The Redhead: Why We Fight

[AgentAnia]

redheadfullofsteam | coming down upon the opponents of vaping with great vengeance and furious anger

I see a worrisome trend here; it may or may not pan out, but it's worth paying attention to. I'm posting it here rather than in the EU Legislation forum because the PruBot figures rather prominently so it involves US vapers as well.

 

[tommy2bad]

True. They are carefull with how they word things, so should we. Politicians I mean not the PruBot she hasn't a care in the world about lieing.

 

[AgentAnia]

My (somewhat) solace is the Sottera ruling, that said that as long as the manufacturer/vendor makes no therapeutic claim, ecigs cannot be regulated as drugs. That's in the US. Still, I think we all need never to forget that forums like this one are public venues, and anyone and their grandmother, and their research assistants, can access it, can quote from it, and can lift data from it.

 

[Uma]

I wondered what SG was up to in the last few articles he's been in. He a been pushing vapers to defend them as just such devices... Gotta watch those horns.

 

[Vocalek]

My (somewhat) solace is the Sottera ruling, that said that as long as the manufacturer/vendor makes no therapeutic claim, ecigs cannot be regulated as drugs. That's in the US. Still, I think we all need never to forget that forums like this one are public venues, and anyone and their grandmother, and their research assistants, can access it, can quote from it, and can lift data from it.

That's correct. Judge Leon pointed out that whether or not a product could be regulated as a drug depended on the intended use as marketed by the vendor. Consumers are free to say anything they want to say about the product.

So in the U.S., where the Constitution grants us freedom of speech, we can say things like, "I don't smoke any more because I switched to vaping." That's not a health claim (for regulatory purposes) for two reasons. 1) The claim is being made by a private citizen, not the vendor and 2) Smoking isn't a disease.

How such expressions of fact might be viewed by other governments is beyond my expertise.

 

[sebt]

That's correct. Judge Leon pointed out that whether or not a product could be regulated as a drug depended on the intended use as marketed by the vendor. Consumers are free to say anything they want to say about the product.

So in the U.S., where the Constitution grants us freedom of speech, we can say things like, "I don't smoke any more because I switched to vaping." That's not a health claim (for regulatory purposes) for two reasons. 1) The claim is being made by a private citizen, not the vendor and 2) Smoking isn't a disease.

How such expressions of fact might be viewed by other governments is beyond my expertise.

Good explanation - I was hoping there was a precedent elsewhere for this line of thinking, but didn't know about this US case. Interestingly, I think the recent EU TPD amendment is on the same lines as the Sottera ruling. The paragraph in Amendment 170 that might "catch out" e-cigs and make them "pharmaceuticals" is this:

2. Nicotine-containing products that are presented as having properties
for treating or preventing disease may only be placed on the market if they
were authorised pursuant to Directive 2001/83/EC.

The ambiguity lies in the verbs with a hidden subject ("are presented", "placed on the market"). I think that the hidden subject of the first one should be interpreted as being the same agent who's the subject of the second one - in other words, it's whoever "places the thing on the market" who has to "present it as treating or preventing disease" for this paragraph to apply.

There's also the point you mention that smoking isn't a disease. I agree. But what confuses me about this is - why, then, are/were other products (gum, patches, Chantix) treated as pharmaceuticals, when they were intended to treat the "non-disease" that is smoking? (Am I correct about the history?).

On patches and gum at least, I'd argue that however they were originally treated by regulators, they've long since broken out of whatever carefully-dosed, therapeutic role they ever had, and are now completely available for people to use as they like (even as elective nicotine-consumption devices, like e-cigs). Here in the UK, for instance, there's nothing stopping an adult non-smoker from walking into a shop and buying as much nicotine gum as they like.

What I suspect might emerge is that this has happened precisely because regulators took a pragmatic view on gums and patches, because they only deliver nicotine, which is a well-known substance with well-known (low) health risks. Whereas Chantix, in contrast, delivers things which were and are much less well-known.

 

[Vocalek]

I think that the hidden subject of the first one should be interpreted as being the same agent who's the subject of the second one - in other words, it's whoever "places the thing on the market" who has to "present it as treating or preventing disease" for this paragraph to apply.

That's how I would interpret it as well. But to be sure, see if you can get an opinion from an expert in law.

There's also the point you mention that smoking isn't a disease. I agree. But what confuses me about this is - why, then, are/were other products (gum, patches, Chantix) treated as pharmaceuticals, when they were intended to treat the "non-disease" that is smoking? (Am I correct about the history?).

Well, you see, that's where the "N" comes into the acronym ANTZ. The disease to be treated is "nicotine addiction" (or as the medical code books are now calling it, "tobacco dependence.") The gum, patches and other Nicotine Replacement Therapy products are actually intended to wean the "addict" down off nicotine by providing progressively lower doses of nicotine.

What's confusing for the ordinary person who interprets words via their literal meaning is when the FDA, MHRA, ALA, AHA, etc. call something "smoking cessation" when what they really mean is achieving "nicotine abstinence." You may have seen comments on articles: "If you are using an e-cigarette that contains nicotine, you haven't really stopped smoking."

To this English literature major "smoking" means setting something on fire and inhaling the resulting smoke. If I no longer inhale smoke, I'm not smoking.

On patches and gum at least, I'd argue that however they were originally treated by regulators, they've long since broken out of whatever carefully-dosed, therapeutic role they ever had, and are now completely available for people to use as they like (even as elective nicotine-consumption devices, like e-cigs). Here in the UK, for instance, there's nothing stopping an adult non-smoker from walking into a shop and buying as much nicotine gum as they like.

The weaning thing didn't work for me. Maybe it's because they never started me out anywhere near the daily dose of nicotine I got from smoking. Two-1/2 packs a day--even of light cigarettes--comes up to more than the 21 mg. of nicotine in a patch. So I was already on shaky ground for the full six weeks, and then when they cut the dose in half, things were getting much worse. By the time I was "weaned" down to no nicotine, I was a basket case.

You're right about people using the NRTs in ways that work better for them. I used gum to reduce the number of cigarettes per day I was smoking down to 10, but I was never able to increase the number of pieces per day above 4 or 5 without my stomach getting upset. It took e-cigarettes for me to eliminate those last ten cigarettes.

What I suspect might emerge is that this has happened precisely because regulators took a pragmatic view on gums and patches, because they only deliver nicotine, which is a well-known substance with well-known (low) health risks. Whereas Chantix, in contrast, delivers things which were and are much less well-known.

According to this site: How It Works

CHANTIX is different from most other quit-smoking products. It targets nicotine receptors in the brain, attaches to them, and blocks nicotine from reaching them. By activating these nicotine receptors, it is also believed that CHANTIX causes less dopamine – compared to nicotine – to be released.

And maybe it is this situation of less dopamine being released that causes some people to become depressed to the point of suicide when they take Chantix. If you ask me, the ANTZ got carried away with the idea of dopamine. They believe that smoking acts just like "hard" drugs by stimulating dopamine release which creates pleasure. (We mustn't have that. Pleasure is evil.) But they overlook the fact that all things are relative. The amount of pleasure that is elicited by some opiates is huge compared to what most people experience from smoking. And it is possible that the reason some of us are more prone to become dependent on nicotine is that our dopamine machines never worked well enough in the first place. Forget feeling "high"; we need extra dopamine to get up to normal.

NOTE: For those new to this forum, ANTZ stands for Anti-Nicotine and Tobacco Zealots.

 

[SyncVaper]

Sorry to be a wet blanket but from where i come from, my country imposes a 1000% tax on analogs.
No kidding! Doing a direct comparison with our neighboring countries, converted in USD$, a pack average around USD$1/pack whereas it is USD$10/pack here.

Them top animals are following suit with FDA's reasoning that it is not clinically proven as "safe" and therefore it is banned; dumb ... homo.. as if they banned analogs although it has been proven a million times over that it is hazardous!

The main concern these animals have is the lost of revenue through taxes. AND the selfish huge ... pharmaco company will lose big money once everyone starts vaping instead of smoking.. Whatever reasons they provide is, but just a sham...

If indeed my country follows suit with FDA findings, i would gladly PRAY that e-cig remains banned and NOT legalised. Why?
Because i have people on the inside over at my country that they are indeed in discussion to approve it BUT here's the catch:

a 10ml bottle of e-juice are being discussed to costs between US$80-US$120. Yes, my friend... TEN BLOODY ML for that price.

So, instead, i beseech you guys to NOT fight the ban but instead, ADVOCATE and EDUCATE manufacturers to:

1) start labeling and naming them as BATTERY HOLDERS, BATTERY TUBES, BATTERY CASINGS, whatever~

2) sell them parts by per piece and thus shipped as per piece

Or somewhere along that line.. Strive to look for alternative view and remember, the mistake that started it out was the term itself, "e-cig".
It should have and had always been "Vaporizers"....

My 2cents..