Policy Guidance Document Regarding E-Cigarettes

[Vocalek]

You know something, Phil? I've been giving a lot of thought lately to this FDA-approved thing. That whole New Drug Approval process only works with products that are stable and standardized. If you invent a new knee joint, it has to be your final, final design that you put through the testing process. And you better be willing to manufacture and sell that exact design for years and years, because if you attempt to tweak the product, FDA will be all over your case, telling you that you are now selling an untested, unapproved new device.

Nicotine is not a new chemical, any more than ascorbic acid or caffiene is a new chemical. The "drug" part of this thing wasn't invented by a chemist. It's a substance that's extracted from plants.

The "device" part is a lot more complicated than a new knee joint. It's an electronic product, and like other products of this type, it is continuously evolving and improving based on user feedback. A process like the FDA has in place squelches innovation and evolution of a product. If we are talking about a new pill to treat such and such, maybe that's a good thing. But not with devices like this. Compare the desktop computers being sold today to the ones sold 10 years ago--or even 3 years ago.

What about the machine you use to record your favorite television show? How is that Betamax machine doing? Oops, I mean the VCR. Nope, the DVR.

And what about how you listen to music? 78 RPM vinyl, 45 RPM vinyl, 33-3/3 RMP vinyl, casette tape, 8-track tape, CD, Ipod?

By the time we took a Ruyan 4081 and put it through 3 to 5 years of testing, the product would be obsolete. Heck, it's obsolete today!

That even happens with products less complex. At the Society for Research on Nicotine and Tobacco conference, Spike and I listened to a presentation by researcher Dorothy Hatsukami. She tested low and no-nicotine tobacco cigarettes over the course of a year. By the time she completed her testing, one of the products she was testing was no longer being manufactured.

You also ignore the fact that when FDA says "nicotine replacement" they are pulling your leg. They have no intention of "replacing" your nicotine in the same way that doctors replace your thyroxine hormone if your thyroid isn't working properly. The "R" in NRT really stands for "Reduction."

The only way FDA would put electronic cigarettes into their collection of approved NRT products would be if a) the nicotine dosage was purposely kept well below levels obtained from tobacco cigaredtte smoking and b) the manufacturer included instructions to limit use of the product to 12 weeks. So while it is possible to prove safety, we could only claim "efficacy" for those subjects who were able to give up using nicotine. In other words, instead of being effective for 80%, our efficacy would drop to match that of similar products like the Nicotrol inhaler.

Why do you think so many of us tried and failed to stay away from smoking? We need the nicotine.

This whole "get FDA approval" thing is a losing battle. The only way FDA would approve any particular model of e-cigarette as an NRT would be if the manufacturer designs it to be less effective.

[jiff]

The only way the e-cig will become FDA approved is if pfizer designs one of their own that goes from 12mg to 0mg in the course of 12 weeks and then you will stop... Then a few days later you'll smoke a cigarette or two... the next half a pack... and then back up to what you were smoking before...

[DC2]

I'm going to call all of them, so thanks for the phone numbers!

[PhiHalcyon]

Vocalek,

1. Even though your point about the evolving nature of electronics is obviously valid, your belief that this fact precludes innovation in medical devices is not. I know someone close to me who recently had an IAD implanted (an electronic implantable automatic defibrillator, I believe). It was a third generation model.

2. Just because nicotine is not a new active ingredient does not mean that new drug products that contain nicotine are not new drug products. There are several such nicotine-containing drug products going through the new drug approval process right now.

3. A nicotine replacement product is a nicotinated non-tobacco product and/or device that is intended to deliver (i.e., replace) the nicotine ordinarily acquired via smoking tobacco. It has long been true that nicotine replacement therapy employed nicotine replacement products in a short-term graduated manner only, but, in the Tobacco Act, Congress encouraged the FDA to consider approving the extended use of nicotine replacement products for the therapeutic purposes of craving relief and relapse prevention. Thus, it appears that the replacement and reduction model may well give way to a replacement-only one in some cases.

4. Whether or not someone with the patents and deep pockets required may attempt to challenge your 'losing battle' characterization of seeking to get an e-cig product approved as a nicotine replacement product remains to be seen. But, even if such an effort is undertaken, it obviously cannot not be considered a potential solution for us anytime soon.

5. The real losing battle is trying to argue that the e-cig is something other than a nicotine replacement product. For, whether we think of it as being a nicotine replacement product or not, e-liquid is a prohibited form of tobacco product; and as such, it cannot be legally sold for human consumption unless it is sold and regulated as an approved drug product.

This is why the best use of the time that Judge Leon has granted us is to put ourselves in a position where the fate of the U.S. e-cig industry will be of no consequence to us; not to be all caught up in the delusion-driven drama of trying to save that which cannot be saved.

[BCB]

This is why the best use of the time that Judge Leon has granted us is to put ourselves in a position where the fate of the U.S. e-cig industry will be of no consequence to us; not to be all caught up in the delusion-driven drama of trying to save that which cannot be saved.

By this do you mean stock up on supplies? I understand that to be a very good idea for myself, but worry about other smokers. I want them, too, to be able to change to vaping.

[D103]

If, as Mr. PhiHalcyon suggests, the case "against e-cigs" is such an apparent slam dunk and that many of us have been foolishly and with "delusion-driven' drama been 'spinning our wheels' so to speak, and wasting precious time, then why have attempted State Bans been thus far pre-empted, why have the AHA, ALA, ACS and the other posse members (all organizations that are generally lawsuit adverse) joined the FDA lawsuit, in the eleventh hour, why have all of those very same organizations been acting in a very clear "circle the wagons" manner, especially lately and actively involved in changing their rhetoric, re-instilling banning tactics - making sure everyone is on the same page, literally developing and promoting "talking points" and in many other overt ways "shoring up for a battle". This all seems very inconsistent with what Mr. PhiHalcyon characterizes as a done deal, a foregone conclusion. If this indeed were the case these organizations would not even have to bat an eye, nor would they. But then maybe I'm just deluded.

[PhiHalcyon]

BCB,

Stocking up is an insurance policy to buy time to work out a real solution, but is not itself a real solution. Those who have learned to make their own e-liquid, and re-build their used atomizers, have developed a real solution for themselves and their close friends; but what we really need is a new product that can preserve the benefits of the e-cig in a legal form. Since I know that this can be done, I suspect that we will ultimately have several options to choose from. In fact, I'm working on one myself. So, yes, stock up if you can. For, this may be all that you really need to do to carry you over until there are new options on the market.


D103,

Big pharm is not concerned about what the ultimate decision by the higher courts will be; for they and Phillip Morris wrote and negotiated the Tobacco Act that will decide this case. (And if you think that big pharm signed-on to an Act that would open wide the doors for the e-cig and big tobacco to enter the nicotine market that is its domain, then, yes, you are deluded.) The state ban attempts are nothing more than an effort speed up the inevitable outcome as part of a damage-control agenda. So don't allow yourself to be deceived by appearances.

[Janetda]

D103, I think I like you!


In fact, I'm working on one myself. So, yes, stock up if you can. For, this may be all that you really need to do to carry you over until there are new options on the market.

This explains a lot.

[Vocalek]

Phil: That's very interesting. Do you own a pharmaceutical or medical device company?

[JustJulie]

Phil: That's very interesting. Do you own a pharmaceutical or medical device company?

I was thinking much the same thing.

I seriously doubt that Judge Leon ruled as he did to buy us time . . . he ruled as he did because he feels that e-cigarettes are not properly characterized as drug delivery devices. I find it kind of surprising that PhiHalcyon feels that he has a better grasp of the law than a federal district court judge.

It's been said before, but in my mind, my PV is a nicotine drug delivery device in much the same way as my coffee mug is a caffeine drug delivery device.