FDA FDA deeming regulation proposals

[Coastal Cowboy]

All in all, while this isn't 100%--the approval process' efficiency remains to be seen--I'd say the vaping community got a solid 80% of what it really wanted.

I tend to agree. I'm going to read the entire language later today but as I wrote above, we didn't get the whole loaf, but we got the better part of it.

Another thing that just popped into my head: If FDA does intend to regulate devices along with the tobacco products those devices are intended to deliver, then expect smart business people to market certain devices as flashlights.

 

[DC2]

This is what we have to fear now...

One of the biggest new requirements is that e-cigarette makers will need to apply to the FDA within two years to keep existing products on the market. The agency then will rule on applications roughly as it does on other tobacco products.

Now it's game on.

 

[Coastal Cowboy]

"Components and parts of tobacco products, but not their related accessories, would also be included in the scope of this proposed rule. Components and parts are included as part of a finished tobacco product or intended for consumer use in the consumption of a tobacco product. Components and parts that would be covered under this proposal include those items sold separately or as part of kits sold or distributed for consumer use or further manufacturing or included as part of a finished tobacco product. Such examples would include air/smoke filters, tubes, papers, pouches, or flavorings used for any of the proposed deemed tobacco products (such as flavored hookah charcoals and hookah flavor enhancers) or cartridges for e-cigarettes."

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.

 

[Kryyptyk]

What I'm wondering about now is the DIY flavoring industry.

Further down the proposal FDA states:

"Section 201(rr) of the FD&C Act (21 U.S.C. 321(rr)), as amended by the Tobacco Control Act, defines the term "tobacco product" to mean "any product made or derived from tobacco that is intended for human consumption, including any component, part, or accessory of a tobacco product (except for raw materials other than tobacco used in manufacturing a component, part, or accessory of a tobacco product).""

If that wording doesn't change, than PG/VG and flavorings won't be encompassed in the regulations, only the finished product.

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.

 

[DC2]

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.

 

[Gresh11]

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.

I saw in a previous post that they are backdating the requirements for devices to 2007. This looks like one hell of a set up to me. The patents that BT bought?

 

[Gresh11]

I saw in a previous post that they are backdating the requirements for devices to 2007. This looks like one hell of a set up to me. The patents that BT bought?

Disregard, wrong tangent!

 

[tj99959]

I think the glaring issue is the "FDA Approved" nonsense.I hope they understand that by having to approve vape hardware it will be a nightmare for all of us including them. I understand on the liquid side people should know what they are inhaling but hopefully they will change their position on the hardware. If not then what will it take to get FDA approval?
This is the part we need sorted out so the industry can continue as it has.

The genie is already out, the FDA is late to the game and there will always be a way to sell them even with the regs.

Look at the headshops and what they sell... You just need a disclaimer stating your hardware is not for vaping anything but water right?

I see no way the industry will not get around anything they can throw at it..

I agree, they will need to grandfather some products or the wheels will fall off. Just think about what you have in your hand, and what existed in Feb. 2007.

Otherwise vaping will become a make your own situation.

I would hate to see this become our only future.

 

[Gresh11]

Is the focus going to be on proving harm minimisation for a product, or disproving it. Maybe we've got to get our scientists to work. I know for a fact that BP and BT would of put millions into research to try and discredit us. The best that they can come up with is 'think of the children'.


Edit: It appears that vaping loses any ability whatsoever to even claim that it has any health benefits over traditional smoking. Ummm...Speechless. I see why it took the FDA 4 years to come up with this. It's one huge unsolvable puzzle. A game of snakes and ladders, where every conceivable combo has you back at square 1.

 

[klynnn]

I was surprised by the amount of regulations on cigars, page after page of it. What's the matter aren't they getting their taxes from them. Obviously they missed that gouge in their last reg.

 

[215Z]

I've written to Dr. Hamburg via link on the FDA Voice Blog Entry. She wanted my comment, right?

 

[thanswr]

What I'm wondering about now is the DIY flavoring industry.

You can buy flavorings in a grocery store, hobby shop, craft shop, or online baking/cooking supplies vendor. Grant you, I am not an expert in diy liquids, but I don't think the flavorings involved are specific only to vaping.

Food grade PG/VG are readily available in drug stores, supermarkets, big box stores, and online vendors. The only thing that may change, or be more regulated, are products that contain nicotine. Since there is no ban proposed, it would seem to me there would be an ID check or a "sign for the package" process.

 

[Gresh11]

I was surprised by the amount of regulations on cigars, page after page of it. What's the matter aren't they getting their taxes from them. Obviously they missed that gouge in their last reg.

Stay on topic bro

 

[klynnn]

I'm not a bro and just got done reading the reg lots of cigar influence.

 

[2coils]

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.

I dont understand the celebration myself. I am not a lawyer or anything of the sort. I do know that the SE process was and is a big issue. I really need to hear from the lawyers on this. Interpretation is everything! Not to mention the application/approval process.

 

[Coastal Cowboy]

I saw in a previous post that they are backdating the requirements for devices to 2007. This looks like one hell of a set up to me. The patents that BT bought?

It's built into the statute of the Family Smoking and Prevention Tobacco Control Act of 2009. Where that date comes from escapes me, too. But it's part of the law and FDA is supposed to follow it.

 

[Gresh11]

I'm not a bro and just got done reading the reg lots of cigar influence.

Sorry mate, bro in Aussie must have different connotations???

 

[MorpheusPA]

I'm not a bro and just got done reading the reg lots of cigar influence.

Sis. Yes, cigars were a large part of this as, to date, regulation has been rather lacking.

I've already read the argument that the cigar portion was only included to fog the impact of the e-cig sections. Fortunately, I am not paranoid and am aware that this is entirely a normal thing to do.

However, the FDA does not impose taxes and has no power to recommend imposition of taxes. That is wholly the business of Congress. Plus I think cigars are already taxed, I do know there's an excise tax on them.

So no worries there. Just because the FDA issues deeming regulations on the e-cig and cigar doesn't mean either will be taxed--and if they hadn't, they could still be taxed. Congress has to decide that, and is unlikely to do so in 2014. The House is fully gridlocked.

 

[Gresh11]

It's built into the statute of the Family Smoking and Prevention Tobacco Control Act of 2009. Where that date comes from escapes me, too. But it's part of the law and FDA is supposed to follow it.

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?

 

[thanswr]

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.