FDA FDA deeming regulation proposals

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Jman8

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I just do not understand all the typing and the attempt minimize this.

Glad to explain all the typing, as may be desired.

I'm minimizing the FDA regulatory proposal in lieu of this vendor, because, as I stated in the previous post, the state issues are significantly larger right now.
 

aikanae1

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RTS is expanding (double or triple present size). The reason for no re-open date is they have to get permits.

Government doesn't really like small business. It's easier to keep track of a large corporation than a single person paying 5-10 people.

I didn't mean to imply otherwise with RTS. I kinda put them in the ring of "I WILL SURVIVE, GD IT!" which is sort of a hats off to them.

I guess it's a sport of mine to make predictions. I'm probably guessing at who wlll win / loose and how that could be changed. It's not very practical for this discussion. So never mind.

I think the wisest move small shops could do right now would be to form a cooperative, but I don't see that happening for a variety of reasons.
 
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Jman8

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This is NOT something the public was clammoring for - not until the FDA lies made headlines. I don't think the public wrote those scary "kids" emails that were floating around to parents sent out by schools. They actually said that vaping liquid nicotine was like "free-basing" and I'd love to figure out who to point the finger at for that nonsense. This is clearly a top->down effort.

Somewhat agree, but as I stated in previous post, I see it as all-around effort. You said FDA/CDC. I'd add ALA and ACS as specific entities. Then BP, ANTZ, state governments as general entities.

And for me, personally, it is interesting you cite CDC. I think we all agree they have lied / exercised deception when it comes to harms of vapor. Yet, if I ask people why not fight for smoking/smoker rights, CDC is one agency that is routinely cited as if their data on smoking must be entirely accurate. Same goes with all these entities. Smoking allegedly kills 400K annually. But who says this? I would submit it is mostly the same people going after eCigs, and citing data we all scrutinize and determine as lies. Group that Greg C. is with disputes the 400K number, as do I, and countless others.

For me, it is an all-around issue cause overwhelming majority of people, including vast majority of vapers, have bought into lies that smoking kills, that it deserves shaming, hopefully banning, and that if this new nicotine product called vaping is seeking to do same thing smoking did, then 'we the people' must stop it/slow it down right now.

This is not an 'us vs. them' issue, but us vs. ourselves issue. To the degree that doesn't make sense, doesn't seem pertinent to discussion in this thread, then just realize that States right now are winning in ways that FDA has yet to do literally anything about.

And as I said before, because FDA is at least opening up door for science to have a place, they are possible national platform that could be where tide turns. Not because of them, but because of what they proposed and how they chose to word that proposal.
 

Sirius

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RTS is expanding (double or triple present size). The reason for no re-open date is they have to get permits.

Government doesn't really like small business. It's easier to keep track of a large corporation than a single person paying 5-10 people.
Isn't it ironic that China's economy is growing and ours (the US) is not? A communist country gone capitalist and a capitalist country doing all it can to become socialist! People had better wise the hell up is all I'm saying.
 

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Sirius

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Somewhat agree, but as I stated in previous post, I see it as all-around effort. You said FDA/CDC. I'd add ALA and ACS as specific entities. Then BP, ANTZ, state governments as general entities.

And for me, personally, it is interesting you cite CDC. I think we all agree they have lied / exercised deception when it comes to harms of vapor. Yet, if I ask people why not fight for smoking/smoker rights, CDC is one agency that is routinely cited as if their data on smoking must be entirely accurate. Same goes with all these entities. Smoking allegedly kills 400K annually. But who says this? I would submit it is mostly the same people going after eCigs, and citing data we all scrutinize and determine as lies. Group that Greg C. is with disputes the 400K number, as do I, and countless others.

For me, it is an all-around issue cause overwhelming majority of people, including vast majority of vapers, have bought into lies that smoking kills, that it deserves shaming, hopefully banning, and that if this new nicotine product called vaping is seeking to do same thing smoking did, then 'we the people' must stop it/slow it down right now.

This is not an 'us vs. them' issue, but us vs. ourselves issue. To the degree that doesn't make sense, doesn't seem pertinent to discussion in this thread, then just realize that States right now are winning in ways that FDA has yet to do literally anything about.

And as I said before, because FDA is at least opening up door for science to have a place, they are possible national platform that could be where tide turns. Not because of them, but because of what they proposed and how they chose to word that proposal.

You can add these folks to your list as they are no friends of the vaping industry.
Stop Smoking - American Lung Association
 

aikanae1

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Somewhat agree, but as I stated in previous post, I see it as all-around effort. You said FDA/CDC. I'd add ALA and ACS as specific entities. Then BP, ANTZ, state governments as general entities.

And for me, personally, it is interesting you cite CDC. I think we all agree they have lied / exercised deception when it comes to harms of vapor. Yet, if I ask people why not fight for smoking/smoker rights, CDC is one agency that is routinely cited as if their data on smoking must be entirely accurate. Same goes with all these entities. Smoking allegedly kills 400K annually. But who says this? I would submit it is mostly the same people going after eCigs, and citing data we all scrutinize and determine as lies. Group that Greg C. is with disputes the 400K number, as do I, and countless others.

For me, it is an all-around issue cause overwhelming majority of people, including vast majority of vapers, have bought into lies that smoking kills, that it deserves shaming, hopefully banning, and that if this new nicotine product called vaping is seeking to do same thing smoking did, then 'we the people' must stop it/slow it down right now.

This is not an 'us vs. them' issue, but us vs. ourselves issue. To the degree that doesn't make sense, doesn't seem pertinent to discussion in this thread, then just realize that States right now are winning in ways that FDA has yet to do literally anything about.

And as I said before, because FDA is at least opening up door for science to have a place, they are possible national platform that could be where tide turns. Not because of them, but because of what they proposed and how they chose to word that proposal.

A quick comment, I am not seperating out all those other organization from the FDA/CDC. In this case, they are one and the same often because they are acting on grants from FDA/CDC authorizes among other connected funding sources. I tend to have the view that it's ridiculous for gov't to fund lobbying groups to lobby themselves (gov't) which is what they are doing.

I also think FDA/CDC are puppets on strings. The controlers are corporations who have both more money and power than the gov't does. In economic terms, it is assumed they are too big to fail, even if the bulk of their business (in this case) is overseas - they are not "job creators" and they are tax dodgers = the real welfare queens. However it is the way it is. Now how are we going to deal with it.

Taking the idealistic puritanical stance probably won't get very far. The fastest path from point A to E is to work within their own framework and hopefully turn it against them. Use studies they already approve, etc. The path of least resistance, choose your battles wisely, look for the blind spots, follow the fear, and all this is hypothetical anyway = meaningless. It's not an arguement we need right now. I apologize for getting into this.

I gotta run.

I still say a good counter measure is to ban cigalike that have the risk of renormalizing smoking for children. I don't expect that to go far, but I would expect a reaction that might be revealing to the public.
 
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Sirius

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What's the chance we could get Leo Dicaprio to go in front of congress and get them all to understand e-liquid is not tobacco. After all, they seem to respect actors and actresses opinion even before scientist..lol

tumblr_inline_n1d1fmfDDW1rj0dkd.jpg
 

Talyon

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What's the chance we could get Leo Dicaprio to go in front of congress and get them all to understand e-liquid is not tobacco. After all, they seem to respect actors and actresses opinion even before scientist..lol

tumblr_inline_n1d1fmfDDW1rj0dkd.jpg

In my head there is a place known as the imagination, I'm thinking this is where u speak from. Lol

Unlike the FDA who speaks out of a lower body part.
 

Danoman

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Agreed -- Most of the states may be looking to the FDA to regulate before proposing taxation. If that is the case they my even follow Ohio's lead and put an enormous tax on anything vape related. Look at the cost of cigarettes and how it varies from state to state and you will see what I'm talking about. Like here in Ga. cigs are around $40 a carton and in NY and NJ I think around $100 a carton.
I've never seen any state miss an opportunity to tax anything that is regulated.

I completely agree and remember when that happened. My pack of cigarettes jumped from $1.85 to well over $4.00. All that cost of regulation has to be covered by the consumer. If I sold a bottle of whatever flavor of e-juice for $15, under these type of taxation thoughts and then the regulations being imposed to get that flavor FDA approved, that very same bottle suddenly would jump to prolly well over $60, easily when all was said and done. WE the consumer would be paying for it and I guarantee, it'll be more expensive to vape than to go back to an analog cigarette, effectively destroying the vaping community in one single hit. (on top of everything else included and that's even IF the availability of the nicotine base was available to those that are making the e-juice) For instance, that gallon of unflavored nicotine just cost me about $380. It TOO would go up to i'm sure at least double or triple that because the company that made that nicotine would have to be approved by the FDA as well, and they would need to see a profit margin that was high enough to continue producing the nicotine base so, the rest of it all falls apart at this stage. We can steep our raw tobacco in PG but then, it still wouldn't be much better than smoking an actual analog cigarette in the first place so, why even do it in the first place and just walk out of the game before there is nothing left to walk from.

Oh, and remember when Obama went to Congress to add an additional tax to cigarettes, even though, he himself was a smoker...? These people don't understand what the middle class of society has to endure, THEY can afford it, the milled class and below can't so, it's a form of control imposed on the people and it trickles down from there. Remember, He and the elites are EXEMPT from Obamacare... I believe this says a lot about our government and what it will to do.
 
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Kent C

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And as I said before, because FDA is at least opening up door for science to have a place, they are possible national platform that could be where tide turns. Not because of them, but because of what they proposed and how they chose to word that proposal.

I don't understand what you mean by the bold part. The only place I see where the FDA is "asking" for scientific studies is in the required applications that manufacturers and importers/vendors would have to either conduct and present (quite costly) or refer to studies already made from other sources.

Also in the deeming doc: pg 177

"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."

And this is stated, not as a mere plea for comments and questions, or what the FDA intends to do,

"FDA intends to enforce the premarket
authorization requirements with respect to
the product"

... but what the FDA is required to do by law:

pgs 177-178
FDA is required to deny a PMTA and issue an
order that the product may not be introduced or delivered for introduction into interstate
commerce under section 910(c)(1)(A)(ii) of the FD&C Act if FDA finds that:
• The manufacturer has not shown that the product is appropriate for the protection of the
public health,
• the manufacturing methods, facilities, or controls do not conform to manufacturing
regulations issued under section 906(e) of the FD&C Act,
• the proposed labeling is false or misleading, or
• the manufacturer has not shown that the product complies with any tobacco product
standard in effect under section 907 of the FD&C Act.

This means that the manufacturer will have to show the product is appropriate for the protection of the
public health. How would one think that they do that? Just some 'reassurances' or some scientific studies - at their cost.

This isn't 'opening the door to science', it's shutting it for those who can't afford the key to the door.
 
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twgbonehead

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Thnx Thunder. I know most Dems are not Fox fans and Gutfield can really be annoying but I appreciate you watching. ;)
Sirius,

As a liberal, I've had many occasions to dislike FOX. I think it's very telling that I am now defending and applauding them. The e-cig issues have definitely turned me against the Democrats. (Still a liberal, though; I suspect that's incurable for me).
 

Sirius

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Sirius,

As a liberal, I've had many occasions to dislike FOX. I think it's very telling that I am now defending and applauding them. The e-cig issues have definitely turned me against the Democrats. (Still a liberal, though; I suspect that's incurable for me).

I heah ya Twgbonehead..well it seems liberals, conservatives, and of course us libertarians see the government as being self serving and not doing what they were elected to do. Serve the people of the United States. This FDA thing is just the latest intrusion of government into our lives.
 

Danoman

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I heah ya Twgbonehead..well it seems liberals, conservatives, and of course us libertarians see the government as being self serving and not doing what they were elected to do. Serve the people of the United States. This FDA thing is just the latest intrusion of government into our lives.

And, THAT is the absolute truth...!!! It's not at all about Dem or Rep or other anymore... to the elites, it's about control and power.
 

aikanae1

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And, THAT is the absolute truth...!!! It's not at all about Dem or Rep or other anymore... to the elites, it's about control and power.

Whoopeeeee! I've been saying this for a decade now. You wouldn't believe how many conversations I've had with Tea Partiers, conservatives on issues that we are 100% in agreement on - and I'm a "progressive". IMO the worst nightmare possible is that all of us remember that WE are not the enemy. I can guarentee you Wash. DC is terrified that we will figure this out.
 

EddardinWinter

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Sirius,

As a liberal, I've had many occasions to dislike FOX. I think it's very telling that I am now defending and applauding them. The e-cig issues have definitely turned me against the Democrats. (Still a liberal, though; I suspect that's incurable for me).

Are you a classic liberal, or a more Statist liberal? Liberty used to be the root of a liberal. Personal freedoms should be something we all agree on.

I think both political parties suck, BTW.



Roaring thunderously via Tapatalk...
 
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Danoman

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Whoopeeeee! I've been saying this for a decade now. You wouldn't believe how many conversations I've had with Tea Partiers, conservatives on issues that we are 100% in agreement on - and I'm a "progressive". IMO the worst nightmare possible is that all of us remember that WE are not the enemy. I can guarentee you Wash. DC is terrified that we will figure this out.

Again, we agree.

We just thinking about something... I listen to a lot of AM radio. This might also be another source to get the information out is a massive way. It might just also give us a feel for more of what we're up against, publically speaking. The fact that people can and will call in expressing their voices and opinions will allow more people to know what vaping is all about. I'm going to go down to the local one here in Anniston and talk with the station manager about bringing this topic up with the differences between analog cigarettes and E-cigs and try to start education the local people here with my personal experience and see if this will help any in our direction. This entire thing is about peoples rights to choose, and the people of this country (as a whole) are SO tired of being told what they can't do. It may open some doors, possibly even legally speaking to support this community with the FACTS and not the lies that lobbyists for BT and PC are doing. :)
 

EddardinWinter

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Again, we agree.

We just thinking about something... I listen to a lot of AM radio. This might also be another source to get the information out is a massive way. It might just also give us a feel for more of what we're up against, publically speaking. The fact that people can and will call in expressing their voices and opinions will allow more people to know what vaping is all about. I'm going to go down to the local one here in Anniston and talk with the station manager about bringing this topic up with the differences between analog cigarettes and E-cigs and try to start education the local people here with my personal experience and see if this will help any in our direction. This entire thing is about peoples rights to choose, and the people of this country (as a whole) are SO tired of being told what they can't do. It may open some doors, possibly even legally speaking to support this community with the FACTS and not the lies that lobbyists for BT and PC are doing. :)

That's an excellent idea.



Roaring thunderously via Tapatalk...
 
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