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Law and the E-Cigarette Discuss the laws that govern the sale of e-cigarettes where you live.

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Old 07-15-2009, 06:27 PM   #1
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Exclamation A Pharmacists Point of View

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.
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Old 07-15-2009, 06:49 PM   #2
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Originally Posted by markarich159 View Post
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.
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Old 07-15-2009, 06:49 PM   #3
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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.
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Old 07-15-2009, 07:01 PM   #4
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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.
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Old 07-17-2009, 12:58 PM   #5
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markarich159 -

It is very nice to have your thoughts on this forum. Thank you for sharing. Very insightful and very interesting.
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Old 07-17-2009, 02:17 PM   #6
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Originally Posted by markarich159 View Post
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?
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Old 07-17-2009, 05:35 PM   #7
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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).
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Old 07-17-2009, 05:58 PM   #8
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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?

Will the mg/ml strength be regulated so low as to be essentially useless?
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Old 07-17-2009, 06:20 PM   #9
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Thank you so much for your very valuable info!

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

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.
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Old 07-17-2009, 06:35 PM   #10
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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.
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