New FDA regulations and effect on DIY?

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Bat snap

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I have read through the documents the FDA has posted about thursday''s rule on ecigs. The new amendment is meant to draw awareness to the idea of ecigs to the general population. The regulation will set requirements for in house juices to maintain an FDA standard. However, I'm not informed so well on the issue of DIY juice. Nude nicotine posted something on this. ATM there''s NO ban set in place on ANY e cig products for the moment. Even the FDA states this in their documents. This will most likely drive in house juice makers to stop manufacturing and become more of a retail store to premium line juices. Good thing is if you sell juice your profit margins might be jumping a little higher like mine
 

Capt.shay

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I have read through the documents the FDA has posted about thursday''s rule on ecigs. The new amendment is meant to draw awareness to the idea of ecigs to the general population. The regulation will set requirements for in house juices to maintain an FDA standard. However, I'm not informed so well on the issue of DIY juice. Nude nicotine posted something on this. ATM there''s NO ban set in place on ANY e cig products for the moment. Even the FDA states this in their documents. This will most likely drive in house juice makers to stop manufacturing and become more of a retail store to premium line juices. Good thing is if you sell juice your profit margins might be jumping a little higher like mine

Are you saying that you are a commercial juice maker? Seems like a commercial maker would be upset at this as it will put you out of business in 2 years.
 

Alien Traveler

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I got another liter of nic from Nude Nicotine today in 2 500 ml bottles. They went right into my freezer. I have to say, it arrived really fast. Those guys are good. If you are stockpiling you should consider them...
I got 250 ml of 100 mg nic from nudenicotine in plastic bottle. Is your nic in glass bottles? Only glass for long-term storage.
 

Rossum

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I got 250 ml of 100 mg nic from nudenicotine in plastic bottle. Is your nic in glass bottles? Only glass for long-term storage.
If you want glass bottles, you have to order their "Armor" product. IMO, the original V1 Armor is the best one to order for long-term storage. It comes in glass bottles and is argon-purged.
 

jamesbeat

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Will this definitely affect concentrated nicotine solution?

The reason I ask is that there are no restrictions on whole leaf tobacco because it is a raw material.
As soon as you process the tobacco for smoking ( analogous to diluting nicotine concentrate?) it becomes a taxable tobacco product.

I know the FDA has nothing to do with tax, but does this ruling apply to raw materials that are unsuitable for vaping in their current state?

For instance, would a bar of stainless steel be a tobacco product because it could possibly be machined into an atomizer?

Is my lathe a tobacco product because I could use it to machine an atomizer?
 
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Frocket

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No, just final products sold for use with ENDS. For most, this means atomizers, mods, and finished e-liquid, even if it's 0 nic.

It's highly doubtful they'll be able to fully regulate lithium batteries, resistance wire, wicking material, or eliquid ingredients (excluding nic base) except those wrapped/packaged/labeled for or marketed specifically for vaping. All of these products have established uses in other industries/products. For example, the FDA can't regulate lighters or matches.

My guess is that many products may at some point begin to show "Not for use with ENDS" or something to that effect, just to be on the safe side. Even if they do, what you do with them after you purchase them is your business, FDA can only regulate the market. If you do create an ENDS product, you just can't sell it.

Sent from my D6603 using Tapatalk
 

jamesbeat

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Precisely my point - is 100mg/ml nicotine an ENDS product?

It isn't suitable for vaping as-is, it is merely one of several ingredients that must be mixed together (manufactured) before it becomes an ENDS.

I don't know if what I said above is correct as far as how the deeming regs work, but it's certainly something we need to find out asap.
Could be the one glimmer of hope in this sorry mess.
 
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dannyv45

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Precisely my point - is 100mg/ml nicotine an ENDS product?

It isn't suitable for vaping as-is, it is merely one of several ingredients that must be mixed together (manufactured) before it becomes an ENDS.

I don't know if what I said above is correct as far as how the deeming regs work, but it's certainly something we need to find out asap.
Could be the one glimmer of hope in this sorry mess.

Can market it as a natural insecticide to spray on you vegetable garden..
 
Precisely my point - is 100mg/ml nicotine an ENDS product?

It isn't suitable for vaping as-is, it is merely one of several ingredients that must be mixed together (manufactured) before it becomes an ENDS.

I don't know if what I said above is correct as far as how the deeming regs work, but it's certainly something we need to find out asap.
Could be the one glimmer of hope in this sorry mess.
But ENDS is an acronym for Electronic nicotine delivery system. If it is sold to vape nicotine free juice or whatever else you decide to put in then how does it fall under ENDS?
 

mhertz

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If the regulations set in without me having stocked up yet, then i'd buy nic in china where several nic-manufacturers sells nics to private also over mail/paypal/CC with shipping and labels it VG or PG ;) (they have a bunch of tobacco flavors too and others; one place had 400 i believe; but you'd need to buy atleast 125mls of each I believe)
 

Robert Cromwell

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I work in the dietary supplement and OTC industry. I deal with 21CFR a lot. Let me allow myself to calm some of the anxiety. DIY will not be affected to any extreme degree. The reason for this is all a company has to do is get an unflavored nicotine base approved for sale. DIY people may then purchase that high concentration base and dilute it with USP glycerin and PEG along with food grade flavors as they already do. Other regulations may tax nicotine in the future making the price jump substancially but that has little to do with the FDA regs.

Personally I hope the investigations show reduced harm in comparison to cigs allowing companies to market the devices as such and offering reason to not tax the same as tobacco. Of course, I am eager to have well designed studies tell us the facts regardless of outcome.

On the subject of hardware, voltage regulators and wire will never be regulated as they are utilized in many other unrelated industries. The fact of the matter is these devices are VERY simple and any amateur electrician can design and build one. Atomizers will be the only real target of regulation. We will have to see how that one plays out.

I think the regulations are an overreach but some regulation was necessary and we had to expect the FDA to push loke this because it involves harm reduction. I DO NOT want companies like phillip morris running this industry. I do want to know if the juice is harming me and what my level of risk is.

In the end, even if the FDA goes nuclear a black market will still exist. The US government has been trying to get ........ off the market for the better part of a century...yet its easier for a middle schooler to get a nugget than a 40oz. They arent stupid, they know this, expect final market regulations to reach a happy medium. When the taxes come is when I'll reallt get up in arms.
Vaping specific chipsets like the DNA sets and the Yihi and any other vaping specific chipset will be restriced as I understand the rules.
however the chipset used in the Hexohm mods are off the shelf standard voltage converter devices and will NOT be under the regulations.
 
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dethnode

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It appears that nicotine concentrate will be safe for a while longer, until they know if this will recreate their missing ciggarette revenue.

So, when the regulations go into effect, and more and more people begin DIYing, then they will go after nicotine if their tax revenues are back up to pre e-cig levels.

Just copied this from the FDA regulations:


(Comment 26) Many comments stated that a requirement to prepare PMTAs for all of the many parts and components that go into some of the newly deemed tobacco products would create an effective ban of these products.

(Response) The definition of a tobacco product includes components and parts, and these products are subject to the automatic provisions of the FD&C Act, including premarket authorization requirements. However, at this time, FDA intends to limit enforcement of the premarket authorization provisions to finished tobacco products. In this context, a finished tobacco product refers to a tobacco product, including all components and parts, sealed in final packaging intended for consumer use (e.g., filters or filter tubes sold separately to consumers or as part of kits). For example, an e-liquid sealed in final packaging that is to be sold or distributed to a consumer for use in a finished tobacco product will be subject to enforcement if it is on the market without authorization. In contrast, an e-liquid that is sold or distributed for further 83 manufacturing into a finished ENDS product is not itself a finished tobacco product. At this time, FDA does not intend to enforce the premarket authorization requirements against such eliquids or other components and parts of newly deemed products that are sold or distributed solely for further manufacturing without a marketing order.
 
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Hoosier

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Ah, yeah, the do not intend bit. They said that about the seatbelt law in Indiana when it was first passed. They did not intend to pull people over for the sole purpose of enforcing the law. Now we are subject to week long periods where that is the sole reason for anyone being pulled over.

So, it will give folks some time until their whim changes and there is no planning for a whim.
 
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