FDA Fresh Insights into Tobacco Regulation

[squee]

Five Fresh Insights into Tobacco Regulation from Mitch Zeller at 2015 NATO Show | CSPnet

Interesting read. Some good, some not but still some hope:

4. It's not an e-cig debate; it's a nicotine debate.

Zeller has often cited his position that the public health problem isn't nicotine, it's the delivery mechanism for the drug. During his panel, the director elaborated further on this notion.

"It shouldn't be a debate about e-cigs," he said. "It should be a debate about nicotine with e-cigs as the poster child of that debate."

Which isn't to say Zeller is fully on-board with nicotine being considered a low-risk drug.

"People have said we should treat nicotine like caffeine," said Zeller. "I'm not there yet, but I do agree we have to think about it differently."

5. Nicotine policy at forefront of things to come.

Perhaps the biggest clues Zeller dropped as to future priorities for the agency both centered on the continuum of risk: namely a discussion across multiple FDA centers on defining which nicotine-derived products should be regulated as tobacco and which should be regulated as therapeutic and an easier application process for products on the safer end of the risk continuum.

"Armed with more science, yes, future regulations should take into consideration a products' place on the continuum of risk," Zeller promised.

 

[Lessifer]

hmm.... a spectrum huh? The cynic in me suspects it will end up like this:
1. BP nicotine: patches, gum, lozenges * **
2.
3.
4. Low voltage closed system ENDS * **
5.
6.
7.
8. Open system ENDS ***
9. Non-Combustible tobacco: snus, chew ***
10. Cigarettes

* efficacy in avoiding other tobacco products is not used in determining placement on the spectrum
** Money payed by application/research fees is not(wink wink) used in determining placement on the spectrum
*** placement on the spectrum determined by appeal to youth, possible unknown harms, renormalization, and anything else we can get people to believe no matter how unlikely.

 

[skoony]

5. Nicotine policy at forefront of things to come.

Perhaps the biggest clues Zeller dropped as to future priorities for the agency both centered on the continuum of risk: namely a discussion across multiple FDA centers on defining which nicotine-derived products should be regulated as tobacco and which should be regulated as therapeutic and an easier application process for products on the safer end of the risk continuum.

"Armed with more science, yes, future regulations should take into consideration a products' place on the continuum of risk," Zeller promised.
this is the nail in the coffin. nicotine.
its all about the nicotine. its always been about the nicotine
except when it was about the second hand smoke.
yes,this deadly severely debilitating and horribly addictive
nicotine and the tragedy's resulting to a life long enslavement
to its iron grip.
but wait,there's more. when we get this worked out you can have
all the nicotine you want with the appropriate legislation, taxation and
all at the appropriate price point because I (Zeller) am in charge.
seems legit.

mike

 

[cinetrope]

If the FDA continues to run their workshops without the input of vaping industry and advocacy groups (SFATA and CASAA) their findings and policy implementation will be invalid and history will remember this period as the era when they dropped the ball on the cure for smoking.

 

[Cool_Breeze]

Can anyone imagine this happening if the matter in question were caffeine rather than nicotine? As far as harmful effects, is nicotine any more harmful than caffeine? Caffeine may be a contributing factor in road rage. I don't think nicotine is.

 

[pennysmalls]

If the FDA continues to run their workshops without the input of vaping industry and advocacy groups (SFATA and CASAA) their findings and policy implementation will be invalid and history will remember this period as the era when they dropped the ball on the cure for smoking.

That's what I kept thinking as I read the article. How can any organization attempt to understand something (anything really) they intend to regulate without input from the very people who are literally standing on the frontlines? It's the weirdest thing to witness all of these meetings and conversations taking place without the people being discussed present. This is a people thing, people vape and those vaping people can contribute the most important information to be had. Ask the people how nicotine affects them, ask them if they experience negative side effects, ask them if they feel their lives are in danger from nicotine use. Study the people not the fears/thoughts/opinions on what nicotine may do to the people.

 

[sofarsogood]

I can say something about the effect of nicotine. Something it does not effect is the human balance system (visual, vestibular, neural), at least not negatively. My passionate hobby is a form of motorcycle skills riding that mostly involves balancing the bike at a near standstill, the core exercise. If you get even a little bit good at this your balance system is working better than average. I find nicotine from vaping has zero effect on my balance and might even help it ever so slightly. That is not what I expected. I also don't notice I crave nic so much as it tells me when I've done enough vaping.

A question I keep asking, where the reports of doctors treating illnesses caused by using ecigs. There are 10s of millions of vapers around the world. So far I find zero reports.

 

[pennysmalls]

Interesting sofarsogood- I have a damaged left vestibular system and can say that while my balance issues have roller coastered over the years my continual use of nicotine has never seemed to make it either better or worse, no affect really.

 

[AndriaD]

Can anyone imagine this happening if the matter in question were caffeine rather than nicotine? As far as harmful effects, is nicotine any more harmful than caffeine? Caffeine may be a contributing factor in road rage. I don't think nicotine is.

I think "lack of nicotine" might be, though.

Andria

 

[AndriaD]

That's what I kept thinking as I read the article. How can any organization attempt to understand something (anything really) they intend to regulate without input from the very people who are literally standing on the frontlines? It's the weirdest thing to witness all of these meetings and conversations taking place without the people being discussed present. This is a people thing, people vape and those vaping people can contribute the most important information to be had. Ask the people how nicotine affects them, ask them if they experience negative side effects, ask them if they feel their lives are in danger from nicotine use. Study the people not the fears/thoughts/opinions on what nicotine may do to the people.

They're quite similar to the 3 blind men asked to describe an elephant.

Andria

 

[caramel]

If the FDA continues to run their workshops without the input of vaping industry and advocacy groups (SFATA and CASAA) their findings and policy implementation will be invalid and history will remember this period as the era when they dropped the ball on the cure for smoking.

Except it's the winners that get to write the history so it will be described as the era when glorious government identified and eliminated a bigger threat than even tobacco cigarettes.

 

[SeniorBoy]

The NIC bloviating from Zeller:

Which may lead to discussion across multiple FDA centers on defining which nicotine-derived products should be regulated as tobacco and which should be regulated as therapeutic and an easier application process for products on the safer end of the risk continuum. Armed with more science, yes, future regulations should take into consideration a products’ place on the continuum of risk,” Zeller promised.

So the "deeming" is a done deal! TWO FDA centers regulating NIC issues! Or none!

How comforting! I can hardly wait! /sarcasm

 

[AndriaD]

So... June, right? I should be able to accumulate another year's worth of nic by then -- got about 3 yrs' worth now. They can kiss my shiney hiney.

Andria

 

[SeniorBoy]

They can kiss my shiney hiney.

LMAO

 

[AndriaD]

LMAO

That's just how I feel -- no matter WHAT insanity they come up with, they will NOT stop me vaping as *I* see fit, and devil take their stupid "studies" AND their tobacco tax money. Got 2 mechs (plus all my regulated mods), 6 good rebuildables, 3 yrs' of nicotine, and the ability to make my own ejuice. So they can just kiss it. Another year's worth of nic going into my freezer before June.

Andria

 

[philoshop]

If nicotine was really that deadly wouldn't we be bombing the hell outta somebody for having 'substantial quantities' of it in 'weapons grade'?

 

[Bob Chill]

I always kinda chuckle at "nicotine is dangerous and a problem". First of all, all scientific research that has been done over the last 20+ years (and there's been a good bit) simply hasn't found a single thing "dangerous" about it. It "might" cause temporary constriction of blood vessels or a small increase in blood pressure. That's it. Sound a bit similar to the sought after ingredient in the world's favorite hot black beverage? I've looked pretty hard for real data showing real harm. There isn't anything out there.

I also kinda chuckle at the "nicotine is as addictive as narcotics". But oddly, all those little pieces of gum and lozenges behind the counter of every drug store aren't being touched by anybody except those who are trying to knock off the cigarettes. You would think backpacks in high schools across the country would be stuffed with them. Anybody with an 18 year old brother could buy a billion of them and sell them for steep profits. But there's no market for them....hmmmm....odd...or not odd. More like the people who feed me their BS think I'm an idiot.

I'd like to ask the anti nicotine crowd one simple question and see what their answer is. "If nicotine is massively addictive and dangerous, why are NRT therapies not abused by anyone (especially kids) and why is it approved for long term use with no documented negative health consequences?"

 

[Cool_Breeze]

I think the Nicotine / Caffeine axis 'might' be a good one to play up.

 

[nicnik]

But oddly, all those little pieces of gum and lozenges behind the counter of every drug store aren't being touched by anybody except those who are trying to knock off the cigarettes.

I think there's been some abuse of nicotine gum reported, including a fairly recent case where a bunch of kids got a bit sick and adults frightened that was written about here.

 

[nicnik]

I think the Nicotine / Caffeine axis 'might' be a good one to play up.

Yup. It even involves the kid friendly flavors issue.