Deeming Regulations have been released!!!!

[Kent C]

This is very sad. I've been vaping Green Tea Lung for 5 years or more. I was just about to reorder and found out that it's not available. I sent them an email, but the entire Nhaler forum looks like it's been inactive since April. I wonder if they are going to survive without Drew.

I enjoyed the same GTLung as well as one with Plums. Not sure about the future of nhaler.... no data... In the US, it was nhaler, janty and cignot for me for quite a while. Fresh Smoking as well.... but they got waylaid badly by the earlier customs ban.

 

[DC2]

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.

 

[drum747]

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

 

[Kent C]

Is the FDA going to hire taste testers to determine if e-liquids taste like tobacco? What are they going to do with RY4 a "a sweet tobacco with undertones of caramel and vanilla"?

"And what the he!! is that other flavor note??? Someone call Ludo!" I always thought it was ginger :- )

 

[Kent C]

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.

A valiant effort! Nice job DC2!!

 

[crxess]

Had to do a bit of Skimming to get caught up. Hectic day and had to run a few errands.
Did pick up a Free Mark 10 and Cartridge Pack(coupon)
Notice I said FREE
FREE, Right
FREE Plus MARYLAND State Tax
FREE Plus something like $1.22 to line someones pocket
FREE My
(Not Sheetz problem)

Also stopped by Madd Katts
Signage all over the Door - AGE Restrictions, FDA Info. CASAA info
AGE Signs on EVERY WALL - Big and Visible.
Busy as heck and holding their Spirits, but Well informed and watchful
The Boss has made several trips to DC meetings and trying to stay abreast of countermeasures.
Well, that makes 1 of 3 in my area.

 

[Katya]

I enjoyed the same GTLung as well as one with Plums. Not sure about the future of nhaler.... no data... In the US, it was nhaler, janty and cignot for me for quite a while. Fresh Smoking as well.... but they got waylaid badly by the earlier customs ban.

Yeah. I traveled a similar road after I graduated from V4L. And I liked a few flavors from Decadent Vapours (thanks ) when they were still available here via TW and then, later, Liberty Flights USA.

Now I'm beginning to seriously consider DIY.

 

[Katya]

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

You're my hero, DC2! Bravo!!!!!

 

[Katya]

The latest from Dr. Siegel:

The Rest of the Story: Tobacco News Analysis and Commentary: The Last Straw: Anti-Tobacco Groups are Actively Promoting Smoking

I enjoyed the comments even more than the article.

 

[The Ocelot]

The New England Journal of Medicine has an article on ecigs for smoking cessation open for comments:

MMS: Error

ETA: The link works even though it says error.

 

[Katya]

The New England Journal of Medicine has an article on ecigs for smoking cessation open for comments:

MMS: Error

There's also a poll. I voted!

 

[The Ocelot]

"And what the he!! is that other flavor note??? Someone call Ludo!" I always thought it was ginger :- )

That's just ECBlend's version of RY4, I've heard others are different. I have never vaped a tobacco flavor, so I have no idea of flavor notes. I also can't tell you what flavor notes my tobacco cigarettes had, other than menthol.

 

[Katya]

He is concerned about fine particles.

Really? Tell him to start wearing a face mask. The air he's breathing right now has more "particles" than vapor--please send him the results of the USC study (below):

Here are all the data from the USC study, including Compounds, Outdoor air, e-Cigarette, and normal cigarette.http://www.rsc.org/suppdata/em/c4/c4em00415a/c4em00415a1.pdf

For your convenience, listed below are the amounts of Cr, Ni, Pb, Zn and Al in outdoor air vs e-cigarette vapor:

Cr: 5.53 vs 4.22
Ni: 5.57 vs 6.14 (+/-2.9)
Pb: 13.28 vs 9.85
Zn: 54.31 vs 56.08 (+/- 21 [sic])
Al: 333.27 (±62.93) vs 161.43 (±71.35)

So, vapor is actually healthier, per this study, than the air we breathe here in SoCal.

He thinks the high-powered devices create bad thingies.

So does the carpet in his office. And his bookcases. And the exhaust fumes from his car. Tons of formaldehyde and who knows what else.

He believes that we will still see heart disease and even cancer.

Of course we will. As people live longer, eat unhealthy food and don't exercise, heart disease and cancer rates will keep going up.

He is concerned about dual use.

Dual use is better than exclusive use of combustible tobacco products.

 

[Steamix]

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

chemular --- founded this year. By ex FDA staff.

Founder also listed in connection with a company called AUK Technical Services .

Build a wall. Put in a tollgate. Man tollgate with your staff.

Free capitalism my ..... Oligolopoly. Or...

Advance to Boardwalk.

We all know THAT game. Pulling that one and not owning it spelled doom to countless players...

 

[The Ocelot]

Had to do a bit of Skimming to get caught up. Hectic day and had to run a few errands.
Did pick up a Free Mark 10 and Cartridge Pack(coupon)
Notice I said FREE
FREE, Right
FREE Plus MARYLAND State Tax
FREE Plus something like $1.22 to line someones pocket
FREE My
(Not Sheetz problem)

Also stopped by Madd Katts
Signage all over the Door - AGE Restrictions, FDA Info. CASAA info
AGE Signs on EVERY WALL - Big and Visible.
Busy as heck and holding their Spirits, but Well informed and watchful
The Boss has made several trips to DC meetings and trying to stay abreast of countermeasures.
Well, that makes 1 of 3 in my area.

Have you tried the Mark 10? What's it like?

There's also a poll. I voted!

Thanks! I missed that.

 

[DC2]

A valiant effort! Nice job DC2!!

The weird part was that he sounded like a human being.
That really threw me off guard.

 

[DC2]

Here are all the data from the USC study, including Compounds, Outdoor air, e-Cigarette, and normal cigarette.http://www.rsc.org/suppdata/em/c4/c4em00415a/c4em00415a1.pdf

Ah yes, I remember that one.
I included the link in my email, which I have not sent yet.

 

[The Ocelot]

Really? Tell him to start wearing a face mask. The air he's breathing right now has more "particles" than vapor--please send him the results of the USC study...

Since you live there perhaps you should send it to him.

I plan on sending an email to him and to Tom Frieden, I'm just working on what I want to say. I want it short and to the point.

 

[Eskie]

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

While the FSMA gives the FDA the authority to mandate food recalls, the agency must first provide food companies with the opportunity to issue “voluntary” recalls of tainted food; and almost all food recalls eventually fall under that voluntary umbrella.

In fact, according to the Inspector General’s report, the FDA has only used its authority to force two recalls: First, in Feb. 2013, to take salmonella-tainted pet food off the market; then in Nov. 2013, with a forced recall of adulterated dietary supplements. In both cases, it was months between the FDA learning of the adulteration and the recalls being issued.

The report points to two examples of voluntary recalls in which the FDA identified potentially dangerous contamination in food products but waited months for finally pushing for a voluntary recall.

In July 2014, Virginia state officials notified the FDA that they had found listeria in an Oasis product, and that it had been linked to previous illnesses.........It wasn’t until mid/late-October that a full-scale recall of all potentially contaminated products was initiated. In the nearly three months between the time when Virginia confirmed the tainted cheese was linked to earlier illnesses and that voluntary recall was announced, six illnesses — including the loss of two fetuses — were linked to these tainted cheeses.

And the conclusion

“FDA does not have adequate policies and procedures to ensure that firms take prompt and effective action in initiating voluntary food recalls,” concludes the Inspector General’s report. “As a result, consumers remained at risk of illness or death for several weeks after FDA was aware of a potentially hazardous food in the supply chain.”

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:

However, even as the number of inspections increased, FDA conducted relatively fewer inspections outside the US. In 2011, nearly 60% of FDA's inspections of generic drug facilities were outside the US. In 2012 and 2013, the agency conducted only about half of all pre-approval inspections outside the US.

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.

 

[DC2]

I plan on sending an email to him and to Tom Frieden, I'm just working on what I want to say. I want it short and to the point.

I assume "Die." is too short and to the point?