FDA FDA deeming regulation proposals

[aikanae1]

I think it's safe to say that this thing is going to court...

I haven't heard if that was even an option. It may not be with federal regulations. It may take congress or HHS to over-ride them.

 

[EddardinWinter]

I haven't heard if that was even an option. It may not be with federal regulations. It may take congress or HHS to over-ride them.

It is absolutely an option. We have defeated them before in court in 2009...when vaping was nothing like it is today. That legal smack-down kept the FDA at bay for five years.



Roaring thunderously via Tapatalk...

 

[aikanae1]

Exactly right. The FDA asking for comments, is akin to most TV hosts saying to email them - name and town, name and town.... thousands do and only a few that either make their point, or allow them to reiterate their point are the only ones used.

It is written that the FDA can not ban all ecigs and I'm guessing they think that allowing BT's plastic cigs won't be violating that. I also wonder if the application process being so messed up that wouldn't qualify as a ban (a ban without a ban?). A court case can take a l-o-n-g, long time. As much as a decade. We could be well on our way to wiping out smoking by then.

 

[aikanae1]

It is absolutely an option. We have defeated them before in court in 2009...when vaping was nothing like it is today. That legal smack-down kept the FDA at bay for five years.

Roaring thunderously via Tapatalk...

That didn't involve federal regulations or we wouldn't be deeming right now.
IDK, I just know sometimes these things follow a different course. Congress gave them the authority to do this. Previously they lost because they didn't have the authority. Now they have it.

I'm curious too. I don't want people to think there's a safety net when there isn't and sometimes, if you imagine what could happen (worst case) it's possible to build in protections so they don't.

It also dawned on me, I read through a transcript of an investors meeting wth Lloriand and they said straight out they have been working on their FDA applications for 2 years already, .... yada yada. Well isn't that also an admission that they had the documents in advance? Because I don't know if that's legal. But I'm not sure if the FDA is required to follow open meeting laws.

 

[Kent C]

Without doubt, it was a cheap shot.

To disagree with Him, apparently means we have left the only Righteous path of Wisdom.



Roaring thunderously via Tapatalk...

Yep. We are all sheep.....

 

[Jman8]

It doesn't matter what you or I think, Jman. That's the most troubling part.

To me, it is more troubling that you would espouse this line of thinking.

It's all in their hands. First they deem then they regulate. Period. We won't know what the deeming regulations are until they are passed. And once they are passed, the FDA has full control over everything.

We have good idea what regulations are currently on the table.
We have clear notion that products currently available will be available (all of them) in 2015.

We knew, or I for sure knew, that general public that hates smoking and loves that it is regulated, plus supports FDA controlling smoking is happy that smokers can't have flavors. Thus likely don't care or don't understand why vapers, many ex-smokers, would need 1 million flavor options when perhaps 100, at most, would suffice. IOW, we knew (in 2012, maybe earlier) that if they ever did propose regulations they'd go after flavors. Plus go after variation in gear. Plus ban, nationwide, use by minors. Plus restrict advertising. Plus regulate everything under auspices of "safety." All of this we knew well before 4/24/14. I don't get why anyone on 4/25/14 would be surprised by 'what regulations might do' if they went into effect. It is not FDA or Mitch alone doing this. People, in general, despise / hate / shame smokers/tobacco users and don't care to follow the intricacies of vape culture, nor is it likely they ever will.

We also knew that if they (really anyone, anywhere) decided to go heavy handed in their approach to regulating eCigs, the products, where it can be used, they would be challenged. Very likely in court. Very likely in protest, petitions, civil disobedience.

Those are the facts. Everything else is speculation, wishful thinking, fear mongering--whatever. It doesn't matter.

My wager still stands. eCigs are here to stay, and industry will be receiving 3 times more revenue within next 3 to 5 years. eCigs will be regulated but all bans (except one to minors) will be challenged and all of them, including one to minors, will fail.

 

[Kent C]

It is written that the FDA can not ban all ecigs and I'm guessing they think that allowing BT's plastic cigs won't be violating that. I also wonder if the application process being so messed up that wouldn't qualify as a ban (a ban without a ban?). A court case can take a l-o-n-g, long time. As much as a decade. We could be well on our way to wiping out smoking by then.

Yeah, like if the per capita smoking drops from 18% to 12%. Very possible, but they'll deny it.

 

[Katya]

It also dawned on me, I read through a transcript of an investors meeting wth Lloriand and they said straight out they have been working on their FDA applications for 2 years already, .... yada yada. Well isn't that also an admission that they had the documents in advance? Because I don't know if that's legal.

This is all so dirty. TVECA apparently was also given the draft ahead of time...

Pay to play?

 

[EddardinWinter]

That didn't involve federal regulations or we wouldn't be deeming right now.
IDK, I just know sometimes these things follow a different course. Congress gave them the authority to do this. Previously they lost because they didn't have the authority. Now they have it.

I'm curious too. I don't want people to think there's a safety net when there isn't and sometimes, if you imagine what could happen (worst case) it's possible to build in protections so they don't.

It also dawned on me, I read through a transcript of an investors meeting wth Lloriand and they said straight out they have been working on their FDA applications for 2 years already, .... yada yada. Well isn't that also an admission that they had the documents in advance? Because I don't know if that's legal. But I'm not sure if the FDA is required to follow open meeting laws.

The FDA seized shipments and declared dominion over them. Hang on...

Here is the link.

http://casaa.org/site/mobile?url=http://casaa.org/E-cigarette_History.html#2602


So check it out.

BTW, Congress never gave the FDA this authority, they are attempting to take it.



Roaring thunderously via Tapatalk...

 

[Katya]

My wager still stands. eCigs are here to stay, and industry will be receiving 3 times more revenue within next 3 to 5 years. eCigs will be regulated but all bans (except one to minors) will be challenged and all of them, including one to minors, will fail.

From your mouth to God's ears. I hope you're right. We all do.

As long as you admit that it's just pure speculation/wishful thinking at this point.

Also, define ecigs. I don't want to go back to BT superminis with tobacco and menthol flavors only, 12 mg/ml max, $15 per 5-pack of cartomizers. Do you?

Mitch is calling this proposal "foundational" over and over again for a reason.

 

[Kent C]

The FDA seized shipments and declared dominion over them. Hang on...

Here is the link.

http://casaa.org/site/mobile?url=http://casaa.org/E-cigarette_History.html#2602


So check it out.

BTW, Congress never gave the FDA this authority, they are attempting to take it.

...

I. Introduction, Summary and Need for the Proposed Rule

A. Introduction and Summary

FDA has examined the impacts of the proposed rule under Executive Order 12866, Executive Order 13563, the Regulatory Flexibility Act (5 U.S.C. 601-612), and the Unfunded Mandates Reform Act of 1995 (Public Law 104-4). Executive Orders 12866 and 13563 direct agencies to assess all costs and benefits of available regulatory alternatives and, when regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety, and other advantages; distributive impacts; and equity). The agency believes that this proposed rule would be an economically significant regulatory action as defined by Executive Order 12866. (my emphasis)

 

[Roger_Lafayette]

It is absolutely an option. We have defeated them before in court in 2009...when vaping was nothing like it is today. That legal smack-down kept the FDA at bay for five years.

The old court case may not be applicable to the current situation:

1) Everyone agrees that the FDA has jurisdiction over "[recreational consumer] tobacco products." The question is how it exercises that jurisdiction. The case you cite was clear about the fact that they could do so via making rules (and then publishing reg.s), that apply to such tobacco products. (Including components and parts, BTW: CASAA has just come out w/ a press release saying that FDA is asserting authority over "refillable devices" which presumably includes at least tank[O]s, hybrids, RDAs, and cart[O]s.)

2) Assuming that FDA exercises this jurisdiction by making rules and publishing regulations, they can't be taken to court until they actually act on those rules (which is what Greg Conley said in the conference call, and I believe that is true based on a legal doctrine known as "justiciability") That means they have to sieze something, or issue a cease and desist order before a court can get involved. Long before they do that, the effects of their activities will become manifest: local vape stores will close (and these are crucial to helping new vapers get up to speed), plus e-liquid and hardward manufacturers will leave the business, and distributors + online sellers will bail out too - unless they only want to sell approved cigAlikes.

Granted, it may be two years until the proposed rule becomes final (Bill Godshall) and the FDA is allowing another two years for enforcement. However the second two-year period assumes that all manufacturers register. Many will throw up their hands and leave, and some registrations may be rejected. (Assuming that a manufacturer registers, FDA does say that it will not remove a product until an application is rejected. But FDA can refuse to accept an application, according to Bill Godshall - who also says that filing an application is not easy).

All of this will occur long before the first "cease and desist" letter goes out, or the first shipment is siezed. And there will be no court action uintil then.

The question we should be asking ourselves is: who will be left in the market, by the time the FDA gets around to sending a "cease and desist" letter or siezing something, so a court can act - if these rules become final?

(And these are only the first step, says Mitch Z.)

 

[skoony]

i still cant see the banning of hardware as an accessory.
the regulation states accessories used in the consumption of a finished tobacco product may be
regulated. its says used in,not used for.
what is a finished tobacco product?
certainly my favorite full flavor menthol 100 was.snus in a pouch.machine wrapped cigars paper or tobacco.
leaf chew out of the pouch,pipe tobacco,etc... .
they are talking about a finished tobacco product that is consumed with its accessories.
the paper,glue,chemical additives,filler.
then we have the disposable ciga-like.only one purpose for this.finished tobacco product.
then the ciga-like starter kit.one or two batteries,charger,and pre-filled carts.
it starts to get murky here.to much like a pack of winstons,only you have to charge the butts.
then starter kits that dont have pre-filled carts.with no nic based e juice included,a-ok.
now if you add a bottle of nic based e-juice what do you have.certainly not a finished tobacco product.
the finished tobacco product is the juice.the tank,coil,wick,and battery are used for the consumption
of the finished tobacco product,the juice.you are not consuming them with the finished product.
i can see why every one is having a hard time.i am not sure my take is the right one.
i do agree though,the nic based e-juice is all up in the air.

regards
mike

 

[Spit]

I am going to apologize beforehand. I'm new to vaping. I've been doing it for a month and it got me off smoking analog cigarettes. For that I am so thankful to this entire community. All of you Rock. Maybe I'm a little more conservative then most members. Or maybe I'm getting more libertarian in my old age. I still remember being able to smoke inside. I have slight twinge in my neck from this. Why is the government regulating this at all? Smoking cigarettes doesn't kill you, not even remotely. There has never been a recorded case where someone smoked a cigarette and died immediately. Now if you drink an entire bottle of straight nicotine, perhaps you will die though not immediately, maybe within a few hours. With that said, i do believe smoking is very dangerous and causes a whole host of issues with the human body that can develop to lethal states if left untreated namely cancer, emphysema, heart disease, etc. You can get those illnesses from a host of other activities. I don't agree with everyone rolling over and their fear of the federal government. I'm going to put up the "Don't tread on me!" sign.

You know my Grandmother, may God bless her, died at 93 yrs old last year (Holocaust survivor). She started smoking in 1935. Quit in 85 She knew I smoked and I remember having a discussion with her, about the harms of regular cigarettes. She tried telling me once that back when she started they didn't have warnings on the cigarettes. I was like really grandma, you didn't know it was bad for you back then. She finally conceded and laughed and said yeah they did even though there weren't warnings. She tried so hard to get me to quit smoking and thank God I can finally say "Grandma I did it!"

People, politicians, and lawyers are getting so lazy these days

I don't know it just really upsets me to see government officials trying to justify their existence with more regulation and more taxes. I remember once taking a closer look at a label affixed to my daughters' hair dryer and it said "Warning: do not use while taking a bath or shower." Are you serious!? This was probably federally mandated. This might sound cruel but anyone clueless enough to use any plugged in electrical device inside a shower or bathtub, lacks the common sense to purchase the item IMHO. If I was a judge and someone brought a negligence case to me seeking damages for someone dying because of using a hair dryer in a shower, I'd be "...., use your brains". I know, I'm sorry again. Maybe I'm loosing patience now and take a chill pill, I'm just trying to stir up some conversation.

That's why i will be signing the petition to veto this. I'm a little of a pessimist and see this as not being veto'd. Probably the Jew in me. But I would like to see this industry left alone. Just like the health care industry.

Anyway, God bless you all. And thanks again. Keep up the good info and fight.

-Michael

 

[Katya]

Hello Michael!

If I could like your post a 100 times, I would.

 

[EddardinWinter]

The old court case may not be applicable to the current situation:

1) Everyone agrees that the FDA has jurisdiction over "[recreational consumer] tobacco products." The question is how it exercises that jurisdiction. The case you cite was clear about the fact that they could do so via making rules (and then publishing reg.s), that apply to such tobacco products. (Including components and parts, BTW: CASAA has just come out w/ a press release saying that FDA is asserting authority over "refillable devices" which presumably includes at least tank[O]s, hybrids, RDAs, and cart[O]s.)

2) Assuming that FDA exercises this jurisdiction by making rules and publishing regulations, they can't be taken to court until they actually act on those rules (which is what Greg Conley said in the conference call, and I believe that is true based on a legal doctrine known as "justiciability") That means they have to sieze something, or issue a cease and desist order before a court can get involved. Long before they do that, the effects of their activities will become manifest: local vape stores will close (and these are crucial to helping new vapers get up to speed), plus e-liquid and hardward manufacturers will leave the business, and distributors + online sellers will bail out too - unless they only want to sell approved cigAlikes.

Granted, it may be two years until the proposed rule becomes final (Bill Godshall) and the FDA is allowing another two years for enforcement. However the second two-year period assumes that all manufacturers register. Many will throw up their hands and leave, and some registrations may be rejected. (Assuming that a manufacturer registers, FDA does say that it will not remove a product until an application is rejected. But FDA can refuse to accept an application, according to Bill Godshall - who also says that filing an application is not easy).

All of this will occur long before the first "cease and desist" letter goes out, or the first shipment is siezed. And there will be no court action uintil then.

The question we should be asking ourselves is: who will be left in the market, by the time the FDA gets around to sending a "cease and desist" letter or siezing something, so a court can act - if these rules become final?

(And these are only the first step, says Mitch Z.)

Indeed it is apples to oranges. You are correct.

I only used it to show it can, has, and could be done again if needed.

I would argue, however, that a lawsuit is possible (not necessarily likely) as soon as the regulations are declared final by the FDA.



Roaring thunderously via Tapatalk...

 

[Myk]

Yeh,,,, my conservative friends say I'm a liberal and the liberal ones say I'm a conservative ... that's why I've come to saying "both."

Let me guess, they're all self-described moderates.

Chose to snip excerpts from these posts.

To me, these statements are very counterproductive. As you two aren't only people saying this sort of stuff, then I wish to make clear that I see this as unhelpful wherever it is stated, regardless of how elevated in experience or stature the person is who says or writes this.

From this perspective, I see no reason to submit a response to the FDA. If on the one hand, you see the current written proposal as "very bad" and "killing eCigs" plus also see no reason to trust the FDA, then what could you possibly say (to the FDA) that would be of any use to the vaping industry/vapers going forward? Under what context would you think they would be open to whatever it is you are saying in your response?

To me, if this is the general sentiment, and no leader can find a way to change that sentiment, then we need to avoid the FDA. Perhaps put out a public announcement on some web page that announces this, and plan a new course of action, such as writing to congress.

But then what about all the people that have no trust in Congress, as I understand their approval rating is around 15%? So, arguably, Congress is not the path to take regarding future market of eCigs.

Who here has full faith in current POTUS being the way for vaping to go? Anyone?

So then what. We do nothing and hope for the best?

(Parenthetically, I am compelled to add that I strongly disagree with this sentiment. I don't implicitly trust the FDA, but do see 'what is written' in a different light than these sentiments. I could be dead wrong, or naive, or what have you. But I feel it is critical to go over exact wording of proposal than toss out general statements of "as written it will kill eCigs." I'm not sure how to get around prevalent sentiments that have absolutely zero trust in government and FDA, but to me, it is fact that people will respond to FDA letter even if everyone that has ever visited ECF and/or is member of CASAA chooses not to. I'm also fairly certain CASAA will advocate for a response, and also mostly confident that people who say 'no reason to trust FDA' here on open forum, are actually going to write to the FDA. I do wonder why they would if trust is zero, but I guess this sort of rhetoric is actually just venting huge frustrations with past record of FDA and people will hope for the best going forward.)

I don't understand why you don't get it.

Liquid should be regulated and by the FDA at this point. I can accept that.
The problem is you want to import 50 Vamos to sell. You have to pay a lawyer between 2100 - 125,000 hours to apply for you.
Another store wants to do the same. They also have to pay a lawyer between 2100 - 125,000 hours.
Now both of you also have to pay that for every gauge of wire you carry. Every wick. Every topper. And ever drip tip.
Do the math.

Now do the math that a roll of kanthal sold at Radio Shack doesn't have to go through that approval system. Are you going to buy the kanthal trying to pay off a $100,000 - $3,000,000 (maybe even $10,000,000) expense or are you going for the same old stuff you've been buying for 10¢/ft?

As written only the very wealthy companies (Big Tobacco) will be able to afford to produce ecigs and they have every incentive to keep them as basic as possible.

That's why i will be signing the petition to veto this. I'm a little of a pessimist and see this as not being veto'd. Probably the Jew in me. But I would like to see this industry left alone. Just like the health care industry.

Don't bother. It's poorly written and doesn't understand the issues or the law (this can't be vetoed).
Wait for CASAA to issue the call to action to comment and then write up your thoughts on the points they make (and any you want to add) and comment. The official way to take care of this is to comment not sign internet petitions.

 

[Kent C]

Hello Michael!

If I could like your post a 100 times, I would.

Ditto! .........

 

[mkbilbo]

That didn't involve federal regulations or we wouldn't be deeming right now.
IDK, I just know sometimes these things follow a different course. Congress gave them the authority to do this. Previously they lost because they didn't have the authority. Now they have it.

That's not actually correct. The FDA tried to assert jurisdiction over e-cigs by "deeming" them to be medical devices. The court ruled e-cigs were no such thing and sent the FDA packing.

They have a scope of authority granted by Congress and if something new comes along, they have to assert it's one of the things they have authority to regulate. Hence, "deeming". The legalese equivalent of saying, look, a tobacco product!

Nothing stops us from suing to say, "Nuh uh".

 

[CES]

I do kinda of like this petition though https://petitions.whitehouse.gov/petition/stop-fda-taking-away-our-e-cigarettes/GyWSSVWj