Deeming Regulations have been released!!!!

[Kent C]

I don't. Sorry, Les. There's plenty of evidence out there proving beyond any doubt that e-cigarettes are way less harmful than smoking. If he doesn't see it, then he doesn't want to see it.

For these types, it's almost always that they want other people to think they are doing good. Usually to distract from the crimes.

 

[crxess]

That's the dangerous part, DC2. Not weird. Beware. Zeller also sounds like a human being. So does Califf.

Hi, I'm Mitch Zeller and Big Pharma has a hand Squarely up my

 

[The Ocelot]

FDA KMA!

KMA is a radio station licensed to serve Shenandoah, Iowa. (Never mind, I found what you meant in the Urban Dictionary.)

 

[crxess]

KMA is a radio station licensed to serve Shenandoah, Iowa. (Never mind, I found what you meant in the Urban Dictionary.)

busted

 

[Eskie]

I've heard the Vuse is high in nic too.

48 mg. I will say that Vuse Original is far from tasty, especially compared to a good juice in a real tank, but the things got me to stop smoking. I sure prefer what I have now, but I can't deny Vuse can work if it's just about the nic.

 

[VNeil]

Hmm. This is far more detail than I have seen before about juice and the pmta:
FDA Deeming: Beyond the Sticker Shock - The Hidden GMP Requirements

All that and a million bucks later you have FDA permission to mix a gin & tonic. For another million they might let you bake a chocolate cake.

Or maybe just "sorry, this cake doesn't benefit public health".

 

[Lessifer]

I don't. Sorry, Les. There's plenty of evidence out there proving beyond any doubt that e-cigarettes are way less harmful than smoking. If he doesn't see it, then he doesn't want to see it.

Just me trying to believe that people aren't truly evil.

Even if you believe that vaping is 99% less harmful than smoking, if you actually believe that vaping could lead to smoking, drastic measures could be justified, in the minds of anti tobacco people.

Not that there's any actual evidence of that either...

Either way, if he's a zealot, or just a greedy SOB, I doubt he'll be converted by reason.

 

[classwife]

and to think...those people could actually go down in history as heroes of public health by supporting vaping if they REALLY CARED about public health

 

[Katya]

and to think...those people could actually go down in history as heroes of public health by supporting vaping if they REALLY CARED about public health

Apparatchiks don't become heroes. They are loyal servants and their main purpose in life is to support and enforce the party line. Because the party knows best. They have no courage and no imagination.

And they know better than to rock the party boat.

And even if they have their own opinions, they don't agree with them.

 

[Steamix]

What's interesting when thinking about these extensive regulations, and the apparent zeal of those biting at the bit to enforce it, is to consider how the FDA runs overall as an agency. There's a lovely story on Consumerist about the FDA and how wonderful they are about enforcement after the Food Safety Modernization Act was passed several years ago. It can be found here https://consumerist.com/2016/06/09/inspector-general-fda-still-takes-too-long-to-recall-tainted-food-products/ (sorry, not sure why it isn't showing up a as a proper link).

Here are a few of the issues noted by the Inspector General









And the conclusion


What's the point of all that? Well, if the FDA is struggling to devote resources to handle issues that that cause documented illness and even deaths, and taking months to finally get around to some type of action, why is it now about to regulate thousands of vendors of vaping products, of which there is way less, if not an outright no risk to public health?

Let's not forget either that regardless of statements from the Center for Tobacco Products about going out to ensure compliance, they're going to need inspectors to do that inspecting. Right now, the FDA is still working on obtaining sufficient inspectors for drugs. There are many drug manufacturers that only get inspected every 5 years rather than the more frequent 2 to 3 year guideline because they don't have enough inspectors to go around. It's even worse overseas, where many companies manufacture pharmaceuticals either to send to the US for final preparation (active ingredients) or outright medications for distribution directly to pharmacies and hospitals, yet the FDA have even fewer inspectors there and to deal with the volume of work necessary.

Here's a quote from a recent article on regulatory affairs:


source http://www.raps.org/Regulatory-Focu...nspections-of-Foreign-Generic-Drug-Companies/

If these Deeming regulations pass, it will certainly be interesting how the FDA will go about its enforcement. Maybe they feel inspecting vaping stuff is way more important than inspecting medicines and food.

Easier for a cop to write twenty traffic tickets and get promoted thanchasing some hard-nosed armed-to-the teeth dealer.
Easier for some FDA minion to play god by pushing around the owners of some small mom 'n pop store than going after some major leagure food processor whose lawyers gonna crucify you for the slightest misstep.

The way of least resistance - human nature.

If you wanna pick a fight and get to choose between a 100 pound deskjockey and 200 pound martial arts specialist...

 

[halonut]

I don't see him being grilled tbh. I am genuinely interested on what vendors are doing in this regard, and my purchasing decisions will be made accordingly. He was kinda striking attitudes though imo. His first post on the topic, called anyone who questioned a vendors actions ( or lack thereof ) and motives, busybodies.

I was not referencing anyone here specifically or even the deeming regs issue in general. It is just my observation and opinion of the American condition...nothing more, nothing less.

I certainly didn't feel like I was being grilled & I, like you, did not understand the comment by Senior Boy of being disappointed in the responses to me. I didn't find anything harsh or offensive...and if I did I'd fire back.

 

[The Ocelot]

(This is actually the response to the request I posted further down. I happened to find it first.)

GAO Report to the Committee on Finance, U.S. Senate September 2015
Regarding the effect ecigs on Federal Excise Tax (FET)
Most of it is "We don't know," but it does say:

"...we found no significant evidence of a decrease in FET revenue from cigarettes at a rate greater than the 6-year historical trend during the time frame when e-cigarettes have been on the U.S. market. We estimate that cigarette FET revenue would need to decrease by an additional $2 million to $3 million per month to signal a significant effect from e-cigarettes."

"If the percentage of high school students using cigarettes continues to decline, and if other factors such as current levels of regulation remain constant, the number of cigarette smokers could dwindle further in the coming years as the current cohort of high school students ages. [This was before the deeming regs.]

"A continued decline in cigarette smoking among high school students—which could be due, in part, to increased use of e-cigarettes—would reduce cigarette FET revenue at a greater rate than the average historical trend."

http://gao.gov/assets/680/672467.pdf

 

[Steamix]

Just me trying to believe that people aren't truly evil.

Even if you believe that vaping is 99% less harmful than smoking, if you actually believe that vaping could lead to smoking, drastic measures could be justified, in the minds of anti tobacco people.

Not that there's any actual evidence of that either...

Either way, if he's a zealot, or just a greedy SOB, I doubt he'll be converted by reason.

That's the catch.

Believe.

If you want to believe - feel free to go to a church, a mosque, a synagogue, a temple, whatever.

Believe.

That's a very personal matter between you and the deity/dieties of your choice.

It's - unfortunately - the hallmark of any zealot to foist his/her beliefs on the rest of the world.

AFAIK, USA isn't a theocracy (yet), so might be better to stick to the facts.

And no matter how irksome these facts might be - act in accordance with that.

And fact is that smoking comes out as a very distant second in comparison to vaping.Period.

 

[Lessifer]

I was not referencing anyone here specifically or even the deeming regs issue in general. It just my observation and opinion of the American condition...nothing more, nothing less.

I certainly didn't feel like I was being grilled & I like you, did not understand the comment by Senior Boy of being disappointed in the responses to me. I didn't find anything harsh or offensive.

You've stated that you are trying to inform your customers about the regs and steer them toward resources like CASAA. I applaud you for that. I wish more vendors did the same, and that's the only point I was trying to make throughout this whole thing.

This next part is not a comment on you, but rather an observation of the industry.

For years, I and many others have been doing everything we can, participating in calls to action, writing legislators, going to hearings, reading and digesting every piece of information that comes our way. Reaching out to other vapers, friends, family, trying to gather support. We do this because we believe in vaping. Not just to save ourselves, as many of us are prepared for whatever comes, but to save the industry so that others may have the opportunity to make the switch.

There are many vendors who are also doing everything they can to help. There are also vendors who are not.

In all honesty, it's sometimes hard to keep up my resolve to fight for an industry that seemingly won't fight for itself.

ETA: Again, I'm not suggesting that there aren't those in the industry fighting to keep it alive. Even remaining open at this point is a big thing.

 

[Lessifer]

That's the catch.

Believe.

If you want to believe - feel free to go to a church, a mosque, a synagogue, a temple, whatever.

Believe.

That's a very personal matter between you and the deity/dieties of your choice.

It's - unfortunately - the hallmark of any zealot to foist his/her beliefs on the rest of the world.

AFAIK, USA isn't a theocracy (yet), so might be better to stick to the facts.

And no matter how irksome these facts might be - act in accordance with that.

And fact is that smoking comes out as a very distant second in comparison to vaping.Period.

Yeah, no one in public health or public policy should be basing any actions on belief.

 

[mpols]

While I understand the intent - to get attention, I cringe at every "another ecig explodes" title in our Media forum. Or some such negative title that almost always is 'user error'.

Great article: E-Cigarette Battery Hazards Minuscule and Overblown

The National Fire Protection Association has a few different numbers than the above article, but same idea, they state that in 2015 there were 15 e-cigarette explosions and fires reported in the media. 12 incidences required medical treatment. There were no deaths.

They report more fires in 2011 (this article is from 2013). They state that there were 17,600 house fires attributed to smoking materials (tobacco products/marijuana). There were 490 deaths and 1,370 injuries.

 

[The Ocelot]

Committee Reports
114th Congress (2015-2016)
Senate Report 114-009

Avoidance and Evasion of Tobacco Excise Taxes:

"In August 2014, Chairman Wyden and Ranking Member Hatch requested that GAO pursue inquiries regarding two related tobacco tax issues: illicit imports that evade Federal taxation and e-cigarette manufacture and distribution. E-cigarettes constitute a growing part of the smoking market, but are not subject to Federal excise taxes because they are not tobacco products under the tax code even if the nicotine they contain is derived from tobacco."

I've asked this before (rhetorically): Can the FDA change the tax code just by deeming a non-tobacco product a tobacco product?

From all that I have read so far, the goal of FSP&TC Act was to discouraging minors and young adults from smoking. The authority of the FDA over tobacco products is pretty vague:

[The authority] "shall apply to all cigarettes, cigarette tobacco, roll-your-own tobacco, and smokeless tobacco and to any other tobacco products that the Secretary [of Health and Human Services] by regulation deems to be subject to this chapter." [The chapter on authority.]

That's it. Nowhere does it give the authority for the FDA to change the tax code.

 

[mpols]

Okay, again, holy crap.
So I called back.

He is concerned about fine particles.
He is concerned about dual use.
He thinks the high-powered devices create bad thingies.
He believes that we will still see heart disease and even cancer.

He kept mentioning the results of his "meta-analysis" and wanted me to take a look at it.
I assured him that I was quite familiar.


He thinks someone should put an ecigarette through a drug application.
He believes that they can be effective and should be used that way.

I explained everything to him.
Well, every damn thing I had time for before he had to go.

I doubt I said anything new that he hadn't heard.
But I am sending some information he claims to not have been aware of.


As to the person who said take notes.
I wish I had.

The main thing I wanted to ask him was if he believes the crap he spews.
And while I didn't quite word it that way, I did ask.

No way of knowing for sure whether or not his answer was honest.

I thought this article was good:
Professor Stanton Glantz makes an irresponsible and baseless claim about vaping risks

 

[Katya]

I thought this article was good:
Professor Stanton Glantz makes an irresponsible and baseless claim about vaping risks

Nice! Maybe I'll just send him a link to this article instead of writing a letter.

And this:

Medical Study: Smokers Switching To E-Cigarettes Unlikely To Go Back

"The big public health takeaway for Siegel is that if a smoker successfully switches from smoking to vaping, there is a very strong chance they will remain an ex-smoker."

 

[Kent C]

Nice! Maybe I'll just send him a link to this article instead of writing a letter.

And this:

Medical Study: Smokers Switching To E-Cigarettes Unlikely To Go Back

That and the decreasing smoking rates and increasing ecig rates are putting the 'gateway' argument in the dustbin of anti-ecigarette propaganda. Once more studies come out on how nicotine isn't that addictive, the idea of ecigs harming the 'net population' (Zeller) will be added to that same junk pile.

Doesn't mean they won't continue to use both arguments though ... with the media following suit.