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Saturday, September 17, 2016

FDA ENDS - It's What's for Dinner...

The FDA has tried to be very clever about what makes a vape an "ENDS" and hence something to be regulated.

If you parse the regulatory language you see that basically the term "ENDS" is simply an assertion that vaping devices "meet the statutory definition of a "tobacco product." (This discussion generally excludes "cig-a-likes" that are fully integrated devices including liquid, battery, etc.)

However, since e-liquid (the part that theoretically contains tobacco) isn't the "tobacco product" one can only conclude that you have to "consume" your ENDS...?

Doesn't make any sense, does it?

It does if you think of how a cigarette works: the "components and parts" are consumed by using (burning) the cigarette.

Not true of the ENDS - so perhaps we have to BURN or VAPORIZE our mods to consume them...

The FDA has simply made a pig into a goat and said to the vaping community: you're fucked because we say you are.

So let's go through this bit by bit:

The deeming regulations depend solely on this sentence (page #8 of this) which links a "deemed" tobacco product to a "component or part" under the Tobacco Act:

"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." (quote #1)

Now things like lighters, humidors for cigars, and so forth are not tobacco products and they are not controlled or restricted by the FDA.  One imagines that these are "Accessories" which the FDA does not currently regulate.

So the thinking at the FDA would seem to be that "Component and Part" is the only way to cover what is otherwise not made from tobacco, e.g., software or a battery.

So let's think about what these words mean: "alter or affect."

That seems pretty clear - burn, heat, change state, e.g., from liquid to gas, and so on.  But what does this apply to here?

In this case its should be the "tobacco product" which is clearly "nicotine."

So what part of the FDA regulations cover nicotine exactly?

None that I can find in the regulations.

Which is interesting...

From what I see the inclusion of nicotine and ENDS is covered by this sentence on page #11:

"Products that meet the statutory definition of "tobacco products" include currently marketed products such as dissolvables not already regulated by FDA, gels, waterpipe tobacco, ENDS (including e-cigarettes, e-hookah, ecigars, vape pens, advanced refillable personal vaporizers, and electronic pipes), cigars, and pipe tobacco." (quote #2)

So let's accept this for the moment even though how ENDS meets this is not defined, specifically because its not made of tobacco...

So if an ENDS already meets the statutory definition of "tobacco product" then "alter or affect" must apply to the physical ENDS device unless the ENDS is a "component or part" of itself.

Now "components and part" really don't seem to have direct definitions in the FD&C Act except as they relate to the definitions of "drug" in  Chapter 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT 21 U.S. Code § 321 and in 21 U.S. Code § 387 defining (1) "additives" and (17) "... chemical or chemical compound in mainstream or sidestream tobacco smoke that either transfers from any component of the cigarette to the smoke or that is formed by the combustion or heating of tobacco, additives, or other component of the tobacco product."

(Again here's that pesky definition that really, truly does match that of cigarette.)

So ENDS is a tobacco product and its components and parts are, well components and parts of itself.

Also note that e-liquid is apparently not a tobacco product - so yes, Virginia, the FDA knows that nicotine is not a tobacco product.

So the "component and parts" language is talking about the components and parts of the ENDS I guess.

So the "hand wave" (like a magician) being used by the FDA comes from quote #2 - the list includes things both made of tobacco, e.g., water pipe tobacco, and things not made of tobacco, i.e., ENDS.

This is a logical inconsistency in that tobacco products cannot be made from something that is not tobacco.

But the only relationship between ENDS and tobacco is apparently how someone uses it.  It is not innately made "of tobacco."  But then quote #1 says: "... to be used with or for the human consumption of a tobacco product."

So we have to consume the actual physical ENDS device!?!?!?

So it would seem and ENDS is only an ENDS when its used as an ENDS and that would mean we have to consume it (either vaporize it and grind it up into a powder).

Unless, of course, it alters its own characteristics when we we are not consuming it...

But this is an "or" clause, as in A or B, in which case we would not be consuming it.

It would be altering itself - except we aren't consuming it at the time.

Am I right?

Take a look at the FDA web site - they are very careful to skirt around these issues.

Is this what Congress intended with the FD&C Act?

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