What will the US do?

[TropicalBob]

I've posted concerns elsewhere in this forum about the FDA banning these products as soon as the agency focuses on them. Read the sales pitches at Web sites selling e-cigs, etc., and then consider these words from the FDA in 2002 when nic-laced lip balm and lollipops were banned:

"Today FDA issued warning letters to three pharmacies that are selling "nicotine lollipops" and/or nicotine "lip balm" over the Internet. The letters inform the pharmacies that FDA has found their nicotine lollipops and lip balm to be illegal. Based on statements from the pharmacies' Internet sites, the products are promoted as aids for smoking cessation or to treat nicotine addiction.

"FDA is concerned about the health risk of these products because they appear to be compounded and dispensed without a doctor's prescription, contain a form of nicotine that is not used in FDA-approved smoking cessation products, and because these candy-like products present a risk of accidental use by children."

The pressure is greater in 2008 than it was in 2002 to restrict all but Big Pharmaceutical solutions for smoking cessation or replacement products. I fully expect all e-cig products to be banned in the US, probably this year. To enforce this in an Internet world, government bodies are considering restrictions that would prevent any delivery of tobacco-related products -- or banned products like e-liquid. The products would simply be confiscated.

I'm planning a rather sizable order of e-liquid and the injector real soon.

 

[Oliver]

Interesting stuff.

You may well be right but could you explain this sentence? -

The pressure is greater in 2008 than it was in 2002 to restrict all but Big Pharmaceutical solutions for smoking cessation or replacement products.

Also, do you have any idea what the FDA meant by contain a form of nicotine that is not used in FDA-approved smoking cessation products?

SJ

 

[TropicalBob]

SJ,

Here's the remainder of the FDA's public statement from 2002. I left it out only because of length and repetition. You'll find the nicotine answer here:

"The products cited in the letters include compounds incorporating nicotine salicylate, natural sweeteners, and flavorings in a sugar-free base and are available in ½ mg., 1 mg., 2 mg., and 4 mg. dosages. The claims on the websites include that the products help alleviate the "hand to mouth fixation" associated with smoking and are a "convenient, tasty way" to replace the cigarette habit. After investigating and carefully assessing these websites, FDA has determined that the pharmacies' nicotine lollipops and nicotine lip balm are intended for use as "drugs" and appear to be illegal for the following reasons:

"They are compounded and dispensed without a doctor's prescription.

"They are unapproved new drugs which need, but do not have, FDA approval.

"They are made from a drug substance, nicotine salicylate, which is not permitted for use by pharmacists in compounding drugs. The FDA-approved smoking cessation products are made from different forms of nicotine.

"They are misbranded because their labeling does not have adequate directions for the uses for which they are being offered and does not have adequate warnings against use by children.

"FDA is requesting a response from the pharmacies in writing within 15 days of receipt of the warning letters stating the action the firms will take to discontinue marketing of these drug products. Failure to do so may result in further regulatory action, potentially including a seizure or injunction action. FDA will take appropriate action to protect the public health."

As for the 2008 reality versus 2002: We're in the final year of a Republican presidency that is repaying party debt to Big Buck contributors. 'nuff said about that. We also have a public mood that condemns everything about tobacco and smoking. Ditto for marijuana. But praise glory for alcohol! There's no reason here, only perceptions of Evil Tobacco. The products we now buy and covet will be considered tobacco products whether we agree or not. And likely banned. As for making them legal: I'm sure no company wants to spend 10 years getting certified for medical delivery of a substance that might be declared a health hazard and "regulated" by the FDA.

I see no happy ending for any inexpensive, non-government regulated nicotine-delivery device or system in the US.

 

[Oliver]

Bob, what do you make of this from the crown7 FAQs:

Is Crown7 approved by the FDA?

The Alcohol and Tobacco Trade Bureau (TTB) and the Food and Drug Administration (FDA) have formally stated that Crown7 is not a product that warrants the involvement or oversight of either government entity. The FDA notes that Crown7 do not fit the classification of products it governs. The TTB (Tobacco and Taxation Bureau, formally the ATF, Alcohol Tobacco and Firearms) has formally determined that the TTB has no regulatory interest in Crown7 because it does not contain tobacco.

 

[Oliver]

Oh and thanks for explaining the politics involved, all very interesting stuff.

I do have an interest in US politics, but you'll forgive me for not being so clued up about some of the intricacies, so these sorts of explanations are very eye opening.

Take care,
SJ

 

[woody]

Nicotine is derived from the tobacco plant so it must be a tobacco product. Let's hope, though, that the powers that be are able to view the e-cigs as a safer alternative to smoking with the potential to save millions of lives. I can understand nicotine lollypops being banned because they would be so attractive to children.

 

[TropicalBob]

SJ,

I read that Crown7 statement and don't believe its implication. I note that it doesn't say anything has been approved by the FDA. Just that it doesn't warrant their attention. Ah, but it does. And as soon as they figure it out, the stuff will hit the fan. At a minimum, we'll get "Use It and Die" warnings on our e-cigs and a whopping tax on e-smoking products. But I fear the worst - the same fate nicotine water, lip balm and lollipops drew when the FDA noticed them.

By profession, I'm a veteran magazine writer. It would be so easy for me to call the FDA's press hotline and ask about electronic cigarettes. But that might trigger action from them that I don't want, and I doubt any of us do. The longer they stay in the dark, the better for us.

Just don't pretend they've approved these products. They haven't focused on them yet.

Until they do, I'm enjoying my e-Pipe and e-cigar.

 

[TropicalBob]

SJ, Woody:

A few more thoughts.

Nicotine-replacement and smoking cessation products are not about saving lives or creating healthier Americans. This is about, always, money. Follow the money! If smoking is made unattractive or impossible, what are the consequences? Here's the one that counts: Thousands or millions of smokers will want to give up their habit/addiction. They'll look for a painless way out. They'll turn to ... nicotine-replacement products!

And -- follow the money -- who profits when these befuddled smokers buy expensive gums, lozenges, patches and other equally futile devices that continue addiction? Big Pharmaceuticals like Johnson & Johnson, that's who. Those are also the folks responsible for the Robert Wood Johnson Foundation, a charitable group devoted to making America healthy. WInk, wink. The foundation funds anti-tobacco groups who promote smoking bans. Industry hands money to an allied charity, who hands it to chosen fanatics, who insist to weak leaders that they know what's best for everyone. Now you get the picture. Push a ban, boost the bottom line. And if some upstart nicotine device comes along, like nic-laced lip balm, have it declared illegal by your friends in high office.

Have you noticed how the anti-smoking pressure keeps getting greater? And it's global, just as Big Pharma is. First there were bans in public buildings. Then in parks and arenas. On beaches. Now come proposals to ban smoking in grouped dwellings, like apartments and condominiums. And even in vehicles containing anyone under 18 (is that almost funny?). But the push is on to create more buyers of Big Pharma's products. The projection is that NRT will become a $4.6-billion US business by 2016 as more doors are shut to smokers. We're enroute to that glorious Smoke-Free America. Ain't it grand, brother? Get aboard, friend, and buy some J&J stock. It'll never go down like smoking will.

Good luck to any David taking on this Goliath that wants as many people on perpetual drug maintainance as possible.

I do have this ray of hope for our e-smoking products. I am now opening a sealed packet of java-flavored Stonewall "dissolvable tobacco pieces." From experience, I can tell you that these are every bit as effective as the FDA-approved nicotine lozenge. Both are used the same way: let them dissolve in the mouth. The cheapest lozenge I could find on the Internet is 45 cents each; the Stonewall piece costs me 18 cents each. They do the same thing with the same impact. So the very fact that the Stonewall product is still available gives me some hope that e-smoking will make it to the American market.

But I wouldn't put too much money on that bet. I'd be more likely to bet Stonewall sometime soon runs into "legal difficulties" and the product disappears.

 

[Oliver]

Fascinating stuff as always Bob,

I know what you mean about accidentally tipping off the FDA with an innocent question! I was considering trying to see what the legal status in the UK was by getting in touch with a friend who works in the Ministry of Health, but then thought better of it.

I know what the civil service is like in this country, and I am sure it is similar in the US - they tend to just get on with their day to day pen-pushing and administrative stuff, don't want to rock the boat - It is a plum old job on the CS gravy train, so there's no incentive to go poking their noses into stuff that hasn't yet been brought to their attention. But when something is "brought to their attention" they are on it like pack dogs.

I'm not going to be the one that brings it to their attention but I'm sure someone else will pretty soon though, even if accidentally - it'll probably be someone like cigatronic.net who make stupid claims about the electronic cigarette being a smoking cessation device, that'll sure get the heckles at J&J up.

 

[Atrack421]

Wow guys, all interesting stuff!

Revelle's nicotine does not come from tobacco. It is derived from potatoes.

Also, we explain on our site that the FDA has no approved this product for smoking cessation.

As far as the product itself, it does not fall under any FDA regulations.

http://www.myrevelle.com/aashay

 

[womaninterrupted]

Maybe we should have a section on how to grow potatoes and how to extract nicotine from them. I can just see driving down a road and knowing who smokes e-cigarettes by the big potato fields in their backyards ;-)

 

[katink]

Or tomato's, or aubergines... I'm wondering if not even the simple weeds from the nightshade family could be used.
Trouble would be, to keep all those things on the safe side, I think... haven't seen any 'nicotine-measurement-devices' anywhere myself; without that it will be hard or impossible to know what you are doing.

 

[TropicalBob]

On the other forums I frequent, on snuff and snus, some are already growing their own tobacco. A great deal of information is being presented on making your own product.

P.S. The snus ban is an EU ban, with Sweden specifically exempted. Attempts are being made to overturn the ban, but that likely won't happen. And if something with a 300-year history of safe use in Sweden (snus) isn't allowed in England, then that tells you Trog what the likelihood is of e-smoking being accepted by government. There is nothing proven about e-smoking. Just compare our unregulated, untested Chinese E-Liquid to Sweden's food-grade demands for the purity of snus ...

 

[leaford]

Bob, you just created an Oroborus.

That link links to the beginning of this thread.

 

[TropicalBob]

Cool. I had no idea!

Actually, it was intended for another thread here. I can edit .. and will. Thanks.

While I'm posting ... I went to inquire today about ordering some exquisite pipe tobacco called Blatter Reserve. Sold in Canada. Roughly $10 an ounce! Anyhow, on the home page, Blatter & Blatter states that a photograph of the store cannot be shown because it would violate Canada's anti-tobacco law because the word "cigar" is on the plate glass window. Hmmm. So I followed a link to the pipe tobacco section. There I read that a description of the tobacco cannot be provided because it would violate Canada's anti-tobacco law, etc. ad nauseum.

I emailed the store for prices and shipping costs. This has really gotten beyond ridiculous, hasn't it?

 

[ktribe808]

Tobacco is ridiculously easy to grow. It is interesting to note it is extensively used for agricultural and plant genetics research. While I am waiting for my e-cigarette kit to arrive, I am currently rolling my own cigarettes at a cost of 1USD per pack. I ordered the e-cigarette to use in places where smoking is banned so I don't have to go outside in bad weather. But I am fully prepared to grow my own tobacco if it comes down to that.

 

[prestontiger]

heres a couple things that I hope TBob reads XD he seems to be one of this forums best "thinkers" (no offense to the rest of you of course)

A new ray of hope, nicowater is back on the market after 6 years of being baned by the FDA, they got around the ban by doing 2 different things (they have 2 new products now) the first one is water with nicotine that actually contains tobacco, therefore is a tobacco product and we all know that, the FDA can't do anything about tobacco products (even though, the want to so badly)

The second one is a new blend (I was kinda confused by this while reading it so forgive me of any misrepresentations to this product) that does contain nicotine, just a very very small amount of it.

This makes me think that since nicowater found a way around it, E-liquid should be able to as well, and definitely E-Liquid without nicotine should be safe from the ban, which leads me to the next part

E-cigs, could be changed to a device that is only intended to be used with this new e-liquid (I.E. the kind that doesn't have tobacco) so since these devices have a purpose that I don't think can be regulated by the FDA, since the FDA can't regulate stuff like this without an active ingredient (correct me if I'm wrong please just trying to see if its possible to exist even after were told this is no longer legal in the states)

So you would end up with 3 different suppliers for everything, the "vapor devices" that have warnings that say you shouldn't use this product with products not approved for it, The *clean e-liquid* the stuff that has no nicotine, and the "tobacco e-liquid" has nicotine and tobacco, not for use in "vapor devices" of course lol .

Another note on the tobacco e-liquid would probably have to be filtered in some way at your home *again, the company selling this should warn against this practice, to be on the "right side of the law" so that the small tobacco particles would not clog the atomizers or add 4000+ carcinogens to your vapor

anyway sorry for the long post, I just kinda look at this as a new age Prohibition, and if you do some history research during Prohibition, the beer factory's did almost the same thing lol, (sold a beer kit, with instructions *ehm, warnings* to not do this, or you would end up with an alcoholic beverage)

 

[TropicalBob]

I certainly hope you're right. And no one knows yet how this story will end. Personal vaporizers are legal, of course, and that's what our devices are. So I don't see the devices per se as the target of regulation. The liquid will be the target because nicotine is a drug and the FDA has clear authority over it when it comes from anything other than a tobacco product.

But remember that Waxman-Kennedy have sponsored a bill in Congress to explicitly give the FDA authority over tobacco products. The bill is given an excellent chance of passage, but Bush has said he would veto it. That stalls things until we get Obama or McCain.

If the FDA has authority over tobacco, it will seek a "non-addictive" level of nicotine in products it regulates. That means we would have legal e-liquid with no more than about 2mg nicotine per ml. Very "low". Or we could choose "no". And that would be it for legal sales. See the Health New Zealand studies for addictive levels.

Fortunately for us, this all might take years to play out.

And, even if it does, we are likely to be able to buy devices and then order liquid online from foreign sources. Policing the world is getting impossible these days.

The next generation of e-smoking devices -- like the "cigarette lighter" model from LoongTotem -- is not going to look like cigarettes anyhow. The quicker we dump the ... look, the better for this practice.

 

[prestontiger]

I agree that they shouldn't look like the cigs of yesterday much, I mean these are the cigs of the future ^^ I did want to mention one thing though, in regards to your previous post, you said "this stalls things till we get Obama or McCain, now I don't want to turn this into a political debate, but in 1998 McCain tried to pass a bill giving the FDA rights to regulate non tobacco nicotine products (basically anything thats not made by big pharma) so I'm not to enthused with him holding the veto, and I've heard that Obama used to be a smoker, so maybe he would be better (on this issue alone, cause I don't want to touch anything political here that isn't involved directly with the e-cigs)

Plus in 2000 the supreme court told the FDA that they couldn't regulate tobacco products for some reason, maybe that would still hold up if congress tried to pass a bill or something (not entirely sure, should of paid more attention to how politics work in High school lol)

 

[TropicalBob]

What I meant was that it will be the next president who will have an approved bill on his desk.

And, yes, the Supreme Court said the FDA did not have authority to regulate tobacco products. Congress had set up other agencies to do that. In order for the FDA to have such authority, Congress must approve it and the President must sign off on that approval. That's what's in the works now.