Smoking Everywhere V. FDA Daily Docket Sheet Update--APPEAL's COURT ISSUES STAY
- Thread starter Sun Vaporer
- Start date
- th_trl_thread_readers 0
- Status
[Quote:=JerryRM]
I have to defend Sun also. IMO he has done a great job in keeping us informed as to what is happening in the legal battle. If there is something going on that he doesn't want to tell us about, I am sure there is a good reason.
You don't send a copy of your battle plans to the enemy. [/QUOTE]
Kristin--Jerry was not refering to CASAA as the "enemy". Please try to read the posts and understand what people are saying.
Jerry is saying that others entites also may read this thread like ASH and it might not be a good idea to post.
Sun
I have to defend Sun also. IMO he has done a great job in keeping us informed as to what is happening in the legal battle. If there is something going on that he doesn't want to tell us about, I am sure there is a good reason.
You don't send a copy of your battle plans to the enemy. [/QUOTE]
Kristin--Jerry was not refering to CASAA as the "enemy". Please try to read the posts and understand what people are saying.
Jerry is saying that others entites also may read this thread like ASH and it might not be a good idea to post.
Sun
I realize that many of the problems with the FDA are better attributed to bad laws and that there are some good people working in the agency. Unfortunately, it seems that the real decisionmakers are more interested in protecting financial interests than public health.
What safety standards does Big Tobacco have to comply with would be unreasonable for electronic cigarettes?
Limiting nic levels is a red herring. Limiting them to what per what? ..as compared to what?
The difference is that if the court rules that it is a tobacco product, the FDA will not be able to prohibit the sale of products that do not meet compliance standards that don't yet exist. If the FDA is allowed to regulate them as a drug device, it not only allows the FDA to place a de facto ban on them...it basically REQUIRES it.
In other words, as a tobacco product, the FDA gets to regulate it but they can't ban it in the intervening time. As a drug device, even if "fast tracked", the e-cig can't be sold until AFTER the regulations are created and AFTER companies figure out how to comply with the regulations and AFTER multi-year studies on the effectiveness as a smoking cessation device are completed and AFTER the 360 days it takes for the FDA to even review the application and AFTER you get a prescription... and something tells me all that won't be free, and guess who foots the bill? ...any former vapers who manage to live to see the day.
Is the FDA poised to make tobacco regulations that will be a major pain in the @$$ for tobacco companies? Perhaps, but PM has managed to fill the tobacco review board with enough of their employees that it is quite doubtful. ...but even if they do, Congress said they can't ban tobacco in the intervening time.
Given the choice between a present and inevitable ban on e-cigs now (what happens if e-cigs are a drug device), and the future possibility of potentially unreasonable regulations on an industry by an agency under the clear influence of the companies it is intended to regulate making it possible that the e-cig will look different in a few years depending completely on how effectively We The People advocate for reasonable regulation on tobacco products..... I'll take the latter.
Sun,
Kristin specifically asked why this information was not shared with CASAA after you implied that we were not aligned with these organizations and Jerry suggested that they would not want to reveal their strategy to the enemy. Kristin was correct in context and anticipating that businesses would not want to place the information in a public setting she even suggested that you (or they) could have done so with CASAA privately.
In other words, instead of publicly stating that CASAA would/could/should support the alternate strategy you claim is underway...perhaps you would/could/should have simply given us the opportunity to know who these people are and what their strategy is so that we could decide if we want to endorse the strategy or not?
I'm not stupid. And I'm not the one not reading posts.
I've already asked why we couldn't have been informed off the forum.
EDIT: Thad beat me to it again, lol!
That is true Thulium
Again check around and ask the people that are in this business. Big tobacco pays huge licence fees each year as well as having the saftey standards spelled out and implimented and inspected---again all fees for the Goverment.
This is also correct Thulium, we all pretty much know this and I addressed this as the e-cig's intended use being a recreational nicotine delivery device with no threaputic value.
Trust the FDA? No my friend, that is not a road I want to walk down. As I stated, they will regulate the E-cig to the point of the E-cig being of no value and I am not one for going along with that. That was the fiction of SE. NJOY actually was negotating an agreement with the FDA before SE filed suit.
So there is plenty of time to try to correct errors that occured along the way here and no reason to just assent to what SE has argued.
IMO, aligning the e-cig with being a "tobacco" product is a fatal mistake. It is a product that can stand on its own.
And just so you know where the 4 mg comes from, the FDA has tested nicotine and found that you must consume at least 5 mg a day to become addicted. They do now what a product out there that addicts people. That is why they are agreeable to 4 mg.
Sun
Last edited:
When someone decides that the ban of pipes and bongs will be enforced, it is enforced with great success. They recently swept through our entire area and confiscated all of them.I have a question about that statement. How can they force the e-cigarette to zero nic and still declare that it is an NRT device. They banned drug paraphernalia such as pipes and bongs years ago and you see today how well that worked out. You sell the hardware as a personal vaporizer with flavored PG and you have a novelty item in my humble opinion. Its not a food and not a drug so how does the FDA get involved? Just curious.
All it takes is someone to care enough to do it.
So now the question is, do you think that anyone banning them is going to care enough to enforce that ban? I know what my answer to that question is.
Sun,
Kristin specifically asked why this information was not shared with CASAA after you implied that we were not aligned with these organizations and Jerry suggested that they would not want to reveal their strategy to the enemy. Kristin was correct in context and anticipating that businesses would not want to place the information in a public setting she even suggested that you (or they) could have done so with CASAA privately.
In other words, instead of publicly stating that CASAA would/could/should support the alternate strategy you claim is underway...perhaps you would/could/should have simply given us the opportunity to know who these people are and what their strategy is so that we could decide if we want to endorse the strategy or not?
Thulium--I never implied anything about any orginizations--so lets keep it in check. If these people wanted any group to know the full details of who, what, where, and when, than they would. Again as I stated, just as Alliance did, that is not a good idea for many reasons.
As we see now by how CASAA board directors responded in this thread, that they are not open to any new ideas anyway and want to stay the course and that they think the current course is a winner. Further they think that "tobacco" is the way to go and that nothing further needs to be done in the Court and that SE and NJOY have everything under control.
So again this thread produces some positive and informative information. I do not think that SE's position is the only way to plead this case and I welcome alternatives.
Sun
I'm not stupid. And I'm not the one not reading posts.
I've already asked why we couldn't have been informed off the forum.
No one in this thread said you were Kristin. But you do keep asking questions that have already been answered. What others do is their business. They are the ones acting and funding. If they wanted other involved, they would ask. After they act, ask them is all I can tell you as it is not my place. I put out there the alternative theory so people would know there are other options.
Sun
And therefore you've been cryptic. Which is fine and I think we all respect it. Not a problem I think, just a fact.
I think you are overstating things here Sun. I feel sure that the CASAA directors are open to new ideas. We can't blame them for not being supportive of something they know nothing about. They've shown here that they are open by their understandable desire to know more. I think that the suppliers involved would do well to confidentially communicate with CASAA. They might get some help there. I don't think it could hurt. I know that CASAA was aware of the AAPHP petitions long before they became docketed at the FDA, and nothing premature slipped out from CASAA.
I think we all welcome other ways to plead the case. Any one which wins will make progress and need not preclude other actions from continuing.
Sounds to me like CASAA board members have been kept in the dark regarding any new approaches, and haven't been given any prior opportunity to re-evaluate their stand on these matters.
And I, as someone who wants to throw my support behind everyone who can help, have always intended to throw my support behind CASAA as I was not aware of any other approaches either.
Now I sit here questioning and wondering, and being told that being in the dark is the best approach for now. Well, maybe it is, and maybe we all just have to trust that someone, somewhere, is doing something, that is super duper good.
I don't know, this just doesn't seem like how it's supposed to go though.
And I, as someone who wants to throw my support behind everyone who can help, have always intended to throw my support behind CASAA as I was not aware of any other approaches either.
Now I sit here questioning and wondering, and being told that being in the dark is the best approach for now. Well, maybe it is, and maybe we all just have to trust that someone, somewhere, is doing something, that is super duper good.
I don't know, this just doesn't seem like how it's supposed to go though.
I wasn't referring to a private message to CASAA, I was referring to a post on this thread, that no doubt would be read by the opposition.
DC--read the thread--I spelled out the theory of the case and why some Suppliers are not happy with the current one. I also spelled out how the case would be framed. So what are you in the "dark" about. The name of the Suppliers? You will know that when they act. Being in the "dark" would mean that you are left with the impression that there is no other options.
If you read this thread, you will see that a long time ago, I reached out many times for Suppliers to implead into this case. I have been working with Suppliers for months. It is all posted in this thread and all you have to do is read it. So there is nothing new here other then a new approch that these Suppliers would like to take as they are not buying SE's theory of the case. I am not either and never have.
Sun
I disagree about what you did or did not imply, but since you are not calling out anyone in particular I agree that we should keep the posturing in check.
Woah! I thought we agreed to keep this in check: For the record, two board members, Kristin and myself, have replied in this thread so far and both of us I would argue are open to considering new ideas. Even if we were unwilling to change our opinions, that is only 2 of 13 votes so lets not be drawing conclusions about people who aren't even in this discussion.
On the contrary, the reason I'm in this thread is because I AM open to new ideas...but I haven't heard any yet. The closest is that you are telling us that there are some unnamed companies submitting the e-cig for FDA approval without specifying it as a tobacco product or drug device. That's not really new because I've heard of lots of companies claiming to have submitted their products for FDA review which only served to put them on the FDA's radar to get their imports seized.
The only other option any of us are aware of is "modified risk tobacco products" which are still within the "tobacco theory" and according to the FDA, nobody has applied for that status yet anyway
I totally agree that SE's position is not the only way to plead this case. In fact, I specifically suggested an alternate strategy that I called "Smoking Replacement" which led to my haranging because I dared to use the word "therapy" in some of my statements... "Think outside the pack" was my idea and the phrase "playing Devil's Thadvocate" exists for a reason...
As far as CASAA is concerned, I want to point out for the record that the only "official" stance we have on the issue is that we have publicly come out in support of the AAPHP endorsement of electronic cigarettes being classified as a tobacco product. That does not mean we would not also support a business that chooses to market their smoke-free alternative as a medical device intended to treat an addiction, nor does it mean that we would not endorse an alternate strategy like you or I have suggested in the past.
The very fact that I am endorsing "the tobacco theory" rather than pushing my own "Smoking Replacement Theory" should serve as evidence that I am willing to put aside my own opinion and admit the relevance of another viewpoint. Getting e-cigs classified as a tobacco product is NOT my goal, but keeping them available and affordable is so I am in favor of the most likely means to that end; which at this point appears to be the protection offered by tobacco classification with the intention of applying for expanded first amendment protection as a Modified Risk tobacco product as it would then be marketed as a recreational tobacco product (HOW we intend to use it) but manufacturers should be free to make truthful claims about reduced risk (WHY some people choose it).
Last edited:
Mister--No one asked for CASAA's support and just because these Suppliers are laying out real money and actually are going to act, does not give CASAA the right to blast their stance because they were not somehow apprised about it. I highly doubt that their Counsel would want that or allow it.
CASAA decided to clearly lay out that they are only on board with "tobacco" and are aligned with SE and NJOY. Go read the posts. That is CASAA's right.
But to readily dismiss a new play because somehow it "had to be known to them" is absurd. The posts clearly show there is an issue there with staying the course and being closed minded to people that are actually going to fund litigation---Suppliers that we use---not SE or NJOY.
A little respect for those that step up is needed. Funny how that was not the case with Alliance but is the case here.
Sun
Left in the dark until just recently.
Unless this alternative approach was just taken up in the last few days?
Sounds to me though like it was not only taken up awhile back, but it is well underway.
I am assuming that it just came to your attention recently as well.
Last edited:
That's an interesting analogy but it falls apart because tofu is not made with an ingredient from meat. It would be more like substituting the coffee you drink with a caffeinated (or caffeine free) coffee flavored hot beverage--you know, something that was designed to look and taste just like coffee and provide the same physical effect (if caffeinated) without the toxins and carcinogens found in "the real thing"
YouTube - Denis Leary - Coffee
Well you know what they say about opinions... Everybody has one, but some are just wrong. The PACT act applies only to the specified products and e-cigarettes aren't specified--it doesn't matter if they are classified as tobacco or not.
Probably, but in the meantime, the FDA won't be able to have them banned or require the nicotine level to be reduced to zero. If they are not classified as a tobacco product, the FDA could completely ban their sale until they are proven to be "safe" in absolute terms rather than just safeR than cigarettes in relative terms AND proven to be effective as a smoking cessation device.
Tobacco bans? There is no such thing and congress has specifically told the FDA they can't ban tobacco--but the FDA can ban products containing nicotine that aren't tobacco products. Taxes? When a product is um, legal, it is subject to being taxed. I'm afraid you'll have to live with that because that's how things work in the real world. However, as Bill Godshall pointed out, most (if not all) states do not have a standing tax on tobacco products in general but rather tax specific tobacco products (which is some stores in some states sell "mini-cigars" that are cheaper than cigarettes because they aren't taxed the same).
Turn them into an unsavory alternative when compared to NRT's? Dude, NRT's make analogs seem savory. 8-o Ain't nothing they can do to e-cigs to make them unsavory compared to NRTs.
When did Big Tobacco become the nemesis? Tobacco companies aren't calling for the bans of e-cigarettes--tobacco companies want to sell them, actually.
In case you hadn't noticed, it is the pharmaceutical companies like GlaxoSmithKline and Pfizer (makers of Nicotrol/Nicoderm/Nicorette and Chantix) who line the pockets of the FDA and anti-smoking prohibitionist nazis like John Banzhaf. (ASH Introduction)
It is my opinion that getting it classified as a tobacco product will kill all of the bans that make e-cigs so much more difficult to purchase than other smoke-free tobacco products as an alternative to smoking cigarettes that kill people.
That is just plain wrong. The FDA has expressed its full intention to regulate e-cigarettes as a drug which means they will not allow them to be SOLD at all unless and until they undergo years of research to prove that they are effective as a smoking cessation device and then only by prescription...and the FDA would be able to require the nicotine levels to be reduced to zero if they want, whereas they are specifically not allowed by law to require zero nicotine in tobacco.
Hey Thulium Thanks so much for the Denis Leary Clip!! I'd seen it before but it'd been awhile and it made my day - my sentiments exactly.
I have a question - I read somewhere recently, and I apologize for not having the specific source/link, an article by a Physician who is pro-electronic cigarettes and he was advocating that they be classified under the tobacco product classification and purview of the FDA as "an alternative tobacco product" he later went on to agree with what many have posted in terms of seeking harm-reduction or MRTP status down the road. Am I just splitting hairs with this language or is there a meaningful and distinct difference and possible advantage. Thanks in advance
Last edited:
Well you are on the Board and seem firm in your stances here. Read what you wrote about it. When you talk, are you not talking for CAASA? Thank god the Supplers did not post here.
I am not here to defend what these Suppliers do or do not do. I spelled
out an alternative theory of the case and dispelled the statement that any new litigation would not be feasible. Take it for what it is worth.
Sun
CASAA has not blasted anyone's public stance. 2 members of CASAA have questioned its feasibility and we don't expect an answer until the strategy is made public.
That is absolutely not true. CASAA has come out in favor of the AAPHP's petition to the FDA to classify electronic cigarettes as tobacco products rather than drug devices. Some members of CASAA (including several members of the board) joined the AES to join the Amicus Curiea brief in the SE/NJoy case as an interested third party, but we have absolutely no affiliation with Smoking Everywhere or Njoy.
I for one supported CASAA endorsing the AAPHP petition because I feel that SmokingEverywhere and Njoy are doing a service to the vaping community as a whole by challenging the FDA's authority to regulate e-cigarettes as a drug device. That does not imply that I agree with any of the plaintiff's business practices. Smoking Everywhere is also responsible for making me aware of the existence of electronic cigarettes and I appreciate that too, but that doesn't mean I'll ever give them another dollar of my money.
I think I agree.
That link made me physically ill. The FDA needs to be blown up (figuratively speaking) and congress has to learn how to delve out power. This is agency out of control.
After reading this article, I do now understand how they can claim the PV is a medical device, just about anything they claim to be becomes one. Unless, off course, you beat them in court. We better be careful of suggesting sucking on a lolly pop to help quit smoking for fear that the FDA will declare the stick a medical device. Those Le Whiffs certainly could be considered a medical device also.
Too much power, to little common since.
- Status
Similar threads
- Locked
- Locked
- Locked
