FDA FDA bans 7 Star Ariva and Stonewall dissolvable tobacco lozenges (that are very similar to NRT lozenges)

[Katya]

Good points. The FDA does have very strict requirements for SE, and it does not surprise me that these products do not meet those requirements.

No, those are not good points. It's a smokescreen. Please read Phillips's article that Agent Ania linked above.

I am very familiar with Star Scientific products, BTW. They are, just like the orbs, lozenges and CigRX, very good and effective tobacco harm reduction products. And much, much healthier than cigarettes, cigars or chewing tobacco.

However, it still begs the question: does this mean the FDA is already enforcing their deeming regulations? Or are they just getting a head start and saying if the deeming regs go through, then these products do not meet the requirements for SE? I was of the understanding that there are no current enforceable FDA regulations in place for tobacco products, hence the proposed deeming.

And read it again--just in case.

 

[Katya]

Imagine a world in which they banned cigarettes, only cigarettes, but allowed every other nicotine product to be freely legal. That would actually make some sense... but of course that will never happen.

Just a reminder--this was published in 2012:

http://www.cbsnews.com/news/fda-dissolvable-tobacco-better-for-health-but-could-lead-to-more-users/

FDA: Dissolvable tobacco better for health, but could lead to more users

According to the report, exclusive use of dissolvable tobacco products by an individual would "greatly reduce risk" compared with regular use of cigarettes. It also could reduce population-level disease burden caused by tobacco use if the products decrease the number of people who smoke or don't start smoking.

"Based on understanding of the delivery of toxins to cigarette smokers, exclusive use of (dissolvable tobacco products) should be less hazardous than regular smoking of cigarettes now marketed in the United States," the report said.

Sounds familiar? Yes, it should:

"If we could get all of those people [who can't or won’t quit smoking conventional cigarettes] to completely switch all of their cigarettes to the non-combustible products that would be good for public health."

"It is not the nicotine that kills half of all long-term cigarette smokers. The nicotine creates and sustains the addictions, but it's not the nicotine that kills people."

--Mitch Zeller (about electronic cigarettes, 2014, Senate hearings)

I rest my case. Off to buy some nic.

 

[Jman8]

No, those are not good points. It's a smokescreen. Please read Phillips's article that Agent Ania linked above.

Why not just quote that directly?

Acetaldehyde is not good for you, but like most small organic molecules, is a constant exposure among those of us who eat food, and not harmful in reasonable quantities. It is difficult to imagine the quantities in the Ariva/Stonewall variants were enough to pose any real concern (more on that when the rest of us outside the star(!) chamber have a chance to look at the data). I would bet that the difference is far lower than, say, the differences you might find between two apples or two cups of coffee (let alone between those and zero). Basically, if you change the formulation of anything (or nature does it), you will get a little bit less of some chemicals that are bad for you in large doses, and a little bit more of others. This ruling suggests that FDA will use the inevitable latter part of that observation to ban any variation on a product. Note for those who only care about e-cigarettes, this should be seen as the final blow for any hope of being able to exist under the CTP regime (even if there is not an immediate ban of legal sales from the start): If FDA is going to do this for an incredibly well-controlled and clean product like Ariva/Stonewall, there is no hope vaping products will ever get SE approval

*Bold emphasis mine.

"should be seen as the final blow for any hope of being able to exist under the CTP regimen.... there is no hope vaping products will ever get SE approval."

...strikes me as fear mongering. Again, we are talking about a product that isn't even being sold (marketed, nor distributed) by them that submitted SE application. Also talking about a product that could file for PMTA, as if it is not banned forever. And yet, we are to filter this ruling only through the prism of doom and despair? For what? A product that had so little sales, it is not still marketed by the company that developed them.

Who amongst us were claiming that eCig products must go the route of SE submission? Who amongst us is claiming that eCigs (made by non BT companies) were going to go away without a forceful (legal) fight?

Speak now, or remain in the shadows with your apparent need to preach hopelessness.

 

[dragonpuff]

No, those are not good points. It's a smokescreen. Please read Phillips's article that Agent Ania linked above.

I am very familiar with Star Scientific products, BTW. They are, just like the orbs, lozenges and CigRX, very good and effective tobacco harm reduction products. And much, much healthier than cigarettes, cigars or chewing tobacco.



And read it again--just in case.

I never said that the deeming regs weren't a smoke screen for a de facto ban; I believe they are, but that is beside the point I was making. I am simply agreeing with jman that technically they aren't banned just because they didn't meet requirements for SE - they still have the opportunity to file a PMTA. I highly doubt that they will get approval that way either, but failing to meet SE alone does not mean a product is banned.

 

[dragonpuff]

Just a reminder--this was published in 2012:

http://www.cbsnews.com/news/fda-dissolvable-tobacco-better-for-health-but-could-lead-to-more-users/

FDA: Dissolvable tobacco better for health, but could lead to more users



Sounds familiar? Yes, it should:


--Mitch Zeller (about electronic cigarettes, 2014, Senate hearings)

I rest my case. Off to buy some nic.

I do hope you understand I was being heavily sarcastic when I wrote that I am fully aware the FDA (and other organizations) have been doing this for a long, long time...

I can't help it; blatant sarcasm runs in my family, and it is incurable

 

[Jman8]

I never said that the deeming regs weren't a smoke screen for a de facto ban; I believe they are, but that is beside the point I was making. I am simply agreeing with jman that technically they aren't banned just because they didn't meet requirements for SE - they still have the opportunity to file a PMTA. I highly doubt that they will get approval that way either, but failing to meet SE alone does not mean a product is banned.

I understand the ruling as a de facto ban.

A meaningless de facto ban considering the lack of sales on this product. I realize for users of the product it is both enjoyable and not meaningless. Yet, it is a product that has nowhere near the growth potential of what eCigs currently offer. Plus it still does have other avenues for distribution. PMTA being one of those, though really who cares at this point. Black market is another avenue, for those that truly desire this product, is another. Sucks that it can't be sold as SE, but is hardly the end of vaping as we know it.

Would be nice to get another version of the story from Star Scientific, but alas, that seems unlikely. Instead, it feeds into a common narrative here on ECF and elsewhere: our version of propaganda that consistently suggests that we are doomed. Doomed, I tell ya.

 

[sqirl1]

This SE bull$&@% is such a joke, they're not even trying to be subtle about the conflicts of interest associated with it at this point, there has to be a way to demonstrate the biased and unfair manner this section of FSPTCA is being used in court, the minute they approve camel/marlboro snus -- which have gone through several changes since their inception -- is the minute we have evidence that they are complete hypocrites about this.

 

[Katya]

I do hope you understand I was being heavily sarcastic when I wrote that I am fully aware the FDA (and other organizations) have been doing this for a long, long time...

I can't help it; blatant sarcasm runs in my family, and it is incurable

I know.

The FDA has been trying to ban e-cigarettes since March 2009, when they fired the first salvo by adding electronic cigarettes to Import Alert 66-41 and directing the U.S. Customs and Border Protection to reject the entry of electronic cigarettes into the United States.

If it hadn't been for the constant vigilance and activism of people like Godshall, Oliver Kershaw, CASAA etc., and the courts, it all would have ended then.

FDA to Ban Electronic Cigarettes - Hit & Run : Reason.com

So far, I haven't seen any evidence that the FDA has changed their plans. Au contraire, a rabid anti-vaping campaign, full of lies, distortions, faux science and fear mongering, has been launched by the FDA, CDC and all the other "public health" agencies. This campaign, dutifully parroted by the media, shows no signs of relenting--with very few exceptions.

Top scientists warn WHO not to stub out e-cigarettes | Reuters

"We want to make sufficient noise now before things get too set in stone."

-Gerry Stimson, emeritus professor at Imperial College London

 

[Katya]

I haven't even had a chance to try them.

I don't know if I'd like 'em or not, but if all hell breaks loose, I say road trip to Bill's!

I have 11 boxes of Ariva (1.5 mg) and 12 boxes of Stonewall (4 mg), assorted flavors. If you want a sample, just send me a PM. I'll share. No expiration dates.

I also have 8 boxes of CigRX (anatabine and mate) and several tins of Swedish snus--in my purse, on my desk, and in my freezer.

I prefer snus. General Mini Mint is my favorite.

 

[sonicdsl]

I have 11 boxes of Ariva (1.5 mg) and 12 boxes of Stonewall (4 mg), assorted flavors. If you want a sample, just send me a PM. I'll share. No expiration dates.

I also have 8 boxes of CigRX (anatabine and mate) and several tins of Swedish snus--in my purse, on my desk, and in my freezer.

I prefer snus. General Mini Mint is my favorite.

Oh, thanks Katya, but I'm an adult, ergo I don't like flavors!

 

[Katya]

Oh, thanks Katya, but I'm an adult, ergo I don't like flavors!

Drats! Too bad I threw away my Stonewall Natural (tobacco flavor)--that was naaaasty.

But I still have some Wintergreen--that's allowed, no? It's like menthol.

 

[sonicdsl]

Drats! Too bad I threw away my Stonewall Natural (tobacco flavor)--that was naaaasty.

But I still have some Wintergreen--that's allowed, no? It's like menthol.

For the time being

 

[Kent C]

I have 11 boxes of Ariva (1.5 mg) and 12 boxes of Stonewall (4 mg), assorted flavors. If you want a sample, just send me a PM. I'll share. No expiration dates.

I also have 8 boxes of CigRX (anatabine and mate) and several tins of Swedish snus--in my purse, on my desk, and in my freezer.

I prefer snus. General Mini Mint is my favorite.

Just got some Ariva Java at amazon.... 16 left!

 

[Katya]

Just got some Ariva Java at amazon.... 16 left!

You should have called me first.

 

[aikanae1]

Just got some Ariva Java at amazon.... 16 left!

I have PRIME!

Dang. Just looked at Amazon and that's no deal unless you got in on a special. I'm eyeing some on ebay but that's about it from what I can tell in the first few pages on Google. My issue with snus is I don't like it in my mouth that long and it's s-l-i-m-e-y. Gets ucky and icky-poo (BUT better than nothing). This sounds like a nice compromise.

End of the month - labor day sales - oh man, what bill isn't going to get paid now?

 

[Katya]

I have PRIME!

Dang. Just looked at Amazon and that's no deal unless you got in on a special. I'm eyeing some on ebay but that's about it from what I can tell in the first few pages on Google. My issue with snus is I don't like it in my mouth that long and it's s-l-i-m-e-y. Gets ucky and icky-poo (BUT better than nothing). This sounds like a nice compromise.

End of the month - labor day sales - oh man, what bill isn't going to get paid now?

Ahem....

http://www.e-cigarette-forum.com/fo...very-similar-nrt-lozenges-2.html#post14046817

Snus is not slimey!

 

[DaveP]

Why does the idea that this is like banning beer and wine and leaving hard liquor alone come to mind?

 

[Katya]

Why does the idea that this is like banning beer and wine and leaving hard liquor alone come to mind?

 

[aikanae1]

You should have called me first.

Why do you WANT to give yours away?
hmmm...

 

[Katya]

Why do you WANT to give yours away?
hmmm...
View attachment 370418

Because I'm a nice person.

PM sent.