FDA FDA deeming regulation proposals

[Danoman]

I believe the 'core' of the issue at hand is the cost of submitting a particular "flavor"... i'm thinking about small business here. If we allow them to rule on the cost of the application and fee associated with it, we allow them to do what ever they like with no limitations on cost to apply for that flavor. There HAS to be limitations on the submission cost and a grace period given while they are "so called" 'testing' that particular individual on the pureness of the flavor they submitted to the FDA, what else is important is a timely response to the submission of that particular flavor on the market, so the small business owner isn't in levitation while this process is going on, it's in the business owners BEST interest to submit 'his' flavors to the FDA. Maybe the news media isn't the best idea, I agree BUT, there is a give and take on this submission thing. Something will have to be given in order to get what we all want, we know this.

 

[Danoman]

Been thinking..


There's probably going to be a lot of fairly similar comments submitted to the FDA...

In which case, I'm considering "burning" my one shot & going a different & probably somewhat unique route, aiming to stand out a bit from the rest in a certain way, by putting some creative writing skills to work & reaching deep into a part of my mind that can be quite sick & disturbing...


Oftentimes it gets me in trouble, as evidenced throughout my life, whereby I conjure such bizarre thoughts, images & scenes, using just the right words & phrasings, worming into the reader's psyche & oftentimes evoking some pretty strong psychological reactions & haunting memories...

Although I prefer not to use this "gift" too often these days, I certainly have the experience, and have only honed my craft over the years..

I won't go into any particulars here for this FDA comment, as I'm already formulating some bits & pieces, and I'd prefer not to share here in fear of having my post yanked or getting banned (I like ECF too much )...


But in my response, I'd paint an extremely dark & bleak world of what a post-FDA ruling would look like where only cigalikes are legally available to those who were once used to much, much more.. Think something along the lines of the Prohibition era -- but instead for nicotine... I already know that history fairly well, and some pretty gruesome things happened to the common man looking to get a little tipsy, with unfortunate results...


I understand it's a bit unorthodox, and probably not publicly recommended by some.. But it is my choice & my right, and I personally see nothing wrong with giving them a taste of their own medicine by using a little psychological warfare, myself..


Basically, I want my comment to give these guys nightmares..

And in doing so, it could potentially help make them think twice...


Then again, their sick sociopathic minds might actually get a kick out of it..

Either way, I think it might be worth it to me...

I'm not a single bit against that AT all...!!! Sometimes, that's what it takes...

 

[Jman8]

Listening to the roundtable podcast thing as I type this and while I disagree with question much of what Bill G. is saying, I do agree that a top point is to push for longer comment period.

I think we do need to organize in a way that has a wave of us 'wasting' our one and only comment by saying that that more time is needed. If this request for more time doesn't waste the 'one and only' comment that a person can submit, then all the better.

I see that being both strategic and also helpful in making sure we respond appropriately with later comments.

But to be clear, I see it as mostly strategic, and pretty sure that is what Bill is saying. I agree that 2017 could change how this regulation looks or if it even exists. But then again, it could plausibly get worse as ANTZ wasn't happy with proposal either and could lobby for say Pubs (Rhinos) to make this 'their issue' going forward.

I must admit if we are sure FDA is going to reject 'things that favor vapers' then I'm thinking they may reject requests to extend comment period. Just saying.

 

[Danoman]

Listening to the roundtable podcast thing as I type this and while I disagree with question much of what Bill G. is saying, I do agree that a top point is to push for longer comment period.

I think we do need to organize in a way that has a wave of us 'wasting' our one and only comment by saying that that more time is needed. If this request for more time doesn't waste the 'one and only' comment that a person can submit, then all the better.

I see that being both strategic and also helpful in making sure we respond appropriately with later comments.

But to be clear, I see it as mostly strategic, and pretty sure that is what Bill is saying. I agree that 2017 could change how this regulation looks or if it even exists. But then again, it could plausibly get worse as ANTZ wasn't happy with proposal either and could lobby for say Pubs (Rhinos) to make this 'their issue' going forward.

I must admit if we are sure FDA is going to reject 'things that favor vapers' then I'm thinking they may reject requests to extend comment period. Just saying.

I'm holding this thought, knowing that their full intent is to alleviate the entire e-cig scenario, if they could. I agree with you, in certain perspectives. WE know the directives they adhere to and we also know the direction they are pushing, even though NOT fact.

 

[Jman8]

Why #5...? It clears all our batteries in any form... and doesn't allow them to 'item' each part of our machines as a 'tobacco' "TYPE" product...

I agree with what you are saying, but it reads as impractical to me. To consider everything safe means defective products are safe until FDA gets around to proving that they are not. See what I'm saying?

I addressed this in my previous post, and admittedly what I wrote wasn't rock solid. But I agree that something on this front needs to be written and I'd put it in my top 3 (currently). I say if it is non-nicotine product, it ought to be allowed to stay on the market unless 'anyone' proves (and can/will disclose their proof) that in all/most cases it is unsafe, defective, or otherwise hazardous. But I also do think it ought to be submitted for market application under the regulation if vendor is going to advertise it as intended for vapers.

Again, even that isn't rock solid logic to me, but I can't emphasize enough that I think this is a talking point to elevate near the top for what I'd like to see us responding with.

 

[Jman8]

I believe the 'core' of the issue at hand is the cost of submitting a particular "flavor"... i'm thinking about small business here. If we allow them to rule on the cost of the application and fee associated with it, we allow them to do what ever they like with no limitations on cost to apply for that flavor. There HAS to be limitations on the submission cost and a grace period given while they are "so called" 'testing' that particular individual on the pureness of the flavor they submitted to the FDA, what else is important is a timely response to the submission of that particular flavor on the market, so the small business owner isn't in levitation while this process is going on, it's in the business owners BEST interest to submit 'his' flavors to the FDA. Maybe the news media isn't the best idea, I agree BUT, there is a give and take on this submission thing. Something will have to be given in order to get what we all want, we know this.

Agreed with the bolded part, and bold it because it is my number one item, as it relates to 'application from small businesses.'

The grace period is already established with this proposal. So, take vendor like xxx that has a million flavor combos (actually closer to 15 million). That means million+ are in grace period already. And xxx is welcoming the FDA regulations.

As I noted elsewhere, if these figures being tossed around are accurate (i.e. $10 million for each review application), then xxx has got to be planning to spend 1.5 quintillion dollars or some obnoxiously high figure like that. Frankly, I don't buy the $10 million dollar figure, but whatever the figure is, it would be ridiculous expensive for company like xxx.

Anyway, back to matter at hand, I wish to emphasize that I fully agree with, "There HAS to be limitations on the submission cost"

And a demand from us to either learn (from the FDA) specifically what justifies that cost or need to learn that that on our own. Having an expert say 'trust me, it is that amount,' doesn't work for me in this moment. Sorry.

ETA: changed vendor to "xxx" as I went to their website and interesting their FDA announcement doc, noting they welcome the regs, is 'not found.' So, I just not assume that this is still the case.

 

[Danoman]

Agreed with the bolded part, and bold it because it is my number one item, as it relates to 'application from small businesses.'

The grace period is already established with this proposal. So, take vendor like xxx that has a million flavor combos (actually closer to 15 million). That means million+ are in grace period already. And xxx is welcoming the FDA regulations.

As I noted elsewhere, if these figures being tossed around are accurate (i.e. $10 million for each review application), then xxx has got to be planning to spend 1.5 quintillion dollars or some obnoxiously high figure like that. Frankly, I don't buy the $10 million dollar figure, but whatever the figure is, it would be ridiculous expensive for company like xxx.

Anyway, back to matter at hand, I wish to emphasize that I fully agree with, "There HAS to be limitations on the submission cost"

And a demand from us to either learn (from the FDA) specifically what justifies that cost or need to learn that that on our own. Having an expert say 'trust me, it is that amount,' doesn't work for me in this moment. Sorry.

ETA: changed vendor to "xxx" as I went to their website and interesting their FDA announcement doc, noting they welcome the regs, is 'not found.' So, I just not assume that this is still the case.

I agree... But, to get all in perspective, if I was a small business owner, this is nothing more than an additional "tax" being place on that owner of 'said' business... any way one looks at it, it's the same thing. Thing is, isn't CONGRESS the only one that can imply taxes...? This would be beyond what the FDA is allowed, by LAW to do... correct...? Didn't Obamacare HAVE to go before the Supreme Court and it was labeled a "TAX", no matter what the issue at hand. It's STILL controlled by our Congress... So, doesn't that give us free will on those elected to hit up Congress on this...? Keeping in mind, it's a mid term election cycle...? Maybe we shouldn't go directly at the FDA... Maybe it's our Congress we need to be addressing and focus on as THEY are the ones that make law. I'd say, maybe Trey Goudy from S.C. would be the first one we make our address to... Any thing less is asking for problems, as they don't have the power to make law, in ANY rhelm. But, our Congress does...

 

[pamdis]

The problem with trying to limit costs is that most of it is not what is submitted WITH the application, but the costs they estimate will be incurred to COMPOSE the application.

 

[EddardinWinter]

This process of approval was designed to screw over the tobacco companies. Altria, RJR, etc. are not daunted by the costs, and have hundreds of product lines grandfathered into the market. So they have a base of products to sell to the consumers while dealing with the applications. Demanding a life-cycle adjusted timeline seems perfectly fair to me.

Perhaps this is where the FDA's proposal can be attacked. This was a settlement made by another industry. There is no basis for it's application to e-cigarette vendors due to the difference of the market.

I am gonna draw something up on this, and I will post here in a bit.



Roaring thunderously via Tapatalk...

 

[patkin]

I don't want to sound like a broken record and, truthfully, having read the pertinent sections several times, my blood pressure rises (not verified) every time I read them. I'm sick of reading their threats, IE: what we propose being so much better than what we could do regarding components. So, without posting quotes and assuming everyone has read those sections and, thus, why I'm asking: can anyone tell me what Fed Depts/Agencies currently handle tobacco pipes, he*d shop materials, syringes, cell phones, electric razors, etc as they pertain to public safety or if the FDA controls any of them under the "public health safety" umbrella? Hate to sound like an apathetic idiot but, heretofore, have had no reason to delve into how any of those are handled. I'm trying to understand the "component" issue and the validity/invalidity of their "We could" threats regarding them. I want to see what process some of those items have to go thru and where.

 

[skoony]

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.

the proposed regulation seem to be trying to say both are true.
but they can only regulate as stated in the original 2009 law.
it clearly wasn't written with anything like e-cigs in mind.
i think that is why the proposed regs are so confusing.
the FDA is trying to muddle things up in hope they can try to drive
the proverbial truck through the closed door.
the big problem the FDA has is i don't use my zippo to light the end
of my ego c.
i don't think they can change by new regs what the definition of accessories used in the consumption
a tobacco product to accessories used for the consumption of a tobacco product.
as i said before the lawyers on both sides of this are going to be very busy.

regards
mike

 

[EddardinWinter]

So here is a little timeline I put together for reference.

IT is still a work in progress, but I think it makes my point that the date selected was both arbitrary and capricious. If this law, that was made for another product is to be applied to a new product, should the same basic parameters govern it's application? It is patently unfair to stand firm with the current date selected. Take a look...

I'll be expanding this point soon in a blog. I will update here.

 

[Sirius]

This is what CASAA had to say about it:

CASAA: FDA regulation of e-cigarettes: huge costs, little or no benefit, says CASAA
"It is estimated that as many as a million American smokers have quit or substantially reduced their smoking thanks to e-cigarettes, and many are already making plans for a black market if these regulations take effect."

Big money must be behind this FDA decision to propose regulations. Who knows in two years time the black market may include e-liquids.

 

[Thundernoggin]

There are other ways to deal with that. Complying with state and local food handling laws would be a start. This doesn't need to elevate to this level of complexity. In fact I feel less safe with BT manufacturing cartridges in China. I'm exapggerating (I hope) but some melamie or other toxic substance could get slipped in, which has happened before. Industrial grade ingredients. I'd know less about the eliquid than I do now. As it stands, I have a choice. After FDA, there will be little choice.

I agree completely. Two of our biggest problems are ruthless local profiteers and substandard foreign production companies aimed at producing the cheapest e-liquid possible. My concern is the FDA will use the somewhat broken e-liquid market as an easy means to drop the hammer on everything.

.....Then again, their sick sociopathic minds might actually get a kick out of it..

More than likely this is what will happen. To me it sounds like you are writing their great victory tale. From what I've gathered so far this all about money and they could care less about the consequences. Personally, I'm thinking of a much more straight forward approach detailing my 40 year struggle with tobacco that began without a choice (thanks parents and BT) and detailing my encounters with other locals here who are also using vaping to quit cigarettes. And I do plan to address directly the human cost of such a ban. Even though their recent comments demonstrate a complete disregard for the rest of us I will still not let them forget it.

 

[Sirius]

This is what the CDC has to say:

“E-cigarette use is growing rapidly. There is still a lot we don’t know about these products, including whether they will decrease or increase use of traditional cigarettes,” CDC Director Dr. Tom Frieden said in a news release. E-cigarettes appear to have far fewer toxins than traditional cigarettes, but the impact of the devices on long-term health requires more research, the CDC researchers said.
They also called for more studies on how e-cigarette marketing may affect the use of traditional cigarettes, particularly among young people. “If large numbers of adult smokers become users of both traditional cigarettes and e-cigarettes — rather than using e-cigarettes to quit cigarettes completely — the net public health effect could be quite negative,” said Dr. Tim McAfee, Director of the CDC’s Office on Smoking and Health.

www. drugfree .org/join-together/tobacco/one-fifth-of-adult-smokers-in-united-states-have-used-e-cigarettes-cdc

 

[Thundernoggin]

This is what the CDC has to say:

“E-cigarette use is growing rapidly. There is still a lot we don’t know about these products, including whether they will decrease or increase use of traditional cigarettes,” CDC Director Dr. Tom Frieden said in a news release.....

Good old Dr Frieden has already demonstrated the CDC's complete lack of understanding on this topic courtesy of his recent news bite ready comments about cotton candy flavored e-cigs. I was really mad after seeing that and it did not fill me with hope. I'm vaping Smores right now.

 

[skoony]

I don't want to sound like a broken record and, truthfully, having read the pertinent sections several times, my blood pressure rises (not verified) every time I read them. I'm sick of reading their threats, IE: what we propose being so much better than what we could do regarding components. So, without posting quotes and assuming everyone has read those sections and, thus, why I'm asking: can anyone tell me what Fed Depts/Agencies currently handle tobacco pipes, he*d shop materials, syringes, cell phones, electric razors, etc as they pertain to public safety or if the FDA controls any of them under the "public health safety" umbrella? Hate to sound like an apathetic idiot but, heretofore, have had no reason to delve into how any of those are handled. I'm trying to understand the "component" issue and the validity/invalidity of their "We could" threats regarding them. I want to see what process some of those items have to go thru and where.

i have been trying to find this out also.
i googled "how does the government regulate tobacco pipes?" and variations of that and
found nothing of relevance.
i do remember those little pipe filters though.could be they were considered an accessory used in
the consumption of a tobacco product?
regards
mike

 

[Sirius]

Good old Dr Frieden has already demonstrated the CDC's complete lack of understanding on this topic courtesy of his recent news bite ready comments about cotton candy flavored e-cigs. I was really mad after seeing that and it did not fill me with hope. I'm vaping Smores right now.

Me either..I feel we are being ganged up on by the bureaucrats and kidstapo.

 

[Gato del Jugo]

To me it sounds like you are writing their great victory tale. From what I've gathered so far this all about money and they could care less about the consequences.

Sadly, this is what the FDA has become..


Still, if I could help put some doubt in the mind of at least one FDA employee about their choice of employer, then my goal will have been accomplished...

I say this because, and certainly not to dissuade anybody here, but I don't think even the most scientifically-backed comment submission will be worth a lick in the eyes of the FDA..

They already know their plan of exactly what they're going to do..


Their ears might just perk up in federal court, though...

 

[Gato del Jugo]

“If large numbers of adult smokers become users of both traditional cigarettes and e-cigarettes — rather than using e-cigarettes to quit cigarettes completely — the net public health effect could be quite negative,” said Dr. Tim McAfee, Director of the CDC’s Office on Smoking and Health.[/I]

www. drugfree .org/join-together/tobacco/one-fifth-of-adult-smokers-in-united-states-have-used-e-cigarettes-cdc

The reason why I was a dual-user of both traditional & e-cigs at first, is because the BT cigalikes I was using at the time were extremely inadequate..

If I had my ProVari & some decent juice right out of the gate, I probably would have quit smoking the very 1st day, instead of being a dual-user for 8 months...


I suspect the correlation between dual-use & cigalikes is quite high..

Which is exactly why those studies they use are bunk...