FDA WV Politician takes on FDA
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Even though this is synthetic nicotine, I still think it comes under the purview of the FDA deeming regs. Can't find the exact wording but I recall reading something which told me they closed this loophole.
Yeah, but I did say readily available. That sight is just a press release, if anything, at this point.
Yeah, and skepticism reigned supreme over that one: 100% Tobacco Free Nicotine??? Marketing Ploy or Truth?
I find it very peculiar that there is pretty much zero info out there regarding this Company, other than a filing for a trademark extension.
I would also be very curious to know what the Organic Chemistry Department at University California Irvine would have to say about Next Generation Labs, since they are espousing "all data collected and verified" by UC Irvine - which in itself is a rather obtuse way of saying nothing much at all.
Regardless, this is digressing into irrelevance as what bought this topic up was whether or not there is an error in the complaint filing - and only Larry Faircloth or his legal staff can answer that question.
Here's mention of it in the deeming. It's not entirely clear in their response but it appears that the "catch all phrase" - "subject to FDA's tobacco control authorities, if they are an assembly of materials intended or reasonably expected to be used with or for the human consumption of a tobacco product"
And here you have to understand what is meant by "tobacco product" in FDA language - any component part used in the human consumption - ie drip tips, clearos, tanks, wire, etc. etc.
(Comment 164) Some comments sought clarification as to FDA's authority over e-liquids
that do not contain nicotine or other chemicals derived from tobacco plants and those e-liquids
that contain nicotine derived from a nontobacco source (e.g., eggplants or tomatoes). Others
claimed that FDA does not have regulatory authority over e-cigarettes that are refillable and do
not contain nicotine, but does have authority over e-liquids if the liquid contains nicotine. Yet,
some said that e-liquids used in e-cigarettes should have an entirely new classification, because
use of the words "tobacco product" in marketing materials would cause undue confusion for
consumers.
pg257
(Response) As stated in section 201(rr) of the FD&C Act, the definition of "tobacco
product" includes any product made or derived from tobacco, including any component, part, or
accessory of a tobacco product. An e-liquid made or derived from tobacco meets this definition
and, therefore, is subject to FDA's chapter IX authorities. E-liquids that do not contain nicotine
or other substances derived from tobacco may still be components or parts and, therefore, subject
to FDA's tobacco control authorities, if they are an assembly of materials intended or reasonably
expected to be used with or for the human consumption of a tobacco product and do not meet the
definition of accessory.
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I don't think there is currently any classification for nicotine not derived from tobacco.
But my assumption is that they WOULD declare it as a drug.
What it takes to make that happen I have no idea.
If the FDA can't stop the import or manufacturing, then the EPA can (under the TSCA) or the DEA can by whatever means necessary. If they are really determined to kill the free nicotine market, they will find a way to do so, and all we can do is make it more difficult for them by influencing the public perception about vaping.
Where i live the government, both federal and state have failed to stop, in no particular order: murders, prostitution, smoking, vaping, alcoholism, drug abuse.
Their track record of making people change their behaviour by banning things or making laws against them is not good.
T
Their track record of making people change their behaviour by banning things or making laws against them is not good.
T
Looking forward to being incarcerated for vaping.
Someone pays to feed the prison population - it's not all fun and mailbags i'm told!
T
Someone pays to feed the prison population - it's not all fun and mailbags i'm told!
T
How many times I gotta tell you - you aren't supposed to notice things like that.
Someone argued since the gubbermints "war on..." policy seems to have the exact opposite of the intended effect then perhaps it's time to declare a War On Jobs Creation, War on Good Politicians etc. - see how that works out.
Life, liberty - some other thing i forgot about since i got married.
Can you imagine a war on vaping? On what basis? That it's 95% less harmful than cigarettes.
For years now they have been hiding behind the 'we just don't know how safe it is' nonsense. But now we do. The FDA just refuse to acknowledge scientific fact despite protestations of being a 'science-based' organisation.
My suggestion for those people is to stop interfering in the relatively harmless leisure pursuits of people trying to stop smoking, other than ensuring that basic standards of hygiene are adhered to by vendors of liquids.
Batteries, wire, all the rest are mission creep and they don't have the ability or knowledge to make impartial decisions; those things fall outside their area of expertise. They are not food nor drugs. I'll refrain from citing their stellar record in those areas.
Stockpiling supplies and preparing for ill-thought out and drafted legislation is not something we ought to have to do.
T
Can you imagine a war on vaping? On what basis? That it's 95% less harmful than cigarettes.
For years now they have been hiding behind the 'we just don't know how safe it is' nonsense. But now we do. The FDA just refuse to acknowledge scientific fact despite protestations of being a 'science-based' organisation.
My suggestion for those people is to stop interfering in the relatively harmless leisure pursuits of people trying to stop smoking, other than ensuring that basic standards of hygiene are adhered to by vendors of liquids.
Batteries, wire, all the rest are mission creep and they don't have the ability or knowledge to make impartial decisions; those things fall outside their area of expertise. They are not food nor drugs. I'll refrain from citing their stellar record in those areas.
Stockpiling supplies and preparing for ill-thought out and drafted legislation is not something we ought to have to do.
T
I believe @Kent C found the appropriate section. I too am alarmed by the inference that
nicotine is not a derivative of tobacco leaf. It most certainly is. Synthetic nicotine would
be derived from tobacco as it would substitute the organic nicotine found in the tobacco
leaf. The same goes for nicotine from other organic sources. I also understand why non
nicotine containing products would be of concern to the FDA as the other ingredients
are the ones that contain cancer causing ingredients of concern. From the metal
in the coils to the flavors and by products of the base liquids when they decompose
to the metal filings that were found in the testing of all those Chinese carto's. I
don't agree with the assessment of risk associated with these things in the form
of vaping but, I understand why the FDA is blowing them all out of any semblance
of reality.
So here I am wondering why such a statement would be made. I have
a pretty far out tin foil hat theory that I will keep to myself as I am not
sure exactly what to look for. Until then I am as stumped as anyone.
Regards
Mike
Yes he did. But unlike our scholarly KentC I was too lazy to look for it again.
After reading that back in May I immediately recalled an attorney at a vape conference back in 2014 when the deeming were proposed. He said (paraphrasing):
"All it takes is some 12 year old genius to figure out how to synthesize nic or make it more economical to extract from a tomato and all these regs are null and void. The FDA will be stopped in their tracks!"
Of course this was meet with resounding applause, much hand-wringing and maniacal laughter. Oh my. How wrong we were.
If you do a search on "nicotine" with the deeming doc, you'll see much more about what 'worries' the FDA about nicotine, wrt addiction and effects of it on teen brains, etc. (all junk science or we'd all be idiots, not just me
) They, at the same time, exclude their NRT's from this effect! Yet, by their actions, may still allow (force on the population) what they consider the worst source of nicotine and unhealthy side effects - cigarettes.If you do a search on "nicotine" with the deeming doc, you'll see much more about what 'worries' the FDA about nicotine, wrt addiction and effects of it on teen brains, etc. (all junk science or we'd all be idiots, not just me
The whole NRT versus vaping nictone issue is simply maddening. "Oh, well this nicotine, why that - that's good nicotine. But that nicotine, that's the spawn of Satan, and cancer stuff and... children."
So the objection must be the delivery system, right? "Inhaling. Inhaling nicotine is bad."
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They attempt to make that argument but when confronted with pipe and cigar smokers who don't inhale, they take another tack - also more junk science....
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