FDA FDA deeming regulation proposals

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Bob Chill

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The proposed regulations will wipe out all the small e-liquid manufacturers. The rules requiring chemical analysis of each new product will be prohibitively expensive. Only large producers will be able to meet the technical requirements. B&M stores will only be able to sell larger manufacturer liquids meeting the regulations while consumers will be able to mix their own at home. All B&M's will be driven into extinction.

The little guys don't really manufacture anything other than mixing already readily available ingredients that are all approved by the FDA for the most part except for nic base. Glass half full would think that if the FDA approves nic base from the large suppliers and the rest is already readily available for anyone to purchase then it could be inferred that circumventing the entire testing/approval process is "possible".

Glass half empty could easily mean it isn't worth trying to get anything with nic in it approved because it's simply not worth it. But there is still the loophole of simply selling concentrated flavors with no nic. Anybody can do that. Let the consumers buy their own "approved" flavorless nic and mix the 2. I see a lot of loopholes here. There are many imperfect solutions but viable ones. I think the FDA see what they are up against. And it all comes down to the nic. If they really really want to nail us to the wall, simply ban bottled nic juice and require it to be in a sealed and prefilled single use unit.
 

Jman8

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Yep, I mostly to totally disagree with many posts on this thread.

SE arguments that amount to defacto bans and all refusals on applications are supposition at best, and fear mongering, most likely.

As I read the same document, I see FDA providing an avenue. I acknowledge they could delay on this and play games with vendors (especially newer ones), but to go in direction of all products will be removed from the market is I think unfounded and troublesome rhetoric. So much so, that I am willing to wager with anyone in vaping community who believes, because of this version of FDA proposed regulations, the industry will be decimated. Some of you all saying in 2 years. Heck, I'll go with 3 years to be generous to what you're getting at. My side of the wager is that 3 years from now the business will be double in gross revenue than what it is today. The other side is seemingly claiming it'll be very low to non-existent. For the wager to make sense, given the sort of rhetoric that is being allowed, I say that as soon as the comment period ends, so does the window to making this sort of bet.

If things remain about the same, I'd win the wager. But I'm at least 50/50 on the idea that gross revenues could double, maybe even triple in that time frame.

I'm thinking no one will take me up on this wager and will still feel comfortable espousing doomsday scenarios.
 

scartn

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As for as internet sales go just look for the only legal places to buy cigarettes online. I think there is already laws on this. With this thing lumping everything in with cigarettes look for the same rules to apply.


Unflavored nic. can be labeled as pesticides not for human consumption. Flavors sold for baking.

Devices can be sold as flashlights with interchangeable heads (to allow for 510 connector) even with vv or vw.
 

nomore stinkies

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Here ias an excerpt from the Federal Register. OMG. They should categorize them as a cessation aide otherwise we will get slammed with taxes and still be called smokers. Get off the kid stuff and nicotine addiction. Twinkies and caffeine are addictive for crying out loud. These got me off the combustibles that they hated so much. Just stop it already. I like fruit and candy too.....ARG


In addition, FDA realizes that there are distinctions in the hazards presented by various
nicotine-delivering products. Some have advanced views that certain new tobacco products that are noncombustible (such as e-cigarettes) may be less hazardous than combustible products given the carcinogens in smoke and the dangers of secondhand smoke from combustible products. Accordingly, FDA is seeking comment in this proposed rule as to how e-cigarettes should be regulated based on the continuum of nicotine-delivering products. We welcome comment on how to implement the provisions in the FD&C Act with respect to e-cigarettes. We also welcome any health and behavioral data about the effects of using e-cigarettes.
Also as noted in this document, some have advanced views that certain new tobacco products that are noncombustible (such as e-cigarettes) may be less hazardous, at least in certain respects, than combustible products given the carcinogens in smoke and the dangers of secondhand smoke. FDA also notes the increase in e-cigarette use by youth and the availability of fruit and candy-flavored e-cigarette liquid. We do not currently have sufficient data about these products to determine what effects e-cigarettes have on the public health. Accordingly, FDA is seeking comment in this proposed rule as to how such products should be regulated. We particularly request comment on behavioral data related to co-use of e-cigarettes and more traditional tobacco products, including data on the effects of e-cigarettes on the initiation and continuation of use of other tobacco products.
4. FDA is proposing to deem those products meeting the definition of "tobacco product" in section 201(rr) of the FD&C Act, except the accessories of proposed deemed tobacco products to be subject to chapter IX of the FD&C Act. FDA is seeking comment on how its proposal to exclude accessories from the scope of the deeming rule would impact the public health.
8. Some have advanced views that certain new tobacco products that are non-combustible (such as e-cigarettes) may be less hazardous, at least in certain respects, than combustible products given the carcinogens in smoke and the dangers of secondhand smoke. Nevertheless, all tobacco products containing nicotine are addictive, and FDA is not currently aware of any tobacco products that do not contain nicotine. Thus, FDA is seeking comments, including supporting research, facts, and other evidence, as to whether all tobacco products should be required to carry an addiction warning and, if yes, whether different warnings should be placed on different categories of products.
 

Talyon

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Yep, I mostly to totally disagree with many posts on this thread.

SE arguments that amount to defacto bans and all refusals on applications are supposition at best, and fear mongering, most likely.

As I read the same document, I see FDA providing an avenue. I acknowledge they could delay on this and play games with vendors (especially newer ones), but to go in direction of all products will be removed from the market is I think unfounded and troublesome rhetoric. So much so, that I am willing to wager with anyone in vaping community who believes, because of this version of FDA proposed regulations, the industry will be decimated. Some of you all saying in 2 years. Heck, I'll go with 3 years to be generous to what you're getting at. My side of the wager is that 3 years from now the business will be double in gross revenue than what it is today. The other side is seemingly claiming it'll be very low to non-existent. For the wager to make sense, given the sort of rhetoric that is being allowed, I say that as soon as the comment period ends, so does the window to making this sort of bet.

If things remain about the same, I'd win the wager. But I'm at least 50/50 on the idea that gross revenues could double, maybe even triple in that time frame.

I'm thinking no one will take me up on this wager and will still feel comfortable espousing doomsday scenarios.

1. People mentoring defaco bans etc here or in many other posts is not fear mongering but simply letting people know of the possibility not probability, no harm in having knowledge.
2. The way the rules are written can be interpreted as all current PV's etc will or could be banned pending FDA approval, which for a fact doesn't look good, again not fear mongering but simply making people aware they need to be on this NOW, I won't wait.
3. This wager is silly, and I don't care who wins, as long as I'm allowed to legally Vape.

These are my opinions only. The choice is simple sit and wait by doing nothing, or get up and stand against these deeming rules, what have we got to lose? Another life choice. I choose to fight, not sit as I don't trust these regulations as they stand.
 

ClintS

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I'm new to vaping but here is what I see -

Tobacco is the subject that has provided the FDA a means to regulate smoking and its products as a "known public health hazard.". Which in turns provides state and local governments federal regulations as justification to ban or control tobacco products and usage as they see fit.

In all cases the only real link between vaping and tobacco products is nicotine, a byproduct of tobacco; that allows the government to define anything using nicotine as a tobacco product and regulated accordingly.

Without nicotine how would the federal government or others relate personal vaping gear or liquids to tobacco usage laws???? Vaping with nicotine has allowed the FDA the ease of proposing such regulations and if the FDA regulates e-cigs in the described manner proposed, they open the doors for lot of other things that some apparently do not see.

Is nicotine vital to the vaping community? Without nicotine could the FDAs proposed regulations stand?
 

badwolf91

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they cannot take the current models that we already own away... they can just not let them be sold going forward. If the suppliers are actually able to easily register their product with no hastle this could be okay.. but I doubt they will make it easy. logic is beat out by money. it seems the regulations they are imposing are not actually concerning safety at all. they should study inhaling of flavors maybe that's about it. hopefully in this time we have to dispute we can get some good arguments on the table
 

Gato del Jugo

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I'm only about a quarter of the way through with the proposals..


But is it just me, or does it seem like the FDA sort of has no clue to what vaping is like at this point, and how advanced it's become..

They keep talking about pre-filled cartridges (assuming for cigalikes), like it's still 2009 or something...


I've yet to see any real mention of APVs, various toppers, even bottled e-liquid...
 

Dj Xy

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What I have read is not good for us or the industry as a whole, liquids as well as devices will fall under FDA's control, and there will be a lengthy, expensive application process to get approval for ANY product not on the market prior to February 2007.
This means 99.9% of what we currently use is affected by this, and if a vendor can afford to apply for approval of a liquid or device there application can be rejected for any reason that the FDA feels, almost all of your small vendors, and most of your medium vendors will not be able to get approval, this huge influx of devices and liquids we see now will be non existent, the FDA does not have the man power to approve everything we enjoy now in the 2 years till everything really kicks in, not to mention any new liquids and devices that aren't even out yet.
And this affects EVERY vaper and vendor, everyone needs to get involved or everything the vaping community has fought for will have been in vain.
 

Jman8

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1. People mentoring defaco bans etc here or in many other posts is not fear mongering but simply letting people know of the possibility not probability, no harm in having knowledge.
2. The way the rules are written can be interpreted as all current PV's etc will or could be banned pending FDA approval, which for a fact doesn't look good, again not fear mongering but simply making people aware they need to be on this NOW, I won't wait.
3. This wager is silly, and I don't care who wins, as long as I'm allowed to legally Vape.

These are my opinions only. The choice is simple sit and wait by doing nothing, or get up and stand against these deeming rules, what have we got to lose? Another life choice. I choose to fight, not sit as I don't trust these regulations as they stand.

1. Agree that there is no harm in having knowledge. But if basing logic of defacto ban on supposition, then it is fear mongering. Here is some info from FDA proposal that deals with the 'knowledge' and 'probability' going forward for what many seem to be prattling on about (here on day 1).

FDA does not intend to initiate enforcement action against products on the market for failing to have an FDA marketing authorization until 24 months following the effective date of the final rule. In addition, as described in section VIII.A.6.c, we intend to continue that compliance policy pending review of marketing applications if those applications are submitted within the 24 months after the final rule's effective date. We intend to work with industry to assist them in making submissions. We expect that our proposed approach, as discussed in this section, would help minimize disruption while FDA conducts its pre-market review. Further, we request comment on whether there are ways that we might provide additional flexibility with respect to PMTAs that would still be appropriately protective of the public health.

*Bold emphasis mine.

2. I think the reason people are engaged in fear mongering is two fold. One to rally the troops (and eh, who cares if we aren't being completely honest with the troops. They need fear of ban to get them going.) and two, because of FDA track record.

But I see FDA bending over backwards in this report to work with industry as cited above and if desired, I'm glad to post more from the proposal that backs up where I stand on all this. That was one excerpt among several that make it clear FDA is not going the heavy handed route in this. eCigs are new, and they get this. They also are charged with public health, at least on the surface of things, and so they are doing a huge CYA with this application process. But, if they wanted to play hard ball with industry, things would be worded differently and thus the supposition would be easier to float out there without the likes of someone like me being able to call that out.

3. You are going to be allowed to vape. I'll concede that we are in a new 'wait and see' game, but this one is, IMO, far different than the one leading up to today. And this one tells me, based on this report, and based on 'genie out of the bottle' and based on very basic trust in 'way world works' that vaping will be legal, and it won't be only BT that is making a profit.

Yet, there are others who are engaged in fear mongering. Some who I respect, even admire. And so the 'wait and see' is about best we can reasonably hope for, but my wager is, at least a little bit, rhetorical as I'm willing to go on record and say that despite FDA proposed regulations, which we now are fairly well aware of, the eCig industry will double or triple its gross revenue from 2014 in next 3 to 5 years. I'm at least 60% confident on that. I'm around 90% confident it'll be about the same or better. And 99.9% confident that the eCig industry will not be decimated. Those who conclude otherwise, IMO, are engaged in fear mongering.

I'd also just add that in my worldview, and what makes me as confident as I am in above scenarios, is that 'way world works' is there won't be people sitting around doing nothing. I see that as impossible. Fear need not be brought in to get people to do something. Reality of local/state and other country politics on eCigs will be motivation enough, plus I see the opposition working against eCigs for as long as I'm alive and probably for 1000 years after that. Vapers, with history of smoking rights being decimated, are likely to stay motivated for at least next 50 years when it comes to politics of eCigs.
 

ClintS

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In effect the FDA proposal classifies e-cigs right along with a known public health hazard (tobacco) and by association e-cigs would be a "known public health hazard." This carries many unwritten consequences. And there are some confusing statements (at least to me) in the proposal as posted earlier

Further down the proposal FDA states:
"Section 201(rr) of the FD&C Act (21 U.S.C. 321(rr)), as amended by the Tobacco Control Act, defines the term "tobacco product" to mean "any product made or derived from tobacco that is intended for human consumption, including any component, part, or accessory of a tobacco product (except for raw materials other than tobacco used in manufacturing a component, part, or accessory of a tobacco product).""

What got my concern was two parts, (1) what makes the e-cig viable as a tobacco product (the answer is nicotine) and (2) the " or accessory of a tobacco product" - What are the accessories?

A quick internet search turned up this list of items from various sections of the FDAs web site - tobacco accessories, defined in the Tobacco Act as a product that may be used in the consumption of a tobacco product, includes; pipes, cigarette holders, cigar clips, lighters, matches, bidi, kretek, cigarette papers, tubes and filters.

Considering the intent of the current tobacco laws, implication that e-cigs fall in the same category, and list of accessory items above - I can easily see e-cig accessories being defined to include; any item used to hold and provide e-liquids to the e-cig for consumption (atomizers and tanks of all kinds), mods used to power the consumption, and the liquids.

I think we should be very, very concerned. Posting about after the fact law suits, work arounds, DIY means - is all unnecessary if we can turn the FDA proposal.
 
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