FDA Common misconceptions about FDA regulations ( I hope CASAA will address at some point in the next few weeks)

Status
Not open for further replies.

wv2win

ECF Guru
ECF Veteran
Feb 10, 2009
11,879
9,045
GA by way of WV
.......................

CASAA is going to provide an analysis of the facts as we understand them and a GUIDE for submitting comments, not "telling people what to say."

I would hope that most of us understand this point. I think guidance on "points to make" and either study documentation to either refer to or include would be helpful. But crafting replies in our own words makes sense.
 

Stosh

Vaping Master
ECF Veteran
Oct 2, 2010
8,921
16,789
74
Nevada
.... As soon as the FDA starts taking applications for SE or new products, it can start rejecting them. Then what? What if an application is denied on the last day of the 24 month period? Do they still get to keep selling if they do not have new application in before the deadline? If their application is denied, do they have to stop selling immediately? What if the FDA doesn't accept anything before the deadline for other companies to use as a predicate?......

From what I've read on the FDA website, once a SE application is rejected, the manufacturer must stop distribution and all sales immediately.....:(
 

Jman8

Vaping Master
ECF Veteran
Jan 15, 2013
6,419
12,928
Wisconsin
I don't know what the way forward is, but Roly's point about black markets continues to play on my mind. There's a lot to be said for it.

Yeah, that's a good point there hey? Glad Roly brought that one up.

Guess if you (on the sky is falling side) keep ignoring the other side, eventually you'll start to listen to those who you can't put on ignore and who speak to this issue with reason and legitimate hope.
 

SeniorBoy

VapeFight.com Founder
ECF Veteran
Verified Member
May 21, 2013
1,738
5,170
Las Vegas, NV
vapefight.com
I think their is confusion with respect to the time line which is nine steps total before it becomes law. Obviously, the FDA regulations must be the law of the land before the two year effective date as drafted kicks in. The FDA is currently at step 6 which is the critical comment period. Step nine is the other critical step since it involves Congress and our collective opportunity to apply pressure. How fast Congress acts is any ones guess ? but based on past performance I guess at late 2015 or 2016 before it's the law of the land. I'm only offering an educated guess and understand and respect that others may disagree. ONLY then will the FDA be legally empowered to accept SE applications and the two year (as drafted) compliance period kicks in. I just covered this issue.

:)
 

Jman8

Vaping Master
ECF Veteran
Jan 15, 2013
6,419
12,928
Wisconsin
There is so much left up in the air that it is impossible to claim to know what the FDA will do or how this will play out.

CASAA is going to provide an analysis of the facts as we understand them and a GUIDE for submitting comments, not "telling people what to say."

Combine these two assertions and there is reason to believe, from a CASAA perspective, that we stand a chance in shaping the final rule for FDA regulation on eCigs.

NOT we will get everything we vapers want.
NOT that FDA will ignore us and do whatever FDA wants.
 
Jan 19, 2014
1,039
2,370
Moved On
This isn't your father's FDA anymore.....

Obama Food Safety Czar Defends Armed Raids

SWAT Team conducts food raid

FDA Police? The American Police State


The FDA may be a group of incompetents, but their actions speak louder than words....:facepalm:

Point taken on all of that. As you may recall from some of my other posts, I refused to have "pet milk" at The Co-Op when I was store manager. Customers were griping because they said that they could buy it from our competitors. One or two board members disagreed w/ my decision. While you won't catch me drinking raw milk because I don't really buy the science and I don't drink milk anyway, I think the raw milk co-op raids are horrendous. Cow shares have proven to be an effective workaround in Indiana, but I don't know that this model would work for vapers quite obviously :laugh:

However this does raise the interesting Q of what happens when "DIY" equipment clubs spring up, as I'm sure they will. And then there's the whole extraction-from-tobacco business, which I know has been discussed in detail here.

EDIT: Last sentence removed as per Kent's observation in #109 :D
 
Last edited:

Kent C

ECF Guru
ECF Veteran
Verified Member
Jun 12, 2009
26,547
60,051
NW Ohio US
Point taken on all of that. As you may recall from some of my other posts, I refused to have "pet milk" at The Co-Op when I was store manager. Customers were griping because they said that they could buy it from our competitors. One or two board members disagreed w/ my decision. While you won't catch me drinking raw milk because I don't really buy the science and I don't drink milk anyway, I think the raw milk co-op raids are horrendous. Cow shares have proven to be an effective workaround in Indiana, but I don't know that this model would work for vapers quite obviously :laugh:

However this does raise the interesting Q of what happens when "DIY" equipment clubs spring up, as I'm sure they will. And then there's the whole extraction-from-tobacco business, which I know has been discussed in detail here.

That said, there really is a difference between cold war East Germany, the Stalinist USSR, Nazi Germany, and what we have in the US right now. I know many here on ECF believe that we are only separated by time, geography, etc., so I'm not going to debate the Q ;-)


Reintroducing politics into the discussion. What? you guys get to and we don't get to respond? Is that the game?
 

beebopnjazz

Vaping Master
Supporting Member
ECF Veteran
Verified Member
Jan 20, 2010
7,829
8,247
PA
One of the things that hadn't been discussed is that once the FDA takes control - you do have to consider the TCA as written. They could very well immediately ban all but tobacco and menthol - as that is as it's written in the TCA- and somewhere I read that a study is due congress on the menthol question....again....this month.

Flavorings are in cigarettes - just nit detected by the smoker as a predominant flavor - I don't know if we could argue about them based on this.

In 2010 you could read the ingredients in cigs - once the FDA took control - only THEY know the ingredients - BT is no longer required to provide the listing.
 
Jan 19, 2014
1,039
2,370
Moved On
Vapers getting everything we want wouldn't happen, regardless. Vapers don't even agree on what we want. ;)

Most of us wouldn't object if the current scope of Federal, state, and local regulation could be simply frozen in place (and that includes having the FDA's proposed rule never becoming final).

Granted, that would be an unfortunate result in a few states like MN (with its tax) and the indoor/outdoor usage bans that presently exist in many major US cities as well as various states (UT, ND, NJ). I hate the idea of throwing anyone under the bus, as it were.

But if a plebiscite of this nature were to take place among American vapers, I think that option would beat the status quo (with its uncertain future) in a head-to-head contest.

(I would also advocate for Canadian participation, since they will obviously be affected by whatever happens here in the states.)
 

Kent C

ECF Guru
ECF Veteran
Verified Member
Jun 12, 2009
26,547
60,051
NW Ohio US
I removed the bolded sentence. I even credited you. Happy now? :)

http://www.washingtonpost.com/blogs...ted-paid-pro-government-shills-in-chat-rooms/

The Obama administration is reportedly proposing Cass Sunstein as a member of a panel to review the surveillance practices of the National Security Agency (NSA), among other former White House and intelligence staffers. Sunstein was the head of the White House’s Office of Information and Regulatory Affairs until last year, when he returned to teaching at Harvard Law School.

As one of our intrepid commenters pointed out yesterday, while at Harvard in 2008, Sunstein co-authored a working paper that suggests government agents or their allies "cognitively infiltrate" conspiracy theorist groups* by joining "chat rooms, online social networks or even real-space groups" and influencing the conversation.

Sunstein's paper defined a conspiracy theory* as "an effort to explain some event or practice by reference to the machinations of powerful people, who have also managed to conceal their role," and acknowledges that some conspiracy theories have turned out to be true. It also specifically notes that his plan of "cognitive infiltration" should only be used against false conspiracy theories that could be harmful to the government or society.
 
Last edited:

KODIAK (TM)

Ultra Member
ECF Veteran
Jan 31, 2014
1,898
4,983
Dead Moose, AK
They could very well immediately ban all but tobacco and menthol
But exactly what is a "tobacco" flavor? Excluding NET formulas, E-luiquid has none. It's a subjective concoction of food flavorings intended to simulate tobacco taste and aroma. I've vaped a gazillion so-called tobacco flavors none of which even remotely taste like what I ever smoked. I'd just like to see the FDA attempt to define "tobacco taste". It would be quite funny actually. :)

That said, given their new found authority and premise that nicotine = tobacco (Hey, it ain't a drug except when it is), they can force all us to buy unflavored nic base. Which wouldn't necessarily be a bad thing for us so that most assuredly won't happen. :)

The more I think about this whole quagmire the more I feel the final proposal will be rife with legal-fodder just waiting for the first violation.

Of course we could all stop this unpatriotic, rebellious behavior now and execute our law-abiding and civic duties by just smoking again. That would be the *right* thing to do in the eyes of the FDA. :confused:
 

Anjaffm

Dragon Lady
ECF Veteran
Sep 12, 2013
2,468
8,639
Germany
http://www.washingtonpost.com/blogs...ted-paid-pro-government-shills-in-chat-rooms/
...
Sunstein's paper defined a conspiracy theory* as "an effort to explain some event or practice by reference to the machinations of powerful people, who have also managed to conceal their role," and acknowledges that some conspiracy theories have turned out to be true. It also specifically notes that his plan of "cognitive infiltration" should only be used against false conspiracy theories that could be harmful to the government or society.

Bwaaahaaahaaa at the bolded part!
So, any person using their brains instead of relying on sound bites, propaganda, misinformation and outright lies is engaging in "false conspiracy theories"? Because anybody not swallowing lies "could be harmful to the government"?
:lol: :lol: :lol:

I wonder whether the Washington Times engages in "false conspiracy theories":
America is an oligarchy, not a democracy or republic, university study finds - Washington Times

(And thank you very much, Kent C., for catching what you did :wub: )
 

Kent C

ECF Guru
ECF Veteran
Verified Member
Jun 12, 2009
26,547
60,051
NW Ohio US
Bwaaahaaahaaa at the bolded part!
So, any person using their brains instead of relying on sound bites, propaganda, misinformation and outright lies is engaging in "false conspiracy theories"? Because anybody not swallowing lies "could be harmful to the government"?
:lol: :lol: :lol:

I wonder whether the Washington Times engages in "false conspiracy theories":
America is an oligarchy, not a democracy or republic, university study finds - Washington Times

(And thank you very much, Kent C., for catching what you did :wub: )

As said in another article about the same subject:


You Know You Are a Conspiracy Theorist If…

You are capable of critical thinking.

You distrust mainstream media.

You like nature.

 

skoony

Vaping Master
ECF Veteran
Jul 31, 2013
5,692
9,953
70
saint paul,mn,usa
4) However the "intended or expected use" as a "component or part" of a "regulated tobacco product" issue still applies. If someone (especially a known vaping equpment manufacturer) were to suddenly start selling a "homeopathic" product vaporizer, that would likely draw the FDA's attention. That said, if it turned out that some battery for a popular homeopathic product vaporizer happened to be similar to an EGO battery, or some homeopathic product manufacturer started using EGO batteries, well that would be a tricky one for the FDA. Since there are no such applications on the market that I know of right now, I suspect any future developers will be careful to steer clear of vaping-compatible products for this very reason. At least I would - why risk having the FDA raid you, sieze all your products, and shut down your facilities?
but our devices are not part of a finished tobacco product as defined by existing law.
are they trying to change the definition by fiat.
clearly the existing law as written was for regular cigarettes.the filters,papers,materials,and glue being the intended expected use
or as a component or part of the finished tobacco product.
used in the consumption of a finished tobacco product,not used for the consumption of.
the later,our hardware i believe is just paraphernalia.is my take just a distingtion with out
any difference?
regards as allways
mike
 

DrMA

Ultra Member
ECF Veteran
Jan 26, 2013
2,989
9,887
Seattle area
http://www.washingtonpost.com/blogs...ted-paid-pro-government-shills-in-chat-rooms/

The Obama administration is reportedly proposing Cass Sunstein as a member of a panel to review the surveillance practices of the National Security Agency (NSA), among other former White House and intelligence staffers. Sunstein was the head of the White House’s Office of Information and Regulatory Affairs until last year, when he returned to teaching at Harvard Law School.

As one of our intrepid commenters pointed out yesterday, while at Harvard in 2008, Sunstein co-authored a working paper that suggests government agents or their allies "cognitively infiltrate" conspiracy theorist groups* by joining "chat rooms, online social networks or even real-space groups" and influencing the conversation.

Sunstein's paper defined a conspiracy theory* as "an effort to explain some event or practice by reference to the machinations of powerful people, who have also managed to conceal their role," and acknowledges that some conspiracy theories have turned out to be true. It also specifically notes that his plan of "cognitive infiltration" should only be used against false conspiracy theories that could be harmful to the government or society.

Cass Sunstein is one of the most dangerous figures today. He's one of the few proponents of criminalizing free speech by opening people to prosecution under libel laws for opinions posted online. For Cass, the fundamental human right of Free Speech is a "problem".
Democracy and the Problem of Free Speech: Cass R. Sunstein: 9780028740003: Amazon.com: Books

[url]http://www.prisonplanet.com/obama-information-czar-calls-for-banning-free-speech.html

[/URL]
 

Anjaffm

Dragon Lady
ECF Veteran
Sep 12, 2013
2,468
8,639
Germany
@DrMA:
OMG!

that in the same 2008 dossier he also called for the government to tax or even ban outright political opinions of which it disapproved

Several forms of "government" - past and present - come to mind.

That is why they are now engaging in full on information warfare in an effort to undermine, disrupt and eventually outlaw organized peaceful resistance to their growing tyranny.

Hm.... that reminds me of something... information warfare... hm.... undermine, disrupt and eventually outlaw... .. now, what ongoing misinformation campaign comes to mind?
 
Last edited:
Status
Not open for further replies.

Users who are viewing this thread