FDA Denies 55,000 "Vape" Products by Denying Marketing Applications

[BrokenRecord]

I'm vaping Blueberry Lemon E-juice as we speak. Some of us don't have the luxury of being able to smoke a pipe at work. That said, I'm all for the kids. Yada, yada, yada...we will find a way to persevere.

 

[--dante--]

Personally, I found vapes to be very helpful in quitting the cigs. I only vaped the plain "tobacco" flavored ones. Cigarettes have a lot more engineered into them than just nicotine to addict you (including chemicals to allow nicotine to break the 'blood-brain' barrier). Once I was off the cigs through vaping, I found it much much easier after a while to quit the vapes as well. Juul was a big part of the problem with teen vaping. They clearly marketed to young people, rather than as an adults-only smoking cessation aid (at least at first) and were very successful at it. The popularity of Juul vape devices in the schools is what got the Fed attention, and the eventual FDA regulations.

 

[smokeymo]

I've heard that vaping causes Ovarian Cancer in men.

 

[sandollars]

Ooh, I actually know something about this!

That particular industry basically did it to themselves--it all started out with pretty basic, low-powered, and temperamental cigarette-like devices developed in China by Hon Lik in the early 2000s, and the two flavor choices you had back then were basically "stale cookie" or "toothpaste"...sorry, I mean "tobacco" and "menthol". The intentions were good; Hon Lik was after a way to quit smoking, and it wasn't really viewed as anything else.

Once it caught on in other countries as a means to quit smoking, a LOT of sketchy people jumped into the industry to make a quick buck alongside a number of honest purveyors who just wanted to see people kick their cigarette habit, and things went Wild West pretty fast.

There was also an active scene of people building their own devices by modifying flashlights (a basic vape was pretty much the same thing as a common flashlight in principle, except the "bulb filament" is wrapped around a wicking material soaked in e-liquid), and China caught onto that craze and started putting out mass produced, higher-power devices with onboard electronics to handle power adjustment. On top of which, there wasn't a whole lot of education, not much focus on user safety, and then shit like people's vapes exploding and starting fires became a thing.

Juul came along in the mid-2010s and introduced a small, more reliable, and sleek pod device that used what are called "nicotine salts" (protonated nicotine using either benzoic acid or salicylic acid to make higher nicotine strengths easier to inhale, much more closely mimicking the way a cigarette feels).

Their big mistake was deliberately marketing to a very young audience, and suddenly, there was an epidemic of teenagers and middle school children getting their hands on Juul devices, which really wound up a lot of parents and brought vaping to the attention of anti-tobacco and "think of the children" lobbying organizations. The first PMTA deadline was actually around August 2016, but the FDA kept kicking the can down the road.

Fast forward to a few years later...remember those sketchy people I mentioned earlier? Well, some of 'em figured out you could vape cannabinoids, and then a few of them decided to squeeze more profit out of their margins by cutting their product with vitamin E acetate, and still more of them had basically zero quality control and/or just didn't give a toss one way or the other. Throw in the wide prevalence of sketchy bootleg products that people in many places could only get from sketchy sources, and you have a recipe for a budding public health disaster.

Unfortunately, people started getting dramatically ill from using these sketchy products, and doctors dubbed that illness EVALI (E-cigarette or Vaping Use-Associated Lung Injury), and a whole bunch of people absolutely lost their shit. A number of groups used this as an opportunity to lump in nicotine vaping as well, and...so much FUD was spread around. This pushed a federal judge into tearing off his wig, demanding that the FDA pull its finger out, and splintering his gavel. That's when the FDA finally started the ball rolling on actually following through with regulating the vape industry via PMTAs.

You know all the stereotypes and attitudes (some demonstrated in this thread) against vaping? That's part of what I mean by the industry collectively doing this to itself. They lost the plot, steered the bus away from the well-intentioned road of helping people quit smoking, and careened it straight off the cliff of greed and shortsightedness, and that gray chicken has well and truly come home to roost.

This isn't a popular opinion in vaping circles, but the vaping industry is in dire need of regulation and a better focus on user safety, so even though the methods used to push things along were treacherous and unsavory and certainly favored Big Cigarette, the end result is going to be something more grown-up and responsible than the crazy Wild West stuff that was going on over the past decade.

Well said.

And very well written.

 

[sandollars]

A very early vape device loaded with "Stale Cookie" helped me quit Cigs in 2001. It was shaped like a cig and you screwed refills onto it. Barely put out any smoke, nothing like the ones the kids use today..

I have never seen a "Grown Up" use a vape device, though my definition of a grown up may vary from yours....

 

[lawdawg]

I'm just gonna hope this is one of those things where the pipe community avoids becoming collateral damage.

Seems we've been caught in the crossfire for a while now since the advent of FDA deeming regulations. I've heard tell of statements from the FDA that pipe tobacco is not an enforcement priority, so hopefully that will remain the case, and manufacturers of pipe tobacco will keep doing their thing.

The bottom line is that the regulatory environment for tobacco does not look good, so stocking up on your favorite blends is a wise idea at this point if it's important to you to ensure they are still available (to you) in the future.

 

[bullet08]

Come on, who wants to suck on Juul? Or those impotent little toys? Maybe kids. I want cloud. I want flavor. I started with tube with no electronics, and moved to controlled three cell devices. These are simple devices. But you need to know Ohms law and the limit of the battery. Yeah, Darwin awards should be given to those who didn't educated themselves. Why does this country insist on educating those that really don't want their fingers? Why do others suffer for idiocy of morons who short batteries in their shorts? I mean, if they do not take simple precautions, why does that limit options for those who follow the simple idea of don't blow up battery in your hand? I have known idiots who lost their fingers playing with fireworks. I can tell you they won't play with fireworks any longer.

 

[sasquatch]

I'm just gonna hope this is one of those things where the pipe community avoids becoming collateral damage.

Seems we've been caught in the crossfire for a while now since the advent of FDA deeming regulations. I've heard tell of statements from the FDA that pipe tobacco is not an enforcement priority, so hopefully that will remain the case, and manufacturers of pipe tobacco will keep doing their thing.

The bottom line is that the regulatory environment for tobacco does not look good, so stocking up on your favorite blends is a wise idea at this point if it's important to you to ensure they are still available (to you) in the future.

Remember which way the wind is blowing - these FDA deemings were pushed for by big tobacco in order to gain a hold (a big hold) in the very profitable and previously unregulated vape world. Pipe stuff is so small and meaningless that it was easily swept in with just a few words. Your advice is right. Cellar wide, cellar deep, and do it now.

 

[Worknman]

Ooh, I actually know something about this!

That particular industry basically did it to themselves--it all started out with pretty basic, low-powered, and temperamental cigarette-like devices developed in China by Hon Lik in the early 2000s, and the two flavor choices you had back then were basically "stale cookie" or "toothpaste"...sorry, I mean "tobacco" and "menthol". The intentions were good; Hon Lik was after a way to quit smoking, and it wasn't really viewed as anything else.

Once it caught on in other countries as a means to quit smoking, a LOT of sketchy people jumped into the industry to make a quick buck alongside a number of honest purveyors who just wanted to see people kick their cigarette habit, and things went Wild West pretty fast.

There was also an active scene of people building their own devices by modifying flashlights (a basic vape was pretty much the same thing as a common flashlight in principle, except the "bulb filament" is wrapped around a wicking material soaked in e-liquid), and China caught onto that craze and started putting out mass produced, higher-power devices with onboard electronics to handle power adjustment. On top of which, there wasn't a whole lot of education, not much focus on user safety, and then shit like people's vapes exploding and starting fires became a thing.

Juul came along in the mid-2010s and introduced a small, more reliable, and sleek pod device that used what are called "nicotine salts" (protonated nicotine using either benzoic acid or salicylic acid to make higher nicotine strengths easier to inhale, much more closely mimicking the way a cigarette feels).

Their big mistake was deliberately marketing to a very young audience, and suddenly, there was an epidemic of teenagers and middle school children getting their hands on Juul devices, which really wound up a lot of parents and brought vaping to the attention of anti-tobacco and "think of the children" lobbying organizations. The first PMTA deadline was actually around August 2016, but the FDA kept kicking the can down the road.

Fast forward to a few years later...remember those sketchy people I mentioned earlier? Well, some of 'em figured out you could vape cannabinoids, and then a few of them decided to squeeze more profit out of their margins by cutting their product with vitamin E acetate, and still more of them had basically zero quality control and/or just didn't give a toss one way or the other. Throw in the wide prevalence of sketchy bootleg products that people in many places could only get from sketchy sources, and you have a recipe for a budding public health disaster.

Unfortunately, people started getting dramatically ill from using these sketchy products, and doctors dubbed that illness EVALI (E-cigarette or Vaping Use-Associated Lung Injury), and a whole bunch of people absolutely lost their shit. A number of groups used this as an opportunity to lump in nicotine vaping as well, and...so much FUD was spread around. This pushed a federal judge into tearing off his wig, demanding that the FDA pull its finger out, and splintering his gavel. That's when the FDA finally started the ball rolling on actually following through with regulating the vape industry via PMTAs.

You know all the stereotypes and attitudes (some demonstrated in this thread) against vaping? That's part of what I mean by the industry collectively doing this to itself. They lost the plot, steered the bus away from the well-intentioned road of helping people quit smoking, and careened it straight off the cliff of greed and shortsightedness, and that gray chicken has well and truly come home to roost.

This isn't a popular opinion in vaping circles, but the vaping industry is in dire need of regulation and a better focus on user safety, so even though the methods used to push things along were treacherous and unsavory and certainly favored Big Cigarette, the end result is going to be something more grown-up and responsible than the crazy Wild West stuff that was going on over the past decade.

Nice analysis. But I think the industry heading in the direction it took was bound to happen anyway. This new device that looks cool and is different than those sticks that killed grandma and grandpa was already something primed for teenagers to latch onto. The industry basically did what all industries do, which is optimize their product according to the demands of their customer base.

I remember in the beginning they tried to market it as a way to quit smoking. But that whole shtick was doomed to fail from the beginning due to the appeal of curious kids wanting to try something new.

 

[greeneyes]

None of the unsuccessful applicants were Big Tobacco. I wonder how the big boys will do when they step up to the plate.

I'd say you nailed that one:

BBC News - Vaping: FDA approves e-cigarette in US for first time

Vaping: FDA approves e-cigarette in US for first time

The drug regulator says the benefits of adult smokers switching to the product outweigh the risks.

www.bbc.co.uk

 

[Merton]

Citing the FDA Report: They say "OVER 80%" but an old college Professor taught me that "There are lies, damn lies, and statistics". It's pretty easy to look this stuff up, ya know...

Does it really matter if it's 80% or 50%? Point is still sound.

Official Magazine - Tobacco Business Magazine

Welcome to the new chapter of Tobacco Business Magazine, now exclusively available to Phillips & King customers. Full of content that celebrates the stories of the people, places, and products behind our industry.

tobaccobusiness.com

The "lies" quote is generally attributed to late British PM Benjamin Disraeli

 

[Briar Lee]

About five years ago my adult daughter wanted to travel to Hutchison Kansas to sell a horse at an auction there.

She asked me if she could use my one ton Dually diesel flatbed Dodge truck to pull her horse trailer, and I naturally agreed, at a chance to pretend I was a real truck driver. Off we went to Kansas, about a four hour pull.

She doesn’t smoke, and doesn’t like the smell of smoke, especially not in a confined cab of a truck. So I bought a little vape pen, one with cartridges, at a local gas station.

After I felt a need for nicotine she helped me get the gadget all ready, and I sucked on it like I would a cigarette, and inhaled the vapors.

I’m glad she was driving, because I thought I might cough myself to death.

I said how do you kids smoke these things, and she said take smaller puffs.

If I just barely puffed on it, I could stand it. But what taste it had was bad, so I just went without nicotine until we arrived at the sale barn.

I’ve still got it in drawer, like new, used very little.

This summer my daughter was blowing vapor out like a steam train and seemed to be enjoying it, so I got brave and asked for a puff, just to see, if they’d improved those gadgets.

Geezus, it was delicious, smooth, and tasted like bubble gum.

If they’d had those fifty years ago, I’d have liked those as well as I did Happy Days Raspberry flavored snuff, which was a little cheaper than Copenhagen.

There was Happy Days Mint flavor too, for the beginning smokeless tobacco user.

And Lemon Twist cigarettes, too.

When marijuana is fully legal they’ll put it in a vape cartridge and it will taste like strawberries.

 

[anotherbob]

When marijuana is fully legal they’ll put it in a vape cartridge and it will taste like strawberries.

At the dispensary they have that. And my favorite name for one was Sundae Driver. A name that gives one a genuine gawf.

 

[Adopteros]

To be honest, I don't see anything good in it.

 

[Adopteros]

To be honest, I don't see anything good in it. I don't smoke cigarettes, I don't smoke marijuana, I don't drink alcohol. The only thing I like is iGet Vape. For me, this is the only way to relax and get high. And I don't do it very often. I believe it is unnecessary to prohibit everything for everyone because of teenagers. If they want to vape, they will find a way to do it. I think that many will agree with me. Teenagers can be monitored more carefully and not cause inconvenience to other people.

 

[solideogloria86]

I am sure Vaping has helped people quit the "Evil Weed" but I bet no one quit by vaping Apple Crumble....

I quit smoking cigarettes vaping Sugar Drizzle (Tasted like snicker doodles)

 

[bullet08]

I vaped before. Coil my own. Have enough parts to go back if I want. Making my own liquid is none issue. It's a fact that vape will help you quit nicotine dependence. It has been done by countless people in this country and others like UK.

It sucks that the liquid vendors are putting names on the product that might entice young kids, but adults do enjoy those flavors also. Look at how well aromatics sell.

If FDA is truly looking after kids, they would go about the other way to leave room for adults who wants to quit without giving up on flavor.

I started smoking when I was 12 yrs old in NYC. And I'll do it again if I was 12 again.

Only thing that helped me to quit cigarettes and keep it off was vape. Of course, now I don't vape, I'm back to cigarette. Just too lazy to charge batteries, coil wires, buy juice.. A bit of leg work. Pipe definitely helps.

 

[bullet08]

Oh.. I commented before. Yeah, I'm passionate.

 

[K.E. Powell]

I can't add anything that Misanthrope and Lawdog haven't offered already, but I will say that I am 35 years old, and will smash a bowl of Cinnamon Toast Crunch any day of the week.

 

[anotherbob]

one fact younger people are more willing to try new things. Especially when you consider more things are new to them at that point. So to my mind the number of kids using it over any other nicotine delivery system isn't really anywhere near as meaningful as it's presented to be. Especially when you consider that less kids vape now compared to how many kids smoked cigs when I was a kid.