FDA Denies Authorization to Market JUUL Products. Currently Marketed JUUL Products Must Be Removed from the US Market

[Arcadia]

https://www.fda.gov/news-events/press-announcements/fda-denies-authorization-market-juul-products
“Today, FDA issued marketing denial orders (MDOs) to JUUL Labs Inc., meaning all JUUL products currently on the U.S. market must be removed, or FDA may take enforcement action. 

The MDOs issued today by FDA apply to the following marketed products: 
➡️ JUUL Device 
➡️ JUULpods (Virginia Tobacco 5%) 
➡️ JUULpods (Virginia Tobacco 3%) 
➡️ JUULpods (Menthol 5%) 
➡️ JUULpods (Menthol 3%) 
 
Any products subject to an MDO may not be offered for sale or distributed in the United States, or FDA may take enforcement action. FDA denied marketing authorization after determining JUUL’s premarket tobacco product applications (PMTAs) 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.  

FDA cannot and will not enforce against individual consumer possession or use of JUUL products or any other tobacco products.”

[Moodflow]

Good! Now ban all the other tobacco vape products that get kids hooked on tobacco.

[Catwoman]

1 hour ago, Arcadia said:

https://www.fda.gov/news-events/press-announcements/fda-denies-authorization-market-juul-products
“Today, FDA issued marketing denial orders (MDOs) to JUUL Labs Inc., meaning all JUUL products currently on the U.S. market must be removed, or FDA may take enforcement action. 

The MDOs issued today by FDA apply to the following marketed products: 
➡️ JUUL Device 
➡️ JUULpods (Virginia Tobacco 5%) 
➡️ JUULpods (Virginia Tobacco 3%) 
➡️ JUULpods (Menthol 5%) 
➡️ JUULpods (Menthol 3%) 
 
Any products subject to an MDO may not be offered for sale or distributed in the United States, or FDA may take enforcement action. FDA denied marketing authorization after determining JUUL’s premarket tobacco product applications (PMTAs) 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.  

FDA cannot and will not enforce against individual consumer possession or use of JUUL products or any other tobacco products.”

Thanks for posting this -- I saw it on the news earlier today and was very happy about it!

[TravelingChris]

I hate smoking, and cannot be around it but am against this.  I certainly prefer vapers of unscented products than smokers----it is so much better for 2nd hand smoke.  And anyway.- I am really not interested in giving Mexican cartels or any other criminal group even more products to sell on the black market.

[AmandaVT]

Vaping is such a big problem in middle and high schools right now. At least if kids are smoking cigarettes, it's relatively obvious. Vaping in hallways and bathrooms is much easier to hide. We've had a few incidents of kids ending up in the hospital from vaping this year. Anything that may help is good from my point of view. I'm allergic to cigarette smoke, so for me, people vaping is much better personally, but the current levels of vaping in kids is terrifying. 

[Lisa]

This is good news. When vaping first was popular, I knew it was not the "safe" way of smoking as many made it out to be. Many teens are into vaping, and its very sad.

[whitestavern]

8 hours ago, Moodflow said:

Good! Now ban all the other tobacco vape products that get kids hooked on tobacco.

Right? This doesn’t help kids stop smoking. They’ll just move on to another brand. 

[Guest]

I was thinking about this a little bit today and I wonder if anyone else finds this aspect uneasy? It seems like market control by government dictate. It’s not banning all vaping products, just JUUL. I heard yesterday that it opens the market for smaller providers. If that’s accurate, it seems like fed market control and does not seem to have much to do with underage vaping. 
 

I am not an economist and I don’t play one on TV. I am completely open to someone telling me why it’s not what I said. 
 

From a mom perspective - and as one who has dealt with that issue - I’m happy for the ban. 

[whitestavern]

1 hour ago, Quill said:

I was thinking about this a little bit today and I wonder if anyone else finds this aspect uneasy? It seems like market control by government dictate. It’s not banning all vaping products, just JUUL. I heard yesterday that it opens the market for smaller providers. If that’s accurate, it seems like fed market control and does not seem to have much to do with underage vaping. 
 

I am not an economist and I don’t play one on TV. I am completely open to someone telling me why it’s not what I said. 
 

From a mom perspective - and as one who has dealt with that issue - I’m happy for the ban. 

This was my thought as well. I applaud the efforts but I feel like only taking action against Juul is unfair. Seems like there would be legal challenges. 

[AmandaVT]

5 hours ago, whitestavern said:

This was my thought as well. I applaud the efforts but I feel like only taking action against Juul is unfair. Seems like there would be legal challenges. 

I agree with both of you - I'm not sure why only Juul is being targeted. They should get them all off the market - or at least the flavored ones. Let them be tobacco flavored.

[Janeway]

Thank God!!!!! I found it hard to take any of the Covid regulations seriously while tobacco products are still out there. This is one good step toward improving people’s lives.

Edited June 24, 2022 by Janeway

[TravelingChris]

7 hours ago, Quill said:

I was thinking about this a little bit today and I wonder if anyone else finds this aspect uneasy? It seems like market control by government dictate. It’s not banning all vaping products, just JUUL. I heard yesterday that it opens the market for smaller providers. If that’s accurate, it seems like fed market control and does not seem to have much to do with underage vaping. 
 

I am not an economist and I don’t play one on TV. I am completely open to someone telling me why it’s not what I said. 
 

From a mom perspective - and as one who has dealt with that issue - I’m happy for the ban. 

That is absolutely right.  But I actually heard from my chief state health official on the local news from last night and he explained that Juul was banned because of basically mislabeling.  Like the amount of nicotine they said was in it was actually the same amount as in a full pack of cigarettes.  If that is the reason for the ban, I am all for it.  No item that the FDA regulates should be so mislabeled, etc.  

That is why so many others will still be there which is something I am really happy about because I prefer vaping over smoking for all of us who have lung issues and aren't smokers.  Second hand smoke issues are very, very real,  Also, I am kind of libertarianish on vices- not because I use them but because I think the whole drug war and before any of us was born, Prohibition, raises a lot of other issues like crime, corruption, terrorism, and on and on and on.  For example, the giant crackdown on Opioids led to true pain patients having a lot of pain, and drug addicts turning to the street--- you can track it and see that  opioid deaths greatly increased and almost all of that is illegal use.  Then you have all the unintended consequences like the shootings in Oklahoma this year and in Wisconsin or Minnesota last year and all the suicides of people who cannot bear the pain because their opioids have been halted and nothing else is helping them.  

[Janeway]

6 hours ago, whitestavern said:

This was my thought as well. I applaud the efforts but I feel like only taking action against Juul is unfair. Seems like there would be legal challenges. 

I hope all vaping is obliterated and that tobacco companies have to pay for rehab for every single teenager they roped into this. they actually focused on teenagers in their marketing and even donated money to schools and slipped stuff in there. It’s disgusting.

Edited June 24, 2022 by Janeway

[Janeway]

10 hours ago, whitestavern said:

Right? This doesn’t help kids stop smoking. They’ll just move on to another brand. 

I disagree. If 12 and 14--year-olds can no longer get the vaping products and can no longer see the sexy advertising, I don’t think they’re just gonna move on to other brands especially when they’re not sold in this country.

[whitestavern]

There are many vaping products in the market. Juul is just one of them. Addicted kids will move onto one of them. This is more about punishing Juul (which I’m fine with) and less about helping kids/teens addicted to vaping. 

[GoodnightMoogle]

The year I did my student teaching (back in 2018) juuling was suddenly a massive problem in the high school I worked.

I asked my students what the deal was with the juuls. They proudly told me people could easily hide them because they look similar to a flash drive, and kids would wear hoodies and juul in class, blowing vapor into the sleeves.

We had a massive crackdown, over a hundred kids got in school suspension for having vapes in school. And parents complained, of course.

I remember feeling so much culture shock in that moment. I was only a couple years older than these kids, but I felt so far removed from them. I went to the same district, and sure you had your stoners and a couple of kids that were known to smoke, but it really wasn’t a big thing. No one smoked in school, and if someone did and got caught it was big gossip. Just a few years later, and a vast amount of the student body is smoking in school with little consequences or cares. 
 

I admit I don’t know all the ins and outs of the juul ban and if it’s a good thing or not, but part of me is glad. It was insidious the way they marketed to these kids and got them addicted to nicotine. And shame on all the parents of these gen -z-ers for letting their kids do that to themselves. 

[AmandaVT]

2 minutes ago, GoodnightMoogle said:

 And shame on all the parents of these gen -z-ers for letting their kids do that to themselves. 

They don't usually know - seeing these kids sneak stuff into school regularly - the parents don't know. Some find out when the ambulance is called and they need to get to school fast because their kid is having a seizure. Some find out when the school calls to let them know their child has been suspended. 

[Arcadia]

23 minutes ago, GoodnightMoogle said:

. And shame on all the parents of these gen -z-ers for letting their kids do that to themselves. 

Parents aren’t bodyguards of their children. They are not supposed to be helicopter parents either. Vaping is harder to detect compared to the stink of cigarettes or weed on clothes. 

[GoodnightMoogle]

Many of them probably don’t, but some do and just don’t care. The school was bombarded with phone calls furious that their kids were given in school suspension (which is barely a punishment honestly) over having drugs in the school. You would think they would have been more concerned their kids had the drugs in the first place. 

I know from my younger brother that the parents of his friend also vape and would supply him with the juice for it 😕 

I think the main issue is a lot of people don’t see vaping as a real drug or a big deal. Especially when they have all those crazy flavors like “cotton candy”

Edited June 25, 2022 by GoodnightMoogle

[Arcadia]

https://www.npr.org/2022/06/24/1107605984/juul-fda-vaping-e-cigarettes
“A three-judge panel of the U.S. Court of Appeals for the District of Columbia Circuit granted Juul's request for a hold while the court reviews the case.
…

Juul said that the FDA cannot argue that there was a "critical and urgent public interest" in immediately removing its products from the market when the agency allowed them to be sold during its review.

The company noted that the FDA denied its application while authorizing those submitted by competitors with similar products.

The FDA has OK'd e-cigarettes from R.J. Reynolds, Logic and other companies, while rejecting many others.“