Carl Phillips: FDA reveals its views on ecigs in new publication

[AgentAnia]

This just posted on the Good Doctor's blog: FDA reveals its views on ecigs in new publication | Anti-THR Lies and related topics

He nails it. Do I hear heads exploding at FDA CTP HQ?

 

[RosaJ]

I understand that Dr. Farsalinos addressed the FDA during a meeting, so they do know where to go to get information in his case. If the task is so daunting for the FDA to make the effort to understand everything there is to know about ecigs, then they should leave them alone until such time (if at all) they hire the people with the intelligence required to do so. But, they're probably too busy covering their rear ends fending off the finger pointers on products such as Chantix where they were too trigger happy to approve without due diligence.

By the way, I was going to just bump this post but couldn't help myself.

 

[carlvphillips]

I understand that Dr. Farsalinos addressed the FDA during a meeting, so they do know where to go to get information

CASAA has talked to them at length multiple times, so they know where to get info from the leading consumer organization. Vendors have talked to them even more times, so they know how to find out about products. I have talked to them multiple times about the other point noted in the blog. So this is not just a matter of a few random individuals who have given three minute talks at meetings. They know exactly how to learn about everything in today's post.

 

[Rickajho]

IMO the observations so far are nothing new. The most perplexing part of this process has been the FDA presuming it has the capacity to regulate a product it does not understand, either due to sheer will or enforced ignorance. The CDC is no better, still citing their example of an e-cigarette in their current teen survey as a product made by either njoy or Ruyan. Really?

This is why I cannot get all worked up over theoretical regulation to date, because the FDA seems to be largely stuck in a groove trying to regulate a narrow definition of a "product" that, based on it's own definition, hardly no one actually uses. If they care to regulate njoy e-cigarettes that's no skin off my nose. They will never regulate "a battery", "a piece of wire", "a cotton ball" etc. because it is not within their purview to do so. Restriction on sales of nicotine is a concern. But as long as our real world e-cigarettes are a sum of parts that individually the FDA has no power to regulate, while they continue to insist an e-cigarette is a product fixed in time circa 2008...

What was I saying about being stuck in a groove?

 

[swampergene]

The problem isn't finding information, it's finding information that supports their agenda.

 

[swampergene]

It's difficult to find any optimism in our corner, but the FDA does not have an easy road ahead here. They already lost one attempt and the decision that was handed to them was not light, they were spanked majorly by the court. And they have a very thin thread tying this together for them now in that the nicotine connection is the only way they will be able to anything at all as far as regulating e-cigs under current tobacco laws. If someone finds a reliable way to source nicotine from anything other than specifically a tobacco plant...they wouldn't be able to touch this without starting from scratch. This, and the fact that zero-nicotine juice exists, is going to create some serious difficulties for them going forward.

 

[AgentAnia]

I have this vision of Zeller at FDA and Samet et al tearing their hair out with the realization that the electric cigarette of today is so vastly different from the ecig of 2009, that the number of users has increased tremendously, and that vapers are knowledgeable, assertive, and vocal in their support of the practice and its benefits. (I bet they had NO idea in 2007 what their job was going to involve!)

That being said, I have no doubt they will continue to muddle their way through to attempting as much control as they think they can get away with, driven by arrogance and ideology. And, of course, politics. And the lucrative positions they'll be offered at Big Pharma when they leave government service.

 

[2coils]

Double A said That being said, I have no doubt they will continue to muddle their way through to attempting as much control as they think they can get away with, driven by arrogance and ideology. And, of course, politics. And the lucrative positions they'll be offered at Big Pharma when they leave government service.

We no longer need a forum You pretty much summed this whole mess up with a gift bow on it! very well said!

 

[aikanae1]

There's no doubt vaping's best defense is to increase our numbers as fast as possible. I see vaping appear in culture at every level, more and more everyday.

What I don't understand is why vapers don't think regulations are going to affect them? Online sales, nic bans, taxes, state stamp requirements, outrageous costs. Cities an states and anyone else was given the auority to make whatever restrictions they want including vaping in your own private car. Fines, prisions, and worse, when smoking rates climb those newly addicted won't know what might have been possible - just like most forgot less harmful cigarettes were a movement in the 70's and 80's too.

I'm really at a loss trying to understand why stores and others in the vaping industry seem so calm about all this movement going on in states and federally. It's almost as if there's a denial bubble of some sort. I know people know this and I'm just preaching to the choir.

 

[swampergene]

There's no doubt vaping's best defense is to increase our numbers as fast as possible. I see vaping appear in culture at every level, more and more everyday.

What I don't understand is why vapers don't think regulations are going to affect them? Online sales, nic bans, taxes, state stamp requirements, outrageous costs. Cities an states and anyone else was given the auority to make whatever restrictions they want including vaping in your own private car. Fines, prisions, and worse, when smoking rates climb those newly addicted won't know what might have been possible - just like most forgot less harmful cigarettes were a movement in the 70's and 80's too.

I'm really at a loss trying to understand why stores and others in the vaping industry seem so calm about all this movement going on in states and federally. It's almost as if there's a denial bubble of some sort. I know people know this and I'm just preaching to the choir.

I agree 100%, especially with the last part. Hell manufacturers and even many small shops are still pushing the whole "with these, you can smoke anywhere" thing. It's like they have no clue.

 

[AgentAnia]

Double A said That being said, I have no doubt they will continue to muddle their way through to attempting as much control as they think they can get away with, driven by arrogance and ideology. And, of course, politics. And the lucrative positions they'll be offered at Big Pharma when they leave government service.

We no longer need a forum You pretty much summed this whole mess up with a gift bow on it! very well said!

Thank you for your kind words, but...

We will always need ECF and the Legislation forum! As long as there are legislators/regulators at any level trying to control vaping (which means: as long as there are legislators/regulators...), we need a place to post alerts, develop strategy and tactics, pass along information, and provide support and comfort. This is that place. But you knew that, didn't you?

 

[Berylanna]

The problem isn't finding information, it's finding information that supports their agenda.

Nope. The problem, and they have publicly pointed this out many times, is that they only pay attention to information that is submitted as part of a request for a pharmaceutical product approval, and now for cigarette approval. So until they deem, they can't charge $$$$$$$ for submissions, which means they can't find out anything.

They have also pointed out that controlling ecigs is "a great opportunity for the FDA" -- aka, new market for multi-million-$$$$$ department and lots of hiring. Just like any business.

 

[aikanae1]

I agree 100%, especially with the last part. Hell manufacturers and even many small shops are still pushing the whole "with these, you can smoke anywhere" thing. It's like they have no clue.

Yeah and now you all know how much I need spell check

It's like I want to make a list of all the states / towns that have faced legislation this year, list types and bills and print it up on top of some Disneyland movie scene with a huge header saying WAKE UP! with CAASA info on the bottom.

And then pass it out to vendors, retailers - heck, even the public.
The thing is a business can get an audience with a local rep much faster than someone off the street.

Here's a few good ones from around the net:

 

[Berylanna]

Yeah and now you all know how much I need spell check

It's like I want to make a list of all the states / towns that have faced legislation this year, list types and bills and print it up on top of some Disneyland movie scene with a huge header saying WAKE UP! with CAASA info on the bottom.

And then pass it out to vendors, retailers - heck, even the public.
The thing is a business can get an audience with a local rep much faster than someone off the street.

Here's a few good ones from around the net:

View attachment 326825 View attachment 326826 View attachment 326831



View attachment 326829

I like these better than the one I helped design for CASAA (the final design is not mine) but there is a NEW $30 vendor kit here:

theCASAAstore

The $30 is casaa's COST (presumably including shipping) this is not meant to be a fundraiser.

It would be fun to include some of those other things with the kit, to put onto walls.

 

[DrMA]

I'm afraid I disagree with CVP in that it's not «unwillingness of FDA officials to spend the time it takes to understand the products,» but rather they're spending time in a concerted effort with other ANTZ, BP, and quite possibly BT, to manufacture an image of the products in such way that it aligns with FDA's predetermined position. Elsewhere, CVP does mention that «this process was not about seeking the truth, but rather creating the “truth”.»

On another topic, it's interesting that the last article in the series actually provides a token citation for the Burstyn study, but uses it in the weakest possible way, to highlight potential methodological problems in ecig and vapor studies. Not a single mention of the Burstyn conclusions is discussed. I say interesting, because I expected the Burstyn study would not be mentioned by any of the articles, all of which are by FDA/CTP staff. Several studies by Farsalinos are also cited in the other articles in the series, also without mentioning any of the positive findings of that research.

 

[aikanae1]

«"this process was not about seeking the truth, but rather creating the “truth”.»

On another topic, it's interesting that the last article in the series actually provides a token citation for the Burstyn study, but uses it in the weakest possible way, to highlight potential methodological problems in ecig and vapor studies. Not a single mention of the Burstyn conclusions is discussed. I say interesting, because I expected the Burstyn study would not be mentioned by any of the articles, all of which are by FDA/CTP staff. Several studies by Farsalinos are also cited in the other articles in the series, also without mentioning any of the positive findings of that research.

I'm not sure how this usually works, but it seems to me that if a study is referenced they are also acknowledging the validity of that study; like it or not, for better and for worse. It's undeniably there.

 

[aikanae1]

I like these better than the one I helped design for CASAA (the final design is not mine) but there is a NEW $30 vendor kit here:

theCASAAstore

The $30 is casaa's COST (presumably including shipping) this is not meant to be a fundraiser.

It would be fun to include some of those other things with the kit, to put onto walls.

It's possible a few of those things would sell well in places like Zazzle / Cafe Press and I think a few others. That way people can get them as stickers, magnets, shirts, mugs, etc. For all I know, they may even have a ecig holder in there for printing on. That's the distance between the general public and regulation.

I thought an interesting poster would be pics of all the various forms of harm reduction (seat belts etc) with the final pic an ecig. That's more appropiate to what they should be viewed as. There's a lot of potential for parody - ya' just can't make this stuff up.

I just don't see many manufacturers or retailers interested in doing anything. A few have stepped up and I don't want to discount that, but for the most part even those few have done a one time thing as a singular effort rather than contribute to a sustained approach. Do they really think if they beat back a bill one year that the threat is gone forever - or it can't happen here?

I think they need a graphic wakeup call.

LOL! What I'd like to say to the FDA



(as far as I know, those images are passed around as open for non-commercial uses)

 

[swampergene]

I know this will probably be flame bait and I really don't mean it as such, but going by the handful of B&M's I've been in and live vids and such that I've seen online, I'm mixed on weather or not their involvement would help or hurt our cause.

 

[AgentAnia]

I know this will probably be flame bait and I really don't mean it as such, but going by the handful of B&M's I've been in and live vids and such that I've seen online, I'm mixed on weather or not their involvement would help or hurt our cause.

I'd like to see more B&Ms joining and supporting SFATA, their trade organization. I think that's how they could be most effective. (We can't expect each individual business owner, who's busy running a business, also spend a lot of time being an involved, informed activist. Isn't reasonable.)

 

[Berylanna]

I just don't see many manufacturers or retailers interested in doing anything. A few have stepped up and I don't want to discount that, but for the most part even those few have done a one time thing as a singular effort rather than contribute to a sustained approach. Do they really think if they beat back a bill one year that the threat is gone forever - or it can't happen here?

If you can see them doing something, they are probably hurting us. They represent Evil Tobacco Pushers (TM) as far as legislators go -- the best they can do besides join SFATA is put up CASAA cards FOR THEIR CUSTOMERS.

Example from today's Local Alert for San Jose, CA:

Councilmember Rose Herrera sent an email yesterday to members of her district asking that residents show up in support of the ordinance, noting that, "Going up against big tobacco and addiction is not an easy feat and I need your help." She apparently doesn't realize that the battle she is waging isn't against "big tobacco," but, rather, against thousands of individual vapers in San Jose who have improved their health and dramatically reduced their health risks by switching (either in whole or in part) to a product estimated to be 99% less hazardous than smoking.