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Saturday, January 6, 2018

The Chine Nual...

Interesting history for the Lisp Machine Manual. I had the green version with three authors...  Sorry to say I lost it over the years...

This is probably the closest living relative: Clozure CL.

Saturday, December 30, 2017

Consequences of FDA Required E-Liquid Mislabeling

Grandpa's Little four year old Suzy A relative has collapsed during the holiday's at a table in the next room.

The symptoms: no breathing...

You urgently call the poison control center and report what you see in the photo above.

Can your relative be saved?

Let's see, the poison control center needs to know:

- The person's age, weight, and condition
- Name of product (as well as the ingredients and strength, if known)
- When it was swallowed or inhaled
- The amount swallowed or inhaled

However, DO NOT delay calling for help if this information is not immediately available.

Your holiday ends in a panic... ("not breathing" is a symptom of both choking on the cap - notice the cap is not visible - and nicotine poisoning).

Only problem is that the vial shown above is mislabeled.

The contents DO NOT contain nicotine because it's 0mg liquid.

Yet you will report incorrect information to the poison control center.  This may delay the proper treatment of your loved one and could lead to serious health consequences or even death.

Now, as it turns out 0mg e-liquid contains the same ingredients as cake frosting (examples here).

It would seem that the FDA requires (according to their own website) that "Foods Must Contain What the Label Says."

So which is it?

Seems like the FDA is talking out of both sides of its mouth...

Of course, you know that some lawyer will sue the vape shop and/or e-liquid manufacturer that created this product because it is incorrectly labeled and the incorrect labeling delayed the poison control center.

The manufacturer or shop owner will have no recourse because the FDA required them to mislabel the product.

So what's the FDA's intent here?

Do we label products based on what's actually in them or lie about it?

Why is our government requiring us to lie?

Deeming Regs: A War on Science and Common Sense

What will be shown here is that a careful reading of the "Deeming Regs" reveals a totally ambiguous, illogical and poorly thought out attempt to define something which is quite technical, detailed and scientific, that is, what an e-cigarette is and does, with vague colloquialisms, pseudo science, and descriptions that are so poorly written and unclear that they include most of the human activities on the planet.

From the deeming regs (page 8): "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."

So in no particular order let's think a bit about one example here: "digital display/lights to adjust settings."

First off, the statement fragment is nonsensical.  Lights (devices which emit photons) and digital display's (devices which emit patterns of photons) convey information to a user's eye or a camera or other photo receptive device, i.e., they indicate a value of something (through shape or color or arrangement of these photons) typically contained in software or electronic hardware to a "user." 

Secondly, "lights" and "digital displays" only pass information from within a device to a user.  You would need a "control system" of some type, a physical element which translates the actions of a user, e.g. a switch or button, into a value inside the device.  These lights are not directly connect to a "tobacco product," of course, either.

So common sense says that "digital display/lights to adjust settings" cannot be used "to alter or affect the tobacco product’s performance, composition, constituents or characteristics;"  Perhaps one could use these devices to monitor the what a device is doing to a "tobacco product" but they themselves cannot "alter or affect" it.  They could also affect what a device does to a "tobacco product" but not the tobacco product itself.

(We are going to use "tobacco product" here as a stand in for something which actually contains some detectable element which is truly unique to the tobacco plant ( such as nornicotine, anatabine, and anabasine (see this).  Nicotine is found elsewhere in nature so it doesn't count as unique to tobacco.  We exclude the same things the FDA does, e.g., synthetic nicotine, because it has no relation whatsoever to tobacco - or, inversely, tobacco plants contain water which is clearly not a "tobacco product.)

So let's consider "digital display/lights to adjust settings" in the context of "to be used with or for the human consumption of a tobacco product."   To me this is at best ambiguous.  While it could mean a light or display to adjust, say power, on a mod it could also mean a lighted sign hanging in a window that says "set your power level to 15W."  Again, a "control" that allows a user to alter things is different from an indicator.

But even if a "digital display/lights to adjust settings" were a control what does it alter?

Clearly it's not altering the "tobacco product.

Instead it's altering the internal state of some electronic device, let's just say a computer for the sake of argument.

However, the computer is not connected to the "tobacco product" in any way.  It's simply sending signals to some kind of power controller that, again for sake of argument, alters the temperature of a heating element.  A "tobacco product" cannot receive electronic signals in any practical physical sense.  Yes, I could embed wires from a computer in a pile of tobacco leaves but there would be no significant measurable change to the tobacco leaves because there isn't sufficient power in such a digital signal.

But for a power controller to affect a heating element it must amplify the signal in some way.

That seems to be what is meant by "atomizer" - which is really something that emits a fine spray of particles.

At best the "voltage" and "software" are affecting this "atomizer" and not the "tobacco product" itself.

Even if I put the "tobacco product" into a tank on an atomizer and apply power via "lights" through "software" etc. etc. nothing happens...


Because whatever means is used to transport the "tobacco product" out of the mod, say with heat via a coil of wire to vapor, does not directly touch the "tobacco product."

So either the user is placing the "tobacco product" directly on the coil or the "tobacco product" is transported to the coil via a wick.

So I underlined transported above because the location of the "tobacco product" is a characteristic of the "tobacco product."  So clearly "characteristic" is called out in "1) to alter or affect the tobacco product’s performance, composition, constituents or characteristics;"

And in this case the only the characteristics of the "tobacco product" would be its location as the wick draws the liquid from the thank to heating element.  Wicking works by capillary action.  The substances being transported are not altered other than their location.

Since atomizers are called out directly and wicking is transporting "tobacco product" to the heating coil than it is reasonable to assume that a "tobacco product" can be modified by changing its location all other things being equal.  And, it seems quite rational that the location of an object is a characteristic of that object.

So it would seem that moving "tobacco product" from one location to another means that whatever is transporting the "tobacco product" is a "component or part" of a "tobacco product."

So does anything that changes the location of a "tobacco product" qualify as a "component or part?"

For example, the USPS box the "tobacco product" arrived in?  Clearly it "transports" the "tobacco product" closer to the user. 

And what about the bottle it is contained in?  Clearly there is transportation, just as with wicking, to the user from the "tank" portion to the nozzle.

And if we heat a solution combining nicotine and a carrier with a boiling point less than that of nicotine it seems clear that the vaporization of that solution simply transports the nicotine closer to the user, just as the USPS box does: the vapor carrying the unmodified nicotine through the air.

After all the nicotine is not chemically decomposed - if it were then you would be able to vape it.  But then again liquids evaporate on their own.  So how is this different?

Though to be fair I suppose that the temperature (a "characteristic") of the nicotine is affect by the atomizer, just as the temperatures of the nicotine is affected when it leaves the air conditioned post office and sits in my hot, black mailbox for several hours in the summer.

This of course, begs the question of exactly what degree of heat (as it applies to "characteristics") matters?

In general the "deeming regulation" is, as stated at the outset, a set of vague colloquialisms, pseudo science, and descriptions that are so poorly written that they include most of the human activities on the planet.

These FDA descriptions are themselves "dual use" in the sense that they pretend to describe something very specific relating to e-cigarettes but in fact are so vague as to take in vast swaths of human engineering, electronics, and general activity.

Of course, the intent is that FUD (Fear, Uncertainty and Doubt) will prevent anyone from questioning this.

Thursday, December 28, 2017

Facebook: How to Make the ENDS Justify the Means

A couple of weeks ago I wrote about making Facebook part of an ENDS system (see this post, ENDS page here). 

I am relentlessly pursuing this because no one appears to be able to successfully legally challenge the utter insanity contained in the FDA deeming regulations. 

This leaves the only rational challenge a technical or scientific one.

While the FDA is free to "deem" whatever laws into existence they choose there are technical and legal consequences where existing science and law requires consistency (for example PA tax law: "[a]ll taxes shall be uniform, upon the same class of subjects, within the territorial limits of the authority levying the tax, and shall be collected under general laws.", plug in air fresheners meet the definition of ENDS, etc.).

So we need to push the envelope and spread the pain of the FDA deeming regulations to other businesses who stand to lose great deal more than a few thousand lousy vape shops.

The FDA identifies any "software" used in an e-cigarette as an "component or part" of an ENDS system (see this video around 0:25s, all in the published regs).

Clearly Facebook supports the FDA mission on e-cigarettes as demonstrated by their bans on vaping ads and it's big and in every tax jurisdiction, so its reasonable to assume it will be unhappy following the FDA regulations.  Hence it will bitch.

Thus making Facebook's software into a "component or part" of an e-cigarette demonstrates the lunacy of the FDA regulations and will hopefully offer a legal entry point for lawsuits.

There is no requirement Facebook be cooperative or complicit in this as far as the FDA deeming regulations are concerned as far as I can see.

We do this by making the core function of Facebook (or iOS, or whatever) integral to an ENDS system (just as I did with the PrimusZ and the iPhone).  We simply pass a message through Facebook to fire the mod.

Once this occurs (and it need only occur once in a reasonably documented fashion), some interesting things result:

• Facebook can no longer have users under 21 years of age.

• Facebook cannot advertise.

• Facebook cannot give free samples (of their software, for example) away.

• Facebook is a "component or part" of an ENDS product by FDA definition.

Should a special exception be made for Facebook then the rigging of the game for everyone else is fully exposed.

Facebook ($500 Billion USD) is far larger than all of "big tobacco" combined (maybe $150 Billion USD).

(Ditto for Android, Apple, all the hardware used to route internet traffic, fiber, wires, etc. etc. etc.  Though Apple at $900 Billion USD is bigger than Facebook).

I would suppose this also works to allow states and localities to tax Facebook as an ENDS product.

The hardware part is now complete as you can see from the various videos I have been posting.  I now have a mod that accepts and sends MIDI commands via Bluetooth.

So the path on making virtually any kind of "software" application part of an FDA ENDS is pretty simple and, while there are obviously many variations, it all boils down to more or less this:

1) Modify the midi4.ino file on my GitHub to accept some MIDI commands, e.g., MIDI Note On/Off to fire the device.  This is trivial.

2) Grab any of a number of iOS or Android apps like musicIO that will route MIDI messages between, say, your Mac and your iOS device (probably equivalents in the Windows and Android world as well).  Again, this is trivial.

3) Set up some kind of software, either Facebook app (using node.js), or other tool, e.g., Sixth Sense, through which you can identify a particular kind of Facebook message (again, this only need be very, very crude).  On the server end monitoring Facebook (something Facebook cannot see) you trap this message and route it to the mod.

This is a bit more work but really not too hard to gin up a demonstration.

Wednesday, December 27, 2017

Fear, Uncertainty and Doubt: FDA's Control of Vaping (+ Video)

So here's the final video in my current series of the OSP Prometheus (Bluetooth + MIDI + 510 + Dean's).  All of this is freely available on this blog (schematics, parts lists, software is on github, etc.):

(Prior video here).

A couple of notes:

First off this thing is not really a mod anymore, or even an Open Source Power module.  It's a fully programmable computer, a MIDI controller, and USB power block.  A whole bunch of things.

It is not intended to affect "tobacco" in any way.  I don't use it for such though the through the FDA regulations I am forced to vape cake frosting falsely advertised and labeled to contain nicotine.

As I have progressed along this path I now believe that the real idea here is the intent of the device.

First off, my device is intended to be a fun, multi-purpose toy that does a number of things.

Secondly, I envision a commercial product that is sold such that it does nothing when purchased, i.e., it has no programming at all.

The purchaser would use some standard, free tools on his or her phone to locate and download a program of his or her choosing to make the thing do whatever they wanted.

My sincere belief is that this makes this something other than any possible definition of an electronic cigarette (state, local, federal).

So as a finer point I can clearly make e-cigarette things with just about anything (from here):

Since it uses wall power does it make the entire US grid (all connected together more or less) something the FDA regulates?

I would hope not (but you never know, I suppose I could resell commercial electricity as a reseller for the purpose shown in the photo to ensure it was FDA regulated...)

Working backwards from this picture eventually we arrive at something the FDA can regulate as an e-cig.

But where, exactly, is that point?

In truth the only possible means to figure this out is intent...  Which is kind of what the FDA alludes too in the video in my recent post.  But they wield fear, uncertainty and doubt (FUD) to frighten people into compliance.

I cannot control what an end-user might do with something I sell.  Guns, for example, are not the problem of the manufacturer, its share holders, or even a pension holding shares in a given murder, instead its the responsibility of the murderer.

I think that holds here as well.

If the vape units sold have no software they are nothing.  They fire no coils and, more importantly, since they have multiple uses I, the maker, cannot say what the intent of the purchase or purchaser is.

Here we are victims of the Chinese and like minded manufactures.  Vapes are basically standard, cheap power circuits with lithium ion batteries.  No one really cares if you have to pay a significant, e.g., 40% tax.  But the end user would buy mods with other features if they net cost where less than simply battery circuits.

As a manufacturer I simply cannot know how a user will use a computer I sell them.

Certainly I cannot arrest every cell phone user because they might hack into the Pentagon with their phone, even if the phone is technically able to do such a thing (which all are).

There's some legal precedent for this argument.  Here in Pennsylvania "Cherry Masters" are illegal - they are basically video slot machines found in bars.  If you had one in a bar you could be arrested, pay fines, etc.  They are games of chance because they have, according to this article, "random number generators" inside.

However, some clever folks figured out that you could modify the basic game and add skill elements (see this court decision).  Since you have to be quick (skill wise with your fingers) to win given these modifications the machines are no longer simple games of chance (like a roulette while).

What does this have to do with vaping?

I think a lot...

Challenges need to be made to force a decision on what exactly the FDA thinks are e-cigarettes and what their, the FDA, rules actually can logically and rationally encompass.

I have written here that many things easily fit the definition that are not vapes: Air fresheners and oil diffusers for example.

The OSP system above is "multi-use" and it's operation is defined after purchase.  Does that meet the definition of an e-cig?

Without action the future of vaping will be wiped out by big tobacco and the FDA.

FUD is being used against vaping.

The ideas are fully irrational.  One a scientific basis air fresheners are far more dangerous than vapes. Yet there is virtually no regulation of those...

What does that tell you about who has your best interest in mind?

Tuesday, December 26, 2017

Calling the Regulatory E-Cig Bluff

About twenty seconds (0:20) into the video below we see precisely what the FDA thinks is an e-cigarette that can be regulated (the video is a clear reflection of the published regulations):

A regulated "component or part" includes "software" or "hardware" that is "intended or reasonably intended" to alter (in any number of ways) the "tobacco product."

So if I sell an electronic device that is multi-functioned (USB charging port, flashlight, 510 connector, dean's connector) and configured for a specific function after purchase by the purchaser how can it be regulated?

How can it be an e-cigarette?

How can it be anything until the user makes a decision.

(See the previous posts on the OSP, also here.  The point of my posts is that such devices, that are not configured until after a user chooses to set it a certain way, cannot be regulated.)

Obviously the intent of such a device is to be "multi-function" so what would the intent (I guess at the point of manufacture) of its use be?

If my iPhone, Facebook, or any other software such as the internet is involved in "altering" a "tobacco product" then, by this definition, they are also themselves "tobacco products" and the target of regulation.  They, the iPhones, must be because they, the iPhones, are altering "tobacco products"...  or are they?

(There is a strong parallel to synthetic nicotine which the FDA says it will not regulate.)

If my iPhone controls my mod but somehow, even if it's integrally required to operate my mod, the "intent" of the iPhone is not to be a "tobacco product" (because Apple says not) and the iPhone cannot "reasonably" be intended to alter a tobacco product because Apple says so, then how can anything be regulated as an e-cigarette (unless the manufacturer says it's an e-cigarette).

It would seem to me that the only things that can be regulated are things which are either 1) declared to and actually involved in the altering of "tobacco products" or 2) declared to be e-cigarettes.

But if Facebook or an iPhone or Android is directly used to do this, they'd have to be regulated by the FDA?  Or would they?

By creating and selling devices which require the use of a cell phone to fire a mod someone will be forced to decide this issue.

An iPhone as a tobacco product is patently ridiculous, but it is one because I sold commercial e-cigarette products that required an iPhone to use.  The 18650's in a Chinese mod are regulated whether or not they were intended to be so it would be true also for the iPhone.

This is all a charade.

An illogical contradiction.

Nothing in a e-cigarette is made out of tobacco unless you, the user, put it there.

I don't vape nicotine, yet I am now forced to purchase products e-liquid products which are required by the FDA to carry a false ingredient list (nicotine in a product which does not actually contain nicotine).

The synthetic nicotine manufacturers have already called the FDA bluff.

Maybe the rest of the vaping industry should too...

Monday, December 25, 2017

Prometheus "Duel Use" Video...

So I published the code (midi3.ino and BluefruitConfig.h) on GitHub that goes with this video...

You want to use midi3.ino just as the AdafruitBluefruit midi.ino file in the Arduino development environment.