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What will the US do?
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.|||Interesting stuff.
You may well be right but could you explain this sentence? - |||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 陆 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.|||Bob, what do you make of this from the crown7 FAQs:
|||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|||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.|||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.|||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.|||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.|||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
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