Juul Activity

[englishmick]

Saw this yesterday. Interesting.

Hope it hasn't been posted already. I did look.

Juul is pitching its e-cigarette as an anti-smoking tool to employers and insurers

"juul has a new program to pitch its e-cigarette to companies and insurers who want to help their employees stop smoking cigarettes as the company continues to stave off criticism that its product has caused an epidemic in teen smoking."

 

[stols001]

Man, I gotta say I dub juul the winner on this one. They really know how to market.

LOL, I hope they include a "vapeverwhere" clause, though. Like, whole companies who adopt the juul get to vape inside.
Anna

 

[Eskie]

Oh great. Now they're pitching it to stop smoking without going through approval for use as such. I'm sure the FDA will love that one. The more headaches they create with the FDA the more they get adverse coverage that slams the whole vaping market.

 

[Jazzman]

Oh great. Now they're pitching it to stop smoking without going through approval for use as such. I'm sure the FDA will love that one. The more headaches they create with the FDA the more they get adverse coverage that slams the whole vaping market.

While I agree Eskie that FDA approval would be ideal for this program the reality is that it would never happen. The FDA is far to entrenched in the belief that vaping looks like smoking so must be bad, and they will continue with this belief until they can find a way to prove or manufacture reasons that it must be true. There would be years of very expensive trying to get approval from the FDA and changing their point of view that ecigs provide harm reduction and do legitimately help with smoking cessation (not news to any of us that quit smoking with ecigs). But in the end of years of lobbying and likely litigation I think the end result would not be positive, but the intended years long delay by the FDA would achieve the same purpose of doing nothing.

Like I said, I don't disagree with you at all, but I think a company like JUUL with the bankroll to give this a try is worth the test. So maybe an end run forcing the FDA to litigate against JUUL instead of the other way around might be a good strategic move. I know, slim chance right? At least it's a different strategy so lets see how this plays out. Perhaps if JUUL can get some big health providers to join with them it might be a coalition that can be effective with the FDA since I don't think an ecig manufacturer alone would be nearly as effective. Bigger money seems to always have a louder voice with government agencies.

 

[Uncle Willie]

Just a Great Idea .. brilliant, in fact ..

Love my JUUL's ..

 

[englishmick]

This part got my attention

"Juul is hoping to sway its critics. It has started presenting results from clinical trials and publishing research in peer-reviewed journals."

I wonder what research they have got involved with? With Altria behind them maybe they have access to some resources.

Hard to tell but maybe they are moving down the road faster than we knew. It could make a difference to vaping generally, for good or bad. They could end up laying down a path through the FDA maze that nobody else could follow.

 

[Eskie]

While I agree Eskie that FDA approval would be ideal for this program the reality is that it would never happen. The FDA is far to entrenched in the belief that vaping looks like smoking so must be bad, and they will continue with this belief until they can find a way to prove or manufacture reasons that it must be true. There would be years of very expensive trying to get approval from the FDA and changing their point of view that ecigs provide harm reduction and do legitimately help with smoking cessation (not news to any of us that quit smoking with ecigs). But in the end of years of lobbying and likely litigation I think the end result would not be positive, but the intended years long delay by the FDA would achieve the same purpose of doing nothing.

Like I said, I don't disagree with you at all, but I think a company like JUUL with the bankroll to give this a try is worth the test. So maybe an end run forcing the FDA to litigate against JUUL instead of the other way around might be a good strategic move. I know, slim chance right? At least it's a different strategy so lets see how this plays out. Perhaps if JUUL can get some big health providers to join with them it might be a coalition that can be effective with the FDA since I don't think an ecig manufacturer alone would be nearly as effective. Bigger money seems to always have a louder voice with government agencies.

But the FDA has a pathway for products that want to market themselves that way, an MRTP, modified risk tobacco product. IQOS and Copenhagen Snuff are currently sitting with active applications, the Snuff already out of the review committee with recommendations for approval of the application.

No idea what Snuff spent to date, but I believe IQOS has already spent close to $100 Million on the entire application process (testing included) which has taken them?5 years to assemble? I'm sure Juul now has the wallet to do the same, but that data isn't pulled from the air, it takes years to run the necessary tests, package everything into an application and then go through several requests for corrections and revisions before even possibly advancing to committee. They haven't even begun the application process.

 

[Eskie]

This part got my attention

"Juul is hoping to sway its critics. It has started presenting results from clinical trials and publishing research in peer-reviewed journals."

I wonder what research they have got involved with? With Altria behind them maybe they have access to some resources.

Hard to tell but maybe they are moving down the road faster than we knew. It could make a difference to vaping generally, for good or bad. They could end up laying down a path through the FDA maze that nobody else could follow.

Well if there was research on peer reviewed journals about Juul we'd know about it. If they're just creating a package of e cigarette studies published to date, it'll look nice for PR but as to any regulatory agency, especially the FDA, it's nice background material but meaningless I'd it wasn't conducted with specific product.

To do that you might argue your product is equivalent to the others that were tested, but then what's so different about your product? In particular the problem facing Juul specifically is the use of nicotine salts, and there's not much literature if any dealing with nic salts versus plain nic in smoking cessation let alone their specific delivery device.

 

[englishmick]

Well if there was research on peer reviewed journals about Juul we'd know about it. If they're just creating a package of e cigarette studies published to date, it'll look nice for PR but as to any regulatory agency, especially the FDA, it's nice background material but meaningless I'd it wasn't conducted with specific product.

To do that you might argue your product is equivalent to the others that were tested, but then what's so different about your product? In particular the problem facing Juul specifically is the use of nicotine salts, and there's not much literature if any dealing with nic salts versus plain nic in smoking cessation let alone their specific delivery device.

There has been speculation over the years that BT may have already have carried out research. Not released because it made vaping look good. It's not impossible that Juul now has access to all kinds of research results.

Or maybe there's nothing there. Guess we just have to wait and see.

 

[Jazzman]

But the FDA has a pathway for products that want to market themselves that way, an MRTP, modified risk tobacco product. IQOS and Copenhagen Snuff are currently sitting with active applications, the Snuff already out of the review committee with recommendations for approval of the application.

No idea what Snuff spent to date, but I believe IQOS has already spent close to $100 Million on the entire application process (testing included) which has taken them?5 years to assemble? I'm sure Juul now has the wallet to do the same, but that data isn't pulled from the air, it takes years to run the necessary tests, package everything into an application and then go through several requests for corrections and revisions before even possibly advancing to committee. They haven't even begun the application process.

Precisely the problem. FDA WILL slow walk any application to the point where it's probably wasted money and time to approach from that regard.

I see your point that you think they should just follow established procedure and go through the very expensive and time consuming process to get approval, even though that is incredibly unlikely. And honestly yours is a valid opinion, I'm not arguing that. I just think that the JUUL approach is interesting and I think there is a chance to effect change through a different means of approach with big money and names behind the attempt. Only time will tell I guess.

 

[United States]

Too little too late.

Insurance companies have already decided vapers are same as smokers...ie additional revenue source by charging higher premiums to vapers.

 

[stols001]

I think this one is like the black box of an airplane, we aren't going to get any information about it or IDEAS about how the FDA will react, until after the fact.

I would NOT be shocked if the tobacco companies had more positive research OR could come up with some fairly quickly. IDK on that.

Is the Juul after or before the deeming date? I have no idea, but if it was before, I don't see how they'd need to submit to the FDA. Again, I don't know and even if AFTER deeming, Juul may well go for it anyway. No one else is paying much attention to that sucker, including the FDA.

This could be great... Or awful. I do kind of think it's going to be interesting, that is for sure.

Anna