Smoking Everywhere V. FDA Daily Docket Sheet Update--APPEAL's COURT ISSUES STAY

[Mister]

But if the troops fail to show up, what can we do?

We ARE working together and we constantly call for support and usually get a lackadaisical response.

I am particularly disappointed by how little effort people have put into supporting the AAPHP petition to the FDA.

As things stand the FDA continues to use its classification of e-cigs as unapproved drugs and has begun to step up enforcement.

Even if you believe the requested reclassification to tobacco to be only a lesser evil, and even if another legal action is started to attempt no FDA classification at all, how can it do anything except a lot of good to support that AAPHP petition? If it succeeds a huge step forward will be made, time will be gained, and it doesn't preclude other actions continuing to attempt to further reduce regulation. And when you read all the supporting materials sent by the AAPHP, it is hard to imagine that anyone will take a better shot at making this happen. This petition is the best, by far, that we're likely to see.

Yet the FDA docket (see this link: Regulations.gov, click on the "Public Submissions" checkbox to see people's comments) shows a mere 64 people have commented.

Even if all 64 came from ECF that's a pitiful turnout. Where the heck is everybody when there's a chance to say something to the FDA? Even if you don't support the petition (please read all about it at Current Federal Tobacco Legislation S.625/H.R. 1180 before you decide; that web page includes all materials which were sent to the FDA along with the petition), you still have a chance now to submit a comment which tells the FDA how you feel about e-cigarettes, e.g. a short story about what they've done for you.

64? That leaves thousands of people here not stepping up when there's a call to arms. Sad.

 

[maxx]

I appreciate all the work that everyone is trying to do....in the real world. But that is the problem I am seeing. The real world is the home field for the FDA and assorted minions...and they also wrote the rule book. I just don't see us getting what we want playing by their rules on their field. The internet is where we need to fight this. It's smaller battlefield, but we have the advantage here. To touch on ECGuy's suggestion about a widget.....yes, that's the kind of stuff we need. Awhile back someone suggested in another thread that people need to make as many videos as possible. Catchy ones that have the potential to go viral. We need a good catch-phrase that can be put on T-shirts and sold at a place like Cafe-Press to generate money for the cause. There's talent out there that can be used indirectly to help out.

If you don't think the internet can do much....I point to the recent global warming events. Cap and trade and new carbon currency was a done deal. Then a few people blogged....then a few more....then a viral video or two. An email dump. Now....the entire idea is headed back to the drawing board. Now it doesn't matter where you stand on the global warming issue, but it is certain that the internet had a massive impact. We can fight in the real world as best we can, but it's the net where we stand the best chance at this stage. I have a domain and webspace. I will put up pro-e-cig material.

I guess what I am saying is that we need a cyber-warfare plan.

 

[LuckyCharm]

I am particularly disappointed by how little effort people have put into supporting the AAPHP petition to the FDA.

Before giving up on people, consider that many have already signed multiple petitions, many belong to causes that generate lots of petitions, and when they see a new petition they may think they've already signed it or it's a duplicate of another and they don't have to.

I don't even know what AAPHP stands for.

If you were clearer about why it's so important to sign THIS petition NOW, you might get more response. Some of us sign so many petitions that after a while, they begin to seem like spam.

~~Cheryl

 

[rothenbj]

I am particularly disappointed by how little effort people have put into supporting the AAPHP petition to the FDA.

As things stand the FDA continues to use its classification of e-cigs as unapproved drugs and has begun to step up enforcement.

Even if you believe the requested reclassification to tobacco to be only a lesser evil, and even if another legal action is started to attempt no FDA classification at all, how can it do anything except a lot of good to support that AAPHP petition? If it succeeds a huge step forward will be made, time will be gained, and it doesn't preclude other actions continuing to attempt to further reduce regulation. And when you read all the supporting materials sent by the AAPHP, it is hard to imagine that anyone will take a better shot at making this happen. This petition is the best, by far, that we're likely to see.

Yet the FDA docket (see this link: Regulations.gov, click on the "Public Submissions" checkbox to see people's comments) shows a mere 64 people have commented.

Even if all 64 came from ECF that's a pitiful turnout. Where the heck is everybody when there's a chance to say something to the FDA? Even if you don't support the petition (please read all about it at Current Federal Tobacco Legislation S.625/H.R. 1180 before you decide; that web page includes all materials which were sent to the FDA along with the petition), you still have a chance now to submit a comment which tells the FDA how you feel about e-cigarettes, e.g. a short story about what they've done for you.

64? That leaves thousands of people here not stepping up when there's a call to arms. Sad.

Does it show the comments? I must be one of the 64 because I commented, but I'm curious to see if it's there.

 

[rolygate]

I agree 100% with Maxx.

Time to go in a totally different direction, and use the power of the web plus a guerilla campaign to counter the dirty tricks, misrepresentations and outright lies of the opposition.

Mr Nice Guy has fallen flat on his xxxx. Time for Mr Nasty.

 

[Janetda]

Before giving up on people, consider that many have already signed multiple petitions, many belong to causes that generate lots of petitions, and when they see a new petition they may think they've already signed it or it's a duplicate of another and they don't have to.

I don't even know what AAPHP stands for.

If you were clearer about why it's so important to sign THIS petition NOW, you might get more response. Some of us sign so many petitions that after a while, they begin to seem like spam.

~~Cheryl

See, here's a great example of the problem (sorry Cheryl). Nobody comes down here to read all this stuff. And when they do, it's almost a full time job trying to keep up with it all and figure out what's important. ECF could have tons of impact, but the powers that be don't allow links to other boards and there doesn't appear to be anywhere with centralized information.

Further, when you do go to places like the Vapers Coalition web site, it looks like it's old, dead or fake. The copyright at the bottom says 2005 and none of the links to tell you who they are work. Casaa is a great idea and I want to participate. I've been waiting for the damned donation link forever. Who do I give my money to? What do you want me to do? I'm sure there are lots of us that would like to be more involved, but we don't know what else to do.

And what about the manufactures. What the heck are they doing?

I'm sorry that I'm venting here, but like many, I'm frustrated and looking for leadership.

Oh, and Cheryl, it stand for American Association of Public Health Physicians. You can read about it here: http://www.e-cigarette-forum.com/fo...s-please-aaphp-petitions-fda.html#post1109631

 

[thorn]

Drug device is a classification we all don't want. We know what will happen if ecigs are classified as drugs. Even if they are approved, it won't be any of the current companies who get it approved, it will be a pharmaceutical or tobacco company because it's going to take years and millions. We all know this.

No, we do not want that. But should it veer that direction (just throwing this out there)....I am sure Tylenol spent thousands to develop their "Quick Releasing Gel Tablets" which only deliver their product about 15 seconds quicker. How much do you think their competitor, Excedrin might spend to get their product delivered almost instantly with the use of a personal vaporizer? Any migraine people out there on board with this one? How fast do you think they could get it through the approval process knowing the sales that would be waiting just at the mention of it?

 

[Bill Godshall]

I consider the hour I just spent reviewing recent posts on this thread to have been a huge waste of time (for myself and everyone who posted) that could have otherwise been spent contacting NY, IL or MD legislators, the FDA (urging support for AAPHP petitions), the news media, and/or urging other vapers to take these actions.

If one or more e-cigarrette suppliers, Sun or others disagree with the legal strategy/arguments made by SE and/or NJ lawyers (which aren't totally consisent with each other), they have been and still are free to file motions to intervene in SE v FDA, and they are also free to file their own lawsuit(s) against the FDA.

Anyone who disagrees with AAPHP petitions doesn't have to submit a comment, and instead can submit their own petition(s) to the FDA proposing whatever regulatory scheme (or lack thereof) they desire.

But I consider it divisive and counterproductive for nonlawyers and/or folks with no background in FDA regulations to repeatedly post notes on this thread criticizing the legal and regulatory actions and strategies that have already been initiated by others (at their own expense and time) to keep e-cigarettes legally accessible and affordable.

There is much more work to do to achieve our collective goals, so please stop the selfish infighting.

 

[JerryRM]

I have said this before and I will say it again. Our arguments for e-cigs have fallen on deaf ears. The more good things we say about them, the more the opposition rants about "anti freeze, kids, cancer" etc. They do their masters bidding, nothing we say will convince them otherwise.

As for convincing the people of the benefits of e-cigs, the majority doesn't care if we smoke, vape, chew tobacco or mainline nicotine, they just don't want to be exposed to it.

IMO, SE and NJoy took the wrong path, the FDA will fight this all the way up to the Supreme Court if they have to and it will be a win for them either way it is finally classified, drug or tobacco. The vaping community needs a powerful ally to lobby the right people to declare e-cigs a smoking alternative and take them out of the hands of the FDA. That takes lobbyists and money, but I believe it is the only way to win this battle. SE, Njoy and the rest of the merchants need to change their tactics, before it's too late.

My two cents worth.

 

[Mister]

I don't even know what AAPHP stands for.

The second link in my post, where I said "please read all about it at" Current Federal Tobacco Legislation S.625/H.R. 1180, explains that and more.

If you were clearer about why it's so important to sign THIS petition NOW, you might get more response. Some of us sign so many petitions that after a while, they begin to seem like spam.

I don't know what I can say to be clearer than what has already been said.

• My post included "As things stand the FDA continues to use its classification of e-cigs as unapproved drugs and has begun to step up enforcement" and "when you read all the supporting materials sent by the AAPHP, it is hard to imagine that anyone will take a better shot at making this happen. This petition is the best, by far, that we're likely to see."
• SmokeyJoe posted a site-wide call to action (a note which appeared at the top of your display until you dismissed it) a few weeks ago urging people to read about and support this petition.
• There's a long thread discussing the petition at http://www.e-cigarette-forum.com/fo...4891-comments-please-aaphp-petitions-fda.html.
• There have been other threads such as http://www.e-cigarette-forum.com/fo...g-points-discussion-comments-submissions.html, searching ECF for "AAPHP" can find them.
• There's a call to action on the front page at CASAA (at CASAA | The Consumer Advocates for Smoke-Free Alternatives Association)

Really, what more can we do to explain its urgency?

 

[yvilla]

To add just one tiny thing to Mister's excellent post just above: the AAPHP petition is NOT just some "petition" that can be thrown together and put up online on some site for people to sign.

It is an extensive and exhaustively documented labor, that took untold hours of hard work done on our behalf, by the chair of the tobacco issues section of the American Association of Public Health Physicians.

Nor is it something people are even asked to "sign". This petition is part of the formal process existing at the FDA for input from citizens. Similar to the input previously being asked for on the new tobacco legislation. We are being asked only to comment on it, as that is part of the process, and hopefully thereby to make some headway in convincing the FDA of the logic and public health benefits inherent in what the AAPHP is proposing.

 

[LuckyCharm]

Thanks for the clarification. I've already commented on Regulations.gov before, but maybe it was for a different petition. I'm confused, though, about what to put for "Organization Name" (required field).

 

[Oliver]

Quite right yvilla - and seriously, if the notice I put up wasn't considered enough of a call to action, I will happily put up another one, more strongly worded this time.

Suggestions welcome...

SJ

 

[Oliver]

For organization, put "e-cig user" or somesuch

 

[StormFinch]

Quite right yvilla - and seriously, if the notice I put up wasn't considered enough of a call to action, I will happily put up another one, more strongly worded this time.

Suggestions welcome...

SJ

Might be a good idea SmokeyJoe, and maybe leave out the word petition? It might be more advantageous to state that the AAPHP is asking that we, as e-cig users, submit our personal, but polite, input to the FDA. It seems, imho anyway, that a majority of people shy away from the thought of a petition, especially when most internet petitions aren't worth the wiring they're transmitted through.

I'm just hoping that the majority will eventually wake up before it's too late and realize that ignoring what is currently going on will effectively send most of us back to analogs and their consequences.

 

[Bill Godshall]

JerryRM wrote:
The vaping community needs a powerful ally to lobby the right people to declare e-cigs a smoking alternative and take them out of the hands of the FDA. That takes lobbyists and money, but I believe it is the only way to win this battle.

The vaping community ALREADY has powerful allies to lobby the right people to declare e-cigs a smoking alternative.

These folks include SE and NJOY (which filed and petitioned to intervene in litigation against the FDA claiming that e-cigarettes are not drug devices, but rather alternatives to cigarettes), the AAPHP (which filed citizens petitions with the FDA urging the agency to declare and regulate e-cigs as tobacco products instead of drug devices), other
public and anti-smoking advocates, and e-cigarette consumer advocacy groups (that are actively campaigning against the FDA and state legislation that would ban e-cigarettes).

In sharp contrast, the ECA hired a well paid lobbyist who did relatively little to defend e-cigarettes, and who no longer works for the ECA because they couldn't afford to pay him the money he continued to request.

 

[PVPuff&Stuff]

Bill, (et.al) have you guys obtained the lobbyists that you think you need? If not I have some connections that I may be able to work. I don't want to step in the middle of something though, and won't pursue it unless you say you need the help.

Dave

 

[laurieok]

Right now I am feeling more than a little stupid. I went several times to the site looking for a petition to sign. I didn't realize that we were just being asked to put a comment in. It wasn't until I read yvillas post that I realized what I was doing wrong...no wonder I couldn't find a petition!! I am sure it was said before and probably on multiple posts, but I never saw it! Thanks yvilla! I guess the bolded type was what I needed to "see" it!

 

[Sun Vaporer]

Today, the Appeals Court docketed the Briefing Schedule as follows:

[FONT=Arial,Bold][FONT=Arial,Bold]O R D E R[/FONT][/FONT][FONT=Arial,Bold]​

[/FONT]It is ordered, on the court’s own motion, that the following briefing schedule will apply in this case:

Appellants' Brief May 24, 2010

Appendix May 24, 2010

Appellees' Brief June 23, 2010

Amicus Curiae for Appellees' Brief July 8, 2010

Appellants' Reply Brief July 22, 2010

All issues and arguments must be raised by appellants in the opening brief. The court ordinarily will not consider issues and arguments raised for the first time in the reply brief.

Parties are strongly encouraged to hand deliver the paper copies of their briefs to the Clerk’s office on the date due. Filing by mail could delay the processing of the brief.
Additionally, parties are reminded that if filing by mail, they must use a class of mail that is at least as expeditious as first-class mail. See Fed. R. App. P. 25(a). All briefs and appendices must contain the date that the case is scheduled for oral argument at the top of the cover, or state that the case is being submitted without oral argument. See D.C. Cir. Rule 28(a)(8).

So the Appellant, FDA's Brief is due late May. Bear in mind that any of the parties can file a Motion it Enlarge Time which is usually granted. So this Briefing period may not be set in stone if such a Motion is filed by any of the parites and granted by the Court.

It is going to indeed be a long, hot, summer.

Sun

 

[Sun Vaporer]

I have said this before and I will say it again. Our arguments for e-cigs have fallen on deaf ears. The more good things we say about them, the more the opposition rants about "anti freeze, kids, cancer" etc. They do their masters bidding, nothing we say will convince them otherwise.

As for convincing the people of the benefits of e-cigs, the majority doesn't care if we smoke, vape, chew tobacco or mainline nicotine, they just don't want to be exposed to it.

IMO, SE and NJoy took the wrong path, the FDA will fight this all the way up to the Supreme Court if they have to and it will be a win for them either way it is finally classified, drug or tobacco. The vaping community needs a powerful ally to lobby the right people to declare e-cigs a smoking alternative and take them out of the hands of the FDA. That takes lobbyists and money, but I believe it is the only way to win this battle. SE, Njoy and the rest of the merchants need to change their tactics, before it's too late.

My two cents worth.

I concur with you Jerry as do quite a few others. I think you will see some movement toward the goals you speak of soon.

Thanks,

Sun