Beat me silly, @jackincali, I read wrong. That schedule is for medical devices, which it seems nobody is proposing that e-cigs are. And if Tom reads right, the equipment isn't going to be regulated - even as a tobacco product. But some other posted mentioned that rolling papers will be regulated - how is that possible if the "accessories" are except per his quote?
FDA FDA deeming regulation proposals
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Answer: if it's a tobacco product or a product that can be tangentially associated with tobacco. Look at how many years they've been putting "NOT A SAFE ALTERNATIVE TO CIGARETTES" on smokeless tobacco containers, when there are literally reams upon reams of scientific evidence attesting to the fact that smokeless tobacco is 99% safer than smoking cigarettes.
We still have a regrettable streak of puritanism that runs through our society, that prevents our leaders and institutions from wrapping their heads around the concept of harm reduction, and hundreds of thousands of people die needlessly every year (not just from smoking) because of it.
Which is one of the reasons why I think the ECF survey results are going to be submitted by whichever vaping group initiated it.. Seems like the FDA is begging for data so they can make better decisions about this...
I read the entire proposal (unfortunately a lot of the cigar/cigarillo, hookah/shisha & dissolvables stuff gets in the way of vape stuff).. Anyway, sounds like the FDA is open to the possibility that (surprise surprise!) vaping might actually be a good thing if it gets people off tobacco..
From page 23:
Emerging technologies such as the e-cigarette may have the potential to reduce the death and disease toll from overall tobacco product use depending on who uses the products and how they are used. If such products result in minimal initiation by children and adolescents while significant numbers of smokers quit, then there is a potential for the net impact at the population level to be positive.
Dimitri and Dr Gilbert Ross on the New Regs. A good perspective for those claiming victory today.
https://www.youtube.com/watch?v=InSCNdJKa0I
https://www.youtube.com/watch?v=InSCNdJKa0I
Only issue with that, per the Q&A of the teleconference, is that there is no real substantial equivalence regarding e-cigs..
Which makes things even messier...
I get the feeling that the FDA already knows this isn't an easy one.. and as such, will probably tread lightly -- for now
I'd rather they pretty much .... out, but that's not going to happen..
Still standing by my prediction that pre-filled cartridges & bottles of liquid, both containing nic, will bear the brunt of this..
Meaning, higher costs to be passed down to the consumer, and less time for the small-biz vape industry to focus on the business itself & on innovation.. This might also give BT some more time to try to catch up, since they're already used to this & already have systems/procedures in place to handle regulatory matters...
These arguments drive me up the wall every time I see them. Talk about some bass-ackwards public health rationale.
Any reasonable person should be celebrating the fact that as teen e-cig usage has gone up, teen smoking has gone down at an inversely proportional rate. Obviously, correlation does not necessarily equal causation, but this is one case where it's hard to argue otherwise. Young kids like to experiment with nicotine. We know this. It's not going to change. And ever-increasing numbers of them are choosing to do their experimenting with devices that won't effectively sentence them to a lifetime of smoking addiction and possibly a painful, agonizing, premature smoking-related death.
We should be celebrating this as a great public health achievement, because it is. More and more of our kids are listening when we tell them not to smoke. And if some of them go beyond experimentation and wind up habituated to the use of e-cigs, so what? Nobody bats an eye at the fact that millions of adolescents are dependent on massive doses of caffeine every day. As a parent, that actually concerns me a lot more than a moderate intake of nicotine through a vaping device.
If a kid is habituated to using only an e-cig (in which case there's very little chance he or she is vaping tobacco flavors to begin with) and tries to smoke a regular cigarette for the first time, what do you think is going to happen? They're probably going to turn green and puke their guts out. If e-cigs didn't exist or were totally inaccessible to young people, almost every one of these kids, experimenters and regular vapers alike, would wind up smoking cigarettes every day for a good portion, and quite possibly the entirety, of their adult lives. I am in favor of any mechanism that prevents that.
Some information regarding what is required is in the linked document from the FDA around page 176.... For example:
"Description of Respondents: The respondents to this collection of information are
manufacturers who are responsible for creating and submitting new tobacco product premarket
applications and who wish to obtain an FDA order to allow them to market their product."
"The draft guidance "Applications for Premarket Review of New Tobacco Products"
explains the requirements and provides recommendations for the contents of an application for
premarket review of a new tobacco product. Contents include a cover letter; an executive
summary; full reports of all investigations of health risks; a full statement of all components,
ingredients, additives, and properties, and of the principle or principles of operation of such
tobacco product; a full description of methods of manufacturing and processing; a listing of all
manufacturing, packaging, and control sites for the product; an explanation of how the product
complies with applicable tobacco product standards; samples and components; and proposed
labeling. If an applicant does not submit information on any of the previously mentioned items,
the application should include a statement indicating which information is not being submitted
and an explanation of why the information is not being submitted."
Check out bottom of pg 177.... and top of 178 plus the tables and the estimation of time for preparation....
https://s3.amazonaws.com/public-inspection.federalregister.gov/2014-09491.pdf
"Description of Respondents: The respondents to this collection of information are
manufacturers who are responsible for creating and submitting new tobacco product premarket
applications and who wish to obtain an FDA order to allow them to market their product."
"The draft guidance "Applications for Premarket Review of New Tobacco Products"
explains the requirements and provides recommendations for the contents of an application for
premarket review of a new tobacco product. Contents include a cover letter; an executive
summary; full reports of all investigations of health risks; a full statement of all components,
ingredients, additives, and properties, and of the principle or principles of operation of such
tobacco product; a full description of methods of manufacturing and processing; a listing of all
manufacturing, packaging, and control sites for the product; an explanation of how the product
complies with applicable tobacco product standards; samples and components; and proposed
labeling. If an applicant does not submit information on any of the previously mentioned items,
the application should include a statement indicating which information is not being submitted
and an explanation of why the information is not being submitted."
Check out bottom of pg 177.... and top of 178 plus the tables and the estimation of time for preparation....
https://s3.amazonaws.com/public-inspection.federalregister.gov/2014-09491.pdf
YES YES YES YES YES YES YES YES YES YES YES YES YES YES YES!!!!!!!!
As a parent, as someone who started smoking at the age of 13, and as a 43 year smoker, I agree with Nate 100000%
I do not agree with the superficial approach to banning sales to minors. This whole concept reeks of unintended consequences, but, it sure sounds good on the surface and makes the proponents feel good about themselves.
Age restrictions do not work. Never have, and never will.
Every smoker out there who started when they were <18, ought to be raising these very same reservations about minor bans.
Back to topic...
My eyes are bleeding. 8-o
I'll translate for everyone:
1.) Few manufacturers will have the stomach or deep enough pockets to jump through these hoops.
2.) Big Tobacco buys out these manufacturers that are on death's door (for a song).
3.) Big Tobacco wins. We are now vaping for twice as much as it cost us to smoke.
Great vid..
Agree with most of what he said.. though I still think the fear of non-nic-containing vape hardware being regulated is overblown..
Of course, that doesn't mean that we -- and especially the vape hardware companies -- just roll over during the next 75 days...
And I hope the smaller vape companies can withstand the temptation of getting gobbled up by BT.. and instead band up among themselves over the coming years, when the need arises...
All of these vendors "welcoming regulation" must have pretty deep pockets?? The way I see it, as of now, there are a very few companies who will be able to get some of their products approved. This is a very complicated process as it stands now.
Never stopped anybody...
But I do agree--FWIW
BTW, my kids graduated high school 3 and 1 years ago, respectively. Their vaping friends were all beginning smokers who tried to switch or quit. Smoking in California is a PITA.
1. I disagree it's fear mongering. informing people makes sense, but u can interpret how u wish.
2. They are setting up for bigger and better things without the fear of losing in court.
3. Yes I'll be allowed to Vape for 2 more years, the. Vape what BT sells, that's my thought I hope your right but I can't bank on your thought.
Don't confuse fear with motivation.
The fees for ecig etc applications haven't been introduced yet but will be by the FDA, watch for it. This we will have to wait on according to the conference call earlier.
I just signed, when i get home from work will be having all of my freinds and family sign it as well.
Watch the Dimitri & Dr. Gilbert Ross video above.. We have more than 2 years.. Probably more like 3-4, minimum...
But yeah, that's been my thought, too.. that they're setting up for "bigger & better" things down the road..
Gotta boil us froggies slowly so we don't jump out...
Hey, we've known it was on the horizon for a while now..
At the very least, fight for the future vapers.. They deserve the same opportunity that we've enjoyed so far...
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