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One Shots/TFN and FDA REGS
submitted about 8 years ago by SophisticatedHack

I am certainly no lawyer and may not be as well read as some others on the issue but I am trying to draw a distinction. There seems to be this growing confidence among several mixers that selling their recipes as "one shots" keep them in the clear under FDA deeming rules. (Caveat: This is a moving target that is hard to predict where it will land). I read an article recently from a legal mind that was addressing TFN (Tobacco Free Nicotine) stating that companies are still likely to be subject to FDA REGS because there product has an expectation to be used in an ENDS or system capable of delivering nicotine. If that logic is sound (and I'm not convinced that it is), wouldn't there virtually be no difference in these one shot flavor recipes as they are clearly intended to be used in the same manner??? Its all cloudy in here so perhaps someone can help clarify this for me?

I personally would much rather see mixers with an interest in selling their recipes being able to do so using a TFN product which is ready to vape by the end user. I think the necessary added steps of mixing base, etc. make large scale success somewhat of a pipe dream. If you are calculating and mixing...your mixing...right?? I think especially in the US consumers want the shortest path to satisfy their wants. I just can't imagine how small this niche market between regular vapors and DIY mixers must be? In other words the vast majority of folks probably wouldn't want to mess with base and nicotine and measuring (as simple as it is) and a high percentage of those that would-are probably going to end up mixing themselves? The gap in between cannot be very large right? I am more than willing to be corrected on this point.

Perhaps I am way off base but based on what I can see TFN or some similar product that allows you to deliver a ready to vape product and stay from under the FDA's REGS would be vastly superior to offering kits? The only industry that operates this way that I know of might be food. If folks approached vaping the way they consume and prepare food then it'd be all good but I'm just not sure the culture is there or not?

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6 points
 
by EdibleMalfunctionabout 8 years agoThat Sugar Cookie Guy

Personally, I don't see what the insistence is on DIYers selling juice. We all got into this hobby in order to save money/create tastier shit than what's on the market. Not make money off our juice. I realize that's how some companies got their start, but that is not how today's market works. The market is oversaturated, and it requires boatloads of money to get up and running legally. People should be happy that we have all these wonderful resources to make whatever we want to, when we want to. Not be concerned with "OH MY GOD I WANT TO START A BUSINESS HOW DO I DO IT?!" The answer to that question is always, if you are in the US, you don't. Sell juice on the classifieds sub if you want to. Or just sell to people you know and trust.

5 points
 
by SophisticatedHackabout 8 years ago

I hear you but is clear that a lot of mixers eventually want to get paid for their talents and/or share their work with non-mixers. Perhaps not as a primary source of income but to help fund their supplies, etc. I personally don't see anything wrong with it if someone wants to pursue it that way. I sometimes pick up on this distinction between the DIY community and commercial mixers which I don't think really exists. Someone with the talent to make a top selling juice has no less credibility than someone who does it as a hobby. They arrived at those recipes through the same process anyone else would have to go through. Whomever created the recipes for say a Cuttwood obviously have a high level of skill. Some of those top selling juices are hype and some are really good.

2 points
 
by EdibleMalfunctionabout 8 years agoThat Sugar Cookie Guy

Yeah and the thing that mixers who want to go "big-time" don't want to hear is tough shit. I was not talking about a distinction between commercial mixers and DIYers, other than the fact that they are selling mainstream and we can't now. Like I said, sell to people around you or sell on the classifieds. This isn't a money-making hobby currently, and probably not ever again as far as we know.

3 points
 
by SophisticatedHackabout 8 years ago

I hear your sentiment but I would just say that there are a lot of mixers getting involved in the "one-shot" market place...I don't know if the intention is to go big time but it certainly has a business aspect to it that personally I'm not averse to. The market will dictate if it is viable or not. Mixing for yourself is a tremendous luxury that we have and I can appreciate that it does have a lot of value in and of itself.

3 points
 
by Severian71about 8 years ago

"...but that is not how today's market works. The market is oversaturated, and it requires boatloads of money to get up and running legally."

Sure, lots of people would love to become rich selling juice, but not that many could, even if they were great mixers. Mixing good juice is, no offense to the great mixers here, probably easier than building a profitable business selling juice in an "oversaturated" market. Running a business is usually harder than it looks from the outside, and making one really profitable is harder still.

I think the market tends to take care of that sort of problem though- some dreams might get dashed in the process, but in the end the people who are able to provide a product people want at a price they are willing to pay will survive, everyone else will go do something else, and we'll all be better for it.

The FDA regs are not what I would consider a normal market force- the opposite, in fact. It doesn't do, IMHO, to conflate arbitrary and capricious regulation with market forces. We''ll be the worse for the former, at least in this case.

2 points
 
by SophisticatedHackabout 8 years ago

Yes, I think you are absolutely right. The marketing/distribution side of the equation seems especially huge in vaping. If that juice isn't available at a shop near you then you are much less likely to every try it and buy it.

I can see perhaps in the more distant future (if things go the way I hope they do) where you have your giant high volume low cost good enough to vape juice and a sub-group of craft juice makers that offer hand mixed, more esoteric and perhaps higher priced liquids for the more discriminating portion of the market. I feel like in every industry you have your high volume low cost products and your low volume higher priced products. I don't see why e-liquids would shake out any different in the long run.

4 points
 
by who_dat_009about 8 years ago

what's a one shot?

4 points
 
by wh1skeyk1ngabout 8 years agoThanks for reading this flair

Basically it's someone's recipe with all the flavor concentrates pre-combined into a single bottle of flavoring, and you add X amount to your preferred VG/PG/nic.

1 points
 
by who_dat_009about 8 years ago

gotcha. we have a local shop here in az that only sells juice that way. their house juice at least

3 points
 
by wh1skeyk1ngabout 8 years agoThanks for reading this flair

I think it's cool that shops do that. Some people can't afford Cuttwood, 5 Pawns, or Suicide Bunny. Shops generally offer their one shots at a much more reasonable cost than commercial, and often times they are just as good if not better (after properly mixed) than the $20-$30 bottles of commersh.

On that note, if you choose to go through the trouble of mixing a one shot, why not just DIY? The roads are endless.

EDIT: words

1 points
 
by TheDonkeyWheelabout 8 years ago

Which store in AZ?

3 points
 
by SumOldCantabout 8 years ago

A one-shot is a completed recipe, but still in the form of a concentrate. You still need to add VG, PG and Nicotine to a one-shot to make it ready-to-vape.

0 points
 
by who_dat_009about 8 years ago

gotcha. we have a local shop here in az that only sells juice that way. their house juice at least

3 points
 
by SophisticatedHackabout 8 years ago

A one shot is a pre-mixed recipe you can purchase and make a finished e-juice with the addition of nicotine/base. You don't have to calculate ratios or purchase individual flavor concentrates-it is more prevalent in the UK but some vendors are offering these premixed concentrates here.

0 points
 
by who_dat_009about 8 years ago

gotcha. we have a local shop here in az that only sells juice that way. their house juice at least

4 points
 
by EdibleMalfunctionabout 8 years agoThat Sugar Cookie Guy

Is there an echo in here?

4 points
 
by Paleone123about 8 years agoProud Sidebar Reader!

The deeming regs work like this:

FDA - we deem "foo" to be a tobacco product if it contains "bar"

Us - we'll just sell "foo" without the "bar"

FDA - To clarify, all "foo" is now a tobacco product

They can do whatever they want.

It doesn't matter though, as long as you don't sell it.

2 points
 
by SophisticatedHackabout 8 years ago

Of interest is that the new head of the FDA has investments in the industry and made some actual indications that he might be 'reasonable' in his approach. We can hope and try to mobilize as well as the cannabis industry has. 40 years ago it was almost inconceivable that cannabis would be legal for recreational use (at least a state level) and that trend is like to just continue until there are so many states on board that it forces the feds to capitulated. Its consistent pressure, changing of public perception and some science never hurts! There is a road map.

3 points
 
by kindgroundabout 8 years agoDiketones, Schmiketones

Nowadays, most Americans consume and purchase ready to eat food from the window of their car. I wouldn't use the food analogy.

Seriously though. I mix and I don't see myself not mixing. No matter what the law is.

The only real thing they can do that affects the average diy mixer is make it harder to get concentrated nicotine.

I think mixing some nicotine into an eliquid or adding flavor from a one shot to a base is something people would and can do. I already have 2 people that I mix for that I make them one shots and base for them to mix when they start to get low. It's much better for them (fruits and mints) than making a very large batch that could lose flavor over 6 months. They took to mixing the 2 bottles together pretty well.

Vaping is here to stay. Be it underground or regulated, it's here to stay. People aren't going to unlearn that it helps quit a deadly habit.

6 points
 
by SophisticatedHackabout 8 years ago

I hear you man. I think the point I'm trying to understand is those that are trying to push their products into the marketplace in some form or other that are trying to steer around the FDA and how effective that strategy might be. The vape shops I go to still operate like the wild west man...if it sells they sell it. It is a straight grab the dollars for as long as possible approach.

I completely agree from a user stand point that vaping isn't going anywhere....whether it is commercially regulated or black market the demand for these life saving products is just too high. It is unfortunate that the feds feel the need to get involved in it at all is unfortunate. If I can buy cigarettes and alcohol it is absolutely nuts to think vaping nicotine would be of any concern to them. Its always about money and not safety.

3 points
 
by wh1skeyk1ngabout 8 years agoThanks for reading this flair

>Its always about money and not safety.

When it comes to federal regulations, you hit the nail square on the head.

1 points
 
by Severian71about 8 years ago

I'm not sure I completely agree. If they can regulate one-shots as tobacco products they can regulate flavors in general as tobacco products. Now, you're right, I think, that vaping is not going away, and DIY is not going away. But it could be regulated to a degree that would make it far less enjoyable and accessible.

3 points
 
by Binsky89about 8 years ago

The problem is that flavors aren't specific to this industry. They can't prove I'm not making candy with my flavors.

1 points
 
by SophisticatedHackabout 8 years ago

Essentially they are trying to use the nicotine as the leverage to control the industry. If you can get around the nicotine issue with TFN then you can keep them out of the industry. Thus far it is not entirely clear HOW FAR they will reach to gain control over the industry. The jury is still out. Fortunately, the current head of the FDA has investments in the industry and has made some statements indicating he is sympathetic to our cause-so there is hope that all of this could be averted. PG/VG and flavorings can't be touched really like you say.

0 points
 
by Severian71about 8 years ago

They don't have to prove anything. They can seize your inventory, fine you, and put the onus on you to fight it in court, pretty much because "We said so, so f*** you." If, as in the case of "Smoking Everywhere," you have the resources to actually fight it you might eventually get some injunctive relief. If you do not have fairly deep pockets it will probably come too late to be of any use.

3 points
 
by SumOldCantabout 8 years ago

One shots are a gateway to diy mixing. A cheap way to dip your toe in the water. And with companies like liquid barn offering pre-mixed nicotine in your chosen base ratio, it's a fairly simple 2-step process that is cheap.

They are also much cheaper than buying ready-to-vape product.

And for the triple-threat, they are a great way for mixers to get their recipes into the public domain without having to worry about the pesky FDA (at least for now)

I think one-shots are going to be huge. (and legal)

Just my thoughts. I don't use them and probs never will, but this is how I see them.

One of the reasons vaping is so popular and successful for people trying to quit cigs is how it can be customised to suit so many different styles of vaper and consumer type.

3 points
 
by SophisticatedHackabout 8 years ago

Your might be dead on right in terms of the cost factor-that is a good point which could be a driver to shift the way e-liquid gets into the hands of the average consumer. It could get traction that way no doubt.

3 points
 
by Severian71about 8 years ago

Th FDA has been a bit coy on the subject of 0 nic juice in general (whether concentrated one-shots clearly intended for mixing juice differ significantly from less concentrated "just add nic" 0 nic juice is one of many open questions.)

In response to a lawsuit (Nicopure vs FDA) the FDA had this to say:

'Not all nicotine-free e-liquids (NFLs) are subject to the deeming rule. Assuming an NFL is not made or derived from tobacco, it is subject to the rule only if it meets the definition of a "component or part"—that is, if it is "intended or reasonably expected" either "(1) To alter or affect [a] tobacco product's performance, composition, constituents, or characteristics; or (2) To be used with or for the human consumption of a tobacco product; and is not an accessory."...An NFL that is intended or reasonably expected to be mixed with liquid nicotine would qualify as a "component or part."'

This is a little less clear than it seems, because the FDA seems to want to consider all vaping hardware you can add juice to "tobacco products," so even if they couldn't show that your flavorings were "intended or reasonably expected to be mixed with liquid nicotine" they might well decide that the fact that it is intended to be put in a refillable tank makes it a "component or part."

And the FDA also has a nasty habit of arguing that companies can't challenge their regs in court because they do not have standing to do so because the regs are so unclear that it can't be determined whether or not they apply to the companies in question without further guidance from the FDA. I wish I were making this up, but I think if you take a close look at the Nicopure case you'll find that I am not, and that my description of their reasoning is accurate.

This should be of some concern to DIYers because the line between one-shot and flavor is a fine one. Companies like Medicine Flower and Loranns, who have never catered particularly to vapers, and primarily produce flavors for other uses, should be fine. But FA has gone so far as to have a "vaping" line, and that might wind up being a problem for them.

And FLV? Well, I think a case could be made that their intention from the outset was to produce flavors for vapers. I don't think it likely that the FDA will go after them any time soon, but I would have thought this whole conversation nuts a few years ago, so...

Anyway, sorry to go on at such length, but I think this is a matter that should be of at least mild concern to DIYers, regardless of whether or not they want to sell one shots.

1 points
 
by SophisticatedHackabout 8 years ago

Yes, this is the meat of the biscuit I was trying to tear off. Where these lines between TFN and flavors get drawn. Essentially I think we can collectively agree that everyone is operating in a suspended state of animation just hoping they are position correctly if they have business interests tied to sales. I am still not too worried that any of these materials will become unavailable for DIYers as it could easily just become a black market type commodity-if there is a demand someone will provide it.

3 points
 
by EJuiceMakersabout 8 years agoMixologist

The reality of a one-shot is it is just flavoring. It can be added to a coffee, soda, water, cocktail, or even soap. If you were to add a base to it ie vg/pg it becomes more in this grey area if you then tried to sell that as a vapable nic free product.

The income one recieves from a one shot is less than a McDonalds employee makes so please don't think anyone is "making money" around these parts. It is just a way for us to add options for mixers and show off our skills.

MixLife App too is on a break even too, even with almost 1k downloads it just pays the fees to exist.

The World is Vaping and there are plenty of markets to start a Vape company without the FDA regs involved at all.

As someone that has sold over 1k bottles of One Shots, the annual profit is less than one bi-weekly check.

1 points
 
by SophisticatedHackabout 8 years ago

I fully support what ya'll are doing-I was mainly just trying to have some conversation about where some of these grey areas lie and perhaps get some insight into things. If someone is buying a product and getting a perceived value from it there is certainly nothing insidious about it. The only portion of the entire marketplace I really have a problem is companies using irresponsible labeling/marketing to make these quick buck hype juices that look on the surface to be marketed towards kids. That is ammunition the FDA and or anti-vaping groups can leverage against us as an industry. That is a topic in and of itself.

I think some feathers get ruffled whenever you bring up any aspect of the business side of e-juice sales in a DIY forum. One shots hopefully will become a way for mixers much better than myself to put a spotlight on their work and get some compensation to further their passions. Alpine strawberry ain't cheap right...hahahhaha...

2 points
 
by vapingatfiftyabout 8 years ago

Do you plan on vaping it?

If so, it falls under the regulations, TFN or not.

1 points
 
by Binsky89about 8 years ago

Yup. If fucking batteries and wire are tobacco products, then you can bet your ass any form of nicotine will be one too.

2 points
 
by Tiptup300about 8 years ago

I use all these flavor one shots to flavor my diy cheesecakes, not sure what you goofballs are doing on this subreddit.

1 points
 
by riedstepabout 8 years ago

So first paragraph is you don't think one shots will get around regulations. Second paragraph is you don't think one shots are a good business idea. Third is it would be better if you could get around regulations with something that wasn't one shots. I'm confused.

1 points
 
by SophisticatedHackabout 8 years ago

My point in the first paragraph is that if the FDA uses the guideline that anything created with the intent of being vaped (ENDS) in a device capable of providing nicotine would certainly include a flavoring concentrate as easily as a TobbaccoFreeNicotine. I'm certainly hoping that doesn't become the case but it is unclear where the ball will drop.

In the second paragraph I am just stating that I believe you will reach more people if you have the ability to provide a finished product. They common thread between the two is whether offering TFN mixed juice is any less compliant than a one-shot under the FDA rules? And if there isn't any meaningful difference than selling a completed juice makes more sense in my mind.

That is a lot of the frustration as folks seeking guidance that want to do business in the marketplace. Truth is everyone is more or less just doing what they want and hoping for the best. Time will tell where the chips fall.

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