FDA A compromise with the FDA

[drummerskey]

Over the past week and a half or so, I have been reading the FDA’s proposed regulations, people’s interpretation of those regulations, White House Petitions and tons of forum posts. Let me first apologize for adding yet one more to the mix. This is just my opinion and it appears to me that it is contrary to popular opinion but please hear me out.

I have put a lot of thought to what my comment would be to the FDA and wanted to do a lot of research before doing so but after my research, I think the best we can hope for is a compromise of what has been proposed. I doubt that either side will actually get everything they want and in my opinion; the battle is now about who can get what. The FDA has a clear focus, the money behind it and they do have the upper hand because they agree on what they want.

First off, it appears that there is a lot of……..you can call it debate; on pretty much everything on our side of the fight. Some think parts of the FDA’s proposal is reasonable, some think that it is the beginning of a larger move by BT, BP or the government, some think that the free market should decide. We disagree on what to call electronic cigarettes, we disagree on whether standards are good or bad and I could go on. I personally think that this division amongst us is going to be our biggest downfall and I really don’t see any way that we all come together as one voice. Even if we could get the entire ECF on the same page, there are millions of vapers out there on other forums, on other websites and there is no way to unify everyone. Some vapers out there have no idea what’s going on and others that do and don’t care at all.

What is worse to me is that the manufacturers are somewhat divided as well. Some are really concerned about the proposed regulations and being vocal and some appear to be operating like nothing is going on. We, as consumers spend the money but the manufacturers and retailers make their money off of vaping and this is their livelihood. If even half of them cannot be bothered to get involved or worse; plan to ride out the wave and fold up their tent in two years, we have a bigger hill to climb.

Additionally, we are not going to win behind our computers or on our phones. We cannot win solely relying on the CASAA or any other organization to do it for us. There will have to be faces for people to see, civil protesting, letters and emails to your politicians, education of the general public, start our own lawsuits, demands for legitimate studies……….but sadly, I don’t see that really happening. Even if there is, it will be a sea of noise; people shouting conflicting opinions, a small group name calling or shouting about conspiracy behind closed doors and the opposition will easily win.


I think the best thing we can do as consumers would be to pick what few things we definitely do not want implemented, fight really hard for that and let the rest of it fall where it may. Pick just a few things that we can all agree on and have that be our purpose.

p.s. and not that I am the smartest man in the room but our arguments should be about things that the general public will care about such as small businesses closed, lost American jobs, less cigarette butts tossed on the ground/environment, less people with stinky cigarettes outside of your favorite business

p.p.s. Why do premium cigars get a pass in all of this?

 

[cbrite]

p.s. and not that I am the smartest man in the room but our arguments should be about things that the general public will care about such as small businesses closed, lost American jobs, less cigarette butts tossed on the ground/environment, less people with stinky cigarettes outside of your favorite business

I agree that this is an important part of the argument we need to make to the public to offset the "save the children" and "danger, danger" still smoke arguments.

 

[2coils]

Over the past week and a half or so, I have been reading the FDA’s proposed regulations, people’s interpretation of those regulations, White House Petitions and tons of forum posts. Let me first apologize for adding yet one more to the mix. This is just my opinion and it appears to me that it is contrary to popular opinion but please hear me out.

I have put a lot of thought to what my comment would be to the FDA and wanted to do a lot of research before doing so but after my research, I think the best we can hope for is a compromise of what has been proposed. I doubt that either side will actually get everything they want and in my opinion; the battle is now about who can get what. The FDA has a clear focus, the money behind it and they do have the upper hand because they agree on what they want.

First off, it appears that there is a lot of……..you can call it debate; on pretty much everything on our side of the fight. Some think parts of the FDA’s proposal is reasonable, some think that it is the beginning of a larger move by BT, BP or the government, some think that the free market should decide. We disagree on what to call electronic cigarettes, we disagree on whether standards are good or bad and I could go on. I personally think that this division amongst us is going to be our biggest downfall and I really don’t see any way that we all come together as one voice. Even if we could get the entire ECF on the same page, there are millions of vapers out there on other forums, on other websites and there is no way to unify everyone. Some vapers out there have no idea what’s going on and others that do and don’t care at all.

What is worse to me is that the manufacturers are somewhat divided as well. Some are really concerned about the proposed regulations and being vocal and some appear to be operating like nothing is going on. We, as consumers spend the money but the manufacturers and retailers make their money off of vaping and this is their livelihood. If even half of them cannot be bothered to get involved or worse; plan to ride out the wave and fold up their tent in two years, we have a bigger hill to climb.

Additionally, we are not going to win behind our computers or on our phones. We cannot win solely relying on the CASAA or any other organization to do it for us. There will have to be faces for people to see, civil protesting, letters and emails to your politicians, education of the general public, start our own lawsuits, demands for legitimate studies……….but sadly, I don’t see that really happening. Even if there is, it will be a sea of noise; people shouting conflicting opinions, a small group name calling or shouting about conspiracy behind closed doors and the opposition will easily win.


I think the best thing we can do as consumers would be to pick what few things we definitely do not want implemented, fight really hard for that and let the rest of it fall where it may. Pick just a few things that we can all agree on and have that be our purpose.

p.s. and not that I am the smartest man in the room but our arguments should be about things that the general public will care about such as small businesses closed, lost American jobs, less cigarette butts tossed on the ground/environment, less people with stinky cigarettes outside of your favorite business

p.p.s. Why do premium cigars get a pass in all of this?

Very will thought out post! My only disagreement is you sound like we should concede too much! I dont recommend that myself, though your point is well taken!

 

[CassiusCloud]

The party just got started,we shouldn't start surrender negotiations just yet..
Mich Zeller is gonna have to win first..

2016 is an election year,if we have another good showing as the past few years in this industry and keep pounding our reps and senators and letting them see a force of votes..
Mich zeller and the FDA will be yesterdays news..

I can't even bring myself to it being a time to negotiate,not when i'm geared up and in the mind set that failure is not an option..It's not,it can't be..
Rather than feeling as if we already lost, we need to show up first and make our stand..
Mich zeller is not gonna compromise..it will be his way and no other way once he is in the door,he's shown that already..

It's far from over,only if we fight for it first will we ever know how good we really are..

 

[drummerskey]

Very will thought out post! My only disagreement is you sound like we should concede too much! I dont recommend that myself, though your point is well taken!

The party just got started,we shouldn't start surrender negotiations just yet..
Mich Zeller is gonna have to win first..

2016 is an election year,if we have another good showing as the past few years in this industry and keep pounding our reps and senators and letting them see a force of votes..
Mich zeller and the FDA will be yesterdays news..

I can't even bring myself to it being a time to negotiate,not when i'm geared up and in the mind set that failure is not an option..It's not,it can't be..
Rather than feeling as if we already lost, we need to show up first and make our stand..
Mich zeller is not gonna compromise..it will be his way and no other way once he is in the door,he's shown that already..

It's far from over,only if we fight for it first will we ever know how good we really are..

I appreciate both of your comments and my personal hope is that we win it all and the FDA gets no regulations. I don't personally like to lose anything but I am a realist and out of 20K ECF members, there are varied factions within. 5K people who sign a petition, 5K who follow the CASAA's exact "Call to Action", another few thousand members who are just planning on stockpiling and the rest who do absolutely nothing is not a winning combination.

Also, to my understanding. After the comment period of 75 days; it is no longer proposed; it is an approved regulation and getting those regulations dropped is not easy to do this. Mid-Term elections are this year and we would have a better shot at the "if you let this happen, I will vote for anyone besides you" but if we wait until 2016; it will already be over.

 

[CassiusCloud]

I appreciate both of your comments and my personal hope is that we win it all and the FDA gets no regulations. I don't personally like to lose anything but I am a realist and out of 20K ECF members, there are varied factions within. 5K people who sign a petition, 5K who follow the CASAA's exact "Call to Action", another few thousand members who are just planning on stockpiling and the rest who do absolutely nothing is not a winning combination.

Also, to my understanding. After the comment period of 75 days; it is no longer proposed; it is an approved regulation and getting those regulations dropped is not easy to do this. Mid-Term elections are this year and we would have a better shot at the "if you let this happen, I will vote for anyone besides you" but if we wait until 2016; it will already be over.

Yes We do need to keep pounding the politicians the whole way,not just wait until 2016..

Also it would be only these regulations that would get passed that would go into effect,but later regulations may be stopped..
there is also court battles to consider which more than likely will be coming up and delaying things..

The longer we hold them off the stronger the industry gets and is seen as a contributing factor ,as well as is seen and learned about more and more by the public..

reality is,it's too early in the game to tell what the real numbers will be when push comes to shove..

 

[Gato del Jugo]

I'm actually against every single e-cig part of that proposal, for many reasons..


Yes, even the 18 years of age thing, which brings about a whole new set of issues, including costs & hoops to jump through for both small businesses & consumers.. There are better ways to ensure that that's taken care of, and it seems like it's already been happening...


I'm not willing to give these guys an inch -- because if you do, you know what happens next..

That slope is way too slippery...

 

[Gato del Jugo]

Also, to my understanding. After the comment period of 75 days; it is no longer proposed; it is an approved regulation...

That's not true..

I've heard from somebody who's been out on the front lines fighting for us that where we're at now is step 5 of a 9-step process...

 

[KODIAK (TM)]

There shall be no hand holding, no first kiss, no spiking of the punch... not even a handshake from the FDA on this matter. I can't post this excerpt enough:

“What we have done today with this proposed rule is foundational. We can’t get to issues like advertising on television or what to do about the flavors in e-cigarettes until we have jurisdiction over them. And we can’t have jurisdiction over them until we complete this rule-making. This is a very important first step.”

Mitch Zeller, Director – FDA’s Center for Tobacco Products - 24 April 2014


Any so-called "compromise" will only come from a Federal bench.

 

[Roger_Lafayette]

The comments are our last chance to have much influence. The rest is in the hands of the executive and legislative branches.

http://www.cspnet.com/category-mana...articles/nine-step-rulemaking-process-and-fda

http://www.reginfo.gov/public/reginfo/Regmap/regmap.pdf

In a nutshell - it will take quite some time after the comments are submitted for the FDA to prepare the "Final Rule." By law, the FDA has to indicate that it has cognized all the comments which are factual/scientific in nature (general statements of opinion don't count). That's why CASAA has asked that we hold off on using our comments (one per person) until there is some larger roadmap/strategy.

Then it's on to OMB for a final review, and once OMB signs off, congress gets a shot. Note that Congress does not have to explicitly approve, but it can vote against the rules if it so chooses (subject to the possibilty of a veto).

Most people who have looked at this process fairly closely believe that the FDA's intent is to eliminate all-but-cigAlikes (and only a few cigAlikes will be permitted). The application process itself is so expensive and the results so unpredictable that there seems to be little likelihood that any manufacturer other than BT or BV (NJOY and LOGIC, maybe with one or two others) will attempt to go through with it.

Bear in mind that eliminating all-but-cigAlikes means e-liquid plus all equipment which is unique to vaping-as-we-know-it (and essential to it ... so relax, you'll still be able to buy EGO carrying cases for your Blus and enjoy your NJOYs while wearing your Provari tee shirt if you'd like).

I don't know what could possibly be meant by the notion of "compromising" with the FDA. Compromise presupposes dialog and negotiation. In what way is either involved here?

 

[MTFogger]

The comments are our last chance to have much influence. The rest is in the hands of the executive and legislative branches.

http://www.cspnet.com/category-mana...articles/nine-step-rulemaking-process-and-fda

http://www.reginfo.gov/public/reginfo/Regmap/regmap.pdf


In a nutshell - it will take quite some time after the comments are submitted for the FDA to prepare the "Final Rule." By law, the FDA has to indicate that it has cognized all the comments which are factual/scientific in nature (general statements of opinion don't count). That's why CASAA has asked that we hold off on using our comments (one per person) until there is some larger roadmap/strategy.

Then it's on to OMB for a final review, and once OMB signs off, congress gets a shot. Note that Congress does not have to explicitly approve, but it can vote against the rules if it so chooses (subject to the possibilty of a veto).

Most people who have looked at this process fairly closely believe that the FDA's intent is to eliminate all-but-cigAlikes (and only a few cigAlikes will be permitted). The application process itself is so expensive and the results so unpredictable that there seems to be little likelihood that any manufacturer other than BT or BV (NJOY and LOGIC, maybe with one or two others) will attempt to go through with it.

Bear in mind that eliminating all-but-cigAlikes means e-liquid plus all equipment which is unique to vaping-as-we-know-it (and essential to it ... so relax, you'll still be able to buy EGO carrying cases for your Blus and enjoy your NJOYs while wearing your Provari tee shirt if you'd like).

I don't know what could possibly be meant by the notion of "compromising" with the FDA. Compromise presupposes dialog and negotiation. In what way is either involved here?

I read the proposal six times now, man my head hurts, anyways could not agree more at this time. I hope that someone here gets to tell me I was wrong, I would not mind that a bit. FDA is doing it by the book, light handed at first and then will sting hard and intent on regulating exactly like analogs.

The smaller company's are worried. Here is a statement posted by a vendor with links to help out on certain studies that can be submitted to the FDA: http://www.mountainoakvapors.com/Articles.asp?ID=262

 

[drummerskey]

Please don't misunderstand and please read my posts in full. I am not debating anyone's views and agree with most of them personally but I am reminded of The Alamo, The movie, "300". The small force rarely wins.

What are WE doing? How are WE going to organize? How are WE going to get all vapers on the same page?

What I am saying is that a small section of all vapers doing little more than letting the CASAA do all the work is going to net us a loss and if that is what we are doing, we better start thinking of a compromise

 

[MTFogger]

I will say this if FDA uses the Regulatory Flexibility Act, rule 4 under the Economic Analyses draft then most could have somewhat a sigh of relief. This is maybe what we need to push for, near the bottom of the draft page 65-71. I rather use the existing law than compromise.

http://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Reports/EconomicAnalyses/UCM394933.pdf

4. Change New Product “Grandfather Date” to the Date of Issuance of a Final Deeming
Regulation Regulatory Alternative

This alternative would change the grandfather date for determining which products are new
from February 15, 2007, to the date this rule is finalized. Therefore, new product submissions
would not be required for products introduced between February 15, 2007, and the date of a final
rule.

 

[pamdis]

Except in the proposed rule, FDA explicitly states they don't believe they have the authority to use that option.

 

[MTFogger]

Yea I read that. I'm not lawyer but when they say I believe we don't verse we don't I think perhaps they do but choose not to use that rule. I may be totally in left field but would like to find out if its a choice (antz) or definite.

 

[Talyon]

I read the proposal six times now, man my head hurts, anyways could not agree more at this time. I hope that someone here gets to tell me I was wrong, I would not mind that a bit. FDA is doing it by the book, light handed at first and then will sting hard and intent on regulating exactly like analogs.

The smaller company's are worried. Here is a statement posted by a vendor with links to help out on certain studies that can be submitted to the FDA: Mountain Oak Vapors - The Best USA Made E-Liquid - Made in Tennessee

Link doesn't work for me, page comes up blank on bottom, with logo on top and working menu items.

 

[zoiDman]

Compromise is a Very Good Way to get Much (not all) of what you would like.

But what the Real Question seems to be is "What would be Appropriate to Compromise on?".

Any Seasoned Strategic Planner with tell you that there is a Fundamental Rule that should Always be considered when waging a Battle.

"Never Fight a Battle that you Know you are going Lose Unless you Absolutely, Positively Have To."

I look at many of the Guideline that the FDA has outlined as a Foundation and many of them I Don't see as a Winnable Fights. Packaging and Labeling is a Good Example of this.

What I would like to see is an Emphasis Placed on Relaxing of the Guidelines in this Document.

http://www.fda.gov/downloads/TobaccoProducts/ResourcesforYou/ForIndustry/UCM252235.pdf

I would also like to know More about How/If Bottled e-Liquids may be sold in the Future? Because if Bottled e-Liquids, at a Reasonable mg level either Flavored or Non-Flavored, is slated for Illumination, all of my Efforts would be going to Maintaining their Sale.

And about Everything else would become Secondary.

 

[Jman8]

Please don't misunderstand and please read my posts in full. I am not debating anyone's views and agree with most of them personally but I am reminded of The Alamo, The movie, "300". The small force rarely wins.

What are WE doing? How are WE going to organize? How are WE going to get all vapers on the same page?

What I am saying is that a small section of all vapers doing little more than letting the CASAA do all the work is going to net us a loss and if that is what we are doing, we better start thinking of a compromise

IMO, a compromise is inevitable. And that goes two (or more) ways. ANTZ is going to have to compromise, again inevitable. All those between (vaping enthusiasts and anti-vapers) are likely more prone to compromise.

In principle, I get that all us vaping enthusiasts rather not compromise. I find that, in principle, I'd probably compromise on less, i.e. ban to minors. I'll accept that compromise, but very very reluctantly. Most seem like they accept that one easily. No problem. Who cares if it paves the way for ALL other pieces of regulation?

But I agree with OP, that when it comes to getting organized, we need around 3 things that we 'mostly agree on.' Even those top 3, and even among the majority, there won't be perfect agreement reached in 75 days. But, if we have 3 items that a majority of us mostly agree on, that gives us a strong basis to approach FDA proposed regulations with power in numbers.

Regarding "what are we doing?" I see us sorting through all this mentally and emotionally. Even while many anticipated this years ago, it hits a little closer to home when it became reality on 4/24/14. We are gathering our thoughts, seeking to calm some very passionate emotions (some of which are not positive), and looking for leadership on how to best proceed. Many are looking to CASAA or other legal minded experts on vaping side to make sense of what is a good way to approach all this. To truly contemplate the plan before acting just because passionate emotions are demanding something/anything. Patience can be very tough when something you value feels threatened. But patience is arguably the best course of action at this time.

Regarding "how are we going to organize" and "How are WE going to get all vapers on the same page?" - this depends on what you mean by "we." Given what you said in OP, if that "we" includes all vapers everywhere, then it is simply not practical to think we will all organize under one umbrella with a leader that we all agree is putting forth our best interest. Even on ECF, we don't see this. But there is power in numbers and we must have faith in the process that other forums, other factions of consumers are coming to similar conclusions as us, and will touch upon very similar ideas in their comments. While ANTZ will be pushing (hard) for the antithesis of what we are going to urge FDA to do.

CASAA is very likely to coalesce a plan of action and moreover, play a key role in having many vaping enthusiasts see a way to approach this with reason and some degree of calmness. It's now first day of May and we have til mid July-ish to deliver our response. By no later than mid May and as soon as 5 minutes before I wrote this post, CASAA will have provided their plan.

I imagine that instructing us to get politicians involved (us going to them) and us emphasizing scientific studies in our responses, and us realizing that the fight is now at another level than we've experienced prior to 4/24/14, but (hopefully) CASAA will inspire one and all to fully believe that we can do this.

We will win.
It is inevitable.

 

[zoiDman]

...

... I'd probably compromise on less, i.e. ban to minors. I'll accept that compromise, but very very reluctantly. ...

Please Do Not Tell Me that You Are In Favor of Minors Using e-Cigarettes.

Because that is Exactly the Kind of Comment that the ANTZ Web Crawlers search this Site For. And I can think of Nothing More Damaging than Giving a ANTZ an opportunity to say that we as Vaper's Want Minors to Use E-cigarettes.

And then Linking to your Posts.

 

[Kent C]

There's a basic principle involved. It used to mean something here. We have the right to do things that are not harmful to others. We also have the right to harm ourselves, so long as it harms no one.

"Contrary to the fanatical belief of its advocates, compromise [on basic principles] does not satisfy, but dissatisfies everybody; it does not lead to general fulfillment, but to general frustration; those who try to be all things to all men, end up by not being anything to anyone. And more: the partial victory of an unjust claim, encourages the claimant to try further; the partial defeat of a just claim, discourages and paralyzes the victim."

"In any compromise between food and poison, it is only death that can win. In any compromise between good and evil, it is only evil that can profit. In that transfusion of blood which drains the good to feed the evil, the compromiser is the transmitting rubber tube . . .

When men reduce their virtues to the approximate, then evil acquires the force of an absolute, when loyalty to an unyielding purpose is dropped by the virtuous, it’s picked up by scoundrels—and you get the indecent spectacle of a cringing, bargaining, traitorous good and a self-righteously uncompromising evil." Ayn Rand