FDA Bill Godshall commentary on FDA deeming proposals

[SensesFailed]

EDIT: After re-watching I realized it would be better to find something else to use to show the FDA's terrible tactics they have used in the past. That's the biggest issue when it comes the regulations, the FDA does in fact over step it's bounds on numerous occasions. They really don't use their own research and instead rely on outside studies to make decisions, of course, which really is a conflict of interest.

 

[aikanae1]

I don't think anyone in a gov't role writes anymore. Usually regulations are written by those being regulated. Why would this be different?

 

[wv2win]

"For them I am concerned and I get the issues." What part of that statement did you miss?!? If you are gonna call me out like some kind of self serving narcissist athen at least have some leg to stand on. I am far from some apathetic fool and I have written, called, and talked in person with my elected officials. I contribute here and have for over two years.

The question I asked was how it effects me. You, need to learn how to read and contain your temper. I expressed my concern for others. No where did I say I was apathetic or selfish.

@Grandmato I havent read the whole document but to me it reads that the only time components or "accessories" will be regulated would be is if it is sold containing nicotine derived from tobacco. So if we are buying just an empty tank, a mod, wick, wire, batteries... separately without any attached nicotine IN the device being sold then there is no restriction or fda approvals needed. I seem to see vastly different opinions on this but that is how I have interpreted it. Am I wrong somehow? The juice/nicotine must be sold as a part of the device to face regulation?

I and based on the likes given, quite a few others read your post the same way I did. Basically, you have a "throw away" line that's it's too bad for the vast majority of current vapers (not to mention those who haven't started vaping yet), but it won't effect me (which is incorrect), so, no big deal.

And contributing to ECF (not that I am against that) is not the same as contributing to CASAA, which I assume you do not support since you didn't even bring it up.

If this is not how you look at the deeming regulations that will be imposed by the FDA and see the need to fight them, as many of us do, then the emphasis in you initial post did not explain that well. Hopefully we are all ready to fight these regs every way we can.

 

[Stosh]

We have 2 years to get ourselves set up pending a mess after that point. Have a vape and start doing homework.

It's going to take quite a bit of homework...

RDA's are not difficult to manage. Many are not even all that expensive. Same goes for mech mods. If you buy quality many will last a lifetime without a ton of work on your part.

RDA's insulation will break down with heat and time, building one takes some machining. Mech mod regardless of quality will fail. I can thread a 2-56 machine screw without cross-threading, but I know a mech's threads won't last forever. Are we going to be ready to put a mech together with a copper pipe, couple ball bearings, and some derlin? Maybe go semi-mech with a box mod and switch?

DIY liquid is not difficult though it does take a bit of practice and finesse to get the flavor you want.

Agreed!!

The big choke points for the DIY person is 510 connections (no idea where one would get them once the supply dries up)

Re-building one with shrink tube and O-rings isn't hard, but replacing it with a better connector (RCA, BNC) is longer lasting.

and nicotine base (still the big choke point unless you can get down to 0 nic).

0 nic with the gum, patches and lozenges was always my downfall when quitting, (along with the taste, and other effects). I will never be down to 0 nic.

The real crying shame is this is going to make it tough for people who have not yet switched to do it at all.

^^^^ THIS ^^^^ there is NO reason current smokers should not have the benefit of using vaping to quit!

 

[buffaloguy]

You know what... Im not going to argue with you. I dont know you and you dont know me. All Ill say is when you make blanket assumptions because you are angry then we know what happens when people assume.

Now you attack me for CASAA? How do you know whether I contribute or not? Where did I mention it in one of my posts?

And dont think the people "liking your post" validate you in any way because to me thats nothing more than validation of not reading IN CONTEXT.

I asked a simple question.... how the regs effect someone in my situation so I can find a way to relate my issues to my representatives more effectively. In turn, makes me a better and more empathetic advocate for others as well. There is nothing wrong with me asking such a question and I am absolutely offended by your responses.

I suggest you take your anger and.frustration out on the FDA and not your fellow vapers. Your comments are out of context, not on topic, and unnecessary. This is the last I will say on this cause I refuse to stoop to your level. Next time stay on topic and if you dont have positive contributions.... dont contribute.

I and based on the likes given, quite a few others read your post the same way I did. Basically, you have a "throw away" line that's it's too bad for the vast majority of current vapers (not to mention those who haven't started vaping yet), but it won't effect me (which is incorrect), so, no big deal.

And contributing to ECF (not that I am against that) is not the same as contributing to CASAA, which I assume you do not support since you didn't even bring it up.

If this is not how you look at the deeming regulations that will be imposed by the FDA and see the need to fight them, as many of us do, then the emphasis in you initial post did not explain that well. Hopefully we are all ready to fight these regs every way we can.

 

[classwife]

Careful please, let's not be jabbing at each other here.

We are all in this together - to protect ourselves and those in the future.

 

[Roger_Lafayette]

{MODERATED}

It's going to take quite a bit of homework...<snip>

What you write regarding the expected (in the statistical sense of the term) longevity of equipment is very disturbing to me, to say the least. Although I am not in a position to evaluate the plausibility of what you say, your past posting behavior and the text of your post tend to engender a great deal of credence on my part.

At the end of the day, I fear that I'm just another selfish person who is concerned about himself first and foremost - which one of us isn't? - and this is not good news from that standpoint alone. (Of course I should add that I'm very concerned about the other smokers who won't have the same opportunity to quit, as I did.)

I know there are clubs out there consisting of folks who are dedicated to keeping antiquated computer equipment like the old Ataris running, just for fun ... and it pains me to think that this may be the future of vaping as we know it. Just a few hobbyists who get together in someone's garage to play with machine tools and electrical equipment.

I'm equally disturbed by the prospect of having to periodically line the pockets of BT (and now: BV = big vapor) by purchasing whatever lousy cigAlikes they manage to get approved by the FDA. Yecch.

***

For what it may be worth, I'm collecting a list of myth-debunking facts about what the world will look like, should the FDA's proposals become final in their current form. Your excellent observations deseve to be on it (see #2).

1) The FDA's proposed rule would permit it to regulate every piece of essential hardware that vapers use as a "component or part of a tobacco product." This means that they will apply the same requirements for approving this hardware as are currently applied to new tobacco cigarettes, which will effectively ban it. As a practical matter, no one expects that equipment with other common applications such as rubber o-rings, kanthal wire, or 186xx batteries will be so regulated. However vapers can reasonably anticipate that the same application and approval standards applied to tobacco cigarettes will be applied to essential vaping hardware which is unique to vaping. This includes, but is not limited to extensive studies on the impact of these products on smoking cessation, and use by minors as well as never-smoker/never-vapers. It also includes detailed scientific analysis of composition, manufacturing, longevity, and the like - including possible injury to consumers based on misuse. Costs for each application are estimated to run into the millions of dollars, which is exactly what a big tobacco company currently has to expend in order to produce an application for a new tobacco cigarette. As is universally anticipated, e-liquid will be treated in the same way, so long as it contains nicotine or any flavoring derived from tobacco.

2) With the possible exception of some metal drip tips and perhaps a few other metal parts that lack threading, virtually all other vaping hardware is likely to break down at some point over the next few years, and be very difficult if not impossible to repair without the types of electrical and machining knowledge as well as equpment possessed by very few vapers. That includes but is not necessarily limited to: MODs (mechs, APVs and standalone batteries such as EGOs), tank[O]s, cart[O]s, hybrids, RDAs, clearomizers and standalone attys.

3) It is very unlikely that any federal court will entertain a challenge to impending FDA regulation until the FDA actually takes action against a specific manufacturer of vaping equpiment or (nic-containing) e-liquid. Such manufacturers will therefore lack the kind of predictability that is usually desired by investors or by any firm that wishes to make investments in R&D, hiring, or plant & equpment. Other organizations (besides the US congress and/or executive branch), such as the WTO, are also very unlkely to act in a manner that's either expeditious or effecatious.

4) Based on the FDA's history of approving new tobacco products, there is little likelihood that any variation between different types of equipment or e-liquid will be tolerated in the approval process. In other words, if there is any measurable difference between two varieties of e-liquid (including the size and composition of the container in which it is sold), the FDA will require a separate application. The same goes for (e.g.) two identically-fabricated drip tips that might differ only in color or finish.

5) Based on the FDA's history of approving new tobacco products, there is little likelihood that the FDA will provide any form of "streamlining" for applications involving either equpment or e-liquid. It is not legally required to do so. Even if it claims that it will "streamline" the application process or requrements for purposes of getting its proposed rule finalized, it may decide against this policy at any point without the possibility of legal consequences (at least until it acts against a specific manufacturer for a particular piece of equipment or e-liquid).

6) The FDA is not required to accept all applications, it may reject any application prior to review - and for any reason (subject only to challenge by an aggrieved party after the FDA takes action against that party in the form of a cease and desist letter or siezure of "adulterated or misbranded tobacco products"). Applications which are not accepted, or which are rejected are obviously not "pending" or "under review" for purposes of the FDA's proposed rule, which means the FDA has the authority to immediately remove the associated e-liquid or equipment from the market, and destroy it on the grounds that it is an "adulterated or misbranded tobacco product." No manufacturer has ever successfully forced FDA to review an application. The FDA is not required to review applications in any particular order, and cannot be legally compelled to do so.

---

Anyway this is my current rough draft of a list which is intended to help disabuse a number of all-too-complacent vapers who seem to be underestimating what we have to worry about.

Comments?

 

[~Sue~Feb2012]

Thanks Roger_Lafayette!

I've been buying and happy with using 650mah ego twist type (Evod, spinner, etc.) because of the small form factor. I have all types of cartos, clearos, tanks etc for the e-liquid. There's no way I'd be able to vape anymore if the proposal gets passed in it's present form, for the reasons you state.

As I've been reading comments all across ECF where people suggest that we vapers can "make" our own vaping devices and not to worry too much, that we have 2 years, or whatever, I've been very dismayed. If that's the case, I would have to hope that I could find those who "make" something like what I'm using now, and want to continue to use, with respect to hardware. I don't like the idea of having to buy cig-a-likes (or whatever few do get "approved" unless it will be the ego-twist types, and not cig-a-likes from BT or BV to line their pockets.)

One of the questions on the BIG survey asked if I would buy my e-cig from a BT company and I answered NO.

 

[Stosh]

....As I've been reading comments all across ECF where people suggest that we vapers can "make" our own vaping devices and not to worry too much, that we have 2 years, or whatever, I've been very dismayed. If that's the case, I would have to hope that I could find those who "make" something like what I'm using now, and want to continue to use, with respect to hardware. .....

I can build my own mod, coils, tanks, and e-liquid. What I can't do is make enough to supply the millions of smokers who would be denied the benefits of vaping if the FDA is successful. That worries me more than anything.

 

[~Sue~Feb2012]

I can build my own mod, coils, tanks, and e-liquid. What I can't do is make enough to supply the millions of smokers who would be denied the benefits of vaping if the FDA is successful. That worries me more than anything.

How'd you know I was kind of wondering whom I'd be able to ask if they'd supply me and the other millions lol j/k

 

[Katya]

Comments?

*sigh*

No, no comments. It's spot on. Zeller calls the proposed regulations "foundational" for a reason.

We'll have to fight it.

 

[Roger_Lafayette]

One interesting thihg just occured to me about the available BT/BV FDA-approved options in the future.

They're going to do their best to make them "tamper-proof," but sooner or later someone is going to figure out how to modify them in such a way that their cartridges can be refilled, and/or their batteries/housings can be recharged/swapped/reused/etc.

So a decade from now, the future of vaping may lie in the creation of weird hybrids, in which some of the parts will be available from FDA-approved cigAlikes. As soon as BT/BV becomes aware that people are modifying their devices, they'll have to submit a new application to the FDA, which will be fast-tracked. More and more R&D money will go into ensuring that these kinds of modifications will become impossible, as the black market in hardware, 3D printer plans for homemade parts, and high-concentration nic. grows.

Eventually states will start passing laws against "nicotine paraphernalia."

 

[FlamingoTutu]

EDIT: After re-watching I realized it would be better to find something else to use to show the FDA's terrible tactics they have used in the past. That's the biggest issue when it comes the regulations, the FDA does in fact over step it's bounds on numerous occasions. They really don't use their own research and instead rely on outside studies to make decisions, of course, which really is a conflict of interest.

Well here, try this FDA to Examine Quit-Smoking Pill Chantix - NBC News

They’ve been well aware that Chantix is actually killing people, now they are going to sit down and talk about it next October.

 

[Katya]

They're going to do their best to make them "tamper-proof," but sooner or later someone is going to figure out how to modify them in such a way that their cartridges can be refilled, and/or their batteries/housings can be recharged/swapped/reused/etc.

You think?

http://www.e-cigarette-forum.com/fo...njoy-king-looks-very-cool-25.html#post8632412

 

[Gato del Jugo]

You think?

http://www.e-cigarette-forum.com/fo...njoy-king-looks-very-cool-25.html#post8632412

Something tells me this part of ECF would become a lot more popular...

Modding Forum

 

[Katya]

Something tells me this part of ECF would become a lot more popular...

Modding Forum

Yeah...

And the FDA is worried about existing batteries occasionally exploding?

 

[Gato del Jugo]

Yeah...

And the FDA is worried about existing batteries occasionally exploding?

Exactly..


And I won't even get into all the potential DIY nicotine extraction attempts by novices across the country..

Again, refer to the Prohibition era...

 

[Katya]

Income tax evasion is a bad thing.

 

[Kent C]

Income tax evasion is a bad thing.

Their last resort. Only thing they could nail him on

 

[rico942]

Again, refer to the Prohibition era...

My Dad was born in 1902, and was a Teamster during much of the Prohibition Era. We would watch episodes of The Untouchables, then he would tell me the real story, having lived through it ...

A vaping black market could be ugly, dangerous, and beneficial mostly to a few predatory dealers who would take advantage of corrupt and misguided legislation ...

Would I buy my supplies from underground sources ? Yup ...

Would I feel comfortable doing it ? Nope ...