FDA announces new webpage for "new tobacco product" applications, would apply to e-cigs if "deemed" under Chapter IX

[Bill Godshall]

After cigarette and smokeless tobacco manufacturers submitted thousands of "substantial equivalence" reports and no "new tobacco product" applications, FDA announces new website for new product applications that falsely claims all tobacco products are "Responsible for severe health problems in both users and non-users, including cancer, lung disease, and heart disease, which often lead to death."
http://www.fda.gov/TobaccoProducts/Labeling/TobaccoProductReviewEvaluation/default.htm?

Please note that if FDA proposes and subsequently approves a "deeming" regulation to regulate e-cigarettes under Chapter IX regulatory provisions (as the agency has repeatedly stated its intent to do), e-cigarette manufacturers would need to obtain FDA's approval to market their products (as a "new tobacco product") unless they submitted "substantial equivalence" reports to the agency last year (which none did since they weren't required to so).

On a related matter, Lorillard submitted a citizen petition to FDA urging the agency to take action on "substantial equivalence" reports (as several thousand were submitted, but the agency has yet to take any action on them).
http://www.tobaccolawblog.com/2012/08/lorillard-pursues-fda-citizen-petition-to-obtain-approval-of-new-tobacco-products/

When the FDA takes action on the "substantial equivalence" reports, the agency will (on a case by case basis) either approve the products as "substantially equivalent" to another product that was on the market prior to Feb 15, 2007, or else the agency will determine that the products are "new tobacco products", which would BAN the product from the market until the manufacturer submits, and the agency approves, a "new tobacco product" application for the product.

 

[GIMike]

So I guess smoke machines at clubs and other places, as well as inhalers will have to be deemed as tobacco products too eh?

 

[Bill Godshall]

Smoke (er fog) machines at nightclubs and concerts do not meet the FSPTCA's definition of "tobacco manufacturer", and as such, are exempt from the FSPTCA.

 

[GIMike]

I know this is slightly off topic, and I'm not trying to thread steal, I promise, just a random quick thought. If all of us stopped smoking by a different means than this, would they fight it too? I mean, if we all bought video game systems, and found that this relieved our strees enough to where we didn't smoke, would they try to ban those too?

 

[TennDave]

The big problem is that what we use contains Nicotine!!!
Fog Machines at night clubs and video games do not... The big difference...AND, what we do looks like smoking, these other things do NOT.

 

[GIMike]

The big problem is that what we use contains Nicotine!!!
Fog Machines at night clubs and video games do not... The big difference...AND, what we do looks like smoking, these other things do NOT.

Looks shouldn't matter. If I hold a pen in my mouth at work, and somebody for some reason thinks I'm smoking, do they ban ink pens from use in the work place? As for the nicotine, they don't have to be used with nicotine. If I'm not mistaken, RYO cigarette tubes, machines, and papers aren't taxed like tobacco, and if you use anything else inside those aside from tobacco, you'll either get sick or you are breaking some anti-drug laws. Our devices can use 0 nic juices without any issues, so it's not really quite the same thing.

I do believe that someday, e-juices containing nicotine will be taxed, and if that was all that was taxed, and 0 nic juices and e-cig hardware was not, I'd probably be ok with that. I wouldn't be happy with it, but I could at least somewhat understand that, and that alone.

 

[DC2]

Looks shouldn't matter.

Nanny State.

 

[nerofiend]

6 Gallons of 100mg Nicotine (Check)
10 Gallons of VG (Check)
5+ Gallons of flavorings (Check)
Multiple Rebuildable Atty's (Check)
5 Pound Roll of Kanthal (Check)
Case of batteries (Check)

BEEPING the FDA/Pharma up the BEEP every single chance i get (Check)

I think we all know its coming down to this. Ill fight every step of the way but unless we somehow get some sort of multi million dollar backing from somewhere those scales of lady justice will always tip in the favor of those that have more gold.

 

[sandybeach]

After cigarette and smokeless tobacco manufacturers submitted thousands of "substantial equivalence" reports and no "new tobacco product" applications, FDA announces new website for new product applications that falsely claims all tobacco products are "Responsible for severe health problems in both users and non-users, including cancer, lung disease, and heart disease, which often lead to death."
http://www.fda.gov/TobaccoProducts/Labeling/TobaccoProductReviewEvaluation/default.htm?

Please note that if FDA proposes and subsequently approves a "deeming" regulation to regulate e-cigarettes under Chapter IX regulatory provisions (as the agency has repeatedly stated its intent to do), e-cigarette manufacturers would need to obtain FDA's approval to market their products (as a "new tobacco product") unless they submitted "substantial equivalence" reports to the agency last year (which none did since they weren't required to so).

On a related matter, Lorillard submitted a citizen petition to FDA urging the agency to take action on "substantial equivalence" reports (as several thousand were submitted, but the agency has yet to take any action on them).
http://www.tobaccolawblog.com/2012/08/lorillard-pursues-fda-citizen-petition-to-obtain-approval-of-new-tobacco-products/

When the FDA takes action on the "substantial equivalence" reports, the agency will (on a case by case basis) either approve the products as "substantially equivalent" to another product that was on the market prior to Feb 15, 2007, or else the agency will determine that the products are "new tobacco products", which would BAN the product from the market until the manufacturer submits, and the agency approves, a "new tobacco product" application for the product.

The Lorrilard petition should help us as an industry if it gets approval.

 

[RosaJ]

I agree with GIMike. I've vaped 0 nic non flavored vg with distilled water and like it. I can buy USB glycerin at CVS or any pharmacy that carries it, the same with distilled water. The regulating agencies would have an uproar from people who don't even vape if they try to regulate those ingredients.

You can buy food flavoring wherever they're sold, either stores or online. Again, there would be a lot of bakeries, and home bakers that would be affected. The tobacco flavored juice doesn't contain nicotine. Can't see how they could regulate those either.

As far as the batteries, how would they know what they're going to be used for? I can't see them regulating flash lights.

The tanks, attys, etc., can be used with or without nicotine. So the only thing they could regulate and tax is the actual nicotine base juice.

Can you imagine how many regulating departments/personnel the FDA would have to hire? They will not only get us with higher sales taxes, but also with higher income taxes to pay their salaries and retirement benefits. Do we really need that much government?

 

[Vocalek]

In a word, "No."

 

[Bill Godshall]

sandybeach wrote:

The Lorrilard petition should help us as an industry if it gets approval.

Not necessarily. Lorillard's petition seeks to get the FDA to take action on the several thousand "substantial equivalence" reports that cigarette and smokeless tobacco manufacturers submitted more than a year ago before the deadline occurred for submitting them.

If FDA endorses all of the "substantial equivalence" reports that were submitted (i.e. agreeing that all of those new cigarette and smokeless products are substantially equivalent to products on the market prior to 2/15/07), that might be good news for e-cigarette companies, but only if the FDA also extends that same 2007 deadline to 2012 or 2013 for e-cigarettes if/when the agency proposes/approves a "deeming" regulation to apply Chapter IX of the FSPTCA to e-cigarettes.

Since no e-cigarette companies submitted "substantial equivelance" reports to FDA before last year's deadline (because e-cig companies weren't required to do so), e-cigarettes wouldn't benefit from FDA endorsing all of the "substantial equivalence" reports that were submitted by cigarette and smokeless manufacturers.

Meanwhile, if the FDA rejects some/many/all of the several thousand "substantial equivalence" reports that were submitted by cigarette and smokeless companies, that would be very bad news for e-cigarettes if the FDA proposes/approves a deeming regulation for e-cigarettes and other unregulated tobacco products even if the FDA extended the 2007 deadline to 2012 or 2013 (as the FDA would then be unlikely to approve any "substantial equivalence" reports filed by e-cigarette companies in the future, which could effectively ban all new e-cigarette products from being introduced into the market.

 

[frosting]

*bangs against wall*


This just.... ticks me off so much. The FDA's ONLY concern should lie in the liquid, the nicotine that is involved but is a choice. To me personally.... making a stink over the devices just makes no sense. All in all.... I want off this planet.

 

[throatkick]

Ultimately, I am guessing, since the 510/808 type models were out in 2007, they are trying to restrict the devices so we can all return to those?

At this point I am not certain even they know what they are doing.

 

[TennDave]

Ultimately, I am guessing, since the 510/808 type models were out in 2007, they are trying to restrict the devices so we can all return to those?

At this point I am not certain even they know what they are doing.

I am certain that they don't.

 

[whynes]

Ultimately, I am guessing, since the 510/808 type models were out in 2007, they are trying to restrict the devices so we can all return to those?
At this point I am not certain even they know what they are doing.

I am certain that they don't.

Please don't mistake my next comment for trolling or flaming.

The FDA knows full well what they are doing. It is a HUGE mistake to think
they are stupid or that they don't know exactly what they are doing.

Implied in your two statements is an assumption that the FDA's goal is to
protect your health. It couldn't be further from the truth. Believing the
rhetoric of their public statements could turn out to be a deadly mistake
for you and/or thousands of other smokers and vapers.

The FDA already lost an appeal to outright ban e-cigs completely in 2010. Their
intentions are a matter of public record. Watch what they do, not what they say.
Actions speak so much louder than words. Now they are busily changing rules
and regulations, with the encouragement and cooperation of Congress, to get as
close to that original goal as possible. Of course it will all be "legal," by the time
they do it.


Consider this:

The fiscal solvency of MOST of the states in the USA depends desperately
on your continued use of combustable tobacco products. If they can't find
a way to take e-cigs away from you completely, they will make them as
expensive, taxable, and as ineffective as they can to compensate for any
lost revenue due to a rapid decline in sales of combustable tobacco products.

Most of the details that will prove that to you beyond a reasonable doubt are
readily available elsewhere on this forum, so I won't repeat it here.

HINT (I will summarize it): Both Big Pharma and Big Tobacco stand to lose
billions, and hence the states will lose billions in MSA and tax revenue,
if everyone switched from smoking to e-cigs tomorrow. (Google "tobacco
master settlement agreement" for info on MSA).

There are just way too many financial misdeeds and shenanagins that get
exposed to the light of public scrutiny if everyone is "allowed" to quit smoking
at the same time.

18 years ago it was Big Tobacco who was lying to you and profiting from your
nicotine addiction. Big Tobacco stopped lying to us a long time ago. In fact,
the FDA now exerts authority over Big Tobacco preventing them from
telling you the truth about reduced risk alternatives.

That doesn't make Big Tobacco angels, but now your own governments, at state
and federal levels, are the ones who are blatantly obscuring the truth--and purely
for the almighty buck. That puts them even further away from being angels than
Big Tobacco.

I promised to keep this a summary, and I'm probably already over that, so I'll
leave it to your own curiosity and investigative talents to figure out why Big
Pharma is the Devil incarnate in the whole story.

Follow the money.

'nuff said.

 

[Drew_]

Does this mean that they are going to go after devices? I can't go back to 510 stick batteries, probably end up smoking again. Very depressing...

 

[throatkick]

Please don't mistake my next comment for trolling or flaming.

The FDA knows full well what they are doing. It is a HUGE mistake to think
they are stupid or that they don't know exactly what they are doing.

Implied in your two statements is an assumption that the FDA's goal is to
protect your health. It couldn't be further from the truth. Believing the
rhetoric of their public statements could turn out to be a deadly mistake
for you and/or thousands of other smokers and vapers.

The FDA already lost an appeal to outright ban e-cigs completely in 2010. Their
intentions are a matter of public record. Watch what they do, not what they say.
Actions speak so much louder than words. Now they are busily changing rules
and regulations, with the encouragement and cooperation of Congress, to get as
close to that original goal as possible. Of course it will all be "legal," by the time
they do it.


Consider this:

The fiscal solvency of MOST of the states in the USA depends desperately
on your continued use of combustable tobacco products. If they can't find
a way to take e-cigs away from you completely, they will make them as
expensive, taxable, and as ineffective as they can to compensate for any
lost revenue due to a rapid decline in sales of combustable tobacco products.

Most of the details that will prove that to you beyond a reasonable doubt are
readily available elsewhere on this forum, so I won't repeat it here.

HINT (I will summarize it): Both Big Pharma and Big Tobacco stand to lose
billions, and hence the states will lose billions in MSA and tax revenue,
if everyone switched from smoking to e-cigs tomorrow. (Google "tobacco
master settlement agreement" for info on MSA).

There are just way too many financial misdeeds and shenanagins that get
exposed to the light of public scrutiny if everyone is "allowed" to quit smoking
at the same time.

18 years ago it was Big Tobacco who was lying to you and profiting from your
nicotine addiction. Big Tobacco stopped lying to us a long time ago. That doesn't
make them angels, but now your own governments, at state and federal levels,
are the ones who are obscuring the truth--and purely for the almighty buck. That
puts them even further away from being angels than Big Tobacco.

I promised to keep this a summary, and I'm probably already over that, so I'll
leave it to your own curiosity and investigative talents to figure out why Big
Pharma is the Devil incarnate in the whole story.

Follow the money.

'nuff said.

I sidestepped the background completely and my post was intended to convey the following: While they may try to tax/ban/heavily restrict the industry, I am hoping it will be very difficult to do so because the cat is out of the bag. Do you think anyone here would go back to a 510/808?

 

[whynes]

Do you think anyone here would go back to a 510/808?

I'm sure there would be a variety of answers depending on the
individual.

My guess is that some would go back to 510/808. Some would go
back to smoking. Some would switch to NRT. All three of these first
options will keep the extorted money flowing.

Then some would tough it out and stay quits. Some would figure
out how to DIY everything at home, and/or source some things
from overseas; whether legally or not. It's anyone's guess what
those percentages would be statistically.

Any who thinks the FDA would act differently, "if only they
knew how far e-cig technology had come since 2007",
should re-read the opener of my last post on this thread.

The FDA knows full well what they are doing. It is a HUGE mistake to think
they are stupid or that they don't know exactly what they are doing.

The real tragedy then becomes existing smokers who would,
either rightly or wrongly, see e-cigs as either ineffective, or
more expensive than smoking, and never give them a try.

We, at least, know the truth of what the FDA is trying to keep
from everyone.