A Pharmacists Point of View

[markarich159]

I'm a registered pharmacist in the commonwealth of PA and a grateful e-cig user. I think it is absolutely ludicrous to even assume that e-cigs are in any way "harmful" as compared to analog cigarettes. I myself recommend them to patients who are looking for an alternative to analog smoking(which is technically "unlawful" on my part). But you have to understand, FDA is a Federal agency mandated by the Food, drug and cosmetic Act(among other acts) to oversee all "drugs" and "medical devices" marketed in the USA. Since Nicotine has recently fallen under their auspices, they have to make it appear as they are concerned about this issue. Believe me, I've lived thru at least 30 prescription drug recalls to know that when FDA gets serious about something they ACT IMMEDIATELY and DECISIVELY. Which is why I'm not at all worried about e-cigs being banned, confiscated, etc... at the moment. Now if you start seeing new articles about websites being shut down and wharehouses being raided, you know the writing is on the wall. But I don't think it will ever come to that. What most likely is going to happen, in my opinion, is that FDA will slowly require e-cig hardware producers(now mostly in China) to register with them(which if you read Ruyan's Chinese website-is already in the works) which will cause an increase in price as these companies will now have to follow US FDA current good manufacturing guidelines. The same will apply to companies making nicotine eliquid(in the US and abroad) and , of course, this liquid will be taxed(raising the price). Johnson Creek is already registered by the FDA, so they have to already follow cGMP procedures, so a precedent has already been set. So e-cigs will never go away, they'll just be regulated federally, like everything else, and the price will go up, as well as a tax thrown in for good measure.

 

[brandeeashlynn]

I'm a registered pharmacist in the commonwealth of PA and a grateful e-cig user. I think it is absolutely ludicrous to even assume that e-cigs are in any way "harmful" as compared to analog cigarettes. I myself recommend them to patients who are looking for an alternative to analog smoking(which is technically "unlawful" on my part). But you have to understand, FDA is a Federal agency mandated by the Food, drug and cosmetic Act(among other acts) to oversee all "drugs" and "medical devices" marketed in the USA. Since Nicotine has recently fallen under their auspices, they have to make it appear as they are concerned about this issue. Believe me, I've lived thru at least 30 prescription drug recalls to know that when FDA gets serious about something they ACT IMMEDIATELY and DECISIVELY. Which is why I'm not at all worried about e-cigs being banned, confiscated, etc... at the moment. Now if you start seeing new articles about websites being shut down and wharehouses being raided, you know the writing is on the wall. But I don't think it will ever come to that. What most likely is going to happen, in my opinion, is that FDA will slowly require e-cig hardware producers(now mostly in China) to register with them(which if you read Ruyan's Chinese website-is already in the works) which will cause an increase in price as these companies will now have to follow US FDA current good manufacturing guidelines. The same will apply to companies making nicotine eliquid(in the US and abroad) and , of course, this liquid will be taxed(raising the price). Johnson Creek is already registered by the FDA, so they have to already follow cGMP procedures, so a precedent has already been set. So e-cigs will never go away, they'll just be regulated federally, like everything else, and the price will go up, as well as a tax thrown in for good measure.

I agree with you 100 percent alot of hysteria has been goin on. The SE vs FDA case will hopefully be in our favor, if not I say that it will be that suppliers and so forthe will have to atleast meet federal guidelines. The taxes for ecig I do not think will be anything compared to analogs. Thanks fo your support we need more like you.

 

[Drunkwaco]

Thank you so much. You bring a new view here that is not seen much on the forums. I've thought about this being the case that it's just how things get done and it's slow just like the rest and normally makes people feel uneasy. The only thing i'm concerned about is the ammount of money Big tabacco can threw at this problem. I'm just worried that FDA is filled with humans that have empty wallets. Besides that thought I normally don't worry. Everything should turn out OK and the level headed ones will shine thru.

 

[wv2win]

Thank you so much. You bring a new view here that is not seen much on the forums. I've thought about this being the case that it's just how things get done and it's slow just like the rest and normally makes people feel uneasy. The only thing i'm concerned about is the ammount of money Big tabacco can threw at this problem. I'm just worried that FDA is filled with humans that have empty wallets. Besides that thought I normally don't worry. Everything should turn out OK and the level headed ones will shine thru.

To the OP: thank you for your perspective. I hope you are right.

I don't think Big Tobacco has a problem with PV's. It's Big Pharm this IS the problem. PV's will gut their worthless, doesn't work, cash cow, NRT products like nic gum, patches, etc. Why do you think Senator Lautonberg (sp) from NJ called for a ban of PV'S? Big Pharm owns New Jersey and is his biggest political contributor. That's no coincedience.

 

[LaceyUnderall]

markarich159 -

It is very nice to have your thoughts on this forum. Thank you for sharing. Very insightful and very interesting.

 

[ramblingrose]

What most likely is going to happen, in my opinion, is that FDA will slowly require e-cig hardware producers(now mostly in China) to register with them(which if you read Ruyan's Chinese website-is already in the works) which will cause an increase in price as these companies will now have to follow US FDA current good manufacturing guidelines. The same will apply to companies making nicotine eliquid(in the US and abroad) and , of course, this liquid will be taxed(raising the price). Johnson Creek is already registered by the FDA, so they have to already follow cGMP procedures, so a precedent has already been set. So e-cigs will never go away, they'll just be regulated federally, like everything else, and the price will go up, as well as a tax thrown in for good measure.

I don't know every state's laws, but medical devices, pharmaceuticals and NRTs are typically tax exempt.

So here's my DQOTD: If the PVs are drug delivery devices and eliquid is the drug, how can they be taxed if there is no tobacco?

 

[markarich159]

I don't know every state's laws, but medical devices, pharmaceuticals and NRTs are typically tax exempt.

So here's my DQOTD: If the PVs are drug delivery devices and eliquid is the drug, how can they be taxed if there is no tobacco?

Again, this is only my opinion, but the new regs that will come down from on high eventually will equate nicotine liquid with a tobacco product. Therefore, eliquid(not the devices themselves) will be taxed(probably based on their nicotine content. I don't think the FDA will ultimately regulate PV as a DME(durable medical equipment), they will be in a category of their own(but still regulated as to manufacturing standards). What we don't want is PV and eliquid regulated as a NRT. In that case, PV's and the eliquid would have to go thru the entire FDA New drug approvals process(which can take up tp 12 years and hundreds of millions of dollars). But again, I don't think it will came to that. PV's will be regulated only as to their manufacture standards. And eliquid will be regulated and taxed ina tobacco like fashion. As long as the Federal Government has some control over qualty control regs and can tax(make money), again in my opinion, that should suffice. If you look at Ruyan's worldwide website, they reference that they are currently cooperating with FDA to come to an agreement on regs and standards. My opinion is flavored by my previous experience with product and drug recalls, which as I stated previously is SWIFT and DECISIVE. In the case of ecigs/nicliquid they are being neither, which is why I'm not worried. I guess to answer your question overall, a NEW category will be defined for PV/nicliquid, which will be regulated and taxed(similarly to tobacco).

 

[tikva]

Again, this is only my opinion, but the new regs that will come down from on high eventually will equate nicotine liquid with a tobacco product. Therefore, eliquid(not the devices themselves) will be taxed(probably based on their nicotine content. I don't think the FDA will ultimately regulate PV as a DME(durable medical equipment), they will be in a category of their own(but still regulated as to manufacturing standards). What we don't want is PV and eliquid regulated as a NRT. In that case, PV's and the eliquid would have to go thru the entire FDA New drug approvals process(which can take up tp 12 years and hundreds of millions of dollars). But again, I don't think it will came to that. PV's will be regulated only as to their manufacture standards. And eliquid will be regulated and taxed ina tobacco like fashion. As long as the Federal Government has some control over qualty control regs and can tax(make money), again in my opinion, that should suffice. If you look at Ruyan's worldwide website, they reference that they are currently cooperating with FDA to come to an agreement on regs and standards. My opinion is flavored by my previous experience with product and drug recalls, which as I stated previously is SWIFT and DECISIVE. In the case of ecigs/nicliquid they are being neither, which is why I'm not worried. I guess to answer your question overall, a NEW category will be defined for PV/nicliquid, which will be regulated and taxed(similarly to tobacco).

Thank you so much for your very valuable info!

Do you think the eliquid will be taxed to a prohibitive level like analogs?8-o

Will the mg/ml strength be regulated so low as to be essentially useless?

 

[markarich159]

Thank you so much for your very valuable info!

Do you think the eliquid will be taxed to a prohibitive level like analogs?8-o

Will the mg/ml strength be regulated so low as to be essentially useless?

Wow, that's a good question. I saw in another thread a suggestion of $1tax/1 mg nicotine. I thinks that's way high. The tax won't be prohibitive, but it will certainly be enough of a nuisance as to turn some off to vaping. I think the current tax on a pack of cigs in PA (Fed and state combined) is $2.36. Reference below:

Biggest U.S. tax hike on tobacco takes effect - USATODAY.com

The tax(both federal and state) will be somewhat in line with how cigarettes are taxed, it's just inevitable. Figure out how much usable Nic is in a pack of Cigs and that MAY give one an idea.

As to the Nicotine level limit in the juice. Anyone's guess. However, since the European standard high seems to be 16mg/gram liquid. Take that as a possibility. Again, this is ALL just my opinion.

 

[Minimike]

I suggested the $1/mg tax level. A nice round number.

Tax on 1 pack in PA = $2.36, you say? that is 11.8 cents per cigarette. How many mg of nicotine in a cigarette? One mg = 11.8 cents/mg, 2 mg = 5.9 cents/mg, etc.

BT will push taxation on our juice just to level the playing field. They will want a higher tax on e-juice so it will not be a financially attractive alternative.

Let me amend my prediction to 50 cents/mg.8-o

 

[LaceyUnderall]

One suggestion that was right on with Buyer/Hagan's bill I believe was a taxing system based on the "dirtiness" of the product. For instance, cigarettes, being the dirtiest would carry the highest taxation and down from there would be different levels. The ecig is definitely a "cleaner" approach to nicotine/tobacco use and should therefor carry much less of a tax for it's users than tobacco cigarettes. It also leans to the tobacco harm reduction philosophy, encouraging smokers to make choices for themselves.

IMHO I thought this was a very good suggestion.... leaving my business bias aside and looking at it from a public health perspective/freedom to choose perspective.

Minimike makes an excellent point here in that it will be up to BT to fight for equal standard taxation across the board... and that will be interesting to see what happens. (Hence the importance of an industry body to sit at the round table when those "decisions" are being discussed.)

 

[zero7starz]

Depending on how much it makes the price go up (I'd like to know, first, if that were possible lol) then I would be rather okay with it. At least (I'd hope) that the FDA standards would keep the strange stuff out of the liquid and give me POM to smoke it.

 

[Junebug]

Markarich- Do you remember the commercials for the inhaler NRT? This was about 7 years ago I think. When patches were going OTC. I can't remember the name or the MFR. I know that my HMO had decided it was non formulary and did not stock it. Then again anything new most HMOs won't approve and it's all out of pocket costs for the patient. I only saw the commercial a few times, then I never saw it again, or even heard about it via patients. Chantix, well when that came out many people were asking about it, then a year later the musician was killed in Texas because he used it in conjunction with alcohol.

 

[LaceyUnderall]

Depending on how much it makes the price go up (I'd like to know, first, if that were possible lol) then I would be rather okay with it. At least (I'd hope) that the FDA standards would keep the strange stuff out of the liquid and give me POM to smoke it.

Here's an interesting tidbit: Did you know that Aveda products would be 100% organic except for the fact that the FDA makes them put something in their formulations to keep it only 99% pure? Crazy isn't it? They have to add a chemical to it in order to publicly dispense it.

 

[markarich159]

Good calculations, but extracted nicotine, again in my opinion would not be taxed that agressively. Than would mean a 10 ml bottle of 16mg/g liquid(assuming density of liquid is 1g/ml) would contain 160 mg nicotine total. at $0.50/mg nicotine tax, that would be an $80 tax on $5.95 bottle of 16mg nicquid. There is No Way the Goverment would be able to square a tax like that. When I made my suggestion of comparison I said "usuable" nicotine in a cig. There is much more nicotine in a cigarette before being burned. So I guess comparing cigs to extracted nicotine for tax purposes, may be like comparing apples and oranges. Perhaps my initial cig to liquid comparison for tax purposes was not well thought out. The tax will be high but FAIR. As Lacey noted with Buyer/Hagans, consideration would definitely be given to "clean" extracted nicotine vs. "dirty" tobacco smoke derived nicotine.

 

[markarich159]

Markarich- Do you remember the commercials for the inhaler NRT? This was about 7 years ago I think. When patches were going OTC. I can't remember the name or the MFR. I know that my HMO had decided it was non formulary and did not stock it. Then again anything new most HMOs won't approve and it's all out of pocket costs for the patient. I only saw the commercial a few times, then I never saw it again, or even heard about it via patients. Chantix, well when that came out many people were asking about it, then a year later the musician was killed in Texas because he used it in conjunction with alcohol.

Yes the Nicorette inhaler, they are still around I think. We got one in stock and it never sold, had to reurn it to the distributor. The Pharmacy I work at is in a large MA(medical assistance) demographic and therefore, NRT's aren't paid for by MA. I beleive the price was like $50 for a box of cartridges. I haven't had one bit of good feedback about Chantix(Varenicline) yet. And most are scared to death of the black box suicide watch warning.

 

[Junebug]

I heard good reviews about Chantix from patients. Even though it was non formulary at the time, many patients were willing to swallow the costs as it helped them. I can't say that now with that black box warning now either. The HMO I have experience with is the CA based non profit HMO.

 

[markarich159]

I heard good reviews about Chantix from patients. Even though it was non formulary at the time, many patients were willing to swallow the costs as it helped them. I can't say that now with that black box warning now either. The HMO I have experience with is the CA based non profit HMO.

I guess it does help some, studies, of course, showed it to be effective, I've not personal known anybody. Again, though, in my experience, black box warnings are usually the death knell for marketed prescription drugs. I remeber SEVERAL years ago Seldane, I believe, got the black box warning for p450 interactions, and was recalled several months later. The same with the COX2 inhibitor Vioxx.

 

[Nix]

Great conversation, thanks for the perspective Markarich. I've been curious what a pharmacist might think on the topic. I always like to here the thoughts of a more experienced and educated person.

 

[Applejackson]

I used Chantix and had great results. Side effects were mild nausea and vivid dreams, but certainly no thoughts of suicide! I just couldn't break the urge when drinking. Enter e-cig. Voila! Cured.