FDA FDA deeming regulation proposals

[grumpypathdoc]

What I see from a quick reading of the proposed regulation is an opportunity for the vaping community and especially for the manufacturers of equipment and e-liquids to influence the regulations and make the best of a bad situation. I think the potential positive impact of the regulation of e-liquid components should be championed and hopefully the suppliers will jump on this opportunity to clean up any potential hazards. I am eager to hear what the vendors will have to say in regards to this issue.

 

[epicdoom]

As far as I'm hearing what the FDA is testing is liquid in cartridges like Blu and others Usually made overseas US Customs has been pulling shipments for the used for testing. I bet that garbage is used to deem the stuff we use Unfit, we use (already approved by FDA VG, PV, Flavorings and Nicotine. Granted they haven't approved VG PG for inhalation but they allow us to put it on our bodies and absorb it So what's the difference. They let us inhale Nicotine and eat and drink things with flavors used. In the end its all Uncle Sam wanting a bigger cut

 

[Coastal Cowboy]

Ha, this stinks to me. Obviously I know nothing of your laws but here in Australia one of the states has used a loophole to prosecute a vendor. They tied a piece of legislation(from 2006) that was created specifically to outlaw pretend cigarettes such as lollies(big boss ciagar, fags), or toys that appeal to children, to include anything that has a hand to mouth action and resembles a cigarette. As a result PVs in any way, shape, or form have been banned for sale. They are making crap up to suit themselves, but its there in black and white. Obviously not the intention of the law, but look what they did. Could that happen where you are?

It could if the bureaucrats believe they could get away with it. One thing about the US' regulatory agencies is that they'll issue regs that are politically popular or won't generate controversy or legal action.

FDA has already been sued once on the regulation of e-cigs, and had their clocks cleaned. That's part of the reason why they haven't proposed any new regs for the last four years.

The possibility of controversy, political unpopularity and the threat of legal action petrifies a bureaucrat.

 

[MorpheusPA]

Sorry if this is OT, but I'm checking my FB page and look what's advertised:

Amazon.com: Propylene Glycol - Food Grade USP - 1 Quart (32 Oz.): Health & Personal Care

Froggy's also sells food grade VG.

I posted this because some wonder what will happen to the diy'ers with the new FDA regulations. Probably nothing as Froggy's has nothing to do with vaping.

Nothing will happen to PG or VG. VG is used in baking, soapmaking, gardening (it's a good humectant for dry periods, plus with a bit of soap it's killer to aphids and harmless to plants, animals, and most other insects), and a thousand other things.

Propylene glycol, if possible, has even more uses, including a humectant in food.

Also, Essential Depot has great prices by the gallon.

 

[pamdis]

Just finished reading through the whole thing, and I think it's completely bad. Here's what struck me that I can remember off the top of my head after a first reading:

1) All e-cig, e-liquid and DIY nicotine mfg's will have 2 years to submit a new tobacco product application. Note that NO new tobacco products have EVER been approved by FDA

2) Flavors - although they don't outright ban them yet, there is a request for comment on whether they should, which means to me, "Please use the comment period to give us some ammunition to allow us to ban flavors"

3) Option 2 which would exempt large cigars reeks of Elite persons who smoke large cigars saying, "Yes, regulation for the masses is fine, but it shouldn't apply to US" and FDA's attempt therefore to justify exempting them.

I plan to print it out and go over it with a fine tooth comb and create my own comment letter.

 

[MorpheusPA]

As far as I'm hearing what the FDA is testing is liquid in cartridges like Blu and others Usually made overseas US Customs has been pulling shipments for the used for testing. I bet that garbage is used to deem the stuff we use Unfit, we use (already approved by FDA VG, PV, Flavorings and Nicotine. Granted they haven't approved VG PG for inhalation but they allow us to put it on our bodies and absorb it So what's the difference. They let us inhale Nicotine and eat and drink things with flavors used. In the end its all Uncle Sam wanting a bigger cut

They HAVE approved PG and VG for inhalation. In the past, PG was used in asthma inhalers. It's still used in nebulizer treatments.

Both PG and VG are approved for indefinite exposure at any level for the operators of fog machines.

Inhalation of some chemicals has vastly different effects on your body than ingestion does. Consider diacetyl. As a flavoring, it's buttery and wonderful on popcorn, as well as utterly harmless. Inhaled chronically or in large amounts? It. Will. Kill. You.

 

[Stubby]

That's the kind of language that I don't think would survive a serious legal challenge. A pipe, for example, could be used to combust almost any herbal substance. Just because it can be used to burn tobacco doesn't mean that it doesn't have other lawful, harmless uses.

Where is the tobacco product in these things?

I'm not being argumentative. I'm just trying to lay out how an innovative lawsuit could go after weak language like this. My bet is that it doesn't survive the public comment and revision process and if it does, it won't survive a serious court challenge.

Cool avatar, btw.

The defense to that is it is all about intended use. The intended use of a pipe is to smoke pipe tobacco. A person can try and get tricky about it and claim the intended use is something else but it is very unlikely that would work.

Liquid nicotine might be regulated, as the nicotine used in vaping is derived from tobacco, and is thus a 'tobacco product' under the amended FD&C Act.

A possible way around that in the future might be the 'synthetic' or 'lab-created' nicotine that is used as an industrial pesticide, though that nicotine is supposedly concentrated and is largely unexplored for the purposes of vaping as it has only been produced in an industrial grade, and is thus unsuitable for human consumption. If tobacco-extracted nicotine rises high enough in price, it may stir more research into 'synthetic' nicotine, resulting in a pharmaceutical grade product.

Another possible avenue is nicotine that is extracted from another plant source, such as eggplants. Both of these options are more expensive to produce, and would only be viable if the cost of mass produced liquids and conventional nicotine were both in enormous excess from over-taxation, leaving no other alternative.

Time will tell, I suppose.

Not going to work. Nicotine extracted from other sources would cost many times that of nicotine extracted from tobacco. Likely 10 to 100 times or more. Synthetic nicotine is very expensive and from what I can gather not as effective as tobacco extracted nicotine. Nether one is a viable solution.

I've been waiting for and studying this whole thing for years now...
And the fact that many vapers seem to think we've been cleared for landing is somewhat disturbing.

The post I made above outlines how they are going to screw us if we don't get active.
Sorry for spreading the fear, but fear is what you need right now.

They proposed the very thing that can kill us.

If you have any questions as to why this can kill us, please post those questions.
That is how we get to the bottom of things.

This regulation certainly can kill electronic cigarettes. The biggest issue is that essentially nothing on the market today is grandfathered. That's what the Feb 15 2007 date is about. That means everything would have to go through the SE process or the new tobacco product process. Does anyone even know what was available in 2007. It sure wasn't much.

Ether of these routes means mountains of paper work, lots of money, with no guarantee of a good outcome. There is no way a small local producer would ever go through the process. Besides the liquid it could very well be the death of innovation. The cost and hassle of bringing a new top end or power supply to the market would essentially kill that.

If the regulation stands as it is there is a 2 year grace period, then the death march begins.

 

[Maestro]

I don't know why everyone is so worried about flavors. Flavoring is the easiest part to get around. Ever bought a margarita mix where you just add alcohol? It wouldn't be very difficult for a vendor to simply mix their flavorings and sell as is. All you would need to do is add it to unflavored nicotine liquid and .....voila......instant Bobba's Bounty

 

[Gresh11]

It could if the bureaucrats believe they could get away with it. One thing about the US' regulatory agencies is that they'll issue regs that are politically popular or won't generate controversy or legal action.

FDA has already been sued once on the regulation of e-cigs, and had their clocks cleaned. That's part of the reason why they haven't proposed any new regs for the last four years.

The possibility of controversy, political unpopularity and the threat of legal action petrifies a bureaucrat.

I know you guys are walking a minefield over there but you are pretty damn lucky. All we've got here is pharmaceutical lobbies and BT taxes and they are winning. Cheers mate!

 

[KODIAK (TM)]

If the regulation stands as it is there is a 2 year grace period, then the death march begins.

I would *think* in addition to the 2 year grace period one would also be allowed the time it takes the FDA to reject said application if it goes beyond that time period. It's called "due process". (Assuming of course the application is filed on time and the holdup is no fault of the manufacturer who filed it).

 

[tj99959]

The bathwater is going to get to murky to see the baby.

The tobacco product approval process has never worked. In fact it was designed so that it can't work. Just look at the number of new products that have been approved in the past.

You wait & see, Njoy and Blu will get fast tracked to approval, and everything else will get hung out to dry.

For example; how is a company like SvoeMesto going to comply? Guess we can say goodbye to the kayFun.
Think about the number of different products offered by some companies, each one needing to go through the approval process. Guess we can also say goodye to the MVP, 134, VTR, SVD as well, they will be lucky to just get their V3 approved.

 

[MorpheusPA]

The bathwater is going to get to murky to see the baby.

The tobacco product approval process has never worked. In fact it was designed so that it can't work. Just look at the number of new products that have been approved in the past.

You wait & see, Njoy and Blu will get fast tracked to approval, and everything else will get hung out to dry.

Easy lawsuit as it would show clear bias. Agencies and bureaucrats are extremely lawsuit-shy, particularly when the bias is too easy to prove.

 

[MTFogger]

Nothing will happen to PG or VG. VG is used in baking, soapmaking, gardening (it's a good humectant for dry periods, plus with a bit of soap it's killer to aphids and harmless to plants, animals, and most other insects), and a thousand other things.

Propylene glycol, if possible, has even more uses, including a humectant in food.

Also, Essential Depot has great prices by the gallon.

Sorry, but if they can take a cold medicine off the self and put it behind the counter, they can just as easy do it with PG/VG

 

[unknown_shooter]

Easy lawsuit as it would show clear bias. Agencies and bureaucrats are extremely lawsuit-shy, particularly when the bias is too easy to prove.

The Chinese manufacturer of $32 ITaste SVD's is gonna take on the US Government's free unlimited-fund's legal team & win?

Have you ever heard of Lik Sang?

Lik Sang - Wikipedia, the free encyclopedia

Millions of customers worldwide & gone from the world overnight..

Njoy & Blu have enough palm-greasing funds to stay legal even if every third user dropped dead on the second puff.

The random website selling super-awesome dual-coil, variable wattage puff-it's doesn't have a chance..

 

[2coils]

The bathwater is going to get to murky to see the baby.

The tobacco product approval process has never worked. In fact it was designed so that it can't work. Just look at the number of new products that have been approved in the past.

You wait & see, Njoy and Blu will get fast tracked to approval, and everything else will get hung out to dry.

For example; how is a company like SvoeMesto going to comply? Guess we can say goodbye to the kayFun.
Think about the number of different products offered by some companies, each one needing to go through the approval process. Guess we can also say goodye to the MVP, 134, VTR, SVD as well, they will be lucky to just get their V3 approved.

The not banning internet sales and flavors is a simple distraction the more I have been thinking about it. People need to look at this below the surface.

 

[Coca]

Some reg's are good in my opinion, i.e. sale to minors, labeling, etc. As far as components and delivery devices go, i'm glad i'm a machinist and can make my own atty and mod if need be. I DIY for friends and family, for me unless i missed something somewhere in the pages, i will still be able to go to the nearest restaurant supply and get flavorings, tractor supply to get PG(worst case scenario), or walmart for VG. If i take a hit anywhere it would be getting unflavored Nic, guess i'll ride this one out and get off at the last stop.

 

[MorpheusPA]

The Chinese manufacturer of $32 ITaste SVD's is gonna take on the US Government's free unlimited-fund's legal team & win?

Have you ever heard of Lik Sang?

Lik Sang - Wikipedia, the free encyclopedia

Millions of customers worldwide & gone from the world overnight..

Njoy & Blu have enough palm-greasing funds to stay legal even if every third user dropped dead on the second puff.

The random website selling super-awesome dual-coil, variable wattage puff-it's doesn't have a chance..

Wow.

I just can't take the Negative Nancies any longer. Have fun, folks.

 

[Katya]

For example; how is a company like SvoeMesto going to comply? Guess we can say goodbye to the kayFun.
Think about the number of different products offered by some companies, each one needing to go through the approval process. Guess we can also say goodye to the MVP, 134, VTR, SVD as well, they will be lucky to just get their V3 approved.

I'm really not sure, but according to their definitions, a Kayfun is not a tobacco product, is it? What if I want to vape non-nic eliquids in it? What if I just like to wind coils as a hobby? Or use it a paperweight?

"For purposes of this part, FDA considers any loose tobacco, including pipe tobacco, and the
nicotine in e-cigarette cartridges to be within the definition of "covered tobacco product." FDA
proposes to treat covered tobacco products in a manner consistent with FDA's treatment of
cigarettes and smokeless tobacco throughout part 1140."

 

[Hollywood puffer]

The proposed regulations will wipe out all the small e-liquid manufacturers. The rules requiring chemical analysis of each new product will be prohibitively expensive. Only large producers will be able to meet the technical requirements. B&M stores will only be able to sell larger manufacturer liquids meeting the regulations while consumers will be able to mix their own at home. All B&M's will be driven into extinction.

 

[vangrl27]

https://www.youtube.com/watch?v=MAa60mWNzXY