FDA FDA deeming regulation proposals

[Roger_Lafayette]

First of all, "accessories" are things like EGO carrying cases and Provari tee shirts (if they exist). These are not at issue.

But "components or parts" of a "covered tobacco product" are.

We have had this argument now since the proposed rule was released, so I'm going to quote directly from CASAA's press release in the hopes that some of you who don't believe that equipment is affected will listen to them:

"Although the regulations do not openly ban the refillable devices that are preferred by experienced users, they impose a costly registration and approval process that would effectively eliminate them.[....]

“Our research and others’ shows that higher-quality hardware and appealing flavors are important for smoking cessation,” says Phillips.“

Now I grant you that a MOD is not a "refillable device" and nor is a separate atty, an EGO battery, or a replacement coil, etc. But any clearomizer, tank[O], RDA, cart[O], or hybrid is. I wish CASAA would go the rest of the way and make it clear that every piece of essential equipment unique to vaping is covered under the "component of a covered tobacco product" language. And as I said, I'm tired of listing all the indications which clearly indicate that this is so.

So if you want to persist in believing that a MOD isn't covered or a spinnner isn't, just because it's not a "refillable device," you can wait for CASAA to take the final step and clarify that point, too. We have been going around and around on this for days now, and there are some folks who just refuse to accept the indications which are clear from both the FDA's PDF and Zeller's statements (such as the interview he gave on the PBS News Hour, in which he talked about exploding batteries, or his answer to Greg Conley's Q on the teleconf. last week).

Just because someone has a freezer full of nic. and they DIY, doesn't mean that they won't be directly affected.

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

 

[Myk]

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".

Also these regulations favor one set of businesses over another.

 

[aikanae1]

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

"Mitch" is also saying the FDA is a "science-based agency" too.

 

[Kent C]

But FDA can refuse to accept an application, according to Bill Godshall - who also says that filing an application is not easy).

Just one of them - FORM FDA 3741:

http://www.fda.gov/downloads/TobaccoProducts/ResourcesforYou/ForIndustry/UCM189555.pdf

 

[skoony]

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...

cassa has stated they believe this proposal will allow the
fda jurisdiction over these devices,not that they absolutely will.
if the FDA can in fact regulate these things they can regulate bic lighters
and zip lock bags.

regards
mike

 

[EddardinWinter]

Also these regulations favor one set of businesses over another.

Naturally.

Their deep pocketed allies love an uneven playing field...and "safe children".

Vomit.



Roaring thunderously via Tapatalk...

 

[Roger_Lafayette]

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

One can file a lawsuit anytime, for any reason. But if it's not a "case or controversy" because it requests an "advisory opinion," then the Federal courts will toss it. That's what Greg Conley said in the VPLive round table. (Well, to be precise he made the more general statement that no one could file until the FDA acts against a specific manufacturer. But that's why he said that, I believe.)

 

[Kent C]

Also these regulations favor one set of businesses over another.

That's actually their purpose. Not their stated purpose - although here they come close but their purpose non-the-less. Reality shows it. It's why there's only 3 big auto makers, about 3 railroads, a few more Big Ag, a few oil companies and no new nuclear plants since @1975.

 

[Roger_Lafayette]

Ditto! .........

This. What Kent & Katya said. Congrats on quitting!

 

[skoony]

First of all, "accessories" are things like EGO carrying cases and Provari tee shirts (if they exist). These are not at issue.

But "components or parts" of a "covered tobacco product" are.

We have had this argument now since the proposed rule was released, so I'm going to quote directly from CASAA's press release in the hopes that some of you who don't believe that equipment is affected will listen to them:



Now I grant you that a MOD is not a "refillable device" and nor is a separate atty, an EGO battery, or a replacement coil, etc. But any clearomizer, tank[O], RDA, cart[O], or hybrid is. I wish CASAA would go the rest of the way and make it clear that every piece of essential equipment unique to vaping is covered under the "component of a covered tobacco product" language. And as I said, I'm tired of listing all the indications which clearly indicate that this is so.

So if you want to persist in believing that a MOD isn't covered or a spinnner isn't, just because it's not a "refillable device," you can wait for CASAA to take the final step and clarify that point, too. We have been going around and around on this for days now, and there are some folks who just refuse to accept the indications which are clear from both the FDA's PDF and Zeller's statements (such as the interview he gave on the PBS News Hour, in which he talked about exploding batteries, or his answer to Greg Conley's Q on the teleconf. last week).

Just because someone has a freezer full of nic. and they DIY, doesn't mean that they won't be directly affected.

you could be right.i could be wrong.i'm just trying to point out why one would think the
FDA cant regulate refillable devises under these very confusing and contradictory proposals.
i think the lawyers are going to be quite busy either way.
for now i'll just call my tank a tobacco pouch,my coil my lighter,and my batt is the lighter fluid.
i wonder why they ask even and how these should be regulated?
if they don't know i am not going to give them any hints.let me close by saying i appreciate all
your doing and look forward to your posts.
regards
mike

 

[Spit]

Thank you Katya.

 

[EddardinWinter]

One can file a lawsuit anytime, for any reason. But if it's not a "case or controversy" because it requests an "advisory opinion," then the Federal courts will toss it. That's what Greg Conley said in the VPLive round table. (Well, to be precise he made the more general statement that no one could file until the FDA acts against a specific manufacturer. But that's why he said that, I believe.)

I don't disagree with any of that. The hasty stroke oft goes awry.



Roaring thunderously via Tapatalk...

 

[Spit]

Yeah I corrected that Myk. Posted before I saw the CASAA announcement.

 

[Danoman]

No, sounds like they're still working on the Call-to-Action.. No need to rush since they want to get it right...


"CASAA is preparing a response that will point out the flaws in the proposed regulations and is organizing its members and hundreds of thousand of other e-cigarette users in an attempt to persuade FDA about the harms this regulation would cause. Should that fail, it plans to fight the regulations in court."


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

I believe so too... and both parties know it already. This will be battled out in the court system I believe as I said last night. Maybe, just MAYBE we have a bit more time on our hands...

 

[Jman8]

You're talking about what goes into effect. I'm talking about as written.

Okay, let's talk about what is written.

There is no hope of talking government out of their stacks of paperwork.

Based on what is written, this could be a good thing.

From p.11 of the proposal:

FDA is aware of new product category entrants into the market after the February 15, 2007, reference date and that the SE pathway may not be available to these newer products. Because this date is written into the statute, we do not believe that we have the authority to amend it with respect to e-cigarettes or other products. FDA is proposing to extend the compliance period for submitting a marketing application under this pathway to 24 months following the effective date of a final rule. FDA is also proposing a 24-month compliance period for the submission of premarket tobacco applications (PMTAs). In addition, we intend to continue the compliance policy pending review of marketing applications if those applications are submitted within the 24 months after the final rule's effective date. FDA is specifically seeking comment on whether and, if so, how FDA should consider a different regulatory mechanism for newer proposed deemed tobacco products that cannot, as a practical matter, use the SE pathway.

So, I am selectively bolding the part here that I think matters for what is written elsewhere. I think all of what is quoted here matters, and I also think the 2nd to last sentence is very critical. Plus I think the last sentence is vital, for where us respondents come in, as it could, plausibly, go in another direction than what is written in the proposal. Might not, but the way it is worded "consider a different regulatory mechanism for newer proposed deemed tobacco products" indicates this.

I had either read elsewhere or just thought that when this 2 year window above ends, that these products would be (somehow) deemed non-compliant. I now no longer think that based on what is written in the supplemental document ("Applications for Premarket Review of New Tobacco Products") and treated as draft of what will likely be enforced when new regulations go into effect.

But I think what needs to be added here (first) is what is stated on p.14 of the proposal:

Therefore, FDA does not intend to initiate enforcement action against products on the market for failing to have made an appropriate submission until 24 months following the effective date of the final rule. If a manufacturer submits a PMTA or SE application for its affected products within the 24-month time frame, FDA does not intend to initiate action against those products for failing to have a marketing authorization unless and until such a time as we have responded to the application.

In essence that says what the draft says, but I'm compelled to make note of that language. On p. 5 of that draft, it says (in table format) with left side reading, "If your new tobacco product . . ." and then that column being for things not covered in current proposal. But the paragraph above this one deals with that compliance policy/dates. So, would be written along lines of "If your new tobacco product . . .Is marketed during the 24 month period between sometime in 2014 and sometime in 2016 and you submit a 905(j) report for the product by same date as mentioned before (in 2016)."

*Obviously I don't know exact dates, but hopefully you are okay with just the gist here. Anyway, continuing with what is in right-hand column:

Then... You may market your product unless and until FDA issues an order stating that the product is not substantially equivalent or not in compliance with the FD&C Act. If FDA issues such an order, you must cease marketing the product and cannot market the product again without first obtaining a marketing authorization order from FDA under either section 910(c)(1)(A)(i) or 910(a)(2)(A)(i) of the FD&C Act.

And so, until FDA has finished its review and/or stated otherwise, you can market the product. Those that come up for market compliance after 2016, do not get this grace period. Yes, that stinks. But all current products do.

As it is written, it is saying the products can stay on the market until FDA issues an order stating that it is not in compliance.

So, unless issuing order is arbitrarily applied, which would be, I think easy to beat in court, then the order would (very likely) come as a result of review process.

But if the review process is backed up for say 5 years, then that would be a very good thing, in a sense. In fact, if it were backed up for 50 years, it would be a great thing.

Thus, either FDA does find a way to streamline the compliance policy of reviews and approvals/rejections (which is also a positive thing, depending on one's perspective) or products that are on the market, during the grace period, by those who think FDA cannot possibly handle all the paperwork that they will have coming to them, is actually a wonderful thing.

But I realize if I say "FDA" and "compliance policy" and "wonderful thing" all in the same paragraph, I just done entered into 'incredibly naive territory for politics of eCigs. Not based on what is written, but based on FDA track record. The same track record that could, theoretically, keep items in the grace period, on the market indefinitely.

Due to what is written, in the proposed documents.

 

[Jman8]

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.

Putting out a public wager doesn't make for idle speculation. Refusing to accept a wager based on speculation, and comments expressing FUD, is one's prerogative. It's actually "wishful thinking" of another kind. The kind that is counterproductive.

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?

Not up to me to define eCigs, but am currently operating under impression that it is products intended for (and advertised as) being used to vape nicotine. How far reaching that is, I don't know, and do care. If they go for all things non-nicotine, I think they'll be so tied up in court, they'd be utterly foolish to not take that out of the equation. If a vendor sells non-nicotine products along with nicotine products (together in any order ever), they'll probably be regulated, I would think. If they don't, I think they won't or if they are, they'll be tying up courts indefinitely, as there isn't just 3 or 4 such vendors.

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

Is Mitch going to be alive forever? Is he going to head this regulatory body forever? Is his opinion and only his, the only one that matters when it comes to federal regulation of tobacco products?

Mitch could be long gone by time 2017 rolls around.

 

[Myk]

cassa has stated they believe this proposal will allow the
fda jurisdiction over these devices,not that they absolutely will.
if the FDA can in fact regulate these things they can regulate bic lighters
and zip lock bags.

regards
mike

Actually the proposal states that. Something like a cigar cutter is an unregulated accessory but something like an ecig kit or parts that the consumer goes home to manufacture are a tobacco product.

Okay, let's talk about what is written.



Based on what is written, this could be a good thing.

From p.11 of the proposal:


So, I am selectively bolding the part here that I think matters for what is written elsewhere. I think all of what is quoted here matters, and I also think the 2nd to last sentence is very critical. Plus I think the last sentence is vital, for where us respondents come in, as it could, plausibly, go in another direction than what is written in the proposal. Might not, but the way it is worded "consider a different regulatory mechanism for newer proposed deemed tobacco products" indicates this.

I had either read elsewhere or just thought that when this 2 year window above ends, that these products would be (somehow) deemed non-compliant. I now no longer think that based on what is written in the supplemental document ("Applications for Premarket Review of New Tobacco Products") and treated as draft of what will likely be enforced when new regulations go into effect.

But I think what needs to be added here (first) is what is stated on p.14 of the proposal:


In essence that says what the draft says, but I'm compelled to make note of that language. On p. 5 of that draft, it says (in table format) with left side reading, "If your new tobacco product . . ." and then that column being for things not covered in current proposal. But the paragraph above this one deals with that compliance policy/dates. So, would be written along lines of "If your new tobacco product . . .Is marketed during the 24 month period between sometime in 2014 and sometime in 2016 and you submit a 905(j) report for the product by same date as mentioned before (in 2016)."

*Obviously I don't know exact dates, but hopefully you are okay with just the gist here. Anyway, continuing with what is in right-hand column:



And so, until FDA has finished its review and/or stated otherwise, you can market the product. Those that come up for market compliance after 2016, do not get this grace period. Yes, that stinks. But all current products do.

As it is written, it is saying the products can stay on the market until FDA issues an order stating that it is not in compliance.

So, unless issuing order is arbitrarily applied, which would be, I think easy to beat in court, then the order would (very likely) come as a result of review process.

But if the review process is backed up for say 5 years, then that would be a very good thing, in a sense. In fact, if it were backed up for 50 years, it would be a great thing.

Thus, either FDA does find a way to streamline the compliance policy of reviews and approvals/rejections (which is also a positive thing, depending on one's perspective) or products that are on the market, during the grace period, by those who think FDA cannot possibly handle all the paperwork that they will have coming to them, is actually a wonderful thing.

But I realize if I say "FDA" and "compliance policy" and "wonderful thing" all in the same paragraph, I just done entered into 'incredibly naive territory for politics of eCigs. Not based on what is written, but based on FDA track record. The same track record that could, theoretically, keep items in the grace period, on the market indefinitely.

Due to what is written, in the proposed documents.

So you think people will get away with inventing a Vamo V6, applying and selling while the application goes through and by the time it is looked at the product will be obsolete?

I'd rather focus on the lie, "we do not believe that we have the authority to amend it with respect to e-cigarettes or other products".
If they actually wanted to change the date to when a product is brought under their control they can go to congress and have an amendment drawn up to say exactly what they want and have it rammed through. They're pretending they can't. Why are they lying?

 

[Roger_Lafayette]

<snip>

In your indefatigable search for something positive, you omit three things:

1) Filing an application is incredibly burdensome. Many manufacturers will not bother. Some may not even register, and just hang up their hats when the regs become final. This will yield an immediate ripple effect on vape shops and distributors plus online sellers. We could even see a stampede out of the market.

2) FDA can refuse to accept an application. Bill G. says that they've done it before. I'm not sure on what grounds. I'm not sure if they're refused to accept registrations (but registrations have to be in at most six months after the rule becomes final, depending on the date of finalization).

3) Given how burdensome the application process is, FDA could easily filter out the applications that don't make a serious effort to comply with the requirements for all of those studies, etc. They are not mandated to process them in order of submission.

 

[Jman8]

You have to pay a lawyer between 2100 - 125,000 hours to apply for you.

Where is it written that you have to pay a lawyer to apply for you?

I already am anticipating your (or others') response to this, but why can't we go with "we don't know what will be required for submission" and so we don't know if this is accurate. Either that you'll need a lawyer/law degree to fill out the form, that it would take that much time/expertise, that it would cost this much.

I'd rather spend time constructing responses to FDA that deals with this hypothesis, based on past experiences with FDA, then thinking it automatically will happen this way and it is hopeless to think otherwise.

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.

As written where?

 

[EddardinWinter]

Putting out a public wager doesn't make for idle speculation. Refusing to accept a wager based on speculation, and comments expressing FUD, is one's prerogative. It's actually "wishful thinking" of another kind. The kind that is counterproductive.



Not up to me to define eCigs, but am currently operating under impression that it is products intended for (and advertised as) being used to vape nicotine. How far reaching that is, I don't know, and do care. If they go for all things non-nicotine, I think they'll be so tied up in court, they'd be utterly foolish to not take that out of the equation. If a vendor sells non-nicotine products along with nicotine products (together in any order ever), they'll probably be regulated, I would think. If they don't, I think they won't or if they are, they'll be tying up courts indefinitely, as there isn't just 3 or 4 such vendors.



Is Mitch going to be alive forever? Is he going to head this regulatory body forever? Is his opinion and only his, the only one that matters when it comes to federal regulation of tobacco products?

Mitch could be long gone by time 2017 rolls around.

http://en.m.wikipedia.org/wiki/Fear,_uncertainty_and_doubt

Fear, uncertainty and doubt (FUD) is a tactic used in sales, marketing, public relations,[1][2] politics and propaganda.

FUD is generally a strategic attempt to influence perception by disseminating negative and dubious or false information. An individual firm, for example, might use FUD to invite unfavorable opinions and speculation about a competitor's product; to increase the general estimation of switching costs among current customers; or to maintain leverage over a current business partner who could potentially become a rival.

The term originated to describe disinformation tactics in the computer hardware industry but has since been used more broadly.[3][dubious ] FUD is a manifestation of the appeal to fear.

A new term to disparage those who disagree with your lofty perspective, and yet another clumsy misapplication.

So everyone who despises the FDA and seeks to voice that mistrust is deliberately misleading the forum, eh? They certainly aren't honest folks who disagree...

Good luck selling that.



Roaring thunderously via Tapatalk...