FDA may soon propose regulation that could ban many/most e-cigarette products, eliminate many/most companies

[CaramelCathy]

They will never be able to stop hardware sales in my opinion, Modders and such will just call them flashlight tubes and sell them under something like this to protect themselves, it's the Nic we all need to be worried about, but even at that there will be black market Nic. Hell they cant seem to stop them from selling all the pills they do on the internet now, I'm not gonna get to paranoid over this but will do whatever I can to help the fight and cause for all of us anyway I can.

I totally agree!

It behooves me to say the least, how they can even ATTEMPT to try and ban E-Cigs trying to claim they are dangerous when we KNOW for a FACT that analogs do serious damage to the human body!

If they take away liquid Nic , and leave the sales of real cigarettes go on, this would be so obvious that it is a huge payoff. People should be knocking down there Gov't officials doors and screaming PAYOFF PAYOFF PAYOFF !!!!

We MUST make our voices heard!!!!

Thank you to the member who posted this important information. Will keep watching for updates.

 

[rothenbj]

I hope, someone like you can sway the game, as the UK NUDGE committee recommended: "We must incentivize this industry with tax exemptions." If you can convince the Domestic Oligarchy to act morally, and to incentivize this industry during the consolidation - you will have a place in history as the man who saved over 500 million lives this century... It is truly a windmill worth tilting at...

emphasis mine

My only question is where we're going to house and how we're going to feed all those extra people!

 

[Bill Godshall]

sqirl1 inquired

Bill, what are your thoughts on the likelihood of the hardware itself being targeted?

Since the FSPTCA only authorizes the FDA to regulate tobacco products, the agency would likely only apply the regulations to e-liquid (that contains nicotine derived from tobacco), to prefilled disposable cartridges, and to other products that contain e-liquid.

Based on my understanding of the FSPTCA, the only way the FDA could attempt to mess with e-cigarette hardware (that doesn't contain any nicotine) is by invoking Section 201(rr)(4) of the Tobacco Control Act, which prohibits the marketing of a “tobacco product” in combination with other FDA-regulated products, which includes "drug devices". If the FDA asserted that e-cigarette hardware are drug devices (which I strongly doubt would occur since the agency would likely lose in court again if/when sued, but if Obama is reelected, anything is possible), the agency could attempt to ban the selling of hardware in the same packages as the FDA regulated nicotine containing e-cigarette products. But even if the FDA did that and won in court, all hardware would just have be packaged and sold separately from nicotine containing e-cigarette products.


rstreet55 inquired

What is the reasoning for only accepting products similar or equivalent to 2007 and prior?

The reasoning behind Section 910 is that CTFK's Matt Myers and his financiers at big pharma (and many of their tobacco prohibitionist allies) wanted the FDA to prevent any and all new tobacco products from entering the market, which is an absurdly counterproductive product regulatory scheme because it grandfathers in the most hazardous tobacco products (i.e. cigarettes) that have been on the market for a century, but bans all far less hazardous new products.

But in 2004/2005, Philip Morris negotiated the details of the FSPTCA with Matt Myers, Henry Waxman and Ted Kennedy and agreed to support the bill because it protected PM's Marlboro cigarette empire from future market competition by smaller cigarette companies, by smokeless tobacco products (which the company didn't sell at that time, but it subsequently bought UST in 2007) and by new tobacco products.

Interestingly, the 2005 FSPTCA legislation established Feb 15, 2005 as the deadline date for new tobacco products in Section 910. And when the FSPTCA legislation was reintroduced in 2007, it established Feb 15, 2007 as the deadline date for new products.

But CTFK, ACS, AHA, ALA, GSK and others were upset that new less hazardous smokeless tobacco products (e.g. Reynolds' Camel Snus, PM's now defunct Tabocca snus, and UST's now defunct Revel snus) had been introduced into the market, and convinced Waxman and Kennedy to keep the Feb. 15, 2007 deadline date in the 2009 FSPTCA legislation (that Congress enacted that year) because they thought they could convince the FDA to retroactively ban those products from the market.


windwalker wrote

this is what it will look like:

1. Imported Tobacco Vapors will pick up a mandatory 32% excise tax.
2. Tobacco Manufacture Certificates and Licensees will become mandatory.
3. Tobacco Control Customs Warehouses will become mandatory as the import trade again swells.
4. Tobacco Retailer licenses will become mandatory industry wide
5. Elaborate State by State Tobacco Tax stamps for Tobacco 'E-liquids' will be issued to licensed Manufacturers.

I'm not aware of any provisions in the FSPTCA (and I've read it many dozens of times) that authorize the FDA to do 1, 2, 3, 4 or 5 lisited above, and it would be helpful if people didn't post inaccurate claims on ECF (as the many dozen actual implications and ramifications of an FDA regulation imposing Chapter IX to e-cigarettes are already extremely complex and confusing).

windwalker wrote

6. A handful of clever entrepreneurs will finally discover the import loophole in the FTC, TTB side of the regulation:

I tend to agree that 6 is likely to occur if FDA proposes and approves a regulation to apply Chapter IX to e-cigarettes.

 

[sqirl1]

sqirl1 inquired



Since the FSPTCA only authorizes the FDA to regulate tobacco products, the agency would likely only apply the regulations to e-liquid (that contains nicotine derived from tobacco), to prefilled disposable cartridges, and to other products that contain e-liquid.

Based on my understanding of the FSPTCA, the only way the FDA could attempt to mess with e-cigarette hardware (that doesn't contain any nicotine) is by invoking Section 201(rr)(4) of the Tobacco Control Act, which prohibits the marketing of a “tobacco product” in combination with other FDA-regulated products, which includes "drug devices". If the FDA asserted that e-cigarette hardware are drug devices (which I strongly doubt would occur since the agency would likely lose in court again if/when sued, but if Obama is reelected, anything is possible), the agency could attempt to ban the selling of hardware in the same packages as the FDA regulated nicotine containing e-cigarette products. But even if the FDA did that and won in court, all hardware would just have be packaged and sold separately from nicotine containing e-cigarette products.


rstreet55 inquired


The reasoning behind Section 910 is that CTFK's Matt Myers and his financiers at big pharma (and many of their tobacco prohibitionist allies) wanted the FDA to prevent any and all new tobacco products from entering the market, which is an absurdly counterproductive product regulatory scheme because it grandfathers in the most hazardous tobacco products (i.e. cigarettes) that have been on the market for a century, but bans all far less hazardous new products.

But in 2004/2005, Philip Morris negotiated the details of the FSPTCA with Matt Myers, Henry Waxman and Ted Kennedy and agreed to support the bill because it protected PM's Marlboro cigarette empire from future market competition by smaller cigarette companies, by smokeless tobacco products (which the company didn't sell at that time, but it subsequently bought UST in 2007) and by new tobacco products.

Interestingly, the 2005 FSPTCA legislation established Feb 15, 2005 as the deadline date for new tobacco products in Section 910. And when the FSPTCA legislation was reintroduced in 2007, it established Feb 15, 2007 as the deadline date for new products.

But CTFK, ACS, AHA, ALA, GSK and others were upset that new less hazardous smokeless tobacco products (e.g. Reynolds' Camel Snus, PM's now defunct Tabocca snus, and UST's now defunct Revel snus) had been introduced into the market, and convinced Waxman and Kennedy to keep the Feb. 15, 2007 deadline date in the 2009 FSPTCA legislation (that Congress enacted that year) because they thought they could convince the FDA to retroactively ban those products from the market.


windwalker wrote



I'm not aware of any provisions in the FSPTCA (and I've read it many dozens of times) that authorize the FDA to do 1, 2, 3, 4 or 5 lisited above, and it would be helpful if people didn't post inaccurate claims on ECF (as the many dozen actual implications and ramifications of an FDA regulation imposing Chapter IX to e-cigarettes are already extremely complex and confusing).

windwalker wrote


I tend to agree that 6 is likely to occur if FDA proposes and approves a regulation to apply Chapter IX to e-cigarettes.

thanks a lot bill! another question I have is do you think if this goes through the FDA is going to ban flavored E-juice? They did it with cigarettes but didn't do it to smokeless tobacco so that makes me wonder. I know that's anybody's guess, but I figured you might know a little better since you have more experience in dealing with these guys than all of us. just knowing them do you think they'd do that?

 

[windwalker]

Bill wrote -

I'm not aware of any provisions in the FSPTCA (and I've read it many dozens of times) that authorize the FDA to do 1, 2, 3, 4 or 5 listed above, and it would be helpful if people didn't post inaccurate claims on ECF

If I am wrong, I am happy to be corrected. But inaccurately quoting me and dismissing my comment doesn't really serve...

You see, I think it is reasonable to forecast that "A Tobacco Product" will be regulated as "A Tobacco Product". The precedent has been set, and the first four steps I mentioned above are merely those that apply to the tobacco industry at large as overseen by the FDA, TTB, IRS, and FTC: Tobacco Excise Taxes, Tobacco Control Warehouses, Tobacco Manufacture Registration and Approval, & Tobacco Retailer Licensure are merely the status quo.

I never said the FSPTCA grants authority to regulate the status quo, that would be unnecessary. I merely suggested that Chapter IX inclusion will serve as a precedent for interdepartmental regulation in accordance with the existing status quo.

It is only: "State Specific Tax Stamps" which vary from "Tobacco Product" to "Tobacco Product". The other rules are largely ubiquitous, and if the E-cig does survive (and it will) a unit will need to be defined.

You make think that's unreasonable, but it is what has happened with every single other tobacco product in the market.

So, Bill, let me say it again - I respect, admire, and support everything you are doing. At the same time, I've successfully Directed and passed 23 pieces of legislation in my career, this isn't my first rodeo. To dismiss my comments while misquoting me weakens our collective strength...

If I am wrong, now or in the future, I'm happy to be corrected. But if I am correct, don't expect me to change my opinion.

I believe, "Chapter IX Inclusion paves the way for PACT Act Inclusion" - I believe it's really just a matter of time and the PACT act or something commensurate will be applied. Chapter IX inclusion fortifies the precedent and paves the way for broad scale regulation and taxation.

So either you're right and it's "Wild Wild West (pure and free trade) versus Doom and Gloom", or I'm right and it's an unwavering march towards Consolidation, Taxation, and Regulation...

Although I'm likely correct, I hope you're right and free trade wins the day.



End Note: I tend to think the ANPRM's the FDA issues are good peaks into the future, this one proposed September 9, 2011 ends it's comment period in 6 days... It's particularly relevant, because Chapter IX inclusion will extrapolate over to all the other FDA regulations with he wording "Tobacco Product" - http://www.regulations.gov/#!documentDetail;D=FDA-2011-N-0467-0001

 

[DC2]

I believe that right is to some degree based in the notion of "consent of the governed."

This is the correct answer.

And the reality is, WE are letting this happen.
We are letting them get away with this kind of crap.

Apathy is our greatest enemy, but they have done a great job of instilling this apathy that permeates our county.
Dump your apathy off at the post office, and grab a handfull of "I give a damn" and do something.

And by do something, I mean do anything... whatever you can, within your means.

 

[cookiebun]

just another reason why I started DIY

That and weaned myself from nicotine as well.

 

[cookiebun]

If it passes, I might just take out a loan and stock pile as much e-juice as possible...

Learn to make your own liquid:
1 Gallon Veg Glycerin + 1 Gallon Propylene Glycol - FREE SHIPPING

 

[Cool_Breeze]

...And by do something, I mean do anything... whatever you can, within your means.

...interesting rally cry, yet I am not shamed.

The "consent of the governed" is granted at the ballot box.

Do you have some constructive actions to suggest?

 

[DC2]

Do you have some constructive actions to suggest?

Oh yeah, I have a lot of constructive actions to suggest.


First of all, everyone reading these thread should be getting actively involved.
Do not EMAIL anyone, but rather call them or write them a letter.

Tell you congressmen, your senators, you city council, your local health board that you intend to be heard.
And then follow up by attending whatever meetings are taking place in your district or part of the country.

Contact CASAA for help on what to say, and what issues to address.

As for the ballot box, I will not get into politics here.
I'll leave that for each person who reads these forums to decide what they think is right.

 

[Uncle Willie]

As I've posted in the past, the FDA will use it's existing powers to control / ban this industry .. it's simple as that ..

We knew it was coming, it was just a matter of time .. if this industry had gotten it's own act together with self regulation, perhaps we'd have a fighting chance ..

And then, we whine about injustice and the Man ..

Fact is, we at the minimum actually need some regulation and standards that vendors must adhere to ..

Of course, most will disagree .. and that won't matter either ..

 

[DC2]

Fact is, we at the minimum actually need some regulation and standards that vendors must adhere to ..

I'm not sure you'll find too many people who will disgree with that.
The question is how to make them come together and be a part of the solution.

 

[Uma]

ends it's comments period in only 6 more days. Regulations.gov

Thanks for the headsup WindWalker

 

[Uncle Willie]

ends it's comments period in only 6 more days. Regulations.gov

Thanks for the headsup WindWalker

Time to break out the plastic and load up

 

[Uncle Willie]

I'm not sure you'll find too many people who will disgree with that.
The question is how to make them come together and be a part of the solution.

That is the question .. however, I think more would disagree with regulation than you think .. seems to me, many prefer the "Wild Wild West" ..

Vendors and manufacterures are the key and always have been .. I still believe with rare exception, it's a money grab / quick profit from an expanding industry and most / many in the business could care less ... maybe I'm just too pesimistic in my old age ..

 

[Eddie.Willers]

I want to toss my two cents in here, and I hope I don't offend anyone too bad in doing so...<snip>

Jeez, that makes for depressing reading!

 

[windwalker]

@Uma - for clarity, the page I linked to is an ANPRM (Advance Notice of Proposed Rulemaking) - the FDA issues them pretty regularly to tell suppliers, retailers, and vendors what direction they are heading in...

This way, vendors and suppliers can get compliant before the rules even pass... (Voluntary Compliance as Professional Courtesy)

The issue Bill is talking about is a kind of Umbrella that has the potential of cascading into all the other stuff. (ie. If E-cigs are included in Chapter IX, things like this current ANPRM I linked to will potentially begin to apply to e-cigs) . . .

When you look at the last three ANPRM's they issued:

1. Applications for NEW Tobacco Retailer License
2. New Tobacco Product Approval process
3. Face to Face sales guidelines / internet sales restrictions

...a clear trend emerges. While none of these directly apply to e-cigs, as E-Cigs become formally regulated as a tobacco products, all three of them will apply...

When you take those three Announcements in order, you can see the clear positioning... They are passing the higher level stuff now with the wording "Tobacco Products", and as E-Cigs stabilize their classification as Tobacco Products, those rules stand to immediately apply... They're modifying the higher level rules now, while no one is watching...

One little interesting sidenote is that on the FDA E-Cig statement page, there is form to file complaints and report vendors... There is no form for success stories or praising vendors...

They are collecting only negative data. It is an amazingly example of researcher bias...

Seriously, what point is there in only collecting negative data? I think the answer to that speaks for itself...

 

[Cool_Breeze]

I'm not sure you'll find too many people who will disgree with that.
The question is how to make them come together and be a part of the solution.

Not precisely addressing your concerns, but perhaps related is a possible method for creating a "war chest" (please pardon me).

Most vendors offer discounts. I realize it would take a little effort in programming and bookkeeping, however a check-box option added to vendors web pages might prove to be an interesting resource. Check here if you would like to donate your discount to (organization?) in order to maintain our freedom of unrestricted vaping. Of course that's just an example. It provides the purchaser to easy opportunity to make donations as they shop. There'll need to be coordination with vendors and agreement on where the funds might be directed, etc.

It's easy to think up. I believe the funds garnered could be substantial. Perhaps there are some here that might have thoughts on what would be required for actual implementation. There may be resources within the community to get the ball rolling.

 

[mechanicallighter]

Gee. It sucks to get this kind of bad news early on a Saturday morning

 

[house mouse]

One little interesting sidenote is that on the FDA E-Cig statement page, there is form to file complaints and report vendors... There is no form for success stories or praising vendors...

They are collecting only negative data. It is an amazingly example of researcher bias...

Seriously, what point is there in only collecting negative data? I think the answer to that speaks for itself...

So, whats to stop someone from using the complaint form in a backhanded manner? Seriously. If all they'll give us to comment on is a complaint form, why not "complain" about how we don't ever want to smoke a cigarette anymore, or we could "complain" about how our health care costs are decreasing because our lung function is improving and we don't need inhalers anymore or complain about blood pressure normalizing and how we don't have to take BP meds anymore. Could we complain about not being able to contaminate innocent bystanders with our second hand smoke? Or not causing fires if we drift to sleep with one in our hand? Could we use their own tools against them? I say FLOOD them with complaints.