Regulating tobacco

[TropicalBob]

The House of Reprsentatives has voted the first step toward complete regulation of cigarettes, tobacco products and nicotine. Now the bill faces the Senate before it can give the FDA full power. For many smokers, this bill is called The Beginning of the End.

The most expected result will be a clamp-down on nicotine at what the FDA considers addictive levels. e-liquid contains nicotine at addictive levels, so our practice is at danger.

Here's a quote:

The bill specifically states that the F.D.A.’s new powers would stop short of the ability to order the elimination of nicotine from tobacco products or place an outright ban on all tobacco products.

But the agency could reduce nicotine to nonaddictive levels if it determined that doing so would benefit public health. The F.D.A. could also require changes in tobacco products, like the reduction or elimination of other harmful ingredients.

Read the New York Times account at:
http://www.nytimes.com/2008/07/31/washington/31tobacco.html?ref=us

This is quite fascinating from a political standpoint. President Bush has said he will veto such a bill as an unnecessary expansion of the federal bureaucracy. He may still be in office when the bill passes both Houses and comes to his desk for approval.

If he is out of office, the likely next President will be Barack Obama, a cigarette smoker now chewing Nicorette gum. At least he understands addiction. Would he veto this? I hope a reporter asks that question in a public forum soon!

 

[MacFan]

The House of Reprsentatives has voted the first step toward complete regulation of cigarettes, tobacco products and nicotine. Now the bill faces the Senate before it can give the FDA full power. For many smokers, this bill is called The Beginning of the End.

The most expected result will be a clamp-down on nicotine at what the FDA considers addictive levels. E-liquid contains nicotine at addictive levels, so our practice is at danger.

Here's a quote:

Read the New York Times account at:
http://www.nytimes.com/2008/07/31/washington/31tobacco.html?ref=us

This is quite fascinating from a political standpoint. President Bush has said he will veto such a bill as an unnecessary expansion of the federal bureaucracy. He may still be in office when the bill passes both Houses and comes to his desk for approval.

If he is out of office, the likely next President will be Barack Obama, a cigarette smoker now chewing Nicorette gum. At least he understands addiction. Would he veto this? I hope a reporter asks that question in a public forum soon!

Bob, great observation!
I wonder if they'll start regulating some other addictive products....like perhaps the bottle of 80-proof rum that I can get at the corner liquor store? Is that considered an "addictive level?"

(just me fuming)

 

[TropicalBob]

Those bunch of drunks! Not a chance.

Seriously, we in the U.S. might travel the route of Israel and a few other countries, where only zero nicotine cartridges and liquids can be sold over the counter. It's the FDA that limited the nicotine in NRT products -- and made them ineffective. If e-liquid is limited, we are left with only a placebo device. Better than nothing, but it won't support a nicotine addict's needs.

I fear some companies will just go out of business, which is why Philip Morris supports this bill. How can the manufacturer of pipe tobacco, for instance, assure that a pipe smoker only gets 4mg of nicotine? Too many variables. Bowl size. Depth of pack. Puff or inhale. No way. So the pipe tobacco manufacturer might opt out of the U.S. or go bankrupt in the face of rising costs to lab analyze each product. Same for many tobacco products that don't manipulate nicotine levels the way cigarette makers do.

Philip Morris is laughing all the way to the bank. This is a competition-killer victory for them.

I'm sure you can find a way to meet any nicotine requirements, however, so this measure is not doom and gloom for you. I expect Johnson Creek to prosper and grow! But if this becomes law, it requires the FDA to approve any "new" way of getting nicotine. We all know what that means.

 

[Ilyanna]

Um, no help there he already supports the bill, think he helped with it and I highly doubt smokers will get any help from that man, smoker or not, he'll help make it worse, in my opinion, along with anything else any do good lobby wants to control. Didn't you know freedom is not cool anymore?We got his buddy Deval as governor here, his term can't be over soon enough that is exactly what its like.

But these quotes are from the ap article on my newspage:

The 326-102 House vote signaled solid bipartisan support for the measure, with 96 Republicans breaking with President Bush's position to vote in favor of the bill. Both presidential candidates, Sens. John McCain, R-Ariz., and Barack Obama, D-Ill., back the legislation.

And

The bill sets up a process for the FDA to scientifically assess manufacturer claims that certain cigarettes are less risky.The legislation appears to set a high bar to such claims. Not only must a reduced-risk product "significantly" reduce harm to tobacco users, but it also must "benefit the health" of the entire population. A less risky cigarette that enticed nonsmokers to light up might not meet that test.

Note the last sentence if looks nice, is enjoyable or is cheap, it doesn't stand a chance, its written right into it, more or less.

Think under that guise, they'll ban these devices in a heartbeat just cause they might look 'neat' to kids or nonsmokers unless they are kept priced above the disposable spending money of the average teenager now. As much as a disposable would be easy to use and nice for us, I think it would doom any hope of ever getting them approved and is the wrong direction to even hint that these companys are going in or should go in, if we want them approved in this country. I think with a little pressure from vegas, casinos, ruyan and hopefully some others, if they go the other route, keeping them basically a fancy tech device that costs upwards of a hundred dollars or more and is not disposable but touchy like any such device and needs to have failed parts replaced, so you have to deal with the companys which is a hassle in any ones mind, is the best direction they can take to keep them from being banned here. Do gooders can always set up bulk discounts for low income heavy smoker rehab but put them in the corner stores or webstores at under fifty bucks a pop, normally, making them disposable and easy to get and cheap to try and just as easily replaced and they will be banned in a heartbeat because they may tempt someone to just try it and heaven forbid anyone have a mind of their own.

Going the route ruyan , jantry and the other brands seem to be, trying to refine them more which adds to their initial price but also offers the user more or will in the future hopefuly, I think actually stands a better chance of avoiding that kind of blanket bann based on appeal, all that fuss doesn't hold a lot of appeal for someone without the habit already, or young with a more limited amount of spending money and lots of other cool things to spend it on that come with less problems. I also think the companys going the other route, trying to make them disposable and cheap and demands for them to be made so, are only going to hurt the attempt to keep them from being banned, the reasoning will be the other companies might go that route after with the product , why chance it, or that banning one and not the other seems like to much work when their basically the same thing, they'll have to monitor them more so why bother, if the possiblity is there at all, if someone is pushing it, then just ban them all and be done with it.

Though it will probably mean loss of some nic levels in the carts at least, and maybe being taxed on the carts and liquid to, making using them just cause they cost less then the real thing in some way probably not likely in the future, that will also mean that as much as a device that works well, good customer service will always be a number one factor if they want a regular smokers business and maybe reasonable cart prices as well to offset the price of the device itself, they'll make money off them in bulk rather per cart price if their smart about it. Keeping the carts cheap holds little meaning in this 'appeal' theory if the initial investment is to high for most folks under twenty to even consider, just to try it anyways and at the same time, offers an alternative to lower income smokers to, if they get help with the initial cost, or save for it, they can still afford to use this healthier device if the carts are not costing them more then a pack of cig's.

Ilyanna

 

[TropicalBob]

I can see many reasons to ban these if they are for (1) smoking cessation, or (2) recreational drug use. I won't reiterate what has been argued here many times before.

The only argument I see with a chance of government approval is that these are simply personal vaporizers. Vaporizers are legal. This one vaporizes a solution with nicotine, so it's a bit different, but these are not cigarettes by legal definition in the U.S., so they must be vaporizers. Cigarettes are legal; vaporizers are legal; so if a device performs as two legal products do, why should it be banned?

Still, I expect anti-tobacco, anti-smoking proponents to scream outrage at the very idea of e-smoking, once they focus on it. They have both the numbers and the clout to crush e-smoking in its infancy.

The liquid is another matter. I cannot even think of one argument to legalize it -- unless severe restrictions and regulations are put in place, and it's easier to ban it than set up a bureaucracy to police it.

We have the devices. Learn how to homebrew liquid.

In the meantime, I hope e-smoking flies WAY UNDER the radar for as long as possible. Even one wave could drown us. Don't you wonder why these aren't being advertised???? Keep your heads (and e-cigs) down.

 

[jimldk]

DIY liquids are the only way to go then if this so called bill takes effect....sheesh... my war plans seems to be heading towards a Blackhole....just when I thought things will get better....Damn...

We have to prove the e-cig delivers a lesser and safer dose than real cig/tobacco ....so If we can show that an e-cig cartridge contains 1 ml of 24 mg Nicotine and can deliver about 30 puffs that means roughly about 0.8 mg of nicotine(which will be lesser if the atomiser is not 100% functional) per puff....that will be theoritically lower than an average real cigarette....If this the case then will it bypass the law...and imagine if we use lower density of Nicotine Carts..then it will be much better....??

What do you think TB...feasible??

 

[Ilyanna]

I agree...I simply don't think they stand a chance even as personal vape's of getting past any of those hurdles based on the yardstick of risk to population that non smokers might try it, they are already trying to write into what the FDA will use for risk evaluation of such products if there cheap and disposable just like a cig. In that case they will flunk that yardstick test of less risk, just on that basis alone, there cheap and easy to try and look just as cool as cigs, triple threat. If they try it they might try to find a nic source even if the liquids been banned! Or decide to try cig's cause its fun to vape, maybe their even more fun! Though why anyone thinks kids think they look cool now days, I don't know, my own kids try to hide them.. . <G>

Personally I think they have a nerve trying to ban or take off the shelves anything with equal or less nic. then cig.,'s as long as cig.'s are still legal, but that argument is never going to work... pfft. <G>

I hope they fly under for a while longer at least, to, maybe i can cut out of the nic carts before then.. but I'm way to new to e-smoking to think about home brewing anything yet, guess I'll just watch for reports on your experiments until I'm ready to...<G>

 

[TropicalBob]

The States don't yet know about e-smoking. We're safe for awhile -- who knows how long? The FDA is overwhelmed anyhow, chasing salmonella threats from Mexican jalapenos, etc. Ha.

It's field tests like yours, Dr. Loi, that can provide useful information that these devices indeed constitute harm reduction, in the way methadone does for ...... addicts. This is safer, not safe, but safer than smoking cigarettes. That notion won't get off the ground without science behind it. You're a field pioneer in that science. Dr. Laugesen is a lab pioneer in New Zealand.

E-smoking will need both of you in months to come, so let Plan B continue.

 

[jimldk]

The States don't yet know about e-smoking. We're safe for awhile -- who knows how long? The FDA is overwhelmed anyhow, chasing salmonella threats from Mexican jalapenos, etc. Ha.

It's field tests like yours, Dr. Loi, that can provide useful information that these devices indeed constitute harm reduction, in the way methadone does for ...... addicts. This is safer, not safe, but safer than smoking cigarettes. That notion won't get off the ground without science behind it. You're a field pioneer in that science. Dr. Laugesen is a lab pioneer in New Zealand.

E-smoking will need both of you in months to come, so let Plan B continue.

And it shall prevail......as long as I am alive and kicking in the right direction....the need to prove is becoming a dire need indeed....the battle plan is now virtually worldwide...and much more intense....

 

[phylo]

There are a few things that I think are being overlooked in this discussion.. The first and main thing is that e-cigarettes are no longer under the radar.. NJoy is selling there product nation wide in Target. That is going to push e-cigs into the view of millions of people that would otherwise not heard of them.

Second, the FDA is already aware of e-cigs. There is already at least one manufacturer on this board that has FDA approval for there device.

I dont think that e-cigs will be banned but I would not be surprised if the cartridges become regulated and taxed all to hell.

Phil

 

[TropicalBob]

Target has yet to promote the e-cig. It's not on sale in stores. It's an online order, as are other e-cigs. In other words, it's hidden. If they promote it, you're right -- it will be noticed Big Time. Let us know the first time it's in a Target print ad.

I'm sorry to say I don't believe that FDA claim. I am "press" so I do have access to the FDA through the press information office, but I've told Smokey Joe before that I'm reluctant to ask them anything about electronic cigarettes. The fewer questions, the better. Note that Ruyan, the biggest of the big, said it will seek FDA approval "when the time is right."

The time is not right.

 

[phylo]

Target has yet to promote the e-cig. It's not on sale in stores. It's an online order, as are other e-cigs. In other words, it's hidden. If they promote it, you're right -- it will be noticed Big Time. Let us know the first time it's in a Target print ad.

I'm sorry to say I don't believe that FDA claim. I am "press" so I do have access to the FDA through the press information office, but I've told Smokey Joe before that I'm reluctant to ask them anything about electronic cigarettes. The fewer questions, the better. Note that Ruyan, the biggest of the big, said it will seek FDA approval "when the time is right."

The time is not right.

I have actually seen the FDA filing, it is filed as a Nasal inhaler under the ear, nose, and throat drug administration device..

They are one of the manufacturers that I have been talking to about carrying there devices.

Phil

 

[karenwest1961]

The States don't yet know about e-smoking. We're safe for awhile -- who knows how long? The FDA is overwhelmed anyhow, chasing salmonella threats from Mexican jalapenos, etc. Ha.

So GreenCig's claim of FDA certification is either BS or something that went straight through without batting an eye. (I doubt that).

Either the states DON'T know, or this is one of the many "little" things on the back burner until the election is over or somebody dies or sues. I'm leaning towards the latter. E-cigs haven't killed anybody (to our knowledge) yet. Sure enough if they ever do, then our government will "shed a tear" like they did for all those who misused Ephedra. The media will drop everything to "cover the story" from every possible scenario and it will all fall apart from there.

 

[TropicalBob]

Okay, we can all go the U S Food and Drug Administration Home Page and type in the search box (with the quote marks) "electronic cigarette". We get only this case, as follows:

Solarium Tanning
Leamington ON, CA N8H2Z7 NOL-DO 112-0433697-1/1/1
66BAQ44 850591983830 NICOTINE DELIVERY DEVICE-- Electronic Cigarette
12-DEC-2007 UNAPPROVED

Reason: UNAPPROVED
Section: 505(a), 801(a)(3); UNAPPROVED NEW DRUG
Charge: The article appears to be a new drug without an
approved new drug application.

We can check for recent applications for devices using the drug "nicotine" and find three transdermal patches (the strongest is 21mg in 24 hours, so Trog is seriously overdosing with his e-pipe smoking!).

So last December the FDA rejected an electronic cigarette proposal because it was a new way to deliver nicotine. A long and expensive procedure is involved for new drug delivery devices. Then we can read what the FDA expects when an application is filed:

"Some products — such as new drugs and complex medical devices — must be proven safe and effective before companies can put them on the market. The agency also must approve new food additives before they can be used in foods. Other products — such as x-ray machines and microwave ovens -- must measure up to performance standards. And some products — such as cosmetics and dietary supplements — can generally be marketed with no prior approval."

(Note that one company tried in another country to get these through as "dietary supplements," the same guise used for Nicowater, and was sounded rejected. Nicotine, they were told, is not a food or dietary supplement. Nicowater was banned by the FDA.)

"At the heart of all FDA's medical product evaluation decisions is a judgment about whether a new product's benefits to users will outweigh its risks. No regulated product is totally risk-free, so these judgments are important. FDA will allow a product to present more of a risk when its potential benefit is great — especially for products used to treat serious, life-threatening conditions.

"FDA reviews the results of laboratory, animal and human clinical testing done by companies to determine if the product they want to put on the market is safe and effective. FDA does not develop or test products itself."

If you have information to point a different direction, please let us know. FDA approval is critical to the future of e-smoking in America. But a "nasal inhaler?" Sounds like another ruse to me. Please point me to FDA approval of an e-cigarette as a nasal inhaler.

 

[karenwest1961]

Dude, when did they post that because I've been going there every single day and I never got even that. Just a page that says nothing matches my query.

 

[TropicalBob]

Been there awhile. I regularly check the FDA and always check "electronic cigarette(s)" to see if any manufacturer has even tried to get approval. None to date.

They know what they face.

 

[karenwest1961]

How did I miss it?

Oh well. Vape 'em while you got 'em.

And GreenCig needs to pull that statement off their site. For sure.

 

[phylo]

Obviously I got the wool pulled over my eyes by these guys....

Thanks for clearing that up for me...

Phil

 

[smoking gnu]

This is a question for Bob I think. Do you know what the pay pals Policy is with regards to accepting payment for Nicotine carts and nicotine liquids is? Thanks.

 

[CaSHMeRe]

gnu ...

Its layed out in Paypals terms an conditions/user agreement. Nothing in regards to Nicotine itself, only tobacco is mentioned twice.