Deeming Regulations have been released!!!!

BigPappa

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Please note that all these figures are generously low, but still prove a point. If a 'mom and pop' type vape shop offers 12 different flavors in 2 different sizes and 4 different nic levels, to the FDA that is 96 separate products, each of which will require a separate PMTA with a cost maybe as low as $350,000. That's a total cost of $33,600,000! That's a pretty expensive pie!
The smart thing to do is if unflavored liquid is approved, they could sell that by itself and then sell "food flavorings" separately in measured amounts to match the bottles of fda approved unflavored liquid to make it easy for a novice to DIY.
 

Rossum

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The smart thing to do is if unflavored liquid is approved, they could sell that by itself and then sell "food flavorings" separately in measured amounts to match the bottles of fda approved unflavored liquid to make it easy for a novice to DIY.
If you sell those flavorings in the same store, the FDA will regard them as a tobacco product too, meaning they'd also need a PMTA.
 

Eskie

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Please note that all these figures are generously low, but still prove a point. If a 'mom and pop' type vape shop offers 12 different flavors in 2 different sizes and 4 different nic levels, to the FDA that is 96 separate products, each of which will require a separate PMTA with a cost maybe as low as $350,000. That's a total cost of $33,600,000! That's a pretty expensive pie!

Well, mom and pop stores haven’t been able to sell in house mixed juice since 2017, only retail juice they buy wholesale. I mean, they can mix if they want to build an ISO compliant dedicated mixing room, but let’s face it they don’t.

As to the commercial juice manufacturers they face significant hurdles with applications. However, so they’re not forced to expose their secret formulas, and use flavorings off a master ingredient list, they can keep it secret. The FDA has already come out and said you can include a juice with different nic concentrations on one application, no need to duplicate. That’s not necessarily a win for smaller manufacturers, but it’s at least some recognition they can’t make it so over the top it’ll get thrown out in court within a week. Besides, if the administration is going to stand by the policy of flavors for open tank systems only, they might have to leave some sorta path that at least a few people can navigate. Granted that’ll be BT, but it can also be the larger brands like Nicopure.
 

Rossum

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Well, mom and pop stores haven’t been able to sell in house mixed juice since 2017, only retail juice they buy wholesale. I mean, they can mix if they want to build an ISO compliant dedicated mixing room, but let’s face it they don’t.
Yet I know of at least one store that still does exactly that and there's no ISO-compliant anything there. Promulgating regulations is easy. Enforcing them is more difficult, and not every B&M owner is a push-over.
 

stols001

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I would support a reasonable tax but that is not going to happen, I do not believe.

I used to think a sin tax would be better than NOTHING but now I don't really.

That is the only kind of tax that will even be considered.

Just go ahead and ban it and let the interesting times begin..... That's sort of my feeling on it now.

I will pay zero cents of sin tax.. ZERO.
Anna
 

somdcomputerguy

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    Well, mom and pop stores haven’t been able to sell in house mixed juice since 2017, only retail juice they buy wholesale. I mean, they can mix if they want to build an ISO compliant dedicated mixing room, but let’s face it they don’t.
    I was aware of that, but forgot to include it in my humble cost calculations. The pie is getting expensiver..
    The FDA has already come out and said you can include a juice with different nic concentrations on one application, no need to duplicate.
    I've been following the ongoings fairly close, but I was not aware of that. I think I'll leave that little tidbit out though if (when) I throw my example into a conversation about costs to another vaper or smoker or non-smoker..
     

    440BB

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    Does "substantially equivalent" play into this at all? As in one product gets approved and another can piggyback off the approval?
    I believe that substantial equivalence will be expanded to accommodate the players that the FDA eventually blesses, once they've let current the market collapse. Pretty much BT and BP controlled businesses.
     

    BigPappa

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    If you sell those flavorings in the same store, the FDA will regard them as a tobacco product too, meaning they'd also need a PMTA.
    Well that doesn't make sense... for example: what if it is sold in a convenience store? Does that mean all of their other products are regarded as tobacco products?
     

    englishmick

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    Well that doesn't make sense... for example: what if it is sold in a convenience store? Does that mean all of their other products are regarded as tobacco products?

    Don't think anyone knows the answer. Vape shops are different in that they are secured and only 21+ can enter. There's been talk of making convenience stores keep vaping gear in a closed off area with a 21+ door if they want to play. Hard to imagine convenience stores being willing to set up a separate vape area with a dedicated employee selling vape gear with bottles of nic and flavor shots. They make money by quick turnover and minimal staff, pods on a shelf by the cigarettes fit in to that model. Mods and tanks and a juice bar don't.

    One day I guess we will know what the new laws are. Until then it's all speculation.
     

    Rossum

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    Well that doesn't make sense... for example: what if it is sold in a convenience store? Does that mean all of their other products are regarded as tobacco products?
    It's a question of intended use. If it's being sold with the obvious intention of being used with a tobacco product, then they'll consider it to be a tobacco product.

    I think the real question at this point is: How strictly will any of this be enforced?
     

    Eskie

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    Yet I know of at least one store that still does exactly that and there's no ISO-compliant anything there. Promulgating regulations is easy. Enforcing them is more difficult, and not every B&M owner is a push-over.


    Not sure a model that’s in violation of regs is how I’d run my business, unless it’s a grab as much cash as possible and then skip out when the time comes. That store isn’t an example of the majority of small vape shops I’ve seen here in NY. Maybe it’s different around you.
    Does "substantially equivalent" play into this at all? As in one product gets approved and another can piggyback off the approval?

    Good question a while bunch of smaller manufacturers are going to be asking. See what’s approved and try to piggyback on that. Still not cheap but nothing like a full application. There isn’t a way to know how those apps will be evaluated.
     

    Sugar_and_Spice

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    Well that doesn't make sense... for example: what if it is sold in a convenience store? Does that mean all of their other products are regarded as tobacco products?
    Since when does this whole deeming fiasco make any sense? The whole tobacco laws expanded to include e-cigs(and anything associated with) has not made any common sense from the minute Congress gave away their job to FDA.
     

    BigPappa

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    I think the real question at this point is: How strictly will any of this be enforced?
    I am betting that at first, many shops resist. And those that initially get busted will be due to actual complaints from people, groups and local government politicians wanting to make a name for themselves that are anti-vaping and would rather see us all die from smoking cigarettes instead.... "anti-vaping justice warriors".
     

    Rossum

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    Not sure a model that’s in violation of regs is how I’d run my business, unless it’s a grab as much cash as possible and then skip out when the time comes. That store isn’t an example of the majority of small vape shops I’ve seen here in NY. Maybe it’s different around you.
    Majority? No, certainly not.

    I think the owner of a rather small shop made a calculated business decision: That his business could not survive without the margins available on house juice, so the question became: Close now, or close at some point in the future, if/when they actually enforce their stupid regs. I'd hardly call that a "cash grab". After all, it's not like what he's doing is going to lead to a felony conviction.
     

    Rossum

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    Many shops will close whether there is enforcement or not. Owner/operators don't want that kind of cloud hanging over their head.
    Yeah. Those are the ones I'll refer to as "push-overs". :p
     

    englishmick

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    Yeah. Those are the ones I'll refer to as "push-overs". :p

    The others we can refer to as "cowboys"

    When the vaping disease was big in the news I saw pictures of unlicensed weed shops in LA. There were blocks where every other shop was a weed shop. Sometimes there was no parking so you just pull up and they bring it out to you. Some of them had been around for a long time, others popped up for a few days and then moved down the street under a different name. Regs are one thing, enforcement is another. The cowboys don't care that much about the occasional rap on the knuckles. In the real world their alternative is likely $7 an hour selling sandwiches. If there's a demand for nic vapes someone will figure out how to meet it.

    Easier in a big city though. A bit harder to pull off in a small town.
     

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