FDA reiterates intent to propose "deeming" regulation for e-cigs and other unregulated tobacco products

[Bill Godshall]

FDA reiterates agency’s intent to propose “deeming” regulation to apply Chapter IX of the FSPTCA to e-cigarettes, cigars, pipe tobacco, shisha/hookah, dissolvables, etc.
Tobacco Product Regulation

 

[Petrodus]

It's clear to me they are going to be "Demon" Regulations

 

[2coils]

It's clear to me they are going to be "Demon" Regulations

I am terrified this is going to be a nightmare. We need to raise a bunch of bread to get this research done!!!

 

[dialx7]

So, shall I order tobacco seeds, and grow my own? Or maybe I should just "register" my tomato plants.

 

[xhuffer]

OK so just WTH does "deeming" regulation actually mean in EffinDA speak? Someone please 'splain.

 

[Trick]

OK so just WTH does "deeming" regulation actually mean in EffinDA speak? Someone please 'splain.

It basically means they're going to "deem" e-cigs to be a tobacco product, and to fall under existing tobacco laws (at least to some extent, if not fully). It means they're planning to regulate them under the same rules they regulate cigarettes.

 

[dialx7]

It basically means they're going to "deem" e-cigs to be a tobacco product, and to fall under existing tobacco laws (at least to some extent, if not fully). It means they're planning to regulate them under the same rules they regulate cigarettes.

Well, ok, I like the explanation, I don't like the FDA stepping in to regulate.

 

[dbeast64]

It basically means they're going to "deem" e-cigs to be a tobacco product, and to fall under existing tobacco laws (at least to some extent, if not fully). It means they're planning to regulate them under the same rules they regulate cigarettes.

Well,that's just gonna suck

 

[sonicdsl]

Well,that's just gonna suck

Yes, it probably will, but we won't know for sure what's going to happen until April (assuming they do it this time, and then there will be a 30-60 day commentary period).

In the meantime, to be proactive, we can all join CASAA.org, read about the legislative issues, respond to the Calls of Action, and contribute to the new research fund! CLICK HERE to learn about this, and see how to donate!

 

[Tankman77]

OK so just WTH does "deeming" regulation actually mean in EffinDA speak? Someone please 'splain.

It means that the government and thier "backers" (BIG Pharma and BIG tobacco) are not making any money off this big vaping movement, so we must "deem" it as "hazardous" and tax the hell out of it!! Regulation is just key for government control and another money making opportunity. I dont think we face a ban, like other parts of the world, but I do think we willl be paying more for any nicotine base juices. We'll see......

 

[tommy2bad]

It means that the government and thier "backers" (BIG Pharma and BIG tobacco) are not making any money off this big vaping movement, so we must "deem" it as "hazardous" and tax the hell out of it!! Regulation is just key for government control and another money making opportunity. I dont think we face a ban, like other parts of the world, but I do think we willl be paying more for any nicotine base juices. We'll see......

On that, I think it might work out as a ban to all intents and purposes. We keep being told that the EU TPD isn't banning ecigs but the regulation will make market access impossible for most products.

 

[Petrodus]

The FDA is just one of many carbuncles
on the rear of the Regulation Nation

 

[MaDeuce]

One issue that needs to pointed out; nicotine is not exclusive to tobacco, there are at least 66 other varieties of plants and vegetables that naturally contain nicotine. Nicotine is just a chemical or as the FDA says, a drug. If tobacco were the only source of nicotine, like another leafy plant is the only source of Top Hat and Cane, then regulating it would be easier. But that's not the case. Whether or not the nicotine we use in our liquid is extracted from tobacco should be irrelevant. If there are other sources of nicotine available it's the FDA's responsibility to regulate ALL sources of nicotine. But are they willing to do that? If they insist on pursuing this course of action against nicotine then we should require them to go all the way and not half-step it. You may think I am crazy, but to force the FDA's hand in their pogrom against nicotine would draw in numerous allies. The tomato growers and all the companies that utilize tomatoes, the pepper growers and all the companies that use peppers. (Could you imagine all the Tobasco and pepper sauce users and manufacturers finding out their product was about to be regulated?) Are you getting my point? If they want to work, make them really WORK.

 

[Petrodus]

Tomatoes and other plants that contain nicotine
with the exception of tobacco ... is of NO concern
to the FDA. The FDA couldn't care less.

On the other hand ...
The FDA would come unglued and go after anyone
processing Tomatoes for nicotine to add to e-cigarette
liquids. Can't have that !!

 

[Tankman77]

On that, I think it might work out as a ban to all intents and purposes. We keep being told that the EU TPD isn't banning ecigs but the regulation will make market access impossible for most products.

I guess we will know more after Feb. 25th.......it is definatey worrisom, the TPD is at the forfront of this and Im sure, the will try to set a precedene and the FDA will follow their lead. We can only wait and see!!!!

 

[rothenbj]

It means that the government and thier "backers" (BIG Pharma and BIG tobacco) are not making any money off this big vaping movement, so we must "deem" it as "hazardous" and tax the hell out of it!! Regulation is just key for government control and another money making opportunity. I dont think we face a ban, like other parts of the world, but I do think we willl be paying more for any nicotine base juices. We'll see......

I believe you underestimate the ability of the FDA to make things very ugly for us and don't understand the history. Once BP made BP their client, they stopped working for our benefit. The FDA has made it difficult for anyone that wants to make health claims about their product that is not a Pharma company that has got their seal of approval. For a brief reading of what they're capable of- Life extension - Wikipedia, the free encyclopedia. Also see how the FDA declared Diamond Foods Walnuts a drug- FDA Says Walnuts Are Illegal Drugs based of what was said in the advertising.

The FDA will remain the police force for BF into the future. However, they will now also be funded, very similar to how BP funds them, by BT. This you can expect will lead to promulgated regulations that will serve their new client, BT.

If I were to guess where this is headed, FDA will want to limit the amount of nicotine allowed in pre-filled tamper proof cartridges to protect against accidental exposure in the name of protecting the children. They probably will want flavors limited to tobacco flavors and may want to limit battery sizes. They may use the battery accidents to justify their stance. Even if they allowed larger batteries, they could force PV's to be designed to not allow battery access. A solid unit with built in batteries dumbs down the units. Just plug in to the unit to charge. I would expect that to be a second wave when BT has developed that type unit. It would satisfy the need for longer lasting batteries and allow BT to sell more units.

One thing I expect is to see a ban on internet sales or, at a minimum what they did with other tobacco products, making USPS shipments illegal and requiring an adult signature on delivery. This in itself becomes very expensive and inconvenient. It has the added advantage of pushing business to their new client, BT.

You don't have to worry about taxation at this point, the government-federal state and local, controls that. However, the regulations will drive the price upward. The FDA does not like to lose when they take a stance and they lost in their first effort so I'm sure they will work within the guidelines that the court gave them and make life as difficult as possible.

Incidentally, beside BT, companies like NJoy that fought the FDA to get where we are today have stuck close to their initial product offering even though veteran vapers have long moved on. That didn't occur because they are stupid businesspersons. They are positioning for the future. Our products are a growing segment of the market as a whole, but most companies are more like the corner store and you know what happened to them. I've been buying most of my product from TW because they are one of the bigger PV companies. I'm hoping that a company like that will be capable and willing to battle for their business. We'll have to wait and see.

Whatever

 

[Petrodus]

Incidentally, beside BT, companies like NJoy that fought the FDA to get where we are today have stuck close to their initial product offering even though veteran vapers have long moved on. That didn't occur because they are stupid businesspersons. They are positioning for the future. Our products are a growing segment of the market as a whole, but most companies are more like the corner store and you know what happened to them. I've been buying most of my product from TW because they are one of the bigger PV companies. I'm hoping that a company like that will be capable and willing to battle for their business. We'll have to wait and see.

BINGO !!
Blu also chose to be "smart" to protect its future LIMITED place in the market.

It really makes absolutely NO DIFFERENCE WHATSOEVER to the FDA
what we think about our choice of vape machines and the benefits to smokers.

The FDA will do as they please.
The only recourse would be legal action.

 

[the_vape_nerd]

One issue that needs to pointed out; nicotine is not exclusive to tobacco, there are at least 66 other varieties of plants and vegetables that naturally contain nicotine. Nicotine is just a chemical or as the FDA says, a drug. If tobacco were the only source of nicotine, like another leafy plant is the only source of Top Hat and Cane, then regulating it would be easier. But that's not the case. Whether or not the nicotine we use in our liquid is extracted from tobacco should be irrelevant. If there are other sources of nicotine available it's the FDA's responsibility to regulate ALL sources of nicotine. But are they willing to do that? If they insist on pursuing this course of action against nicotine then we should require them to go all the way and not half-step it. You may think I am crazy, but to force the FDA's hand in their pogrom against nicotine would draw in numerous allies. The tomato growers and all the companies that utilize tomatoes, the pepper growers and all the companies that use peppers. (Could you imagine all the Tobasco and pepper sauce users and manufacturers finding out their product was about to be regulated?) Are you getting my point? If they want to work, make them really WORK.

what the fda will say is...ok you're right, there's some nicotine in other plants...but judge we aren't here arguing today about nicotine that's been extracted from tomatoes...the plaintiffs products were all derived from the tobacco plant, moreover, derivation from other plants is practically impossible because those other plants do not contain nicotine in enough concentrated form...when and if anyone ever markets some nicotine from tomatoes then we won't regulate that, but since what is before the court today is some nicotine extracted from tobacco plants, we feel this is a tobacco product

 

[MaDeuce]

what the fda will say is...ok you're right, there's some nicotine in other plants...but judge we aren't here arguing today about nicotine that's been extracted from tomatoes...the plaintiffs products were all derived from the tobacco plant, moreover, derivation from other plants is practically impossible because those other plants do not contain nicotine in enough concentrated form...when and if anyone ever markets some nicotine from tomatoes then we won't regulate that, but since what is before the court today is some nicotine extracted from tobacco plants, we feel this is a tobacco product

But Mr. FDA, is there the slightest possibility, no matter how small, that nicotine can be extracted from tomatoes or eggplant or any other nicotine containing substance?

Yes there is your honor.

Then why aren't you moving to regulate ALL nicotine containing substances?

 

[Vocalek]

It means that the government and thier "backers" (BIG Pharma and BIG tobacco) are not making any money off this big vaping movement, so we must "deem" it as "hazardous" and tax the hell out of it!! Regulation is just key for government control and another money making opportunity. I dont think we face a ban, like other parts of the world, but I do think we willl be paying more for any nicotine base juices. We'll see......

The FDA has no power to levy taxes. The US Senate and House of Representatives have that power set aside. "Deeming" applies only to whether or not a specified product is covered under the law. Right now the only covered products are cigarettes, roll-your own, and smokeless. But the law says that if the FDA would like to regulate additional products, all the FDA has to do is to issue a "deeming regulation" which proclaims that henceforth the FDA has the authority to regulate the specified product(s) under the Tobacco Act.

A deeming regulation does not get into specific rules for the products. All it does is proclaim that the products are going to be regulated by the FDA, and that in the future any rules the FDA finalizes must be followed by the regulated companies.

If the FDA does what we fear it will do, there won't be any product on which to levy taxes, even if the FDA could tax things.

Basically we fear that they will apply certain provisions of the law that were designed to deal with combustible cigarettes to these safer alternatives. For example, the law specified that the FDA could ban tobacco cigarettes that have a "characterizing flavor" (e.g., "vanilla.") Another provision that states that any product that was not actively being sold before Feb. 15, 2007 must be taken off the market until approved as a "new tobacco product" or has an application approved to be considered substantially equivalent to another product that WAS being sold before Feb 15, 2007. Note that the deadline for submitting "substantial equivalence" applications has already come and gone, and the FDA has not acted on even one of these applications that were submitted by Lorillard, RJ Reynolds, and Altria.

The results would be either a complete ban on all electronic cigarettes for years and years, or allowing a few of the earliest models (most of which are not even manufactured any more) to stay on the market. These were much less effective than current models.

Assuming some models are left on the market, they can write regulations that would make them much less effective, such as outlawing flavors, setting too-low concentration levels for nicotine, and tinkering with the hardware side of things.