Link to webcast of Dec. 17 FDA Public Hearing on NRT & Innovative Products

[Kytrix]

On nicotine replacement drugs. From what I got is the warning stating "do not use cigarettes with this product " would be changed or just tossed out entirely. Also side note his idea of making these drugs available in smaller quantities would be great more smokers would be looking into it if say you can get the gum in a 5 pack vs only a 25 pack for 50 bucks.

They are indeed excellent suggestions, but they are just that. Suggestions. It would be nice to see those warning labels about exclusive use removed, and costs being lowered. The first is possible, but I see the second as unlikely. It's all about profit margins to Big Pharma and OTC manufacturers. The FDA doesn't control costs.

 

[love_leigh]

Just linked into the webcast - I can't listen to it, is the closed caption being used? Thanks!

Edited: Got it, nevermind.

 

[kristin]

The first speaker got no questions at all. I think the second only got one generalized question. The third and fifth have been the only speakers with any in-depth questioning done so far. I can't speak to any familiarity on the part of CASAA with the FDA.

Keep in mind that 2 of the 4 speakers before Elaine were CASAA board members, as well. (Dr. Carl Phillips and Greg Conley) We only presented Elaine as CASAA because technically only one speaker can represent an organization. I believe we also assist Lori with her testimony. And Bill Godshall, who I think is coming up soon, is an official CASAA adviser. So we had a lot of bases covered. We have dealt with the FDA several times, but I'm not sure about the folks on this particular panel. JParadise - it's not your imagination. They tend to treat us - the consumers who actually are the ones affected by their actions - like our opinion doesn't matter. We've been on the scene for less than three years, though. They will eventually get the point that we aren't going away and will continue fighting for our seat at the table (our = consumers.) The FA is supposed to be filling one spot on the committee with a consumer, but they gave it to an ANTZ doctor instead. We've been trying to get that changed, as well.

 

[KillTheNoise]

I'm getting sound perfectly fine.

 

[kristin]

Who regulates the manufacture of cigarettes? I'm assuming that it's not the FDA, but cigarettes do have a fair number of rules regulating their manufacture and sale.

Is 'our position' that we remain the wild west of no regulation at all (which probably keeps prices down a bit) or are we open to some non-FDA regulations?

Because of FSPTCA of 2009, the regulation of tobacco products now falls to the FDA.

No, we don't say there should be no regulations at all, just a lot more reasonable ones than the FDA and ANTZ are suggesting. At this point, any new low-risk tobacco or nicotine product introduced has essentially ZERO chances of being approved for use.

 

[love_leigh]

I have to have it muted

 

[Kytrix]

Who regulates the manufacture of cigarettes? I'm assuming that it's not the FDA, but cigarettes do have a fair number of rules regulating their manufacture and sale.

Is 'our position' that we remain the wild west of no regulation at all (which probably keeps prices down a bit) or are we open to some non-FDA regulations?

Tobacco IS regulated by the FDA, but in a way that keeps Big Tobacco fat and happy - while consumers stay sick and dying. The regulations are so lax and permissive that PM and RJ are practically cheering in the streets when they pass some overly-inflated piece of legislation that doesn't hurt them at all.

I haven't heard any specifics on regulating ecigs, but I doubt there's much the FDA could do. The devices themselves would be under the jurisdiction of the FTC, and the liquids in juices are "generally recognized as safe" by the FDA. The only thing for them to regulate is the nicotine levels, which doesn't seem to be an issue since there ARE lozenges, patches, etc. It's difficult to say we want anything but for the FDA to stop demonizing the devices we use and the users themselves.

EDIT: I concede both arguments above to be flawed and defer to kristin's post found here.

 

[Kgrin]

Glad they have the closed caption running

 

[scabbytattoo]

Dude just got the brush off.

 

[kristin]

Tobacco IS regulated by the FDA, but in a way that keeps Big Tobacco fat and happy - while consumers stay sick and dying. The regulations are so lax and permissive that PM and RJ are practically cheering in the streets when they pass some overly-inflated piece of legislation that doesn't hurt them at all.

I haven't heard any specifics on regulating ecigs, but I doubt there's much the FDA could do. The devices themselves would be under the jurisdiction of the FTC, and the liquids in juices are "generally recognized as safe" by the FDA. The only thing for them to regulate is the nicotine levels, which doesn't seem to be an issue since there ARE lozenges, patches, etc. It's difficult to say we want anything but for the FDA to stop demonizing the devices we use and the users themselves.

I'm sorry but there are so many errors in this post, but they are common and a lot of people believe them - as the ANTZ hope.

Tobacco is regulated in such a way that it is keeping BIG PHARMA fat and happy. The current regulations require tobacco companies to LIE that their smoke-free products are as hazardous as smoking. The pointless legislation, such as banning flavored cigarettes or plain packages, are the ideas of the ANTZ and supported by them. Tobacco companies basically play along.

The FDA can do A LOT. The FSPTCA gave them the power of "deeming regulations." They could set standards that all e-cigarettes much be tested in such ways as to make it cost prohibitive, ban flavors, limit nicotine levels, require sealed, pre-filled cartridges, claim stronger batteries are dangerous and can't be sold with devices, require e-cigarette companies to label that their products are not a safe alternative to smoking and more. This is why this hearing is so important - we need to get THR ackowledged and accepted so e-cigarettes aren't regulated as either cigarettes OR NRT.

 

[rockymtnrobin]

what is small amount of money when they talk about funding?

 

[kristin]

Oh, I forgot - this is about approving NRT for long-term use. The ANTZ will support this for NRT because they get their funding from Big Pharma. But they will still push for abstinence and only using approved NRT. Listen how the guy from CFTFK is talking about making cigarettes less addictive - based solely on nicotine addiction and ignoring behavior habits and enjoyment. He sounds like he is being reasonable but he is talking about "dual use" as not being a way to quit. They are only happy if everything leads to complete nicotine abstinence.

 

[JParadise]

Was he suggesting they work to make actual tobacco less addictive?

 

[Lbox88]

 

[kristin]

American Cancer Society also objects to e-cigarettes and gets a lot of funding from BP, so they support the FDA "fast-tracking" smoking cessation products. But remember - they MEAN "nicotine cessation." Just quitting smoking isn't good enough for them. You heard Elaine and others giving the facts about the ineffectiveness of NRT for smokers because of this.

 

[KillTheNoise]

Has anyone representing JUST vaping gone on yet?

 

[kristin]

Was he suggesting they work to make actual tobacco less addictive?

Yes. They think low or 0 nicotine cigarettes are better because they blame nicotine as the ONLY reason we smoked. They believe all smokers really hate being smokers, don't enjoy it and want to quit but are just addicted to the nicotine. They ignore the fact that if it was "just" the nicotine addiction, then the gums, patches and lozenges would work. It's akin to saying people eat chocolate because of the sugar, so give them a packet of sugar to eat instead and they should be able to stop eating chocolate. In reality, low-yield cigarettes have been proven to make smokers smoke MORE to compensate for the lack of satisfaction, so they expose themselves to more smoke. Their theory is that people will quit if the cigarettes are satisfactory for nicotine delivery, but they really just smoke MORE.

 

[kristin]

Has anyone representing JUST vaping gone on yet?

This hearing isn't about e-cigarettes, so that would be inappropriate.

 

[Lbox88]

"other tobacco nicotine derived products" greasy ........ Yes, please keep using old data you idiot

 

[Kytrix]

I'm sorry but there are so many errors in this post, but they are common and a lot of people believe them - as the ANTZ hope.

Tobacco is regulated in such a way that it is keeping BIG PHARMA fat and happy. The current regulations require tobacco companies to LIE that their smoke-free products are as hazardous as smoking. The pointless legislation, such as banning flavored cigarettes or plain packages, are the ideas of the ANTZ and supported by them. Tobacco companies basically play along.

The FDA can do A LOT. The FSPTCA gave them the power of "deeming regulations." They could set standards that all e-cigarettes much be tested in such ways as to make it cost prohibitive, ban flavors, limit nicotine levels, require sealed, pre-filled cartridges, claim stronger batteries are dangerous and can't be sold with devices, require e-cigarette companies to label that their products are not a safe alternative to smoking and more. This is why this hearing is so important - we need to get THR ackowledged and accepted so e-cigarettes aren't regulated as either cigarettes OR NRT.

I'm speechless at how unenlightened my post seems now. I've edited it to show my deference to your argument against my post and linked to yours.