So this is quite interesting... I received a second set of FOIA data from the FDA:
The corresponding FOIA PDF docs are here:
https://github.com/OpenSourceVaping/FDA_FOIA_2
The specific request was for "all scientific evidence, emails, scientific evidence, expert information and all validating documents ... 'Not all nicotine-free e-liquids (NFLs) are subject to the deeming rule."
The interesting document is the "Brief" which contains the following (from the brief):
1. “[W]hat is it exactly that a manufacturer of a nicotine-free liquid is required to do to comply with the Rule . . . at this time?”
Perhaps nothing. Not all nicotine-free e-liquids (“NFLs”) are subject to the deeming rule. Assuming an NFL is not made or derived from tobacco, it is subject to the rule only if it meets the definition of a “component or part”—that is, if it is “intended or reasonably expected” either “(1) To alter or affect [a] tobacco product’s performance, composition, constituents, or characteristics; or (2) To be used with or for the human consumption of a tobacco product,” and is not an accessory. 21 C.F.R. § 1100.3. An NFL that is intended or reasonably expected to be mixed with liquid nicotine would qualify as a “component or part.” 81 Fed. Reg. at 29,017.
Apparently there is no scientific evidence at all for the FDA's position. What a surprise. Just a bunch of huffing and puffing (no pun intended) on how, just as in the days of the NICOWater (see FOIA #1 docs), they resort to thuggery in order to bludgeon folks into compliance. But they know their limits and they don't like to be challenged and lose hence they know when to stop.
So since "non-tobacco nicotine" (regardless of the scientific nonsense such a thing involves) is not a "tobacco product" it's effectively not possible for the FDA to regulate it (even though there is no way to determine "where" a given nicotine molecule came from).
What does this mean?
Clearly mods, tanks and so forth contain no actual tobacco.
FDA derives its power from the fact that "nicotine" is a tobacco product even though it isn't by somehow pointing to the tobacco plant as the source. So a mod, tank or coil "become" tobacco products by association (as in "component or part" above) as they move the "tobacco product" (nicotine) from the e-liquid to the human body.
Now if I had a batch of, say 0mg flavoring (like King Arthur's Coconut Flavoring) what would make this a "component or part" as above?
Intent.
King Authur makes flavoring for cupcakes and doesn't "intend or reasonably intend" you to literally put it in your pipe and smoke it...
So TFN from Next Generation Labs is not a "tobacco product" because A) somehow the nicotine molecules in it have nothing to do with tobacco nicotine molecules and B) it's not intended to be mixed with nicotine derived from tobacco. They list the a portion of the quote "Brief" on their website.
It's interesting that "intent" seems to only come into play when a final consumer is involved. For example, 100mg nicotine base is available in a free and unregulated fashion from dozens of sources.
It would seem the only way to regulate TFN or it's friends would be to sell a kit with both "tobacco nicotine" e-liquids and TFN e-liquids together. In which case the FDA might argue that both are now potential "component or part" of a "tobacco product." Though this seems a significant stretch.
(Note that Sottera prevents the FDA from relating any type of "tobacco product" as a drug unless it's marketed as for "therapeutic purposes.")
It's also important to note that state law, in Pennsylvania for example, is quite different in that it calls out "nicotine" explicitly as part of an e-cigarette. So while TFN can't be regulated by the FDA it is regulated (taxed in this case) at the state level (see: PA HB 682, page 4) explicitly when part of an e-cigarette. The only interesting element to the PA law is that the device is regulated only when the vapor it generates involves "... inhalation of which simulates smoking."
As I have argued here extensively the "vaping community" is barking up the wrong tree entirely.
There is ample precedent that enables vaping to be unregulated:
1) Using synthetic nicotine disable FDA regulation as described above. Yes, the nicotine is about 10x the cost but result is freedom.
2) The myriad of state laws all have either significant flaws or involve unenforceable elements which need to be challenged (this has been done here in PA: http://lwgat.blogspot.com/2018/06/kingdom-vapor-wins-against-state-of.html for "component or part" and I believe "... inhalation of which simulates smoking" will not stand up as it regulates free speech).
3) You have a federal right to treat your own disease (see: http://lwgat.blogspot.com/2015/01/the-right-not-to-smoke.html).
4) "Dual use" devices (as outlined here: http://lwgat.blogspot.com/2017/09/thoughts-on-dual-use-regulation-and.html) make regulation impossible (a USB charger cannot be a tobacco product).
There is enough here to make vaping free of all regulation.
The reason there is failure is because most, unlike Kingdom Vapor, are unwilling to challenge the status quo. In fact here's what I see leadership doing (corresponding to the above):
1) "Leadership" wants regulation so aren't really interested in challenging it.
2) "Leadership" has no balls. Kingdom Vapor does and they won. Think David and Goliath. But if you don't try then you'll just get #1 (regulation) which is, as I said, what they want.
3) "Leadership" again has no balls. No one even attempts to make these arguments though the Supreme Court has granted this in numerous cases I outline. Again, look at #2 above. Kingdom is not large but they are tough and relentless. Can't say that for too many others in this business.
4) "King Arthur Coconut" can't be regulated because of it's "intent?" More hogwash - it's simple to construct cases where this BS breaks down (again - Kingdom Vapor and USB chargers).
JUULwill is just rolling over for the FDA - they are no help but represent 70% of the market at the time of this writing.
The FDA knows what it can and can't do.
Apparently most in the "vaping leadership" either don't care, are unwilling or are in league with the FDA as far as allowing the vaping public to be shut down.
For the FDA, they are expert at the "legal threat" model as I describe above. What they can't handle is death by a thousand cuts: repeated, small successes based on the law.
The corresponding FOIA PDF docs are here:
https://github.com/OpenSourceVaping/FDA_FOIA_2
The specific request was for "all scientific evidence, emails, scientific evidence, expert information and all validating documents ... 'Not all nicotine-free e-liquids (NFLs) are subject to the deeming rule."
The interesting document is the "Brief" which contains the following (from the brief):
1. “[W]hat is it exactly that a manufacturer of a nicotine-free liquid is required to do to comply with the Rule . . . at this time?”
Perhaps nothing. Not all nicotine-free e-liquids (“NFLs”) are subject to the deeming rule. Assuming an NFL is not made or derived from tobacco, it is subject to the rule only if it meets the definition of a “component or part”—that is, if it is “intended or reasonably expected” either “(1) To alter or affect [a] tobacco product’s performance, composition, constituents, or characteristics; or (2) To be used with or for the human consumption of a tobacco product,” and is not an accessory. 21 C.F.R. § 1100.3. An NFL that is intended or reasonably expected to be mixed with liquid nicotine would qualify as a “component or part.” 81 Fed. Reg. at 29,017.
Apparently there is no scientific evidence at all for the FDA's position. What a surprise. Just a bunch of huffing and puffing (no pun intended) on how, just as in the days of the NICOWater (see FOIA #1 docs), they resort to thuggery in order to bludgeon folks into compliance. But they know their limits and they don't like to be challenged and lose hence they know when to stop.
So since "non-tobacco nicotine" (regardless of the scientific nonsense such a thing involves) is not a "tobacco product" it's effectively not possible for the FDA to regulate it (even though there is no way to determine "where" a given nicotine molecule came from).
What does this mean?
Clearly mods, tanks and so forth contain no actual tobacco.
FDA derives its power from the fact that "nicotine" is a tobacco product even though it isn't by somehow pointing to the tobacco plant as the source. So a mod, tank or coil "become" tobacco products by association (as in "component or part" above) as they move the "tobacco product" (nicotine) from the e-liquid to the human body.
Now if I had a batch of, say 0mg flavoring (like King Arthur's Coconut Flavoring) what would make this a "component or part" as above?
Intent.
King Authur makes flavoring for cupcakes and doesn't "intend or reasonably intend" you to literally put it in your pipe and smoke it...
So TFN from Next Generation Labs is not a "tobacco product" because A) somehow the nicotine molecules in it have nothing to do with tobacco nicotine molecules and B) it's not intended to be mixed with nicotine derived from tobacco. They list the a portion of the quote "Brief" on their website.
It's interesting that "intent" seems to only come into play when a final consumer is involved. For example, 100mg nicotine base is available in a free and unregulated fashion from dozens of sources.
It would seem the only way to regulate TFN or it's friends would be to sell a kit with both "tobacco nicotine" e-liquids and TFN e-liquids together. In which case the FDA might argue that both are now potential "component or part" of a "tobacco product." Though this seems a significant stretch.
(Note that Sottera prevents the FDA from relating any type of "tobacco product" as a drug unless it's marketed as for "therapeutic purposes.")
It's also important to note that state law, in Pennsylvania for example, is quite different in that it calls out "nicotine" explicitly as part of an e-cigarette. So while TFN can't be regulated by the FDA it is regulated (taxed in this case) at the state level (see: PA HB 682, page 4) explicitly when part of an e-cigarette. The only interesting element to the PA law is that the device is regulated only when the vapor it generates involves "... inhalation of which simulates smoking."
As I have argued here extensively the "vaping community" is barking up the wrong tree entirely.
There is ample precedent that enables vaping to be unregulated:
1) Using synthetic nicotine disable FDA regulation as described above. Yes, the nicotine is about 10x the cost but result is freedom.
2) The myriad of state laws all have either significant flaws or involve unenforceable elements which need to be challenged (this has been done here in PA: http://lwgat.blogspot.com/2018/06/kingdom-vapor-wins-against-state-of.html for "component or part" and I believe "... inhalation of which simulates smoking" will not stand up as it regulates free speech).
3) You have a federal right to treat your own disease (see: http://lwgat.blogspot.com/2015/01/the-right-not-to-smoke.html).
4) "Dual use" devices (as outlined here: http://lwgat.blogspot.com/2017/09/thoughts-on-dual-use-regulation-and.html) make regulation impossible (a USB charger cannot be a tobacco product).
There is enough here to make vaping free of all regulation.
The reason there is failure is because most, unlike Kingdom Vapor, are unwilling to challenge the status quo. In fact here's what I see leadership doing (corresponding to the above):
1) "Leadership" wants regulation so aren't really interested in challenging it.
2) "Leadership" has no balls. Kingdom Vapor does and they won. Think David and Goliath. But if you don't try then you'll just get #1 (regulation) which is, as I said, what they want.
3) "Leadership" again has no balls. No one even attempts to make these arguments though the Supreme Court has granted this in numerous cases I outline. Again, look at #2 above. Kingdom is not large but they are tough and relentless. Can't say that for too many others in this business.
4) "King Arthur Coconut" can't be regulated because of it's "intent?" More hogwash - it's simple to construct cases where this BS breaks down (again - Kingdom Vapor and USB chargers).
JUUL
The FDA knows what it can and can't do.
Apparently most in the "vaping leadership" either don't care, are unwilling or are in league with the FDA as far as allowing the vaping public to be shut down.
For the FDA, they are expert at the "legal threat" model as I describe above. What they can't handle is death by a thousand cuts: repeated, small successes based on the law.
