FDA Submission Date Moved to 8/8/2022

[Kent C]

thanks Kent & Rossum.

Rossum but there are no proposed rules on the table, at least not that I could discern from glancing the stuff over. In addition, it would only seem reasonable if they were going to regulate nicotine, a window of just a few months would seem predatory.

The scope of this seems rather large, I would of thought the labs selling nicotine would have been out of business by august 2018 but now it seems to go on, which I think is huge news.

Im more concerned about my favorite flavorings, you cant store the stuff beyond a year or two.

Your the expert here Kent, you got an opinion? I will be just reading and listening.

There are no new 'rules' but there are "proposed rules" on the table. From the 2nd link in Bill G's post - comments from Gottlieb:

"These are questions that FDA must confront.

I am also directing CTP to explore other aspects of the current application review process. In particular, I have asked CTP to consider whether its current plan, which is to review all of the so-called Provisional Substantial Equivalence products, is an effective use of its resources and whether it should continue to pursue the current approach to these reviews. I have asked CTP to consider whether there is an approach that makes more sense, and whether by not reviewing some of those products, those review resources could be freed up for other purposes and greater clarity could be provided to the market.

In addition, we’ll also be revising the so-called “sunset policy” through additional guidance so that existing products under review remain on the market. The current policy could have forced existing products off the market. We’ll also be working to put in place a more comprehensive, transparent, and vigorous regulatory framework that will make our regulatory efforts more sustainable."

While all seem like good proposals, the one in red is especially good since he sees how the current deeming would, as Bill has said for so long, result in a virtual ban on ecigs - the underlined 'forced existing products off the market' which tells me he doesn't want to see that happening.

As far as flavorings go - as someone said above, they will still be on the market, but perhaps (worst case scenario) not available in vape shops or in any way connected to vaping. So storage of flavorings shouldn't be much of a consideration.

As far as nicotine goes - again - worse case scenario - banning of nicotine would be similar to banning primers for bullets - something that was considered in the 90's. No primer, no bullets so you don't have to ban firearms. (except for black powder weapons...). Although it's becoming more accepted that nicotine is not as addictive as was once thought, and many veteran vapers could, or already have, gone no-nic.... not me though - I like the positive effects of nicotine :- ) ...and it would be really hard for smokers to make the transition if nic was banned for vaping.

 

[sofarsogood]

There are no new 'rules' but there are "proposed rules" on the table. From the 2nd link in Bill G's post - comments from Gottlieb:

"These are questions that FDA must confront.

I am also directing CTP to explore other aspects of the current application review process. In particular, I have asked CTP to consider whether its current plan, which is to review all of the so-called Provisional Substantial Equivalence products, is an effective use of its resources and whether it should continue to pursue the current approach to these reviews. I have asked CTP to consider whether there is an approach that makes more sense, and whether by not reviewing some of those products, those review resources could be freed up for other purposes and greater clarity could be provided to the market.

In addition, we’ll also be revising the so-called “sunset policy” through additional guidance so that existing products under review remain on the market. The current policy could have forced existing products off the market. We’ll also be working to put in place a more comprehensive, transparent, and vigorous regulatory framework that will make our regulatory efforts more sustainable."

While all seem like good proposals, the one in red is especially good since he sees how the current deeming would, as Bill has said for so long, result in a virtual ban on ecigs - the underlined 'forced existing products off the market' which tells me he doesn't want to see that happening.

As far as flavorings go - as someone said above, they will still be on the market, but perhaps (worst case scenario) not available in vape shops or in any way connected to vaping. So storage of flavorings shouldn't be much of a consideration.

As far as nicotine goes - again - worse case scenario - banning of nicotine would be similar to banning primers for bullets - something that was considered in the 90's. No primer, no bullets so you don't have to ban firearms. (except for black powder weapons...). Although it's becoming more accepted that nicotine is not as addictive as was once thought, and many veteran vapers could, or already have, gone no-nic.... not me though - I like the positive effects of nicotine :- ) ...and it would be really hard for smokers to make the transition if nic was banned for vaping.

I've said before, if the science behind removing nic from cigarettes is encouraging then I support it. My refinement would be to say, don't remove the nic from loose tobacco, at least initially, so the most diehard smokers can get their nic by rolling their own. I think most smokers would rather get their nic from vaping if that is available.

Gottlieb said he wants to look into batteries and flavors. The battery issues seems like one for the Consumer Product Safety Comission. The release bullitins. I tell people loose batteries with unprotected terminals and mech mods account for nearly all the reported injury accidents. Avoid those two and the risks of battery problems goes way way down. I think visible vapor is the controling influence with adolecent boys, not flavors, and the girls seem to mostly do what interests the boys. I'm sure that's politically incorrect but that's what I've observed.

 

[DC2]

I'm sure that's politically incorrect but that's what I've observed.

Just as a general rule, if it's politically incorrect, it's most likely true.

 

[azb8496]

I've said before, if the science behind removing nic from cigarettes is encouraging then I support it. My refinement would be to say, don't remove the nic from loose tobacco, at least initially, so the most diehard smokers can get their nic by rolling their own. I think most smokers would rather get their nic from vaping if that is available.

The "Quest" cigarette did this. They had 3 levels of reduced nicotine. While I have read about a study on their impact on smoking habits, the results were somewhat inconclusive as to whether or not it caused an increased desire for nicotine/smoking. The study also didn't measure long-term trends. I tried them (for several months) years ago. My own anecdotal experience points to an increase in smoking, because the "punch" of the cigarette was taken out.

I think this should be tried on the state scale (with appropriate research resources set in place to study the societal effects) for a few years before applying it at the federal level. That would be the responsible & reasonable approach, in my opinion.

 

[stols001]

Lets hope they "try* it in CA. That should be a lot of fun to watch...

Anna

 

[ENAUD]

At the end of the press announcement, Mitch Zeller had said they would be having a follow up Q&A session the following week, anyone got any info on that?

 

[WharfRat1976]

Deleted by OP.