FDA regs worst case scenario?

[kfig]

I think it's a good idea to have it tested also. Although I firmly believe its safer than ciggs I wonder about what it does. Most of the docs I've asked say they don't see the harm compared to ciggs though.

 

[Tanti]

worse case:
the tobacco companys will push in the direction of what they offer, and with all their money and lawers the FDA will fall to their wishes, in that juices, mods, and all the other parts will not be allowed, it will be only prepackaged preloaded carts, with limited nicotine allowed. The cig lookalikes. The flavors will be limited to menthol, mint, tobacco, cherry, maybe not even cherry but they do allow it for the other NRTs. The FDA will find all the juices, kinds of batteries and parts are to much/to many to control to keep it safe for the general public. They will also feel that people could/will take into much nicotine the way it is now. They are going to take up on the whole push of OMG the children. So they will go into looking at what will be the best for the Children.

I really really hope this is not the case this is the first thing that has helped me stop and ive tried all of the other things.

 

[meli.]

Well then, thank the Lord this is the Worst Case Scenario thread and not "This is happening in the Real World - The Facts."

One could never accuse this thread of Sensationalist Extremism.

 

[Abe_Katz]

Link to the bills: http://www.e-cigarette-forum.com/fo...e-cigs-if-fda-determines-tobacco-product.html These were posted in this forum February 9, 2013.

The direct links to the bills themselves weren't effective as they were temp links. Thankfully the blog post in that thread had the bill numbers.

S. 39 introduced by Sen. Durban gets introduced every year, and every year dies in committee. Big Tobacco has bought enough senators that it will never see the light of day. S. 194 to be implemented would require the FDA to determine the presence of nicotine in anything to be tobacco. This would include all members of the nightshade family of plants including but not limited to tomatoes, potatoes, hot and sweet peppers and products derived from these plants. Like S. 39 Tom Harkin introduces the same bill every year and every year it dies in committee. Big Agriculture has enough senators bought off to stop it.

Even if BA and BT didn't have the bought senators required to kill both, the Republicans are likely to filibuster both on general principle (requiring 60 votes to debate the bill). 60 votes that the Democrats simply don't have.

My definition of hobbyist is generally the vaper who is active in ECF, buys or builds mods, buys bottled juice or makes his own and is not using Blu or Njoy type e cigs. We are the minority vapers. The majority of users out there are getting them at the gas store, the convenience store and they are cig alikes with carts. I'm sorry if the term annoys you, we are what we are.

Whether I'm annoyed by your term or not is irrelevant. I would say that your definition though would make a larger number of people than you suspect "hobbyists". When I run into vapers in the street I find that ego style batteries and buying juice is far more popular than Blus or Njoys. Cig-alikes have severe design problems for most people who want nicotine without the nasty tobacco smoke. Design problems that cannot be addressed by juice alone--it is a battery problem really. There are only really two kinds of battery in the world: Big and long lasting, or Small and not so long lasting.

We have a lot of recorded history in the ECF and CASAA of fighting the FDA and various proposed legislation that puts vapers in danger of being unable to get ecigs, of being punitively taxed, of being unable to vape in ones own domicile if it is not a detached dwelling, etc. Most of this comes directly from the FDA's massive and enduring lies about what an ecig contains, illegal funding from the CDC to foster new laws and regulations at the local, county and state level and the rest comes from the alphabet soup agencies functioning as shills for the pharmaceutical corps, and funded by them.

The FDA has an axe to grind here. They were seizing shipments at the ports not all that long ago and were only stopped by a lawsuit in Federal Court. They appealed twice and lost, until very recently they were toying with the idea of going higher. That seems to have fallen by the wayside, they have decided now to rid themselves of these pesky ecigs by regulation. The FDA is allowed by law to regulate 'other tobacco products' and that is what deeming regulations mean. Those will totally be decided by the FDA alone in its glory as the supposed watchdog over public health. Now we all know that the FDA cares not a fig about public health, it is beholden to its real clients, pharmaceuticals and the other industries that fall under its purview. The FDA will do as it pleases unless stopped by the Congress. With the financial and political corruption in the Congress that's a dim hope indeed.

The problem with this line of argument is I've read the relevant laws, now I'm no lawyer here so my views are based on what is actually written rather than lawyer speak, there is a problem with using deeming regulations here. That is the definitions portions of the laws in question which would require the Congress to actually amend the various laws (some of which have been on the books since the 1960s). This means bills and getting bills through the Senate is a pain in the ....

Given that the 112th Congress failed to even pass a farm bill, a bill to redefine tobacco product to include PVs would have to be a rider amendment on the Budget itself to pass. I think our government being fundamentally broken may buy us time here.

As to CASAA, yes I know the history. When I decide to support an organization, I make it a point to study its history.

Anyone so inclined and technically proficient enough can make a mod. We can DIY e liquid as long as we can source nic, which should not be a problem. Those things are a given. If you are only concerned about yourself, fear not.

Even if nic sourcing were completely banned finding it would not be a problem. Other things are completely banned too and I can buy them with cash up front in less than 5 minutes if I go to the right places. As to mods, one merely need a set of plans for a simple mechanical and a set of batteries. It is literally impossible for the FDA or anyone else to ban the components to construct mods--they simply have too many other non-PV purposes.

I am concerned about the 400,000 people a year who will not get the message that e cigs can save their lives, and not be able to quit smoking tobacco due to the reduced nic in 'approved' e cigs. I am afraid their failure rates at that level of nic in a form factor that has a battery that craps out in a couple of hours will deter them from successfully making that change. Not to mention the costs of them both now (ridiculous for what they get) and then when heavily taxed.

Okay, I can understand that fear. However, here's the problem. The FDA doesn't levy taxes--Congress does. Congress can tax PVs now. Hell Congress, assuming it actually worked, could pass a bill tomorrow defining pre-filled cartomizers as "discrete single use units" and as tobacco products without the FDA. Taxes are coming, those are inevitable. But like all laws there are ways around them. Americans have a habit of flouting laws they find repugnant.

The FDA isn't going to prohibit ecigs, they are going to regulate the nic level and form factor so it reduces the ability of people to use them to quit smoking tobacco cigarettes economically and easily. Their masters in pharmaceuticals demand it, they need the money from smokers disease drugs that won't be selling as well when so many have quit putting themselves in danger by making the switch.

I don't think anyone who even just merely wants to play around with an e-cig or two would even bother with a unit that contains the same nicotine as 4 Camels. While I will not argue the point that the FDA is owned by Big Pharma, it is--I'd bet a trillion dollars on it--the fact of the matter is that they would only create a black market (which is completely unregulated) by doing so. Remember, Prohibition didn't stop anyone from drinking. Ridiculous regulations or prohibition of PVs and Juice will stop no one either. Our capitalist society has a habit of supplying demands for consumer goods (which PVs and Juice are) regardless of regulations.

And at each step for the FDA to implement these regulations, they would literally have to redefine the term tobacco product, all of which requires legislation AND judicial review. That will take years to implement, and by that time Big Tobacco will have fully penetrated the market. Lorillard has already lead the way, RJ Reynolds is in test marketing, and Phillip Morris is being very secretive about if they are doing anything.

I would say that if these big companies are about to start tossing around billions of dollars on a young market they plan on laying the ground work before the FDA has mustered the legislative capital pass the amendments necessary to call "e-cigarettes" a tobacco product. And even then there is the potential pitfall that if the presence of nicotine alone makes something a tobacco product that many vegetables (primarily but not limited to, potatoes and tomatoes) would also be tobacco products.

Also one has to remember that the FDA also prefers that industries regulate themselves, so the doesn't have too. (Its cheaper that way.) I know juice vendors are already starting to do that. Until the FDA actually proposes regulations anyone who claims they will do anything beyond regulating the contents of juice, demanding yet more testing [not a bad thing], restricting sales to minors, and requiring licensing for vendors IS scaremongering.

Of course the ANTZ are going to raise a fuss the whole time. I'd be more shocked if they didn't. They are zealots after all.

 

[DaveP]

'Cut' & 'paste' from the communist manifesto. Just saying.

I don't know if I'd agree with that, but taxes are a consequence of using a taxed product. Our government gets taxes when you drive, buy gas, or buy anything. They tax things to produce income as well as discourage usage. The level of the tax can be comfortable, bothersome, or prohibitive. If it's bothersome or prohibitive, you tend to use less of it.

In the communist scenario, you would give them most of your money and they would give you back what they thought you actually needed. Our government is becoming a little more Marxist/Socialist, IMO.

 

[mikejm]

Government is all about screwing the little guy. Ever try running a small business? The government, and by that I mean the entire US Congress, the courts, up to the President, do not want to see you succeed in life. They want a society that obeys them, that is all they really want, you to be subservient and obedient to your masters. The FDA is about that. Shut up and smoke what we tell you, we are the government, we are in charge, start obeying or we will burn down your house and throw you in a cage and make you our slave.

https://www.change.org/petitions/co...arsh-restrictions-on-e-cigarettes-or-e-liquid

 

[DC2]

And at each step for the FDA to implement these regulations, they would literally have to redefine the term tobacco product, all of which requires legislation AND judicial review. That will take years to implement, and by that time Big Tobacco will have fully penetrated the market. Lorillard has already lead the way, RJ Reynolds is in test marketing, and Phillip Morris is being very secretive about if they are doing anything.

The deeming regulations themselves will redefine electronic cigarettes as a tobacco product.
No legislation or amendments are required, just the FDA to say so and then (poof) overnight they become tobacco products.

That is, in fact, what the deeming regulations are all about.

 

[Abe_Katz]

The deeming regulations themselves will redefine electronic cigarettes as a tobacco product.
No legislation or amendments are required, just the FDA to say so and then (poof) overnight they become tobacco products.

That is, in fact, what the deeming regulations are all about.

Not quite. The definitions of the relevant acts specifically define tobacco products as chopped tobacco leaves. If one wants to include an extraction of nicotine be it from tobacco itself or from any other plant for that matter as a tobacco product then the definitions need to be amended. That requires legislation. If it were so simple as for the FDA to simply say "E-Cigarettes are tobacco products because....well because eff you thats why." Then why has the FDA not already done such a thing?

The reasoning behind why they have not done that is simple, there are laws that have to be amended for them to do that--which means Congress must and will be involved.

 

[patkin]

Abe Katz said: "Also one has to remember that the FDA also prefers that industries regulate themselves, so the doesn't have too. (Its cheaper that way.) I know juice vendors are already starting to do that. Until the FDA actually proposes regulations anyone who claims they will do anything beyond regulating the contents of juice, demanding yet more testing [not a bad thing], restricting sales to minors, and requiring licensing for vendors IS scaremongering."

I agree. Even on the hardware issue.. ie: can't sell hardware pre-2007 along with juice or in the same establishment that would do away with all gas station products and if anyone thinks the govt is going to loose revenue that way they need to think again. I think, as vapers, we also forget how many products produce vapor... everything from fogger to the new "gourmet" party devices and medical applications... so being nearly impossible to write laws or levy taxes distinguishing one from another, its going to be the juice they go after by regulations mgs and taxing. That's what they did with smokes... 20 to a pack, 10 packs to a carton, etc. What actually bothers me the worst are the States. Once the Feds start taxing, they will jump on the bandwagon to get theirs and, in my State, that's gets really exorbitant.

 

[Abe_Katz]

I would say if there is a target it has to be the juice. Even if the FDA attempted to ban devices designed after 2007 there is nothing to stop people from building their own mods anyway. The component parts are relatively cheap and can be easily obtained. What may be lacking for many people is know how, but the internet will address that problem.

Regulation and taxation of juices is the most likely and perhaps the easiest way to tax and regulate vaping either out of existence or to simply make vaping so difficult that those who are not vapers now will remain on cancer sticks. I of course am under no delusion that the FDA gives a rodent's hindquarters about public health/safety. If they did, then most of the drugs advertised on TV wouldn't even be on the market.

 

[DC2]

Not quite. The definitions of the relevant acts specifically define tobacco products as chopped tobacco leaves. If one wants to include an extraction of nicotine be it from tobacco itself or from any other plant for that matter as a tobacco product then the definitions need to be amended. That requires legislation. If it were so simple as for the FDA to simply say "E-Cigarettes are tobacco products because....well because eff you thats why." Then why has the FDA not already done such a thing?

Which acts are you referring to?

The deeming regulations will apply the definition of "made or derived from tobacco" to electronic cigarette liquid.
And when they apply Chapter IX of the FSPTCA to electronic cigarettes, they will officially become tobacco products for the purposes of FDA regulation.

Maybe we are talking about two different things?

 

[Abe_Katz]

There is a 1986 law which directly defines what a tobacco product is for advertising purposes. That law would need to be amended. There are several others--the tobacco industry is heavily regulated (and was even before FSPTCA).

Also it is conceivable that nicotine can be extracted from some plant other than tobacco as well. Nightshade family plants in particular (after all even people who have never used tobacco in their life have a background nicotine level of 2ng/mL of blood plasma), but with a little genetic engineering I imagine one could use daisies if they wanted to.

E-liquid would need to be specifically defined as a tobacco product in laws for it to be a tobacco product for there to not be loopholes one could drive a mack truck through. That again requires legislation, and a lot of time.

 

[DC2]

I don't understand what you're saying, so let me try a different approach...

The FDA has indicated their intent to issue deeming regulations to apply Chapter IX of the FSPTCA to electronic cigarettes.
If they do that, then electronic cigarettes will become a tobacco product subject to whatever regulations the FDA sees fit to impose.

So, do you disagree with that?
If not, then what are you saying happens after that?

 

[J.R. Bob Dobbs]

sorry it took so long for me to get back to this thread, someone asked me earlier about them regulating hardware. I guess im thinking that they cannot regulate it because it has a myriad of other uses. you could in all reality vape soda through a clearo or carto. No its not effective but there are many other uses for the batteries and atomizer systems on the market. think of it like some of the "other" stuff sold in specialized stores for "tobacco use only." it skirts the law rather neatly PV devices, attys, clearos, cartos and batteries can do exactly the same very easily. How could the fda say an 18650 battery is only good for heating E juice? or that a provari mod or ego battery is only good for one thing? they cant. It would be like saying pencils are only good for writing on red construction paper or something.


For those of you saying they would be ok with taxes, if you had listened to the vapeteam live last wed you may have heard something about pre-filled cartomizers and the taxes that could be applied to each one. Something to the tune of EACH prefilled carto costing around 12$. If they tax e cogs like cigarettes E cigs will become far more expensive than cigarettes. Your 7$ bottle of e liquid will carry about 15-25$ of tax on it.

I am personally in favor of regulation with regard to manufacturing standards and quality control. I would also be in support of a tax to help pay for the people doing the regulation, but something to the tune of 1-5cents per ml of liquid or maybe something like sales tax wherre they charge %per dollar on e cig purchases. But if it goes beyond 2-4% it would be insane and overboard IMHO.

 

[mikejm]

I'm not in favor of any new tax and I want the FDA completely off the case for all time.

https://www.change.org/petitions/co...arsh-restrictions-on-e-cigarettes-or-e-liquid

 

[Abe_Katz]

Yes I disagree with that. Under the FSPTCA, and other laws the definitions are such that a tobacco product must be either a smokable or smokeless form of leaves (or other plant parts) of the Nicotiana genus of Solanaceae family of plants. Other plants of that family also contain nicotine (though in lower quantities than those of the Nicotiana genus) and could conceivably be used to extract nicotine base for e-liquids. Nicotine is in your tomato juice after all, and no it is not a contaminate.

Seriously if this was merely a matter of making a regulation and then "Poof" e-liquids are a tobacco product, it would have been done already. Big Pharma hates vaping because its cutting into their patches, gums, pills and pills for diseases related to smoking revenue. And the FDA is basically financed by Big Pharma paying them fees for approving drugs.

The FDA has already tried to use a deeming regulation to declare that PVs are "drug delivery systems". However, nicotine is not scheduled--neither is caffeine--under the Controlled Substances Act and therefore legally speaking is not a drug. So they have tried the "poof" method on devices and failed already.

What I think is going to happen is they are going to issue some very common sense regulations, order more testing and leave it be. Big Tobacco is already getting in on this gold mine and many Tobacco State legislators don't want the FDA ticking their bribers contributers friends off. At most we may be limited to the flavors we have now and the juices we have now until the FDA and the ANTZ can work up the legislative muscle to amend the laws to where nicotine is a controlled substance or nicotine in any amount is legally equivalent to tobacco. (Both of which is not going to happen, for various reasons.)

As such anything more than the FDA requiring licensing for distribution, labeling on e-liquid packaging, child proof bottles for e-liquid, inspections of e-liquid manufacturing sites and so on is what they will start with.

As to Taxation--thats not the FDA's province.

 

[DC2]

Yes I disagree with that.

Then you may be in for quite a shock come April.

I suggest, if you firmly believe you are right, that you inform CASAA right away.
I'm sure they would be interested in your interpretation.

 

[Abe_Katz]

Then you may be in for quite a shock come April.

I suggest, if you firmly believe you are right, that you inform CASAA right away.
I'm sure they would be interested in your interpretation.

I could be surprised come April. However, ban or no ban, regulation or no regulation I have no intention of stopping vaping--I'm finally free of stinky smoke for decades. However, from what I've seen on this forum it sounds like there is a lot of scare mongering out there. Not to mention a few half-baked conspiracy theories. That said, there is already Lorillard in the e-cig market, and RJR is test marketing devices and juices now. Like I said previously BT is willing to start throwing around millions if not billions of dollars behind a new product and a new market a ban is unlikely. Those companies unlike Mom and Dad's e-smoke shop (who only have to worry about losing their shirt) have to worry about share price values and stock holders. They aren't going to gamble big unless they are sure it is a sure thing.

Note I'm not saying that BT in the vaping business is a good thing either. It can be good or bad. The good is they have the cash, the lobbyists, and the lawyers to delay anything nearly indefinitely. The bad is they will want a monopoly on the market.

Also I have the CASAA forum and website bookmarked already. I am already now preparing letters for every member of the House and Senate now. All I need is a date and to print them out. So I'm already preparing for the worst politically (and stockpile wise), what I'm not going to do is go off half cocked about things that the FDA might do. There is a procedure to all of this.

 

[DC2]

If you want to discuss your thoughts with CASAA you can contact them at board@casaa.org
They, and their legal advisors, are all operating under the assumption that what I told you is correct.

 

[Abe_Katz]

If you want to discuss your thoughts with CASAA you can contact them at board@casaa.org
They, and their legal advisors, are all operating under the assumption that what I told you is correct.

And they should. I'm actually being (perhaps overly) optimistic in expecting someone in Washington DC, and the FDA in particular, to act with some common sense for a change.

I think that their ultimate goal is to ban all nicotine sources not produced by BP. However, that will require regulatory creep rather than a swift kick in the nads.