FDA Lorillard comments to the FDA deeming regs

[skoony]

moderators: i think this is the appropriate forum to post this but as usual feel free to move it.my belief is this is where it would have the most interest. if the link needs to be broken do so,i for the life of me can't seem to do it.
hi all,
i found this posted on another forum and i thought it would be interesting to discuss here. after perusing these comments i must admit they a a little hard to digest. the one thing i was able to get out of them is while Lorillard wants batteries to be considered accessories for the purposes of the deeming regs., i can find no mention of them requesting tanks,cartos,wicks or coils to be considered accessories. pre-filled carto's anyone? it is also written in such a way as one would have to be a lawmaker or bureaucrat to understand it. my gist is they are asking for all the prerequisite paper work and filings and then some. so if anyone get read this and make any sense out of it,please feel free to post your opinions.


http://www.lorillard.com/wp-content....-FDA-Docket-FDA-2014-N-0189-AS-SUBMITTED.pdf

respectfully submitted
mike

 

[ClippinWings]

WOW!!!

WOW!!!!!!!

Unlike you, I found it to be a shockingly reasonable and well fashioned response.

I don't trust it at all... but it appears they are first pushing for the FDA to not do anything to remove products from the market, but if they must, then at least do as little damage as possible.


My Synopsis:
Lorilard repeatedly states that the FDA demonstrates a clear lack of understanding of eCigs, their market, use, or public health effects. They state clearly and repetitively that the methodology and technology to study ecigs effectively has not been developed or standardized and that studies that would provide for informed rule making are years away. As a result, heavy handed regulation, beyond manufacturing and ingredient standards and registration is inappropriate at this time and consideration of such, should be delayed until such methodology and study results are available.

Must say, I am pleasantly surprised.

a notable excerpt...

To accomplish these goals, Lorillard recommends that FDA do the following:

• Exercise enforcement discretion not to require premarket review for electronic cigarettes on the market before the effective date of the final deeming regulation;

• Allow the substantial equivalence pathway of Section 905(j) to be available to electronic cigarettes by permitting all electronic cigarettes on the market before the effective date of the final deeming regulation to serve as predicates;

• Establish clear requirements for substantial equivalence that focus on the e-vapor produced by the subject and predicate electronic cigarettes;

• Alternatively, FDA could permit the use of Section 905(j) by establishing a monograph-like system that allows new electronic cigarettes to be compared to a “model” electronic cigarette;

• For PMTAs, FDA should issue an electronic cigarette specific guidance to clarify the requirements for electronic cigarette PMTAs;

• FDA should allow manufacturers to obtain PMTA approvals based on a limited dataset coupled with commitments to collect and report post-market data; and

• FDA should establish a streamlined procedure to permit supplemental PMTA approvals for minor or moderate modifications of electronic cigarettes that do not affect the e-vapor delivered to the consumer.

 

[ClippinWings]

-------sorry, combined this with my previous post---------

 

[skoony]

WOW!!!

WOW!!!!!!!

Unlike you, I found it to be a shockingly reasonable and well fashioned response.

I don't trust it at all... but it appears they are first pushing for the FDA to not do anything to remove products from the market, but if they must, then at least do as little damage as possible.


My Synopsis:
Lorilard repeatedly states that the FDA demonstrates a clear lack of understanding of eCigs, their market, use, or public health effects. They state clearly and repetitively that the methodology and technology to study ecigs effectively has not been developed or standardized and that studies that would provide for informed rule making are years away. As a result, heavy handed regulation, beyond manufacturing and ingredient standards and registration is inappropriate at this time and consideration of such, should be delayed until such methodology and study results are available.

Must say, I am pleasantly surprised.

a notable excerpt...

i read all of that. its all the parts in between agreeing with the filing of this and that and about 300 other things with the FDA that has me concerned. is not this the regulatory paper work burden that every one thinks will eliminate 99% of the current e-cig products from staying in the market? are not they saying we hope you are nice but if not we have tons of paper work ready to go? over all i have a hard time getting at what they are really saying. its sort of like the FDA's proposed deeming regs. all over the place covering all the bases. run it up the flag pole and see who salutes at what. perhaps i need more time to digest it. in the meantime check out Bill Godshalls submission to the FDA posted in another link in this sub-fora. get your PV,a cup of coffee and, a bag lunch. its quite the read.
regards
mike

 

[DC2]

Subscribing......

 

[ClippinWings]

i read all of that. its all the parts in between agreeing with the filing of this and that and about 300 other things with the FDA that has me concerned. is not this the regulatory paper work burden that every one thinks will eliminate 99% of the current e-cig products from staying in the market? are not they saying we hope you are nice but if not we have tons of paper work ready to go? over all i have a hard time getting at what they are really saying. its sort of like the FDA's proposed deeming regs. all over the place covering all the bases. run it up the flag pole and see who salutes at what. perhaps i need more time to digest it. in the meantime check out Bill Godshalls submission to the FDA posted in another link in this sub-fora. get your PV,a cup of coffee and, a bag lunch. its quite the read.
regards
mike

Actually they're proposing eliminating that burden of paperwork by:

Changing the pre-market review date to the final date of the regs, instead of 2007

Removing the notion that a color change equals a new product.

Basing the testing and regulatory criteria on the content of the vapor not the hardware that produces it.

Yes Bill's comments are great, I read them and CASAA's last night... But they are exactly what is expected.

By contrast, I expected Lorilard to support the deeming, as proposed. Knowing they could navigate the regulatory hurdles.

They do not.

 

[freeatlast!]

Thanks for posting this, skoony!

 

[CabinetGuyScott]

i read all of that. its all the parts in between agreeing with the filing of this and that and about 300 other things with the FDA that has me concerned. is not this the regulatory paper work burden that every one thinks will eliminate 99% of the current e-cig products from staying in the market? are not they saying we hope you are nice but if not we have tons of paper work ready to go? over all i have a hard time getting at what they are really saying. its sort of like the FDA's proposed deeming regs. all over the place covering all the bases. run it up the flag pole and see who salutes at what. perhaps i need more time to digest it. in the meantime check out Bill Godshalls submission to the FDA posted in another link in this sub-fora. get your PV,a cup of coffee and, a bag lunch. its quite the read.
regards
mike

1) Thanks Skoony for the OP!

2) Totally agree on the reference to Bill Godshall's comment thread!
http://www.e-cigarette-forum.com/fo...t-fear-mongering-claims-about-e-cigs.html#top
I'm just starting part 5, and finished my bag lunch and reaching for my bag dinner (slow reader!)

3) Agree with DC2's idea to subscribe to this thread - that'll allow my brain to focus on digesting not only Bill G's comments, but turn attention to CASAA's 53 pager

4) Also agree with Clippinwing's WOW, WOW assessment! The excerpt is most enlightening and unexpected

Quickie take on it: Lorrilard recognizes the future does not lie in the pre-2007 product, and that true profit (and market growth) is to be found in current and future product design & innovation. Thus their position on establishment of predicate date (or whatever is the correct terminology)

That makes sound business logic to my ear...

 

[DrMA]

Holy comment batman! 132 pages 8-o -who knows what's buried in there... I already found statements as to nicotine being addictive and suggested labeling requirements that are far from ideal, and only serve to suppress the truth of THR.

 

[ClippinWings]

Holy comment batman! 132 pages 8-o -who knows what's buried in there... I already found statements as to nicotine being addictive and suggested labeling requirements that are far from ideal, and only serve to suppress the truth of THR.

so you missed the part where it said nicotine in ecigs was less addictive than in cigarettes?
I included one such mention, in Bold below

I suggest you read through the comments... don't skim through it with a preconceived notion that it's going to be bad...

It's really quite surprising... Here's some more highlights

The emerging body of literature suggests the following:

• Chemical/toxicological lab analyses show that electronic cigarette users are exposed to fewer and much lower levels of harmful constituents than with conventional cigarettes;

• Research on health effects is in early stages but the acute effects of electronic cigarettes are minimal and significantly less than with conventional cigarettes;

• Nicotine-containing electronic cigarettes are addictive, but users may be less dependent on them than smokers are on conventional cigarettes;

• Electronic cigarettes are associated with a significant reduction in number of conventional cigarettes smoked per day and may help some smokers quit;

• Users are almost exclusively current/former smokers; dual use is common but often temporary as smokers transition away from smoking conventional cigarettes; and

• Use by adolescents is low; there is no evidence that electronic cigarettes are a gateway to smoking.

 

[readeuler]

So many massive documents worth reading! The AGs' letter to the FDA was fine to skim; it was garbage. The official CASAA statement was a great read, although I already agreed with almost everything written (still full of great info and analysis, so worthwhile). I will have to take a closer look at this one. We should compile all the "big official documents" into one sticky'd thread; I have a feeling there are more than the 4 I know of (including the proposed regulations themselves) floating around.

Since when is it more entertaining to read about vaping regulation, compared to vaping itself here on the ECF? It's not even wacky Wednesday!

 

[skoony]

Actually they're proposing eliminating that burden of paperwork by:

Changing the pre-market review date to the final date of the regs, instead of 2007

Removing the notion that a color change equals a new product.

Basing the testing and regulatory criteria on the content of the vapor not the hardware that produces it.

Yes Bill's comments are great, I read them and CASAA's last night... But they are exactly what is expected.

By contrast, I expected Lorilard to support the deeming, as proposed. Knowing they could navigate the regulatory hurdles.

They do not.

i have seen that. the problem is every paper work condition of the regs they wholeheartedly support. thats where the devil in the details are.that means in their summary they seem to support lenient regs but,taken as a whole mean regulate away we have our paper work ready to go.

regards
mike
mike

 

[ClippinWings]

i have seen that. the problem is every paper work condition of the regs they wholeheartedly support. thats where the devil in the details are.that means in their summary they seem to support lenient regs but,taken as a whole mean regulate away we have our paper work ready to go.

regards
mike
mike

Again, not true.

As outlined in the my post you just replied to....

They suggest eliminating nearly all of the paperwork by:

1. Changing the date from 2007 to the date of final regs

(meaning every vapor product currently on the market would be legal, a predicate and free from Pre market authorization)

2. Not requiring a new Pre market authorization for minor changes/differences to the products.

(This is huge and would eliminate a large portion of the paperwork and fees that would cripple small business)

3. Basing regulation on vapor produced, not device producing it.

(This is an amazing concept, I doubt it has any chance of happening, but this would further reduce paperwork drastically by sensibly focusing on actual differences in product function)

These changes if implemented would mean NO overly burdensome or costly paperwork for existing small businesses to stay in business and minimal filing for new products developed unless there is substantial change to the vapor output.

I'm beginning to think you're reading a different document than the one you linked to... Because to me it is quite clear that lorilard's public comments to the FDA are much more in line with the vaping community than I ever would have dreamed.

They even go so far as to distinguish that smokers and vapers are not the same thing.

On top of that they go further than most comments I've read and not only explain why the proposed regulations are wrong, but also suggest solutions that are not only, logical and reasonable but also that would benefit vapor product manufacturers large and small, at the expense of traditional tobacco.

 

[GunMonkeyINTL]

I'm not entirely surprised by Lorillard's position.
My neighbor works for them, and their comings/goings are frequently covered on local radio and news, so I hear some things that are not secret but don't necessarily get broad coverage.

Everybody seems to think that Lorillard would want the most aggressive form of regulation since they already have Blu, and want to push the rest of the market out, and they have the money to engage the paperwork drills to get any new products they come up with processed and approved. But, part of their proposed merger with RJR includes selling Blu. That means that whatever entry they have/keep in the e-cig market (Vuse?) would require fresh establishment of market share on top of the FDA approval costs, making it that much more difficult to get a line up, running, and accepted - all without a guaranteed market share like Blu has.

Too, it's common to hear quick news stories about how a new product from Lorillard was "recently approved" that had been in process for several years. My neighbor has brought over new cigarettes and dip several times and said that it'll be a couple years, at least, before they hit the market.

Bottom line: Lorillard knows full-well how big of a pain it is dealing with the FDA, so maybe they really would prefer an environment of less regulation.

We've all been making the assumption that the evil big tobacco companies would prefer to have the FDA cripple the industry so they, although still hobbled, would be the only ones left standing. Maybe they're aware of the extreme advantage that their marketing and distribution prowess give them over the cottage segment of the industry and would prefer a scenario where the little guys are left standing in exchange for their own work being that much easier. Maybe they'll be the first of the traditional tobacco companies to offer a more advanced line of vaping gear than the big tobacco companies have so far- think a Volcano-like company backed by a Lorillard-like company. Even with big tobacco money, it would still be very difficult and expensive to launch a line of 30 flavors and multiple kinds of tanks and batteries if the worst version of the proposed regulation were enacted.

Maybe the big tobacco companies are not the evil entities bent on the wholesale murder of children and impressionable young adults at any cost, like the tin-foil-hat occupy-types would have us believe, and are really just out to stay in business and make money. Capitalism and evil are not necessary mutually-inclusive.

 

[Rlrick]

Here are my thoughts on this matter. I hope this is the right place to discuss this issue. What I am seeing is that Lorillard and the other BT companies are going after the e-juice market and possibly the hardware also. Dow chemicals have already stated they will not sell PG to the e-cig manufactures and one battery manufacture is trying to stop 18650 battery sales. If other manufactures follow suit and only sell to BT then who will we be purchasing our juices and hardware from? This could be just another ploy to gain total control over such a market.

 

[Cool_Breeze]

Here are my thoughts on this matter. I hope this is the right place to discuss this issue. What I am seeing is that Lorillard and the other BT companies are going after the e-juice market and possibly the hardware also. Dow chemicals have already stated they will not sell PG to the e-cig manufactures and one battery manufacture is trying to stop 18650 battery sales. If other manufactures follow suit and only sell to BT then who will we be purchasing our juices and hardware from? This could be just another ploy to gain total control over such a market.

I am continually surprised and yet disappointed how much unsubstantiated information is posted in ECF and shortly thereafter gets repeated, repeated, repeated until it is accepted as gospel.

ECF is a truly amazing machine.

 

[skoony]

Again, not true.

As outlined in the my post you just replied to....

They suggest eliminating nearly all of the paperwork by:

1. Changing the date from 2007 to the date of final regs

(meaning every vapor product currently on the market would be legal, a predicate and free from Pre market authorization)

2. Not requiring a new Pre market authorization for minor changes/differences to the products.

(This is huge and would eliminate a large portion of the paperwork and fees that would cripple small business)

3. Basing regulation on vapor produced, not device producing it.

(This is an amazing concept, I doubt it has any chance of happening, but this would further reduce paperwork drastically by sensibly focusing on actual differences in product function)

These changes if implemented would mean NO overly burdensome or costly paperwork for existing small businesses to stay in business and minimal filing for new products developed unless there is substantial change to the vapor output.

I'm beginning to think you're reading a different document than the one you linked to... Because to me it is quite clear that lorilard's public comments to the FDA are much more in line with the vaping community than I ever would have dreamed.

They even go so far as to distinguish that smokers and vapers are not the same thing.

On top of that they go further than most comments I've read and not only explain why the proposed regulations are wrong, but also suggest solutions that are not only, logical and reasonable but also that would benefit vapor product manufacturers large and small, at the expense of traditional tobacco.

i agree when you say they are asking for a lot of things not to be done. they then list each and every one and what section of which regulation it is applicable too. over all the document in its entirety gives me the general sense they are saying please dont do this but, if you do, we know what to do. i agree my thinking is in a very general. my thoughts are that they are trying to appease us vapors. see look we are on your side. and also letting the FDA know that whatever the regs may be,give it your best shot because we are ready. i am not sure if that last part contains a wink,wink,nod,nod. i do agree i hope the FDA takes a vapor friendly view on it.

regards
mike

 

[skoony]

Here are my thoughts on this matter. I hope this is the right place to discuss this issue. What I am seeing is that Lorillard and the other BT companies are going after the e-juice market and possibly the hardware also. Dow chemicals have already stated they will not sell PG to the e-cig manufactures and one battery manufacture is trying to stop 18650 battery sales. If other manufactures follow suit and only sell to BT then who will we be purchasing our juices and hardware from? This could be just another ploy to gain total control over such a market.

i think Dow has stated they will not knowingly sell to a e-juice manufacturer. Sony has said they have stopped making 18650 type batteries because of unintended use by the public. i cant see how they can quit. they must have tons of contractual agreements to fulfill. its interesting to note radio control hobbyists have been abusing these types of batteries for years and boosted the sales of companies making them, now Sony wants to get a lot of distance between vapors and their products. i think both are just getting some distance for political and liability issues. i am sure the products will be there,just a little further down the supply chain.
regards
mike

 

[Cool_Breeze]

It may be that 'market' is a key word for Dow. They may not list eCigs as an approved use for Propylene Glycol and thus not 'market' to that industry. If that's the case, that's a long way from saying that Dow Propylene Glycol will not make it into eCigs.

I wonder if Tesla will sell batteries to the eCig industry?

 

[stevegmu]

They are smart and should be thanked for spending the money to put together such a well thought out and researched response, rather than the , "You suck" FDA comments most people on here probably submitted...