FDA Deeming FDA regulations regarding the DIY market

[Dkline]

First off let me apologize if this is in the wrong section as well as if this has been addressed already, I did a quick browse through the forum but I haven't been able to thoroughly read through today, extremely busy. Please move this if it's in the wrong section!

I plan on reading the upcoming regulations fully later today or tomorrow, but does anyone know how this might affect the DIY market? I imagine it won't have an impact on the general ingredients such as flavorings, VG, PG, bottles etc. but how is this going to affect liquid nicotine, if it does at all? As well as other DIY components, making your own boxmods, regulated or unregulated. Something as simple as a 510 connector? Thoughts?

 

[B2L]

Short answer, stock up now.

No one really knows for sure but I have a very strong feeling that it won't be pretty.

 

[YoursTruli]

Deeming Regulations have been released!!!!

FDA Deeming updates - Tuesday May 10th community events

 

[squee]

but does anyone know how this might affect the DIY market? I imagine it won't have an impact on the general ingredients such as flavorings, VG, PG, bottles etc. but how is this going to affect liquid nicotine, if it does at all? As well as other DIY components, making your own boxmods, regulated or unregulated. Something as simple as a 510 connector? Thoughts?

According to what they released, it was stated that while components and parts now fall under the regulations, they will not be *enforcing* the regulation on those items for now - their focus is on 'finished products'. So they'll be concentrating on e-liquid/juice rather than liquid nic, etc..

 

[Rossum]

Also this thread:
New FDA regulations and effect on DIY?

 

[sofarsogood]

Simple question really. Is the FDA going to interfere with consumer access to nic concentrate? If the rules stand as they are the answer is probably yes. There might be two more years to stock up, there might not. I don't trust them, do you?

I suspect a careful reading of the rules will show the FDA can change the rules to anything they want any time they want for any reason they want. The rule is the FDA makes the rules so we better be nice and suck up to them or we'll be sorry.

 

[Rossum]

Simple question really. Is the FDA going to interfere with consumer access to nic concentrate? If the rules stand as they are the answer is probably yes. There might be two more years to stock up, there might not.

If they don't, the "informal" market for juice will be as big or bigger than the formal market is now.

I don't trust them, do you?

I trust they will do whatever it takes to give as much of vaping as possible to a very small number of largish companies from where sales can be traced and taxed.

 

[jwbnyc]

According to what they released, it was stated that while components and parts now fall under the regulations, they will not be *enforcing* the regulation on those items for now - their focus is on 'finished products'. So they'll be concentrating on e-liquid/juice rather than liquid nic, etc..

That's assuming they don't conflate nicotine concentrate and ejuice.

If they just limit nic content, that may include both e juice and nicotine in solution.

I don't trust them to know the difference, or care very much. In fact, I'd expect 50/100mg nic to be a big red flag to them.

 

[Verb]

That's assuming they don't conflate nicotine concentrate and ejuice.

If they just limit nic content, that may include both e juice and nicotine in solution.

I don't trust them to know the difference, or care very much. In fact, I'd expect 50/100mg nic to be a big red flag to them.

They explicitly state in the deeming regs they will be treating eliquid, which according to them always contains flavoring, and liquid nicotine as the same in regards to the approval process.

 

[skoony]

I suspect a careful reading of the rules will show the FDA can change the rules to anything they want any time they want for any reason they want. The rule is the FDA makes the rules so we better be nice and suck up to them or we'll be sorry.

You are correct. They stated specifically they have reserved the right to change or modify the regulations
if the deem it necessary to do so for any reason they determine.
Regards
Mike

 

[Bill Godshall]

It appears FDA is preparing to ban all vape shops from mixing their own e-liquid products on August 8, 2016
(because mixing is manufacturing, and because manufacturing new products after 8/8/16 is banned).

But FDA won't be banning bottled e-liquid (that is sold to consumers as a finished tobacco product) until 8/8/18 (as long as manufacturer can show FDA the same product was on the market before 8/8/16).

So vapers will be stocking up, and sales of e-liquid will skyrocket in the next 27 months (before prohibition day on 8/8/18).

Thanks to FDA, the 2,500 vape shops that now mix their own e-liquid for consumers will be replaced by more than a million vapers mixing e-liquid at home.

Florida company gears up to supply the underground “vaping prohibition”
Florida Company Gears Up to Supply the Underground "Vaping Prohibition"

A real disaster could occur if/when vapers begin buying (and trying to mix) 99% nicotine e-liquid, as Clive Bates describes below.

Clive Bates: Regulators and the compliance fallacy – buying 99% nicotine e-liquid from China
Regulators and the compliance fallacy – buying 99% nicotine e-liquid from China « The counterfactual

 

[skoony]

@Bill Godshall Thamks for the post but one question.
i agree that B&M's mixing their own juice are now defacto manufacturers
under the reg.'s. What i don't understand is why they do not get the
privilege to apply through the premarket gateway. Not that many
could afford it or even try if they could. If each new bottle is considered a new
product how does a company like Mt. Baker get around it. There will always
be differences from batch to batch however minuscule.

I believe they FDA will do it but, the regulations say manufactured and
on the market before the 90 day period gets you into the premarket
application process and two year time period. I know the FDA has a plan
to weed out vendors who are just taking a free ride but just getting up to
speed on the process will tale most more than 90 days.
Go figure.
Regards
Mike

 

[lynn508]

I really don't think the FDA has a clue. They have put out 500 pages of junk that usually works with big business. We have to appease people that haven't a clue about it but are scared to death. These days they are dealing with the population and small business and may have bitten off more than they can chew. For a corp their lawyers will handle this. Today this just shows how little the FDA cares about the people or industry in the USA. It is always for the children or to protect you. This is getting really old when we have seen their mistakes. They poopoo all the testimonials that have been sent. Do you really think they have your best interests or their own at heart. It is all about the almighty dollar.

 

[LarryPer]

IMO
Wizard labs for example is already FDA checked as is Cappella because theirs is a food additive

 

[DC2]

IMO
Wizard labs for example is already FDA checked as is Cappella because theirs is a food additive

I know this thread is now too long to read, but no.

FDA Approved is what I think you meant.
And that is just a rubber stamp that says you follow certain procedures.

But it has absolutely NOTHING to do with getting authorization to market new tobacco products.
And that is what will be needed to sell vaping products in the future.

 

[Pamawoman]

It appears FDA is preparing to ban all vape shops from mixing their own e-liquid products on August 8, 2016
(because mixing is manufacturing, and because manufacturing new products after 8/8/16 is banned).

But FDA won't be banning bottled e-liquid (that is sold to consumers as a finished tobacco product) until 8/8/18 (as long as manufacturer can show FDA the same product was on the market before 8/8/16).

So vapers will be stocking up, and sales of e-liquid will skyrocket in the next 27 months (before prohibition day on 8/8/18).

Thanks to FDA, the 2,500 vape shops that now mix their own e-liquid for consumers will be replaced by more than a million vapers mixing e-liquid at home.

Florida company gears up to supply the underground “vaping prohibition”
Florida Company Gears Up to Supply the Underground "Vaping Prohibition"

A real disaster could occur if/when vapers begin buying (and trying to mix) 99% nicotine e-liquid, as Clive Bates describes below.

Clive Bates: Regulators and the compliance fallacy – buying 99% nicotine e-liquid from China
Regulators and the compliance fallacy – buying 99% nicotine e-liquid from China « The counterfactual

I went there and the white clouds vaping site is shut down????

 

[LittleBird]

I went there and the white clouds vaping site is shut down????

Their website says they are undergoing a branding/name change. Not surprising; I suspect most retailers of DIY supplies (PG, VG, nic, flavorings, etc) will have removed references to vaping before Aug 8.

 

[SeniorBoy]

Please note: A typical vendor who sells NIC base and I'm referring to a finished product would need around 40 PMTAs in total for all their skews. The calculation is: strengths (like 24 MG or 100MG as examples) + PG/VG ratio options (like 50/50, 70/30, 100% etc). Per skew. This same calculation applies to ejuice. In the case of a ejuice vendor, it could be hundreds of PMTAs. Their is a bridging option but I'm not optimistic.

I just covered this in copious detail on my Blog. I also posted part of it on ECF.

Stock up today!

 

[LMP]

Is there somewhere I can go to read a concise summary of this stupid FDA thing? I don't want to read their entire 499 page report.

 

[rwoodin]

A real disaster could occur if/when vapers begin buying (and trying to mix) 99% nicotine e-liquid, as Clive Bates describes below.

Clive Bates: Regulators and the compliance fallacy – buying 99% nicotine e-liquid from China
Regulators and the compliance fallacy – buying 99% nicotine e-liquid from China « The counterfactual

I just received my first 3 liters of 10% nic. I was a bit nervous pouring the 3, one liter jugs into 24, 4 ounce amber boston round bottles. I wore latex gloves and performed all the dividing up in the upstairs bathroom sink, with the exhaust fan on. Luckily there were no mishaps. I'll label and wrap each bottle in foil tonight and put them in the freezer in the garage. We had just bought a new fridge this year and have decided to re-purpose the old one for nic storage. I also made and kept aside about 60ml, diluted to ~ 20mg/ml, 80/20% PG/VG mix. I'll start playing around with the few dozens flavorings I just bought to see if I can come up with some palatable solutions, literally and figuratively speaking. I would have been quite happy buying premixed as I have for years, but we are going to have to do what we have to do.