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Saturday, December 30, 2017

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 (https://en.wikipedia.org/wiki/Nicotiana_tabacum) 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...

Why?

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.

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