FDA In Answer to the "What do I do now" Question

[Maxwell_Edison]

Another reason to remain somewhat calm: http://www.ecigadvanced.com/blog/fda-proposes-e-cig-regulations-the-best-and-the-worst-about-it/comment-page-1/#comment-227255

 

[DrMA]

The comment site is up, but please, as Myrany suggests, sit back, have a vape, do your research, and take your time formulating your comment. (Remember, each individual/entity/group can comment only once.)

Start here: CASAA: CASAA Assessment of FDA Deeming Regulation, April 25, 2014

then: http://www.regulations.gov/docs/Tips_For_Submitting_Effective_Comments.pdf

This^^^^
+1

 

[Roger_Lafayette]

See that is one of my unanswered questions.

In one section our PVs and toppers are defined as a tobacco product but then in other sections they are not (as they do not contain nicotine). It makes for real confusion.

Does selling the PV or topper empty make it outside the right of the FDA to regulate?
Does putting a label on it that says something to the effect of "Not intended for use with nicotine liquids" put it outside the right of the FDA to regulate?

The language on p.7 regarding components is fairly clear. It's ridiculously broad and would of course include (say) 186xx batteries included as part of a kit that might include e-liquid. Frankly I'd be a bit surprised if they regulated batteries that have many other uses, but in theory I believe they could. The same goes for drip tips, rubber o-rings and even kanthal wire. (And since drip tips have no other use, I wouldn't be surprised if they shut down sales of Trippy Tips if they aren't complaint. It will be interesting - to say the least - what reg.s they might write for drip tips.)

I just listened to FDA Deeming Teleconference 4/24/2014 - YouTube and Greg Conley asked about this in the first Q. Zeller's response was somewhat vague but he did say that "if the component is intended or expected to be used" as part of a finished tobacco product (i.e. containing nicotine).

Putting aside the peripheral hyptheticals involving o-rings, kanthal wire, drip tips, batteries, etc ... I suspect what concerns us are tanks/cartridges (or tankomizers/cartomizers) and MODs (mech and APVs).

They will have to write rules for tanks/cartridges and/or tankomizer/cartomizers, because Altria's Green Smoke uses them. (And they have to pay attention to Altria's deep pockets: many of their employees may eventually work for Altria, after all).

As far as MODs and Ego batteries go, once again they will have to pay attention to Altria's Green Smoke, which does offer separate batteries. However they may ignore mech mods, I'm not sure. (What happens when there are no standards for a product, and a manufacturer fails to submit an application? I don't know.) Same problem w/ RDAs.

I personally think the easiest way to look at this is to ask two questions: (1) what can the FDA get away with doing, in terms of its statutory authority and the limits of practicality? For ex., it probably does have the authority to regulate 186xx batteries as "components of tobacco products" along with kanthal and O-rings, etc. But that's impractical. It also lacks the authority to regulate (e.g.) vitAcig, which cannot be used to deliver a tobacco product, since the cartridges are proprietary, don't contain nicotine, and are sealed by the manufacturer.

Second Q: what are their objectives? We'd be very foolish to think that they have any goal other than to eliminate all vaping products not produced by BT or BV (big vapor). Whether BV is limited to NJOY + LOGIC, is unclear. But I'd say the chances are slim to none that we'll be able to buy Vision spinners or vivis, Provaris, mech mods, etc. anytime after the 2-year window expires. Not unless they're sold out of the back of a pickup.

Is there a chance that the FDA will decide to leave most of the equipment that we buy alone? Not unless BT and BV are fine with it. But they can read the WSJ and hear what Bonnie Herzog has to say just as well as we can. So can BP.

This doesn't have a thing in the world to do with pubic health. It's a completely corrupt process, controlled by venal shameless folks who are only interested in maximizing their financial returns.

 

[Stubby]

The language on p.7 regarding components is fairly clear. It's ridiculously broad and would of course include (say) 186xx batteries included as part of a kit that might include e-liquid. Frankly I'd be a bit surprised if they regulated batteries that have many other uses, but in theory I believe they could. The same goes for drip tips, rubber o-rings and even kanthal wire. (And since drip tips have no other use, I wouldn't be surprised if they shut down sales of Trippy Tips if they aren't complaint. It will be interesting - to say the least - what reg.s they might write for drip tips.)

I just listened to FDA Deeming Teleconference 4/24/2014 - YouTube and Greg Conley asked about this in the first Q. Zeller's response was somewhat vague but he did say that "if the component is intended or expected to be used" as part of a finished tobacco product (i.e. containing nicotine).

Putting aside the peripheral hyptheticals involving o-rings, kanthal wire, drip tips, batteries, etc ... I suspect what concerns us are tanks/cartridges (or tankomizers/cartomizers) and MODs (mech and APVs).

They will have to write rules for tanks/cartridges and/or tankomizer/cartomizers, because Altria's Green Smoke uses them. (And they have to pay attention to Altria's deep pockets: many of their employees may eventually work for Altria, after all).

As far as MODs and Ego batteries go, once again they will have to pay attention to Altria's Green Smoke, which does offer separate batteries. However they may ignore mech mods, I'm not sure. (What happens when there are no standards for a product, and a manufacturer fails to submit an application? I don't know.) Same problem w/ RDAs.

I personally think the easiest way to look at this is to ask two questions: (1) what can the FDA get away with doing, in terms of its statutory authority and the limits of practicality? For ex., it probably does have the authority to regulate 186xx batteries as "components of tobacco products" along with kanthal and O-rings, etc. But that's impractical. It also lacks the authority to regulate (e.g.) vitAcig, which cannot be used to deliver a tobacco product, since the cartridges are proprietary, don't contain nicotine, and are sealed by the manufacturer.

Second Q: what are their objectives? We'd be very foolish to think that they have any goal other than to eliminate all vaping products not produced by BT or BV (big vapor). Whether BV is limited to NJOY + LOGIC, is unclear. But I'd say the chances are slim to none that we'll be able to buy Vision spinners or vivis, Provaris, mech mods, etc. anytime after the 2-year window expires. Not unless they're sold out of the back of a pickup.

Is there a chance that the FDA will decide to leave most of the equipment that we buy alone? Not unless BT and BV are fine with it. But they can read the WSJ and hear what Bonnie Herzog has to say just as well as we can. So can BP.

This doesn't have a thing in the world to do with pubic health. It's a completely corrupt process, controlled by venal shameless folks who are only interested in maximizing their financial returns.

Thank you for stating the facts.

I think people are a bit naive on just how corrupt the process really is. This whole thing starts with the Family Smoking Prevention and Tobacco Control Act of 2009, which is one of the worst laws on the books. It has been called the Malboro protection act by those in the know as that is what it essentially does. It protects the status quo by stagnating any new products. It was written to prevent any changes in the tobacco industry.

 

[aikanae1]

The comment site is up, but please, as Myrany suggests, sit back, have a vape, do your research, and take your time formulating your comment. (Remember, each individual/entity/group can comment only once.)

Start here: CASAA: CASAA Assessment of FDA Deeming Regulation, April 25, 2014

then: http://www.regulations.gov/docs/Tips_For_Submitting_Effective_Comments.pdf

My bad I guess. I went ahead and responded to the form letter I got trying to sign into Whitehouse.gov for the petition. I doubt it's a real email address, but felt good to vent nonetheless. It appears there's multiple threads discussing this now.

http://www.e-cigarette-forum.com/fo...nse-whitehouse-gov-petition.html#post12958608

 

[Katya]

I would hope that a donation to CASAA is a part of everyone's monthly vaping expense. I would hope that small ecig businesses would donate a larger amount. They are our MAIN ally, and do more than anyone else to help our cause. They do need money to operate, that's just the way it is, and if everyone would donate they could do more. Support CASAA.org !!! Respond to Calls for Action too.

Yup!

Time to contribute; 5 bucks a month, more if you can.

 

[Katya]

The comment site is up, but please, as Myrany suggests, sit back, have a vape, do your research, and take your time formulating your comment. (Remember, each individual/entity/group can comment only once.)

Start here: CASAA: CASAA Assessment of FDA Deeming Regulation, April 25, 2014

then: http://www.regulations.gov/docs/Tips_For_Submitting_Effective_Comments.pdf

AA, I keep checking CASAA's forum and there's nothing new there. Is CASAA going to issue a call to action? It would be nice to have it all in one place--it's impossible to follow all the threads and look for bits and pieces.

 

[aikanae1]

There's too many threads. I think I read they were going to make an announcement on Monday. IMO that makes sense. It'll give them time to make sure they are accurate.

I also hope everyone is reminding people to make sure they are a member too. Numbers do count and that's what they need to represent us.

 

[Katya]

There's too many threads. I think I read they were going to make an announcement on Monday. IMO that makes sense. It'll give them time to make sure they are accurate.

Thanks Aikanae... My head is spinning from trying to follow it all.

[And that includes Zeller's response to that old petition. This is all so bizarre.]

 

[Mowgli]

AA, I keep checking CASAA's forum and there's nothing new there. Is CASAA going to issue a call to action? It would be nice to have it all in one place--it's impossible to follow all the threads and look for bits and pieces.

last paragraph of - CASAA: CASAA Assessment of FDA Deeming Regulation, April 25, 2014

"We expect to provide further analysis on Monday, April 28th, 2014. In the next week or two, we will issue a Call to Action detailing how the proposed regulations affect consumers along with suggested actions so that consumers can respond most effectively. Please remember that a comment to the FDA regulations made on Day 1 is given no more weight than a comment made on Day 75. We urge the vaping community and others interested in opposing regulation that discourages tobacco harm reduction to await further analysis before acting. There is no benefit in acting or opining precipitously."

 

[Katya]

last paragraph of - CASAA: CASAA Assessment of FDA Deeming Regulation, April 25, 2014

"We expect to provide further analysis on Monday, April 28th, 2014. In the next week or two, we will issue a Call to Action detailing how the proposed regulations affect consumers along with suggested actions so that consumers can respond most effectively. Please remember that a comment to the FDA regulations made on Day 1 is given no more weight than a comment made on Day 75. We urge the vaping community and others interested in opposing regulation that discourages tobacco harm reduction to await further analysis before acting. There is no benefit in acting or opining precipitously."

Thanks, I read it...

I was just checking their forum and hoping for a comment there.

 

[AgentAnia]

I've scanned the deems once, and after my blood pressure settled back into acceptable range, I'm reformatting to print out w/ fewer pages, will read again, then re-read w/ highlighter, make notes, check out all the references not behind a paywall, read all the recommendations from CASAA et al, and THEN will begin to formulate my comment.

This will possibly be the best researched and written document I've ever produced. At least it better be... It's the most important one!

Remember, the deadline for comments isn't until July 9. No need to rush!

I sign a petition to the White House and get an email response from Mitch Zeller! ?? ! Ewwww ff to decontaminate my inbox:

 

[Roger_Lafayette]

We have until the beginning of July to submit comments.

Note also that they may respond to accurate comments, and this may slow them down a bit. C.f. Bill's replies in posts #28 and #31 on this other thread: http://www.e-cigarette-forum.com/fo...-e-cig-industry-big-tobacco.html#post12961060

Also note that we only get one comment each.

 

[Rickajho]

We have until the beginning of July to submit comments.

Note also that they may respond to accurate comments, and this may slow them down a bit. C.f. Bill's replies in posts #28 and #31 on this other thread: http://www.e-cigarette-forum.com/fo...-e-cig-industry-big-tobacco.html#post12961060

Also note that we only get one comment each. (emphasis added)

Please give some consideration to what you have to say. Then say it.

 

[mkbilbo]

For ex., it probably does have the authority to regulate 186xx batteries as "components of tobacco products"...

Heh, I'd like to see them try to regulate batteries. That'd be fun to watch.

The FDA doesn't yet seem to quite "get it". Outside of the nicotine juice itself, we're talking common and widely available items. Flavorings are baking and candy making products. The 18xxx li-ion battery is common as dirt out. PG and VG are... everywhere. Pfizer and friends may want to stuff this genie back in its bottle but I'm not sure they realize how heavy a lift that would be. Short of, I dunno, a corporate police state? I mean, if somebody buys 18650 batteries, how do you know what the hell they're going to do with them? Drones mebbee?

This doesn't have a thing in the world to do with pubic health.

Sigh.

Yup.

 

[~Sue~Feb2012]

........This doesn't have a thing in the world to do with pubic health. It's a completely corrupt process, controlled by venal shameless folks who are only interested in maximizing their financial returns.

^^This is how I see it.

 

[Roger_Lafayette]

The FDA doesn't yet seem to quite "get it". Outside of the nicotine juice itself, we're talking common and widely available items.[snip]

Correct in one way: they aren't going to regulate O-rings, 186xx batteries, PG, VG, or water-soluable flavings. That's comletely impractical. They also lack the authrity to regulate PG, VG and flavorings - and they say so, explicitly in the PDF.

But they definitely do have the authority and apparently seem hell-bent on regulating MODs (mech and otherwise, including ego batteries if you consider those mods), carts, tanks, cartOs, tankOs, attys (including RDAs and hybrids like a genisis), and associated supplies (even drip tips) that are uniquely associated with vaping. And quite obviously e-juice so long as it has nic.

We'd all do well to take a deep breath and have a vape as several have stated - insofar as the sky isn't falling yet.

But at the same time, it's probably not correct to believe that we'll be able to order the latest Provari or mech after the 2-year window closes (2 years after the final reg.s, which may not themselves come for quite some time, according to Bill G.).

 

[baseballmom]

This is one of the smartest, thought out posts I've seen-thanks Myrany-you rock as always(and some of the following posts are great too), nice to see you posting again(sound advice as usual) I know it's hard to keep calm and wait especially when we all feel so passionate about vaping and our rights, but this is some good advice to follow and keep level-headed since we only got 1 say, better make it count and worthwhile instead of hasty and irrational

 

[mkbilbo]

Correct in one way: they aren't going to regulate O-rings, 186xx batteries, PG, VG, or water-soluable flavings. That's comletely impractical. They also lack the authrity to regulate PG, VG and flavorings - and they say so, explicitly in the PDF.

But they definitely do have the authority and apparently seem hell-bent on regulating MODs (mech and otherwise, including ego batteries if you consider those mods), carts, tanks, cartOs, tankOs, attys (including RDAs and hybrids like a genisis), and associated supplies (even drip tips) that are uniquely associated with vaping. And quite obviously e-juice so long as it has nic.

We'd all do well to take a deep breath and have a vape as several have stated - insofar as the sky isn't falling yet.

But at the same time, it's probably not correct to believe that we'll be able to order the latest Provari or mech after the 2-year window closes (2 years after the final reg.s, which may not themselves come for quite some time, according to Bill G.).

I don't think they're going to be able to thread that one without blundering through the electronics world and risking having behemoths like, oh, Apple, say, bite back. Targeting regs for one, specific use of common widgets... the thought makes my head hurt.

The "e-cig" is an idea more than a "product". The guy who came up with the modern version patented a novel arrangement of common, widely available components. The only thing unique to this use of those widgets is nicotine. Trying to grab jurisdiction over anything but the nic is likely to take them to some weird, weird places.

Like the whining of the ANTZ about flavors. How do you stop that? The flavorings are baking and candy supplies. Adding them is trivial. I do it all the time. They could, maybe, stop the premix biz from selling anything but 0 nic. Um... whoopee?

They look to me to be floundering. They need to stop listening to the frothing at the mouth set and learn what this "vaping" thing really is. Or they'll just wreck tons of small businesses but accomplish little else.

Well... drive up smoking. They could accomplish that...

 

[Myrany]

Just a heads up that I have not abandoned my thread. I have simply finished my first slog through the regulation and have multiple pages of notes to digest and one big migraine to kick before I am ready to comment on most of it.

Vaping like a fiend. Taking my time and thinking it through.