FDA opens comment periods on two issues regarding Substantial Equivalence Requirements

[Talyon]

tombaker (Professor). I've lived and loved and lost, I have chosen wisely and chosen badly through the years, all part of being human. But one main thing I have learned and stuck to is if it's to good to be true..... Then it isn't.

TY for sharing you Opinions on the matters of CASAA the FDA and ecigs.

I for one have decided (right or wrong) to not believe in your Opinion, Although interesting etal.

A small naive part of me sincerely hopes you are right, but alas I'm afraid u shall not be as I know very well how Goverenments work for their own agendas and not ours...... I can site hundreds of examples of this. Follow the Money, being the simplest.

Someday in the future I hope we speak again, of things less important and far less dire.

Have a good day Sir, I wish you all the best.

 

[rothenbj]

tombaker (Professor). I've lived and loved and lost, I have chosen wisely and chosen badly through the years, all part of being human. But one main thing I have learned and stuck to is if it's to good to be true..... Then it isn't.

TY for sharing you Opinions on the matters of CASAA the FDA and ecigs.

I for one have decided (right or wrong) to not believe in your Opinion, Although interesting etal.

A small naive part of me sincerely hopes you are right, but alas I'm afraid u shall not be as I know very well how Goverenments work for their own agendas and not ours...... I can site hundreds of examples of this. Follow the Money, being the simplest.

Someday in the future I hope we speak again, of things less important and far less dire.

Have a good day Sir, I wish you all the best.

I wish I could remember the fellow that was around here before and after the loss by the FDA in declaring that the e cig was indeed a drug and drug delivery device. Perhaps someone else can remember his screen name. When he finally gave up posting here, he'd show up on Siegel's blog and repeat the same argument over and over again, then he disappeared.

It would be interesting to have he and Tom argue their "legal" points of view of the world. Both know precisely what the FDA can and can't do with great authority but no credentials and their opinions are diametrically opposite each other.

 

[AttyPops]

Can anyone comment here with an opinion (even if wrong?), or do I have to list all of my qualifications first even if I never claimed to be a legal professional?

What if I (gasp) disagree with the "normal" opinion?

Nah. I don't want to be bullied. So I'll refrain.

Mods....please move this thread to the "one sided opinion only" sub-form please.

Oh, or maybe into a "The sky is falling" sub-forum. There's been YEARS worth of threads on that....

I'll contradict myself and state one opinion that:
I do understand the "undue burden" aspect of this whole thing on the vendors. Shame.
They need to streamline that process for the good of the health of the country. Liquids containing _(list of stuff)______ and nothing else are auto-deemed equivalent.

 

[kristin]

Tom is in the enviable position that if the FDA does what CASAA suspects it will, he can say CASAA didn't do enough, but if the FDA doesn't do it, he can pretend CASAA's efforts had nothing to do with that outcome. Funny how its OK for ALA and ACS representatives to repeatedly lie to the public in the media and that he doesn't consider to be "official," but Elaine expresses a concern on some web forum and that's CASAA's "official position."

As far as Tom's claims that CASAA and other experts are idiots who cannot read and have no clue what has been going on for the past 4 years, I guess time will prove who was right. In the meantime, CASAA will continue to inform people of the possibilities and will continue to fight state and local bans. Unless, of course, Tom takes over that task for us. He apparently knows how to do it better and plans to step up and save us all from our own folly. I honestly look forward to seeing his future success fighting all of the bans and taxes. I sincerely hope people keep stepping up and do it. It would take a huge load of work off of our shoulders and I have a member meeting presentation to set up and run tonight, white papers to review, handouts to finish, graphics to complete, emails to answer....a whole "to-do" list we have been putting off while (apparently not) fighting local bans. It will be nice to know Tom is on the job stopping the bans instead, so I can spend a little more time with my husband and kids.

 

[AegisPrime]

Thank you Kristin for your and all of CASAA's efforts on behalf of the vaping community. Please can you hook up with the saveecigs.com people over this: TPD timeline, what happens next and what we vapers can do… so that EU CASAA members have a clearer picture of what they can do (and when they need to do it by) to attempt to prevent e-cigarettes being included in the TPD.

 

[rothenbj]

I believe Tom has volunteered to head up that effort and prove he can do a much better job of it. I fully support his effort. Perhaps he can get other volunteers to work with him.

 

[Rossum]

CASAA seemingly wants to continue to focus on the FDA, which was severly crippled in anything it can do.

The notion that the FDA is "crippled" in what it can do is your opinion, one which is certainly not universally held. But even if your opinion is technically correct, there are numerous examples of federal regulatory agencies overstepping their bounds and doing all sorts of damage in the process.

What is left to do with the FDA, is not going to be changed by writing Senators and Congressman, who don't have standing, against the FDA which is empowered by a law they passed in 2009.

Congress has no standing? Are you serious? Congress could pass a law totally eliminating the FDA's ability to regulate e-cigs and the FDA knows this. Hence if enough members of Congress tell the FDA, "Hey, go easy on the e-cig regulations", the FDA is darn likely to listen.

IMO, your focus on local "bans" is a distraction. Local "bans" don't affect smokers' ability to switch to vaping. Maybe I've missed something, but I have yet to hear of a local ban that prohibits vaping anywhere that smoking is allowed. Local bans are also easy enough for vapers to simply ignore. To paraphrase Catherine Tramell, "What are you gonna do? Charge me with vaping?" OTOH, FDA regulations have the potential to make it much more difficult for smokers to switch, which is what the real issue is.

Kristin when you say that professionals in association with the American Cancer Society, and American Lung Association, lie, and cheat, and don’t care if people die as a result, is over the top.

Is it? Have you read Carl Phillips' analysis of Harold Wimmer's op-ed? Harold is president and CEO of the American Lung Association.

I'm relatively new to vaping, but my considered opinion is that your attacks on the CASAA are unfounded and unwarranted.

 

[AttyPops]

Look folks....it's simple.

You local congressman (Republicans too) State and Fed are more likely to ban internet sales simply by passing laws. Sure the FDA could over-regulate. But Tom's main point...that local bans are a real thread....is not without merit. IDK how much "CASAA bashing" is going on, and I thank CASAA for their efforts. However, the fact remains that there's a battle on all fronts.

I've been hearing about FDA bans for three years. And "deeming regulation" for months. I'm concerned, sure. But so far it's a moving target. All the while, there's big $$$$$ funding local/state/fed efforts at BANNING, and so much misinformation out there.

I'm stocking up. I am lucky to have a B&M near me, assuming they can stay in business. However, I'm stocking up. Pure and simple.

As to the rest...I really can't understand all that mumbo jumbo enough to decipher it. It's too much if you're not doing that for a living. I'll have to trust and support those that understand it and support vaping. But IDK how even CASAA (and us) can stop the Washington D.C. congressmen from messing up. With BT and BP in the mix. We'll see.

The most likely outcome is: "Save the children, ban e-cig and e-juice internet sales". IMHO. FDA: Meh.

 

[Talyon]

Can anyone comment here with an opinion (even if wrong?), or do I have to list all of my qualifications first even if I never claimed to be a legal professional?

What if I (gasp) disagree with the "normal" opinion?

Nah. I don't want to be bullied. So I'll refrain.

Mods....please move this thread to the "one sided opinion only" sub-form please.

Oh, or maybe into a "The sky is falling" sub-forum. There's been YEARS worth of threads on that....

I'll contradict myself and state one opinion that:
I do understand the "undue burden" aspect of this whole thing on the vendors. Shame.
They need to streamline that process for the good of the health of the country. Liquids containing _(list of stuff)______ and nothing else are auto-deemed equivalent.

1. I figured this thread would be closed or moved to the Outside after page 3. But I guess the Mods thought it fitted here and let it remain. I'm good with that.

2. Everyone gave their opinions like them or not. That's also good.

3. Asking for qualifications was important for some to understand the legalize being used wasn't simply wind and hope.

4. Vapeing as u well know saves lives making all here very dedicated to Vapeing but not an excuse to belittle.

5. There was never a need to bash CASAA, it's one thing to state a difference of opinion with CASAA but it's another to come out and say CASAA knows nothing is completely wrong and does nothing for the Vapeing community. I think u know what I mean atty.

Not sure if u followed the whole thread so the above is a very brief summary.

 

[Jay-dub]

That's pretty much human nature for the most part, isn't it?
There is a segment of every kind of community that can be pretty hostile to those that work against popular sentiment.

If one intends to do that, one should have a thick skin.
And one should be ready to remain calm and state their case clearly.

I think the argument for thick skin could go both ways. Maybe if the community wasn't so sensitive they wouldn't get so hostile? It wouldn't hurt for those of us outside of that segment to do more to avoid those distractions. I'm certain that it's not something to encourage.

But if it's his treatment that you're concerned about, just remember how this all started.

Please, not you man! I know you're more deliberative than to use the "he started it" defense. I'm confused.

I got an idea. Is there any productive action we can take other than postulating the current position of a moving target? Does this forum have links to fact points, educational literature or even pro-vape propaganda that members can use or print off as aids for engaging their friends, family and community? Familiarity often breeds trust. Is there a link to tips on how and where to engage authorities and regulators to also breed that familiarity and alleviate distrust? Does ECF utilize it's groups section to organize any type of regional vape events to expose the public in a fun, educational and non-confrontational way? Nearly all of us are guilty of opting to argue over the abstract instead of building something concrete. Does CASAA or ECF have a community action committee to help direct individuals to productive ways of engaging the public and government? Anything of the like?

 

[Bill Godshall]

Regarding SE applications, it is important for vapers and e-cig companies to submit comments to FDA urging them to quickly act on the 4,000+ SE applications (by cigarette, smokeless and RYO companies) that have already been submitted to FDA, to sharply scale back the agency's ever growing demands for additional information and its arbitrary decision making process (i.e. it can deny any application by simply saying "inadequate information provided by applicant" for SE approvals (and for exemptions from SE).

FDA's policy on SE applications since 2009 has been to indefinitely delay the processing of SE applications, and to demand more and more information from applicants (costing them ever increasing amounts of money) in order to prevent new tobacco products from being marketed in the US. By failing to process SE applications in a timely manner, FDA has prohibited several hundred new but SE tobacco products from being marketed since 2011.

Regarding the deeming regulation, unless FDA exempts e-cigs from the 2007 and 2011 deadlines in Section 905(j) and Section 910, ALL e-cig products will be banned.

But even if the FDA exempts e-cigs from the 2007 and 2011 deadlines to avoid losing another lawsuit (e.g. by extending those dates to 2013 and 2015), the deeming reg would still require every manufacturer of every single e-cig product to submit SE applications or New Product applications to FDA, and FDA would have to approve, before those products can be marketed. That's why the deeming and other e-cig regs will give the e-cig industry to Big Tobacco.


On another matter, in the past ten days, tombaker has posted nearly half of all the comments he's ever posted on ECF on this thread and on another thread (that I created describing my meetings several weeks ago with the White House OMB, and staff of House E&C Cmte and Reps. Pitts and Murphy regarding the FDA deeming and other e-cig regs).

In those postings, tombaker has made dozens of totally inaccurate statements about FDA's administration of SE applications and approvals, the impact of the deeming regulation on e-cigs, CASAA and many other e-cig legal and legislative issues.

It appears that tombaker's sole purpose of coming to ECF was/is to lie about FDA tobacco regulation and the agency's forthcoming deeming and other regs for e-cigs, and to attack leaders of our now five year campaign to keep e-cigs legal to manufacture/import/sell/use.

If anyone wants to know about the impact of the FDA deeming regulation, I suggest ignoring everything written by tombaker, and instead reading the sticky posts regarding FDA deeming regs (at the top of the legislative news section).

 

[Jman8]

Look folks....it's simple.

You local congressman (Republicans too) State and Fed are more likely to ban internet sales simply by passing laws. Sure the FDA could over-regulate. But Tom's main point...that local bans are a real thread....is not without merit. IDK how much "CASAA bashing" is going on, and I thank CASAA for their efforts. However, the fact remains that there's a battle on all fronts.

I've been hearing about FDA bans for three years. And "deeming regulation" for months. I'm concerned, sure. But so far it's a moving target. All the while, there's big $$$$$ funding local/state/fed efforts at BANNING, and so much misinformation out there.

I'm stocking up. I am lucky to have a B&M near me, assuming they can stay in business. However, I'm stocking up. Pure and simple.

As to the rest...I really can't understand all that mumbo jumbo enough to decipher it. It's too much if you're not doing that for a living. I'll have to trust and support those that understand it and support vaping. But IDK how even CASAA (and us) can stop the Washington D.C. congressmen from messing up. With BT and BP in the mix. We'll see.

The most likely outcome is: "Save the children, ban e-cig and e-juice internet sales". IMHO. FDA: Meh.

The "I'm stocking up" comment is what I'm most compelled to respond to, cause I am one who has not gone that route yet. And not sure if I'll ever go that route. As I've participated on black market before, I didn't feel need to stock up then so not sure why liquid nicotine would have me suddenly change course on that.

Yet, I've witnessed to a whole bunch of vapers say they are going to stock up and do so based on FDA bans. So, I entered into online discussions on that topic, coming from similar place Tom is, minus what seems to me a much more legal understanding of the issue. Was what my first thread on ECF (that I started in new member forum) was about, but not the first time online that I was engaged in that discussion. I've never been in that discussion and felt like half the participants were on my side. Instead, it truly seems like fear mongering rules this discussion. Whenever us on the other side point to deadline dates that have come and pass with no change, we get the inevitable, but it will happen! I know of a few 'gun rights' people who have similar attitude with gun ownership and have umpteen other theories on collapse of society and government, and in those cases, I can detect a thread of sensibility while feeling / observing a great big dose of paranoia and good ol' fashioned fear mongering. It doesn't help, IMO, that there are groups and publications devoted to making sure that level of fear is kept at a steady minimum and turned up a notch or two when anyone in federal government does pretty much anything at all.

So, I do think it is fair criticism of CASAA to go in direction Tom has gone, though I think it is over the top. Especially now that I finally decided to join with CASAA after a good year of sitting on sidelines and feeling it just wasn't possible that CASAA could speak for me. Now, I recognize it as best possible chance for me, a little guy, to have information directly on hand, and have resources (fellow vapers) willing and able to stand by me and fight the good fight. Moreover, I'd rather be part of solution when it comes to fighting for/with someone else than standing on sideline feeling even more hopeless. Admittedly though, I'm thinking me and CASAA don't see eye-to-eye on all issues. Then again, me and me from say a year ago don't exactly see eye-to-eye on all issues, so I can be pretty forgiving on where CASAA may (or may not) currently stand on all possible vaping issues.

I will also just add that the politics of eCigs and how things are handled at national level often seems disempowering to me as an individual. Even Tom's message is conveying that. I dislike that I need some credentials by my name to even think I could get my foot in the door to be heard in settings where decision-making is possible, and yet I realize it is the normal thing for this world. Get to the top or near top of an organization and then, and only then, will 'we' listen, and we'll call that wise. But heaven forbid you disagree with 'us' cause then we'll love tearing you apart and stripping you of all those credentials that we all thought just 10 minutes ago made you somehow better than the rest of us. All just a silly game, IMO.

Shoot Tom the messenger, or CASAA member, the messenger if that helps you. Seems par for the course IMO. Message, IMO always matters more, regardless of who is speaking it.

 

[Jay-dub]

The FDA says there are toxins in electronic cigarettes.

They don't.
"Electronic cigarettes, or e-cigarettes, are battery-powered devices that provide doses of nicotine and other additives to the user in an aerosol. Depending on the brand, e-cigarette cartridges typically contain nicotine, a component to produce the aerosol (e.g., propylene glycol or glycerol), and flavorings (e.g., fruit, mint, or chocolate). Potentially harmful constituents also have been documented in some e-cigarette cartridges, including irritants, genotoxins, and animal carcinogens. E-cigarettes that are not marketed for therapeutic purposes are currently unregulated by the Food and Drug Administration, and in most states there are no restrictions on the sale of e-cigarettes to minors. Use of e-cigarettes has increased among U.S. adult current and former smokers in recent years; however, the extent of use among youths is uncertain."

Coupled with the fact that the FDA has yet to publish any of it's own findings I'm just not inclined to feel threatened yet. Yeah, it's done a study or two. Much like the industry they're in a lurch since a study or two doesn't produce enough evidence to establish a finding. Oh awesome! I just noticed that the notorious Bill (I kid) has posted. I know nothing of him but I'm excited to see he exists! LOL!

 

[AttyPops]

Yeah Jman8. Good points. Not quoted for brevity. But I'm still keeping about a year's worth (or two!) of base in the freezer. Your computer has a buffer. And your browser has a cache...

I have a cache of base. It lets me weather a storm.

 

[NorthOfAtlanta]

It appears that tombaker's sole purpose of coming to ECF was/is to lie about FDA tobacco regulation and the agency's forthcoming deeming and other regs for e-cigs, and to attack leaders of our now five year campaign to keep e-cigs legal to manufacture/import/sell/use.

Bill, just want to remind you and the other leaders that if you're catching flack you are on target.

 

[DC2]

I think the argument for thick skin could go both ways. Maybe if the community wasn't so sensitive they wouldn't get so hostile?

This community is ALWAYS going to be sensitive, and rightly so.
Many in this community feel the powers that be are trying to take away something that has saved their lives.

It wouldn't hurt for those of us outside of that segment to do more to avoid those distractions. I'm certain that it's not something to encourage.

I would agree it's not something to encourage.

Please, not you man! I know you're more deliberative than to use the "he started it" defense. I'm confused.

Then you have misjudged me.


I have spent time on forums much more hostile than this one, and there is one thing I have learned...
It's not what you say, it's how you say it.

Some people never get that, and others just don't care.
Sometimes I don't care.

But because this is the internet, I have time to think before I speak.
In person, you'd find I tend to be a lot less diplomatic.

 

[patkin]

Personally, I make decisions regarding vaping the same way I do the rest of my life which is to hope for the best while planning for the worst. The majority of times I've thrown that caution to the wind and made the choice not to for various reasons, I've paid a heavy price for it. I don't pay much attention to "fear mongering" which implies appealing on a purely emotional level. I do, however, pay attention to history and the human conditions that created it... thus, I'm stockin up because not to do so, as I see it, would be foolish of me given my age, health and financial situation. As for not agreeing 100%... well, I've experienced that ever since I've cared enough to vote. I haven't agreed 100% with any Party I've seen. Viewing the disparate viewpoints of single-party members, I'm glad the Parties are there or I would be living in mass chaos but I do get extremely frustrated with them... we all do. One of the most encouraging things I've seen here is Kristen saying that various board members within CASAA disagree. I see that as a good thing. People have a tendency to label... I don't know why but they do. Just because a person belongs to CASAA surely doesn't mean they agree with every decision made as those are, of necessity, flexible with changing situations but it does mean they agree with the Mission Statement.

 

[rothenbj]

"6. Kristin when you say that professionals in association with the American Cancer Society, and American Lung Association, lie....."

Here's what a member of tobacco control says about the actions of one of these ?non-profit?"health" associations latest stances-

http://tobaccoanalysis.blogspot.com/2014/01/american-lung-association-massively.html#disqus_thread

Massive deception = extreme lying

 

[DC2]

"6. Kristin when you say that professionals in association with the American Cancer Society, and American Lung Association, lie....."

Here's what a member of tobacco control says about the actions of one of these ?non-profit?"health" associations latest stances-

http://tobaccoanalysis.blogspot.com/2014/01/american-lung-association-massively.html#disqus_thread

Massive deception = extreme lying

Dr. Carl Phillips did an analysis of this hit piece by Harold Wimmer (the President of the American Lung Association) and found...
--It was very difficult to find a sentence that could not be considered a lie
--There were, in total, more lies than there were sentences

In other words, some sentences crammed in a number of lies all at once.

Nice work if you can get it.

 

[Jay-dub]

Please, not you man! I know you're more deliberative than to use the "he started it" defense. I'm confused.

Then you have misjudged me.

Don't sell yourself short. In the least, you've accomplished appearing deliberative.

This community is ALWAYS going to be sensitive, and rightly so.

Yes. And there will also always be individuals with equally justified personal reasons for their sensitivities or preconceived notions. It's a shame that our numbers and over-arching support of this cause doesn't provide the confidence to look past an individuals hang ups. What good is there to being part of a community, or family, or CASAA, if it still participates in altercations out of the same type of reactionary judgments it despises? I see people egg each other on for all sorts of reasons. Why not for rising above individual prejudices? Maybe I'm not old enough to let go of my lofty idealism yet...

Many in this community feel the powers that be are trying to take away something that has saved their lives.

Many people don't realize how threatened some people here feel when
a) they're new
b) the sentiment is expressed by lashing out
c) they're too lazy or unobservant to realize it
I think that last quote from you could be the most helpful insight to understanding the defensive and sometimes cannibalistic nature of this culture to date. Thank you.