water filtration base additives (including those which are flavored); flavored waterpipe tobacco charcoals and the wrappers or boxes that contain the charcoals; and bowls, valves, hoses, and heads.

Note the underline above includes “digital displays” and “programmable software.”

How interesting - software as a “tobacco product.”

Now the PrimusZ Bluetooth controllable mod (discussed on this blog, sold during 2014 and 2015, and actually still available in limited quantities, supporting iPhone, Windows, Apple and Android) would clearly fall under this designation.  The mod is controlled via the phone or computer display (“digital display”) and uses “programmable software.”

Now the software included here would have to include iOS, Android, Windows and Linux (and I suppose BSD) as the PrimusZ requires these to operate (as in "runs on them in the canonical way as appropriate per platform").

But, as they say “Wait! There’s More…”

Additionally these are available as “free apps” in various app stores - so while not "sold" they could not be given away in an app store.  Are they "free samples" as restricted by FDA tobacco regulations?

There’s also GNU-GPL code used (which is freely available) - is this now a “tobacco product” too (and hence no longer "freely available," at least to "the children?"

These control programs are Bluetooth and/or Wifi applications (using third party software technology) not specifically designed to control a mod but instead to control general classes of electronic hardware controllers wirelessly.

Of course, there’s a web site (now dormant), which uses .NET.  This was called "www.vaporscloud.com" at the time - but now its owned by another unrelated party.  It logged data such that you could see how you were using your "tobacco product."

I wonder if any "data" is also included in this...

Now of course, these commercial packages are a “requirement” to operate the "tobacco product" and enable its operation.  So, at least to me, it would seem to qualify under the above FDA language.

The PrimusZ is, of course, not the only mod like this.  There is the Laisimo (shown above) as well as others made by companies such as SMOK.

So, at least from a regulatory perspective, these FDA regulations would be trumping all software licensing on earth.

UPDATE: First lawsuit: https://lookaside.fbsbx.com/file/Halo%20E-liquids%20challenge%20to%20CTP%20Deeming.pdf?token=AWxI38E5I4UFILDdkQsCXaNDYmjMqwwSYv7RCpV4_XF84-894rrxQ12wt-3ASCIzZXk1TejppPcbZr-JV118QdnGVavK7YC74sSZUKjYminZwn56RyzDlXUJa6Wjtobin1wxFbBFYrhlila4FYNq3Tpg

(Software explicitly called out..._

FDA: Genocide by Regulation

New FDA regulations for vaping:

https://s3.amazonaws.com/public-inspection.federalregister.gov/2016-10685.pdf

This fight will not be won in a court room but instead in the court of public opinion.

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

Vaping as it stands today, without FDA regulations, involves "less risk" than smoking.

Some 440,000 people die each year from smoking-related illnesses.

Will these new regulations make today's vaping experience safer?

The FDA is proposing to interfere with a successful "less risk" option.

Can Mr. Zeller guarantee his regulations will not make "more risk?"

He and the FDA must be questioned about this publicly.

Making vaping a "more risk" scenario is genocide (genocide: the deliberate killing of a large group of people).

Unless we stand up and hold the FDA accountable for these facts we are done for.

Chili's Part III

I have now spoken to your local “AD” and with Mr. Bill Himey (sp?) (214) 755-6835 regarding my recent experience with Chili’s.

Most recently Mr. Himey indicated to me the as far as Chili’s concerned vaping and smoking were “the same.”  I find this position troubling from several perspectives.

Most importantly vaping and smoking are not “the same” - not in terms of definition or physics, not in terms of treatment under the law, and not in terms of health.

To “smoke” obviously you must A) involve combustion and, if you extend “smoke” to mean “smoke cigarettes,” B) use tobacco in some form.

The device which I use, which is not an “electronic cigarette,” does not involve either, nor does it involve nicotine.  It “vaporizes” by heating, not burning, and uses the same ingredients that you find in the cake frosting served in Chili’s (see http://lwgat.blogspot.com/2015/01/ejuice-in-indiana-criminalized-frosting.html).

If I wish to use my device under your current policy I am relegated to the area where people are using combustion cigarettes so I can inhale their second hand smoke.  If I am there with my young grand children they would have to accompany me.  This is both unfair and counterproductive to everyones health.

My device is no different than an inhaler in terms of function and uses the same ingredients, save for any prescription medicines which I am forced to inhale from the inhalers of others, as inhalers which are not banned within your establishments.

Next is the issue of the law.

Smoking cigarettes where I live is in fact banned in establishments such as the Chili’s near me.  As this is the law its perfectly acceptable.

On the other hand, there is no law of any kind related specifically to vaping where I live.  So vaping is in fact a perfectly legal activity.

The problem I see here is this: anyone smoking where it is legally prohibited can reasonably be asked to leave. In the case of vaping, however, there is no legality involved so the question becomes very simply: by what authority am I being asked not to engage in a legal activity?

Equating smoking and vaping outside a legal context is merely a fiction or excuse, and also, I believe, a mistake.

It seems obvious that here the “Pennsylvania Human Relations Act” (see http://www.phrc.pa.gov/Resources/Law-and-Legal/Documents/PA%20Human%20Relations%20Act%20(1).pdf) would address this, but it doesn’t.

What is more appropriate to consider is that smoking cigarettes is a disease.  There is a long and detailed Constitutional history of persons having the right to “treat their own disease” (see http://www.rbs2.com/rrmt.pdf).

Tobacco use is a disease - clearly the DSM (http://www.theravive.com/therapedia/Tobacco-Use-Disorder-DSM--5-305.1-(Z72.0)-(F17.200)) indicates it as such and it kills people, some 440,000 a year.  

Vaping, according to many reputable sources, is an effective treatment (see https://www.rcplondon.ac.uk/projects/outputs/nicotine-without-smoke-tobacco-harm-reduction-0).

Federal Courts have, over many decades, repeatedly indicated that you do have a right to "treat your own disease" in numerous of decisions.

So while its possible to pretend “smoking is vaping” and “vaping is smoking” the legal fiction created simply prevents me from addressing my personal health issues in public accomadations.

Finally, a legal fiction is problematic from the perspective of the “Pennsylvania Human Relations Act.”  

While anyone in authority in a given establishment can ask me to leave if I use my vaping device the question is whether that is an actual policy reason or simply a “catch all” reason to discriminate against me based on some other attribute(s).

Here there should be a requirement of rationality.  If, for example, “gang colors” are banned then it seems obvious that the decision to ask someone to leave is based on the science of color, that is, the actual color the person is wearing falls within the definition of a particular gang color.

If “red” is banned then it is questionable that someone would ask an individual to leave who is wearing “green.”

Yet here, by defining “vaping as smoking,” the requirement of rationality is cast aside; am I being asked to leave because I am black, or too old, or is it really because I am simply vaping?

I think you should also consider there is clear evidence (see this: http://www.seattlepi.com/national/article/Flavoring-additive-puts-professional-cooks-at-risk-1259353.php) that merely operating a commercial kitchen may be as or more “dangerous” than vaping.

So what does all this mean?

I think very simply that if I am in your establishment discretely vaping I am causing no harm to anyone else.  I am doing what Chili’s kitchen and other patrons are already doing, basically generating harmless aerosols.

Does Chili’s have the right to ask me to leave if I am a nuisance?  Of course.  Just like asking anyone who is too loud, or too scantily dressed, etc. to leave.

While your organization is certainly free to do whatever it likes I feel obligated to bring these facts to your attention and to no longer patronize your restaurants so long as you continue policies which I consider counter to common sense and my personal well-being.

Thank You

Todd Kueny

CASAA: Vaping On a Plane...

From the "Call to Action"

[I am writing this in part because of the juxtaposition of being hammered in the CASAA Facebook forum for complaining about a commercial vaping ban while in the very same thread reading this call to action... but more on this in another post.  The other part of this is based on some conversations with vaperatti regarding how the vaping industry is ignoring the dangers of lithium ion batteries.]

In the link and image to the right we see CASAA pursuing the notion that, basically, vapes on planes are okay.

So let’s take a look at the technical aspects of this.

First off, as background I have spent the last several years involved professionally with the use of these very same types of batteries and corresponding electrical and software systems.  My background is in both electronics and software with a total of more than forty years of professional experience.

For part (a few years ago) of this I worked on the PrimusZ mod - a wireless bluetooth 60W box mod.  I also work professionally in other industries with these same batteries in a similar capacity.

I have designed and built successful charging systems as well as high output systems power systems (600W).

I have also been involved in vape shops and vaping both in retail and wholesale for the last several years.

Say what you want, criticize, make fun and laugh if you will but I know my around these types of batteries and the systems that use them (basically I’ve insured myself without a claim, designed built and sold systems (often to people who didn't possess the ability to understand what they were doing) without incident over the last several years - both on my own and with others in various organizations).

What follows is the short background of vaping, batteries and mods so that we can get to the real issue…

#1 - Vaping is very different than most lithium ion battery applications.  Why?  For one, generally these devices are looking to discharge the batteries at their maximal rate irrespective of battery safety while being fired.  In general most other types of systems are looking to have a longer-term, low rate battery discharge, e.g., a flashlight or robot.

Batteries are typically rated with a “C” indicating the maximum safe discharge rate for the battery - safe being the operative word here.  Typically this rating is something provided by a manufacturer.  

Vaping, particularly mechanical mods, basically looks to discharge a battery into the smallest possible load (very low ohms) in order to create the maximum amount of heat and hence vapor.  Typical coils may be rated at a .2 ohm value or less.

Ohms law says current (amps) is proportional to volts divided by ohms.  Thus a 7.2V dual 18650 battery set up yields about 36 amps into a .2 ohm load.  Watts, which is volts time amps, represents the apparent electrical power of a given circuit.  In this example 7.2 V x 36 amps = 259.2 watts.

A typical high powered LED (light emitting diode) application, as comparison, might consume one (1) amp for the same 7.2V and represents about 7.2 watts of power.

The difference here is that the LED device will burn much, much longer than the vape - less load, longer life.  This is because in this example the batteries are draining roughly 36 times slower for the LED application.

#2 - Lithium ion batteries are sensitive to discharge rate and temperature.  If I use a much lower ohm coil value, say  .05 ohms, I enter the territory where the battery is effectively shorted.  When this happens the batteries can do any number of bad things such as burn, explode, vent or over heat.  Similarly, heating a lithium ion battery above about 60C creates a similar internal state to a short - also resulting in a potential fire.

Batteries in a sealed compartment, e.g., mechanical mod, face a compounding of these problems.  The venting may increase pressure and temperature in the enclosed space of the mod's metal jacket creating a cascade of heating, additional venting,  and more pressure which in turn generates more heating, etc.

#3 - Most commercial mods have flawed or no safety systems.

In general all mechanical mods, from a battery perspective, are outright dangerous.  The reasons for this are many fold:  poor or no safety mechanism to prevent accidental discharge, non-vented tubes to hold batteries, and cases which efficiently transfer heat from the atomizer directly to the battery.

“Series” and “parallel” box mods with direct wiring and/or a MOSFET-style switch are basically the same as mechanicals in terms of battery safety with the possible exception of nonmetallic cases (which can melt instead of explode).

Neither mechanical or box mods generally support “short circuit” protection.

Most “closed” systems such as a Tesla Spyder or “Ego-type” battery rely on a sequence of button presses to turn the unit on and off.  In fact, the unit is always “on” and just draws a few micro amps (1/100,000ths of a amp) while waiting for you to pretend to turn it on.  The button pressing merely enables the devices ability to actually fire an atomizer.  Some of these systems can shut off on their own - but not all do.

Modern manufactured box mods typically have safety systems to prevent dead shorts for destroying the mod.  Those with internal computer chips typically support a sequence of button presses to turn the device on and off.

In general if you want to ensure a mod is actually powered off you must physically remove the batteries.

Most importantly nearly all mods require some active steps on the part of the user to ensure they cannot firing.  Usually by removing the atomizer and/or batteries.  In general users “forget” these steps.  Nearly every vaper I know has had, at least once, an bad mod/battery experience regardless of how careful they might be: smoking purse, smoking car, melting box mod, etc.

“Naked” 18650-style batteries can also be shorted out by metallic objects such as keys in a purse or pocket.

There are classes of batteries with safety systems to prevent shorts and fires but in general these are not favored by moders and vapers because the safety devices limit the power of the batteries.

#4 - Stored Energy 

So if you check wikipedia you will see that lithium ion batteries rate about equal to wood in terms of stored energy - gasoline, on the other hand, stores about fifty times more energy.

Wood's not dangerous?  So why are vape batteries?

Because the entire quantity of energy in the battery can be discharged in a very short time.  If you through an equal amount of wood into a very hot fire its energy will also be expended quickly - but only if you through it into a fire.  On its own or touching your keys in your pocket or purse it won't do anything - and that's the critical difference.

So what’s the bottom line?

Lithium ion batteries as used in vaping are, for the most part, accidents waiting to happen.  Items in a purse push the fire button on the Tesla Spider and the atomizer turns on and stays on until smoke starts coming out of the purse.  A mechanical thrown careless on a car seat turns on and burns the fabric. And so on…

My guess is that vapers, being former smokers, have an innate feel for things “catching fire.”  Certainly I do - my wife smoked for 40 years through four children - so you tend to catch things before they become problems.

Unfortunately, though, nothing I wrote above gives me or many others in the world faith that vaping devices and batteries are “safe” in the context of something like an airplane cargo compartment.

On the commercial side there are various processes and standards for lithium ion battery testing and safety.  Large shipping companies (like a UPS) have no problem shipping commercially certified batteries because such batteries have been reasonably tested to ensure A) there won’t be any accidental firing and B) are generally handled by a professional who knows to pack the batteries the right way, i.e., out of the device.  Generally batteries are removed from devices for shipping save for cell phones - in the case of cell phones enormous amounts of QA and testing address the general safety issue.

This is not true as far as any vaping devices I know of are concerned (except for some 18650-style mods).

So let’s now think about this from a safety perspective and not a vaping perspective.

If “Joe Random” puts his e-cig or mod in his checked baggage there is a significant chance that this device could fire unexpectedly - whether through jostling, vibration, coincidence, etc.  (This of course excludes physical damage during luggage handling, etc. which adds a whole additional dimension of potential problems.)

My professional view is that uncontrolled packing of vaping devices in airline, or for that matter any form of closed shipping container, luggage, baggage, container, or cargo hold is a very, very bad idea from the perspective of human safety.

When we built the PrimusZ - a system with two internal lithium ion batteries - we provided a mechanical pin/switch combination that physically disconnected the batteries from the rest of the device via a mechanical switch during shipping (remember, I am paying the insurance bills).  We shipped a few hundred around the country without incident.  Similarly, we never shipped a PrimusZ with an attached atomizer because we knew better.

All this for exactly the reasons outlined above: safety.

Can vaping devices be shipped safely?

In checked baggage where we rely on the “user” to do the right thing, i.e., pack it safely, I would say absolutely not.  I have seen far to many “near misses” in cars much less areas where a mistake would cause significant danger.

(This is not to say someone knowledgable couldn’t make things safe: removing batteries and placing them in “battery protector” separated from all metal, removing the atomizer, etc.)

Long ago I worked on flight systems and when you are involved with things like that you take safety far more seriously than your average vaper - particularly when you start to think about what might happen to your family if you make a mistake on the safety side and your family is riding on that plane.

Personally I don’t have a problem with empty (as in no batteries) mechanicals or box mods in checked baggage provided there is an independent (for example, a scanner at the airport) safety check to ensure that there are no batteries present in the baggage.  All batteries should, I think, be allowed in carry on where any evidence of smoke or heat can easily be detected and TSA folks can ensure they are package safely - that is on the floor and not in the overhead compartments.

But again, can we rely on “Joe Random” to take this seriously?

I doubt it.

So, at least in my professional opinion, this “Call to Action” is a very, very bad idea.

Safety in the sense of a battery fire on an airplane, ship or train is a far different matter than somebody annoying someone with their vape or “disrespecting” their right to ban them.

Given what I know I wouldn't want to be on a airplane with one these things in the cargo hold - not me, not my family, and not you.