History of E-Cigarettes and the FDA

[Baditude]

Copied from another group.
With permission

I am the owner of Sapphyre Nicotine. I have been in the e-cig and vape business since 2009. This post is a little long but hopefully it is informative for some.

In 2009 the FDA started seizing shipments of electronic cigarettes under the claim that they were drug delivery devices and therefore need to pass FDA approval prior to being marketed and sold in the USA. The industry was just starting out and this was a big blow. Shipments of product were not allowed to enter the USA. Credit card companies were not allowing ecig companies to work with them. It was not looking good for ecigs. A company called Smoking Everywhere sued the FDA and made the argument that ecigs should be regulated as a tobacco product since they contained nicotine which is derived from Tobacco. Njoy joined the litigation and eventually took over when Smoking Everywhere went out of business. In 2010 Njoy won the litigation and ecigs ended up being regulated as tobacco products. This was the best outcome of two evils. The FDA appealed the decision and lost that as well. That’s when the ecig industry really started taking off. Bigger players got into the market and eventually RJR, Altria/Philip Morris, BAT and other big tobacco companies came out with ecig products. They quickly became the dominant sellers in c-stores. The tobacco companies were happy selling tobacco and menthol flavors only. That’s what they knew and that’s what they were good at.

A few years later eliquids and open systems started getting popular. These products were not very popular in c-stores. That is when vape stores started opening up. They were mainly concentrating on open system (eliquids, mods and great tasting flavors). For a short time c-stores tried to sell eliquids, but they didn’t have the know how or the time to educate customers. C-stores were good at selling closed systems and vape stores were good at open systems.

To the uninformed public we are all lumped in as one industry --- electronic cigarettes.

In reality there are 2 different industries that are somewhat related.

A) The ecig/closed system industry: In the USA as of Sep 2019 is a $6.4 billion industry. It is controlled mostly by big tobacco companies. Juul (Altria/PM), Blu (Imperial Tobacco), Vuse (British Tobacco, formerly RJR), Njoy (only independent supplier), Logic (Japan International). 75% of ecigs are sold in C-Stores, drug stores and food stores. As a comparison, regular cigarette sales in the USA are around $80 billion dollars and about 75% comes from c-stores.

While ecigs sales increased at a 40% year over year rate, regular cigarette sales dropped by 7% year over year. That is a large number that is troubling to big tobacco.

The closed system industry sells primarily tobacco and menthol/mint flavors. If flavors were banned it would not impact the industry very much. The companies selling closed systems are not going to join our fight to save flavors. They have no monetary incentive to do so. In addition all of these companies are going to apply for PMTA. They are not going to sue the FDA and risk getting PMTA approval unless it greatly impacts their business.

The vapor/open system industry: In the USA as of sep 2019 is a $2.6 billion industry. It is NOT controlled by a few large companies. There are a lot of hardware and ejuice suppliers. It is mostly sold at adult only vape stores. $1.7 Billion sold at vape stores, $350 million in c-stores and $550 million online. Lots of suppliers, distributors, small businesses are part of this industry. They mostly sell flavored eliquid as opposed to tobacco and menthol flavors.

Having been involved with both the ecig business and the vape business, I can say that they are completely different. The vape industry is getting punished for crimes committed by the ecig industry. Unfortunately we are being lumped in as one. We are the easier one to target. We need to do a much better job getting this message out.

I would also like to make a point regarding zero nicotine flavors being regulated by the FDA. The reason our industry is regulated by the FDA as a tobacco product is because the eliquid contains nicotine. This is the only reason the FDA has authority over these products. Because zero nicotine ejuice does not contain nicotine, it is no longer a tobacco product. While the FDA is going to try and enforce regulation of zero nicotine ejuice as a tobacco product by using the “intent to use” rationale, that argument is simply not valid. The FDA will also not be able to regulate zero nicotine ejuice as a drug/drug device combination either. Ejuice with no nicotine does not cause a change in the body and therefore will not be classified as a drug. This is only my educated opinion. I am not an attorney and am not making any legal claims.

I hope this was somewhat informative to people that have not been involved with ecigs and vapes as long as I have. Feel free to add, correct if you have information that I missed.

Feel free to share

 

[stols001]

Thank you for posting that and to the vape owner who wrote that. It was extremely informative, and actually (IMHO) opens up a legal argument regarding 0 nic flavored juices, they are not nicotine containing products, and hence cannot fall under the FDA jurisdiction. I would say it's arguably true that vaping equipment purchased for the purpose (or in conjunction with) 0 nicotine eliquid, cannot fall under that clause either.

THAT is a lawsuit I'd have an interest in joining, simply because it has more than a snowball's chance in hell of being at least logically consistent, at least internally consistent, DIVORCE's vaping's interests from big tobacco's interests, and I would also be likely to purchase 0 nic liquid and hardware from the guy who took the time to research it, and conceive of it.

I would also probably be willing to never buy anything other than synthetic nicotine again (not that I would have any need to do so at THIS point, as I can choose to vape 0 nic liquid flavored however) JUST to stick it to big tobacco.

It's such a small market share. Convenience store market shares are only growing.

We all know the kids/flavors argument is meaningless, and that nicotine is the devil, right? Or we did until BT wants to keep IT'S SHARE of vaping, while making EVERYONE else go away, so they can have smoking AND vaping.

I would seriously donate to any lawsuit willing to argue this in court.

Anna

For someone who loved tobacco as fervently and as long as I did, I really have to say, tobacco TURNS on you in so many ways, and big tobacco KNOWS it. They hook you when you are young and dumb.

Ugh.

 

[Baditude]

Anna, you're finally making perfect sense to me.

 

[vaper1960]

Baditude, thank you so much... I needed that

 

[stols001]

Anna, you're finally making perfect sense to me.

That's what they all say to me in the end.... If you wait it out long enough I make perfect sense at all times. I am batting 100% because whatever moderator can post the "ignore" list has been KIND enough not to do that to me... Yet. LOL.

EXCEPT my biological family, they are like my kryptonite. Swear to God, if I was on my dying bed they would not all be like, "We love you Anna," and "Thanks for being in our lives" my mom would be like, "I'm STILL waiting for a logical explanation for why when I left you home with your grandmother and you got mad you cut up YOUR dress, not hers..." And I'd be like, "Mom, I told you a billion times, that woman is TERRIFYING. JESUS. She was like you... squared. I would also point out that like I also never destroyed an item of YOURS although I will admit that unkind words crossed between us" and she'd be like "But-- "

Then my older brother would interrupt and demand (after A FULL YEAR of silence, like "Tell Anna to pass the butter this way..." (MY ENTIRE FAMILY WENT ALONG WITH IT EXCPET ME, I was like, "So, older brother I am right here, and I want you to notice that I am PASSING the butter, sort of like as if you were a spirit or ghost, without ANYONE having to repeat your "butter" request.") And then there would be sighs. Eye rolling. Etc.. Anyway long story short I got into one of those particularly... Well, there are nights that you are just TOO angry to drink.. This was one. I blame my mother for her federal crime in opening my mail before I could get to it and doctor it, since I had FAILED an astronomy class by being accused of cheating which was true, only EVERYONE was, and I could tell the guy didn't like me because he could tell I HATED not only Astronomy but ESPEICALLY HIS INTRO which like, I had been informed, incorrectly as it so happened, that it was a really easy science distribution class and I think "distribution" is lame anyway. I don't need well rounded that is what other humans exist for. But well, this was Swarthmore college they ONCE accepted an Olympic size pool from a former member because he felt everyone should know how to swim, so you had to pass a swim test to graduate. Not for like, safety, either, it was ALL about being a well rounded Renaissance man. I mean, I will take all the biology you WANT but freaking, OTHER science classes?? WHY. Anyway, I wound up taking "Physics for poets" later which I think was pretty boring but easy because I remember absolutely ZERO THINGS about it. But I got an A. Nor did I cheat. Which should tell you about distribution requirements. I think I remember perhaps writing a villanelle about gravity for example. Which still makes no sense, at least not all the time.

So yeah, I was mad at this prof and in full self-destructive mode I just stopped going. I did not drop the class. I did not contest his "cheater" accusation. He had hair growing out of his nose that was terrifying in the sense I wanted to GRAB it and I was afraid of like, an assault charge.

But, I was not the peaceful and cheery person of today, I was an Angry Young Person so I went down and just sort of grabbed my mom's French champagne and just sort of drank however many I drank. It didn't even taste that great, it wasn't chilled. It was more about like, how much of my mother's French champagne I could drink to make her mad. I don't consider that destruction exactly. I was consuming it.

So like, she returned home, words were exchanged (apparently) and like, eventually I ran from my evil mother mail fraud mistress feeling like a bit of a dazed.... Well actually I can't think of the right fairy tale princess. It was more like I was her wicked stepmother and she was mine, sort of thing, but I wound up in my older brother's room smashing it up. I have LITTLE memory of this, but we are talking he had a big chair in there like, iron wrought and so mirrors were smashed, holes in walls, book cases pulled down the commodore 64 went through the window. My brother was convinced I did it on purpose because I hated him. While I hated him with a passion, I still maintain that I just headed the nearest way AWAY from my mother's bedroom because I would not dare smash HERS up, NO WAY and also I was in a blackout and while I believe you are sort of legally responsible for your actions in such a state, really people should NOT ask you for the deep emotional reactions behind them, because your answer was/is/will forever be "I was in a black out. I have no memory of that time. I don't THINK I RAN toward your room because I HATE you, I have hated you long before and I have hated you long since, so who the hell knows. That was the ONLY time it happened though, so I'm inclined to blame the BLACKOUT."

That was how I got to rehab number 1. Older brother was so mad he did not come to family therapy but the rest of that lot did.

My counselor said she could completely understand why I was a drunk and all, but I still had to take responsibility for it. Of course, she was a bulimic so I was like, "I don't see how you would decide that really" and she all got into the addictive tendencies and such but I was like, "Apart from the vomiting, I don't see it."

So yeah, family kryptonite to this very DAY and I hope that clears things up for you. LOL.

The message is, consistency is important and mail fraud SHOULD be punished and if life were fair, my mother would get a felony for opening my mail. But (this is later that night but the hour grows late here too) the cops who brought me back to the house TWICE that night declined my fervent protests to like, lock her up for opening my mail. They were like, "Quit running away. We could take you to jail you know."

So I stopped arguing it. But she was the criminal here, NOT me. Well, technically both. Kind of like big tobacco and tobacco. I was the convenience store vape and my mom was the pack of Marlboros. We both sucked.

Anna

 

[asharru]

Great read. Thank you for passing it along Bad. I'm going to do the same whenever I have trouble describing to someone what makes our market so very different. Most people really don't understand, nor should they really. We are a relatively small group of former smokers who found what we believe to be a safer Nicotine replacement. I thought I'd die an unhealthy, out of shape smoker. Now I'm an extremely active, reasonably healthy and happy vapor. I am, however, surprised at how small our niche is. I always thought there were a lot more of us. I guess when you lurk around here as much as I do, it seems that way. Thanks again.

 

[Rossum]

A) The ecig/closed system industry: In the USA as of Sep 2019 is a $6.4 billion industry.

The vapor/open system industry: In the USA as of sep 2019 is a $2.6 billion industry.

I'm a bit surprised at these numbers. I wonder what the source is? I was thinking the vapor open/system market was roughly the same size as the c-store market, but the claim here is that it's less than half?

Oh well, we know that vaping open systems is way less expensive.

 

[sonicbomb]

A great read, thank you. This makes it clear why the latest attack against vaping in the US does not include menthol and tobacco flavours.

 

[scott58]

I wonder where the cherry cigar market sits in all of this.

 

[United States]

Vaping nicotine is the new smoking. The irony is the kids started vaping nicotine because it was safer than smoking.
Juul was a double edge sword. It helped a lot of smokers stop. But it also became the device that gave big tobacco a viable competitor. Big tobacco bought Juul and that was that but……

Vaping became the new smoking with an entire generation of craft beer and other distilled liquid drinkers. Craft e-juice is now all the rage. Trouble is the market pales in comparison the the pre-packaged items. Meanwhile those who invented and perfected the "craft" vape market are now squarely in the cross hairs of an over zealous governmental system called "the nanny state".

I've known since early on vaping was going to face this scrutiny. Thing is weed smokers have known about vaping since vaping was invented. Now that states galore are legalizing it, that's when the real trouble for e-cigs began. What was once a "craft" industry in the shadows has led to open devices even in states where weed is still illegal. In my town is a chain of head shops touting their roots all the way back to 1988. They skirted the rules by calling their items "tobacco" products when everybody knew that was not the case.

Wal Mart sells CBD back braces and knee braces while they halt selling nicotine vape devices. It has been said that nicotine is the worlds most addictive chemical. Agree or not whether it's THE most addictive we can all agree it is addictive. The kids are getting hooked on nicotine and that's the root of the issue in the eyes of big brother. There will come a time that bulk purchase nicotine will be a controlled substance.

The original post indicated the light at the end of the tunnel, which is nic-free flavored e-juice. The question later will be whether we can add our own nic or not. I never imagined a day where I could walk into a store and buy weed, but have to get my nicotine from a drug dealer. But I may live to see that day if this keeps up.

I started out vaping from pre-packaged cartridges and will resume if it means a choice between that and smoking. Ideal? Nah, not at all nor is handing the government another liberty. But the writing is on the wall. Hopefully the "craft" e-juice industry can figure out how to use the same loop holes as that head shop in my community does. An entire generation of craft alcohol drinkers may end up being the ones who keep a market of flavored e-juice available. They've managed to get around obstacles like added coloring by making it clear, by charging a buck for sampling nic-free juices etc.

Fingers crossed.

 

[Baditude]

In 2012, I visited the first vape shop in Ohio. AltSmoke in Columbus, Ohio. I had been vaping for only two months, and was excited to visit my first real life vape shop.

The owner's name was "AltSmoke Rob". I drove the 2.5 hours one way from Cincinnati to Columbus for what was for me a historic day that would impact my life in the future. The practical purpose of the visit was to replace a battery for my AltSmoke BB mech mod, but ended up being a 4 hour introduction into the history of the E-cigarette and the FDA. The irony is he didn't have the 14500 battery I needed in stock. However, I saw the first real life vapers I had ever seen, shared stories and see the different gear that other vapers were using.

I was using two mech mods purchased from AltSmoke's online store, a Silver Bullet and BB (baby bullet?) topped with cartotanks. I had already switched from a Menthol flavor to a Coffee flavor.

Rob started his online store from his home, using his garage as his warehouse pre-2009. He described when the FDA banned all of his products in 2009. US Customs blocked all incoming shipments of anything e-cigarette related. I don't remember how many months he said that went on, but most online vape businesses were forced to file for bankruptcy with no product to sell for months. No one knows what Customs did with the products they seized.

Anyway, I interviewed for a part time position when AltSmoke's second B&M was about to open in Cincinnati.. It was to be their "flagship" store. I was working for a hospital full time, but since I was an enthusiast I was hoping for part time work maybe on the weekends. Rob was only looking for full time people, but would keep me in mind when a part time position would open up.

Well, I lost my full time job at the hospital about a year later when my health issues got worse, and contacted Rob. Even though he didn't have a position open, he kept his promise and gave me a part time position anyway.

That first store would expand to 11 B&M stores in four states. I don't know if they are going to be able to remain open if this flavor ban goes through.

AltSmoke Cincinnati (Eastgate)

 

[United States]

We have a chain in my state and nearby that has over 100 stores. They also have an e-store that requires outsiders to provide proof of age. If you sign up in person the e-store is pretty hassle free.
Avail caters to vaping and for the years has been selling nicotine vape systems and only those. They are a smoking cessation company who makes you show your ID when you walk in the door. The one in my town is near a college and military base, next door to a bank with an outdoor ATM. Business is brisk, but you can be assured somebody will check your ID or you will be asked to leave.

They have a lineup of flavors that are pretty nice. They also carry big name flavors, some of which are Avail exclusives. In my community literally thousands of young adults have switched to vaping from smoking thanks to Avail. They have recently begun selling CBD devices too. But when it comes down to it the juices are their cash cow. Hopefully they can be around as part of the industry when all the latest dust settles.

 

[Baditude]

AltSmoke has begun selling CBD in the B&M stores, mainly because the manager of all the B&M stores has used it himself (2 back fusion surgeries) and knows it has helped him. I don't know the brand. I got the impression it is the oral form and NOT for vaping.

 

[Punk In Drublic]

In 2012, I visited the first vape shop in Ohio. AltSmoke in Columbus, Ohio. I had been vaping for only two months, and was excited to visit my first real life vape shop.

The owner's name was "AltSmoke Rob". I drove the 2.5 hours one way from Cincinnati to Columbus for what was for me a historic day that would impact my life in the future. The practical purpose of the visit was to replace a battery for my AltSmoke BB mech mod, but ended up being a 4 hour introduction into the history of the E-cigarette and the FDA. The irony is he didn't have the 14500 battery I needed in stock. However, I saw the first real life vapers I had ever seen, shared stories and see the different gear that other vapers were using.

I was using two mech mods purchased from AltSmoke's online store, a Silver Bullet and BB (baby bullet?) topped with cartotanks. I had already switched from a Menthol flavor to a Coffee flavor.

Rob started his online store from his home, using his garage as his warehouse pre-2009. He described when the FDA banned all of his products in 2009. US Customs blocked all incoming shipments of anything e-cigarette related. I don't remember how many months he said that went on, but most online vape businesses were forced to file for bankruptcy with no product to sell for months. No one knows what Customs did with the products they seized.

Anyway, I interviewed for a part time position when AltSmoke's second B&M was about to open in Cincinnati.. It was to be their "flagship" store. I was working for a hospital full time, but since I was an enthusiast I was hoping for part time work maybe on the weekends. Rob was only looking for full time people, but would keep me in mind when a part time position would open up.

Well, I lost my full time job at the hospital about a year later when my health issues got worse, and contacted Rob. Even though he didn't have a position open, he kept his promise and gave me a part time position anyway.

That first store would expand to 11 B&M stores in four states. I don't know if they are going to be able to remain open if this flavor ban goes through.

AltSmoke Cincinnati (Eastgate)

Looks like good wholesome fun for the whole family complete with snacks and soft drinks for the kiddies.

 

[Baditude]

Looks like good wholesome fun for the whole family complete with snacks and soft drinks for the kiddies.

If there were toddlers in the store, we would turn on The Cartoon Network to keep them occupied and distracted so that the adults could do adult thing...within reason. No alcohol allowed.

 

[stols001]

Having frequented the shinyitis thread I was a bit surprised too, but like, even one person can only spend so much. IDK how they are calculated.

BUT it only makes me MADDER. It's like big tobacco is an elephant and we are an ant and it still has to SQUASH us.

Anna

 

[Punk In Drublic]

If there were toddlers in the store, we would turn on The Cartoon Network to keep them occupied and distracted so that the adults could do adult thing...within reason. No alcohol allowed.

By law, no person under the age of 19 is allowed inside a vape shop here in Ontario – and I have to agree with that rule.

 

[Jman8]

My takeaway from the OP:

Because zero nicotine ejuice does not contain nicotine, it is no longer a tobacco product. While the FDA is going to try and enforce regulation of zero nicotine ejuice as a tobacco product by using the “intent to use” rationale, that argument is simply not valid. The FDA will also not be able to regulate zero nicotine ejuice as a drug/drug device combination either. Ejuice with no nicotine does not cause a change in the body and therefore will not be classified as a drug. This is only my educated opinion. I am not an attorney and am not making any legal claims.

That legal battle will be most interesting. If vaping side wins, it would mean flavors are not the issue. Or it would mean vaping eliquid that has everything we currently have in eLiquid, minus the nicotine, would be legal. Possibly even available for all ages (not sure why it wouldn't be). With the politics and money currently involved, I can see vaping side losing, but over the long term (via appeals, black market at work), I see vaping side winning.

I do disagree that vaping and eCigs are "completely different." With perhaps emphasis on completely as to what I disagree with. There's many distinctions to be made between the two, but both are mainly made/purchased as a suitable nicotine delivery system, that involves vapor. Politically, I'm not truly up for throwing either under the bus because of how similar they are, IMO. I'm sure BT/BP will not go to bat for vaping (open systems), but it's not like die-hard politically aware vapers are wanting to get in bed with whatever BT/BP is doing with regards to our love for vaping, and the industry. With that said, and my being cynical, I would have little issue if closed systems went away for good, as that would likely take care of the 'epidemic' of kids using. But alas, we live in a world where the opposite is about to happen, which means kids will continue to be using, and the epidemic will be understood as kids are still participating in the underground market.

 

[stols001]

By law, no person under the age of 19 is allowed inside a vape shop here in Ontario – and I have to agree with that rule.

I have no idea why the magical age of 19 is so freaking great. I mean, if we were to be SENSIBLE we would limit any entry into any store where things of an addictive nature could be purchased to the age of about 24--25 which is the age where the brain finally stops developing so the owner of said brain at least has a CHANCE at making some rational decisions, but it still takes PRACTICE.

Also I am not sure I care who enters stores such as these, either. If anything, it would be more effective to DENY entry to the homeless person who is buying the kids vapes in return for the cost of two Colt 45s (for clarity, I mean the BEVERAGE.)

When things are in society, they are there. What happens to them from THERE is kind of up to a bunch of people.

Banning kids from vape shops might sound good and I have no problem with it but I am TOTALLY serious about banning the homeless as it would be more effective.

Honestly, it's a whole lot safer and cheaper than the black market. Most homeless folks are very accommodating when it comes to these matters.

Or we could just accept that SOME minors will vape accept it, and just SAY NO to the "giving in to the propaganda about saving the children."

F the children! That's what I say. REALLY. Caving to this narrative is NOT smart. I LOVE kids, I work with them daily and some of them DESERVE to die. Not in any kind of moral sense but they're IDIOTS. Why one who tries to kill themselves with a Tylenol O/D and succeeds, and one doesn't? I have NO CLUE.

BTW, Tylenol is one of the most effective inadvertent suicide methods kids have. They think it's all safe and they are like "If I swallow 100 of these someone will pay attention to ME!!!!" (Which is a worthy and valid goal if you are suicidal and you aske me.) Only they secretly are pretty sure it won't kill them and then they die of a liver overdose.

You don't see Tylenol going anywhere do YOU?

KIDS DIE. They die all the time. They die before and after and DURING childbirth.

I see nothing particularly astonishing about this generation that needs to be preserved at all costs, other than perhaps how spectacularly badly they are being parented. But that is the kind of special you DON'T want, frankly.

Anna

 

[Punk In Drublic]

I am going to refrain from using the word homeless for it stereotypes those who maybe dealing with an unfortunate situation with their life. But here it is illegal for an adult to purchase any age restricted product for a minor. Getting caught can lead to criminal chargers here in Ontario. Buying an Eleventeen year old a vape product could very well lead to you sharing a 4x8 cell with some 300lb no neck named Tiny

As for kids in vape shops. The US is dealing with an underage crisis that may have many levels of complexity. I personally do not believe we should leave it for our agencies and governments to combat this crisis alone and that we as responsible adult vapers should contribute where we can. Exposing minors, children in fact, to a fun family oriented environment that involves an adult activity is not what I consider putting forth our best efforts into combating underage vaping.

Tylenol and suicide may be a problem with kids – even if suicide is not the objective and they are seeking attention. But Tylenol is not the problem adult vapers are facing. Fair to draw a correlation, but we should be focusing on the problem at hand.