Deeming Regulations have been released!!!!

[UncLeJunkLe]

WHAAAAAT?

This US News article states...

"The FDA's review of the applications was based on whether the e-cigarettes are effective in getting smokers to quit..."

Since when is the FDA supposed to evaluate PMTAs/ecig products even partially on their ability to make smoker's quit? That would mean it's being regulated as a cessation product. That is not supposed to be the case as it was deemed long ago in court that ecigs could not be regulated that way in the USA. Right?

Fake news? Uninformed journalist? Or am I missing something here?

 

[hittman]

Here is something I got this morning from CASAA.



The headline is click-bait. It isn't really about FDA "cancelling nicotine", but it was an interesting hour nonetheless. It's about FDA's plan to nearly eliminate nicotine from cigarettes. Right. Is it the FDA really?

It still is a cigarette made of tobacco, combusted tobacco, regular or menthol. The tobacco in the VLN is genetically modified to produce very little nicotine.

Of course, as long as FDA keeps doggedly insisting it's the nicotine in cigarettes that makes smokers sick, we're sinking, though we're not sunk yet. Once the VLN cigarette takes hold, and becomes the only cigarette legally available, the idiocracy will want to reduce the nic in vaping, if only to hold their position. I hope I'm dead before we get there. I'm weary of the profit driven charade that passes for science.

The participants in the CASAA video provide a lot of info about testing the VLNC, how people dropped out of the studies, how they were caught cheating, even the test subjects who were locked hotel rooms (discovered through the nic levels in their blood tests), and
how none of those failures counted against the final "yay for us" test results.

I tried to drill down into the ownership of 22nd Century Group, the makers of the VLN cigarette. Nora B. Sullivan, who owns 100,000 shares, is also on the board of seven other companies. 10 million shares are owned by Blackrock, 8 million by Vanguard, and there are three pages of other capital management and institutional owners. The strongest of those players wouldn't take a chance on something like this without knowing their minions at FDA will hold the line for them. When you look at this, it honestly looks like something devised as nothing more than a money maker.

22ND CENTURY GROUP Stock Ownership - Who Owns 22ND CENTURY GROUP in 2022? | WallStreetZen

Looks like another coup against people by the public-private partnership, as the numbers of smokers have continued to fall over the years, and underage smokers are down to 2 percent. Let's make a problem so we billionaires can make some money!

Thanks for explaining that. I'm at work and can't watch it now. If you think about it, it's really kind of a smart business move on the part of the cigaretty companies. If the number of people smoking is decreasing then lower the nicotine level in the cigarettes so the people that are smoking need to smoke twice as much to get what they were getting before.

 

[Bliss Doubt]

Also this:

FDA's New Plan to Eliminate Most Nicotine in Cigarettes

 

[Bliss Doubt]

WHAAAAAT?

This US News article states...

"The FDA's review of the applications was based on whether the e-cigarettes are effective in getting smokers to quit..."

Since when is the FDA supposed to evaluate PMTAs/ecig products even partially on their ability to make smoker's quit? That would mean it's being regulated as a cessation product. That is not supposed to be the case as it was deemed long ago in court that ecigs could not be regulated that way in the USA. Right?

Fake news? Uninformed journalist? Or am I missing something here?

Could be a low level grunt who said something unauthorized, but it could be the little verbal accident we need.

Altria has the wherewithal to sue the FDA. Hope they do.

 

[UncLeJunkLe]

...but it could be the little verbal accident we need.

Altria has the wherewithal to sue the FDA. Hope they do.

Fer sher. If the FDA truly is evaluating, even partially, whether or not an ecig product is effective as a cessation product, this could be a big deal assuming the right lawyers get involved. It will take a court order to smack them down.

 

[Territoo]

Thanks for explaining that. I'm at work and can't watch it now. If you think about it, it's really kind of a smart business move on the part of the cigaretty companies. If the number of people smoking is decreasing then lower the nicotine level in the cigarettes so the people that are smoking need to smoke twice as much to get what they were getting before.

I'd heard about the low/no nicotine cigarettes and that Biden is pushing for it. The thought is that it would lower cancer deaths, but that doesn't make any sense as it isn't the nicotine that is causing the cancer and the myriad of other smoking related diseases, but the 1000's of other toxins in tobacco. If you lower the nicotine, people are just going to smoke more to make up for the lack of nicotine, thus increasing their exposure to those toxins and increasing their health risks. Also, it creates a black market for regular tobacco, because we all know that prohibition works so well. After all it worked with alcohol..

 

[UncLeJunkLe]

Biden

doesn't make any sense

correct

 

[Bliss Doubt]

The thought is that it would lower cancer deaths, but that doesn't make any sense as it isn't the nicotine that is causing the cancer and the myriad of other smoking related diseases...

When government is trying to get into your life, curtail your freedom, squash the free market while making a mint, the elected monkeys and the unelected bureaucracies have to make a case that sounds good on a soapbox. Biden is already saying the mantra. The FDA will start saying it. "Lower cancer deaths, fewer cancer deaths, adults can smoke without fear of cancer". They do it all the time about everything, repeat it, knowing the media won't cover it, knowing no debate will ever be allowed, knowing most of the people are sheep who do as they are told. It's a kinder, gentler form of dictatorship.

And evil vaping will be reduced to very low nic disposables. I almost think the whole scheme is a mechanism to go after vaping.

 

[WorksForMe]

Greg Conley doesn't think Juul is going away anytime soon.


"FDA Banning Juul? Not Likely, Explains Vaping Advocacy Group

Leak to Wall Street Journal leaves out critical details

WASHINGTON, D.C. -- This morning, the Wall Street Journal revealed that the Food and Drug Administration's Center for Tobacco Products will be imminently issuing marketing denial orders (MDOs) to Juul Labs for its current line of vaping products. As would be expected, this leak from the agency has inspired news stories stating that Juul will soon be pulled from shelves.

"Predictions of doom and gloom for Juul are understandable, but may be proven to be premature," explains Gregory Conley, president of the American Vaping Association, a nonprofit that advocates for sensible regulation of vaping products.

Conley cites two factors: (1) the high likelihood that an administrative stay with be issued allowing Juul products to remain on the market while it appeals the FDA's decision; and (2) the fact that Juul still has applications pending at the FDA for its next-generation device that has Bluetooth features to deter youth usage.

As a result, Conley predicts that Juul's current line of products will remain on the market for an undetermined length of time. Meanwhile, the FDA will continue to assess Juul's applications for updated products not currently available on the U.S. market.

"The FDA could very well come to different conclusions on Juul once they study the features of the new Juul device," says Conley.

While Juul remaining on the market would be great news for adult smokers and ex-smokers, this expected decision still represents another in a long line of disastrous decisions from the FDA and the Biden Administration on nicotine and tobacco regulation.

"With rampant inflation and an economy slipping into a recession, one would think that the Biden Administration would be laser focused on taking steps to improve the lives of Americans. Instead, they are ignoring the science and banning hundreds of thousands of products used by adults to stay off cigarettes," said Conley. "The Biden Administration believes in harm reduction for fentanyl users, but their message to adult smokers and ex-smokers is to drop dead."

Juul usage among youth continues to decline. The 2021 Monitoring the Future Survey found that past-30 day use of Juul among 8th, 10th, and 12th graders fell from 28.3% in 2019 to 4.8% in 2021."


.

 

[englishmick]

Fer sher. If the FDA truly is evaluating, even partially, whether or not an ecig product is effective as a cessation product, this could be a big deal assuming the right lawyers get involved. It will take a court order to smack them down.

I've seen comments to the effect that they need to see whether the benefits to adults outweigh the potential harm to children who pick up vaping. Didn't occur to me that this could conflict with the situation regarding them not being allowed to be considered as a cessation product. That one could keep the lawyers busy enough to cause a national shortage of BMW's and Mercedes.

 

[Alexander Mundy]

With rampant inflation and an economy slipping into a recession, one would think that the Biden Administration would be laser focused on taking steps to improve the lives of Americans.

 

[Bliss Doubt]

I've seen comments to the effect that they need to see whether the benefits to adults outweigh the potential harm to children who pick up vaping. Didn't occur to me that this could conflict with the situation regarding them not being allowed to be considered as a cessation product. That one could keep the lawyers busy enough to cause a national shortage of BMW's and Mercedes.

The short circuit to their logic is that some kids will smoke, especially those who grew up in a household where someone smoked, and some kids will vape. It's just the history of the world, that risk taking teens will do anything you tell them not to do. So for kiddies and adults, vaping is just the better alternative.

I'm sure I don't have to convince anybody here. The hypocrisy just gets me going, that kids can drive two ton bullets at age 16, will get into the liquor cabinet, will scrape themselves up on skateboards, will shag each other and get pregnant, will experiment with prescription and illicit substances, but adults can't vape because kiddies might like it too much.

 

[Vapeon4Life]

The short circuit to their logic is that some kids will smoke, especially those who grew up in a household where someone smoked, and some kids will vape. It's just the history of the world, that risk taking teens will do anything you tell them not to do. So for kiddies and adults, vaping is just the better alternative.

I'm sure I don't have to convince anybody here. The hypocrisy just gets me going, that kids can drive two ton bullets at age 16, will get into the liquor cabinet, will scrape themselves up on skateboards, will shag each other and get pregnant, will experiment with prescription and illicit substances, but adults can't vape because kiddies might like it too much.

Once the fix is in, the special interests bought and paid for - They will do anything, tell any lie that suits the agenda.

Tonight for example on the CBS Evening News with Nora O'Donnell, they did a a news clip on the situation with
the FDA and Juul and mentioned and I quote:
"In one 5mg Juul pod THERE IN MORE NICOTINE THAN A WHOLE CARTON OF CIGARETTES !!!

And the people sit in front of their TV sits hearing this ignorant to the fact that THEY ARE BEING LIED TO to suit a bought and paid for agenda!


Now they want to lower the nicotine in cigarettes! How many of you are old enough to remember when the cigarette companies used to fight to come up with the lowest nicotine cigarette on the market until the government stopped them from doing this, forced them to no longer list tar and nicotine amounts on cigarettes because they said low tar and nicotine cigarettes will just cause people to smoke more and inhale deeper - TRUE STORY!

And now they want lower nicotine cigarettes??? The hypocrisy is pathetic!

 

[Rossum]

Well, here it is, the axe has fallen on Juul:
FDA Denies Authorization to Market JUUL Products

the FDA determined that the applications lacked sufficient evidence regarding the toxicological profile of the products to demonstrate that marketing of the products would be appropriate for the protection of the public health.

Really? It would be interesting to compare the PMTA data filed by Juul/Altria with that for products that have been approved. My sense remains that this denial is "political".

 

[mikepetro]

Bittersweet.

While, in principle, I hate anyone being forced out of the ecig market, it couldnt have happened to a more deserving bunch than Altria.

 

[mikepetro]

Dupe deleted

 

[UncLeJunkLe]

...to demonstrate that marketing of the products would be appropriate for the protection of the public health

Well now it really does look like FDA is trying to regulate vape as a medical device or similar.

Cigarettes and other legal vice products do not have to prove they are protecting public health because they are regulated as vice products, not medical or social justice products. And that is the way vape is supposed to be regulated by the FDA - a nicotine delivery device (ENDS). There is definitely a winnable lawsuit here for any lawyers who wish to pursue it, IMHO.

My sense remains that this denial is "political".

That's the most likely case here. And just plane old govt overreach...for your protection, of course.

 

[UncLeJunkLe]

Bittersweet.

While, in principle, I hate anyone being forced out of the ecig market, it couldnt have happened to a more deserving bunch than Altria.

This is true, but they have the means to legally combat this, which can positively affect the whole industry if successful.

 

[Bronze]

I often thought there was a good chance vaping would remain legal but only under the protection of a medical prescription.

 

[MLEJ]

there was a good chance vaping would remain legal but only under the protection of a medical prescription.

...which most or all physicians won't issue until after you've tried every other smoking cessation method (made by the pharma cos that grease their palms).