FDA I think we need to push the zero-nic angle in our comments

[Kent C]

It's more about continuing the revenue stream from a dwindling product by transferring the tax liability to its replacement. Nicotine is the key factor, but its the delivery system that makes it attractive to former smokers. Nicotine gum and sprays just didn't do the trick to attract smokers, ecigs did. So now we have to take on the load of supporting tax laws that were designed to make an industry pay for its sins through monetary compensation to government.

Only, we are fairly certain that it wasn't nicotine that caused the ills and maladies of tobacco. Ironic, isn't it? It's kind of like taxing electric cars just because their fossil fuel predecessors ruined the environment and someone has to pay.

You don't even need to 'hedge' that with 'fairly certain'. It's tobacco combustion that does the damage - even most ANTZ will give you that.

And actually the car analogy isn't that close with electric cars and their fossil fuel predecessors, since the electricity at this point still comes from fossil fuels. One could argue it's worse since there are still coal plants whereas gasoline doesn't use coal (directly).

 

[Kent C]

BTW - How does the Regulatory Flexibility Act work?

See my post # 16

http://www.e-cigarette-forum.com/fo...comment-fda-proposed-rule-2.html#post13421389

Basically they get to smell the food, but they can't eat it or change the recipe. And they can be a 'friend of the court' if it goes that way - in favor of small business, which, imo, may be the best final outcome.

 

[SolRayz]

Listen...if the FDA had any power, they would ban the sale of nicotine concentrate. That would seem like the logical next step. Tell me why they have not proposed that?

 

[Kent C]

Listen...if the FDA had any power, they would ban the sale of nicotine concentrate. That would seem like the logical next step. Tell me why they have not proposed that?

Because nicotine is not considered a drug under their authority. See the Soterra decision:

http://www.cspnet.com/category-news/tobacco/articles/electronic-cigarettes-tobacco-products

"In this decision, the Circuit Court of Appeals held that e-cigarettes and other products "made or derived from tobacco" can be regulated as "tobacco products" under the FDA's Tobacco Control Act, and are not drugs or devices unless they are marketed for therapeutic purposes. The FDA has decided not to appeal the Soterra decision to the U.S. Supreme Court."

 

[NorthOfAtlanta]

Listen...if the FDA had any power, they would ban the sale of nicotine concentrate. That would seem like the logical next step. Tell me why they have not proposed that?

They can't until it's deemed a tobacco product, they tried to ban importation of e-cigarettes in 2009 and got slapped down in court. If deeming under the FSPTCA is done they could then ban it.

 

[SolRayz]

Because nicotine is not considered a drug under their authority. See the Soterra decision:

http://www.cspnet.com/category-news/tobacco/articles/electronic-cigarettes-tobacco-products

"In this decision, the Circuit Court of Appeals held that e-cigarettes and other products "made or derived from tobacco" can be regulated as "tobacco products" under the FDA's Tobacco Control Act, and are not drugs or devices unless they are marketed for therapeutic purposes. The FDA has decided not to appeal the Soterra decision to the U.S. Supreme Court."

Ah ok thanks that. Thus explains why the FDA has virtually no control over cigs as well. It falls under the Tobacco Control Act. And why some fear flavorings may be banned from e-liquids, much like they did with cigs. Pardon my ignorance, but I'm trying to catch up on this silliness.

 

[zoiDman]

See my post # 16

http://www.e-cigarette-forum.com/fo...comment-fda-proposed-rule-2.html#post13421389

Basically they get to smell the food, but they can't eat it or change the recipe. And they can be a 'friend of the court' if it goes that way - in favor of small business, which, imo, may be the best final outcome.

Thanks Ken. I like the Smell but Can't Eat or Change the Recipe Analogy.

The Friend of the Court thing was Kinda where I was Going.

 

[bigdancehawk]

I dunno my friends... You're all making sense here but are neglecting the anti-cultural aspect of smoking and anything that looks like it. It's just a biased hatred towards us and that's tough to beat even with logic and science.

I recall those little candy cigarette stix they made years ago. (We'd get bag-fulls on Halloween ) Don't see those around anymore and for all I know, that kind of product fell under the "secret" Tobacco Control Act even though they don't contain nicotine, you won't find 'em anymore.

That doesn't fully explain the seemingly anti-scientific behavior of Big Tobacco Control. Although they may have cultivated that hatred you're talking about, I don't think hatred is necessarily their primary motivator. They deliberately and carefully developed a strategy to denormalize smoking and marginalize smokers. To implement it, they promulgated junk science about the supposed dangers of "deadly" second hand smoke, thus portraying smokers as potential murderers of every non-smoking person in the country, including their own children. They implemented programs in schools to indoctrinate children in the awful consequences of tobacco exposure in all of its forms. They lobbied legislative bodies to ban smoking in public places and workplaces, even in parks, on beaches and in the privacy of their own offices. In tobacco shops, for crying out loud! They created remote and uncomfortable "smoking areas." Billions were spent on advertising the evils of smoking. They made false allegations to demonize tobacco companies. In their minds, this wasn't because they hated smokers; rather, they thought they could force smokers to quit and discourage others from starting the habit. They believed their noble ends ends justified the means.

Many of them have made a great deal of money doing these things, often funded by Big Pharma, government subsidies and the TMSA. They have been wildly successful, sooner and more thoroughly than many of them had imagined. They routinely attend subsidized conferences praising and congratulating one another and planning their next moves. And then, unexpectedly, along come e-cigarettes, a "disruptive technology." This doesn't fit into their entrenched dogma or with their Utopian plans at all. Former smokers are seen in public puffing on things that look like cigarettes and blowing out what looks like smoke! OMG, the smokers are back! From their point of view, it threatens to undermine everything they did.to set non-smokers coughing and choking and breaking out in hives at the mere sight of a smoker and to ban him/her from their presence. The cheeellldren will see "smokers" for the first time in their lives! They'll think that smoking is a normal, acceptable form of behavior! And if it helps people quit smoking, they can't claim credit for it. The smokers will have done it all by themselves. And if enough people quit smoking by switching to these things, TC might be rendered obsolete, right along with the products of Big Pharma that pay those hefty grants and salaries. It infuriates them even further that Big Tobacco has now entered the e-cigarette market.

EDIT: Clarity, typos

 

[Jman8]

Because nicotine is not considered a drug under their authority. See the Soterra decision:

http://www.cspnet.com/category-news/tobacco/articles/electronic-cigarettes-tobacco-products

"In this decision, the Circuit Court of Appeals held that e-cigarettes and other products "made or derived from tobacco" can be regulated as "tobacco products" under the FDA's Tobacco Control Act, and are not drugs or devices unless they are marketed for therapeutic purposes. The FDA has decided not to appeal the Soterra decision to the U.S. Supreme Court."

This is not saying that nicotine is not a drug. It is saying a) that vendors can have devices / product regulated as tobacco products and b) that if vendors stay away from therapeutic claims, it is not marketing of a drug. From my understanding of eCig politics, this was treated as really great news when it first came about. Now that FDA has moved in the direction that Soterra judgment said it could, vapers are very upset that it is being regulated as a tobacco product.

Yet, some vapers on this thread think it makes sense that non-nicotine products be treated equally as tobacco products as those that contain nicotine. What does Soterra say about that? (Crickets chirping)

 

[Kent C]

Ah ok thanks that. Thus explains why the FDA has virtually no control over cigs as well. It falls under the Tobacco Control Act. And why some fear flavorings may be banned from e-liquids, much like they did with cigs. Pardon my ignorance, but I'm trying to catch up on this silliness.

It explains why the FDA can't ban cigs, but they have a lot of control over them though the Tobacco Control Act.

And everyone has to start somewhere so no pardon necessary - we were all at that point somewhere along the line And you're right about the flavorings - you're a quick study lol.

 

[csardaz]

There is a point in the deeming -paraphrased - the law specifically lets us regulate flavors in cigarettes - can we change the definition of cigarette?

If its specific about cigarettes and flavors you could argue it intended them to control flavors only for cigarettes which means not for little cigars or e-cigs. So they wish they could change it to say " tobacco products used like cigarettes".

My first e-cig was a V2 808d type device from the local tobacco shop. Battery, charger, 1 or 2 cartomizers with "1.8%" nicotine. So all tobacco products as they are sold along with the nicotine. Actually I got 2 disposables before that - so finished devices containing nic. Since then innoken kits, individual batteries, clearomizers, RDA 's atomizers have all come without any trace of nicotine - tho a local shop did give away 10ml of house juice with one purchase. A kit might be considered a finished device - but without juice its useless so unfinished.

Suppose a company got new product authorization for blank juice in 10,20,30, ?40? mg strengths and all flavors were sold as zero nic with extra flavor intended to be combined in some ratio with one of the blank juices?

So there you have the cartos that come with nic, and a few blank juices and possibly some batteries/ chargers that are sold along with loaded carts - and disposables. Perhaps this is what they planned for when they expected 25ish new product applications?

I thought - that sucks, the flavor chemicals are the ones with the most harm potential and could benefit from an ingredient database and tracking/recall-ability. But then I looked at food flavor regulation - also by the FDA - did you know they declined to revoke the GRAS designation for diacetyl? The flavoring industry ID'd over 1300 ingredients of concern re inhalation. FDA has done nothing - does not fit with budgets and priorities. Make the little people that mix vats of flavors do their work in respirators - we aren't OSHA ( of course OSHA was useless in the popcorn lung diacetyl cases as well )

Reading it - I get the feel that some of the authors understand they can't provide benefits within this law and shouldn't be trying to regulate it. Others look instead at what they can get away with outside the law - e.g. will someone pony up millions in legal costs to challenge us if we did X. Still others are thinking -do it even if we know a court will strike it down, it will at least scare investment from the products and break momentum.

 

[Gato del Jugo]

Hey, who lifted my original post & submitted it as an FDA comment..?

Tracking # 1jy-8dii-u44n


Thanks, but I had already cleaned it up, added a few phrases & submitted it myself (tracking # 1jy-8di5-dldh ), while also adding this at the end...


"To reiterate: You have NO right, NO legality, NO jurisdiction & NO authority over ANY of the aforementioned products or their similarities. Any further attempt to do so is over-stepping your bounds as dictated by Congress.

Thank you, and do have a pleasant day."

 

[dragonpuff]

Hey, who lifted my original post & submitted it as an FDA comment..?

Tracking # 1jy-8dii-u44n


Thanks, but I had already cleaned it up, added a few phrases & submitted it myself (tracking # 1jy-8di5-dldh ), while also adding this at the end...


"To reiterate: You have NO right, NO legality, NO jurisdiction & NO authority over ANY of the aforementioned products or their similarities. Any further attempt to do so is over-stepping your bounds as dictated by Congress.

Thank you, and do have a pleasant day."

LOL!!

That's how you know you did a darn good job writing it ha ha!

 

[SaintDynamicz]

Well with this angle we can potentially save the hardware, that's a good step. There is no single angle that can defend against all the regs at once while still being able to hold its ground.

First off, this is an amazing angle that really says "You shouldn't be able to regulate my hardware because it's tobacco free". Well let's say that works and the FDA no longer is allowed to regulate the hardware because it is tobacco free and always will be until a someone comes a long and puts an eliquid in it that is considered a tobacco product. Like you said, just because someone makes a baseball bat doesn't mean they should be considered a weapons manufacturer because someone decided to use it as a weapon.
Sure it still sucks that there would be a regulation on the eliquid but at least we would still have the hardware which is better than the hardware being regulated.
I think this angle can easily hold its ground because there is a LED flashlight with a 510 connection which works on ALL batteries that have a 510 connection. If I were to purchase this and use it as a flashlight, why should it be considering a tobacco product? It shouldn't. Which is really why I think this angle can free us from the FDA's proposed hardware regulation.

This still leaves eliquid. As it stands, the whole "Adults like flavor too" argument isn't going to get us anywhere in my opinion. We need to find a completely separate angle that can really hold its ground. What that may be is completely up in the air, but as it stands, we have a very good start at fight this.

I think over our life spans we have seen numerous times something that says "No for so and so use" when everyone full well knows that's exactly what they are going to use it for. This should be no different. As long as you market the hardware "No non-tobacco use" then legally the FDA doesn't have jurisdiction if I am correct.

 

[KaraDC]

who never started smoking, which is also tricky, but do in fact exist.

Like me for example. I vape to cut down on snacking and because I am thinking of some mechanical mods. Before I started I did notice that they helped some smoker friends quit. I was intrigued by them for that reason alone.

While I like them for calming down it is no different to me than, say, reading a book. Both I can leave for weeks with no ill-effects. My local vape shop knows I was never a smoker ... but they are more than happy to take my money anyway.

Unfortunately because of all of this I did not send anything to the FDA. Not out of laziness (to say I extremely politically active is an understatement) but out of knowing how anti-vaping peeps could spin my story. That I did not quit cigs (technically true since I never started them in the first place). Or that it had attracted someone who was not a smoker (forget that it was for other reasons and at 40+ I think I can make my own decisions). Maybe the ebul of flavors.

What I *DID* do is offer my experience pushing for things to legislators and such another vaping community. How to be the most effective with politicos for not much more of a time investment. With elected politicians for example, while online petitions get people invested they do not count for much. Phonecalls are not much more of a time investment (especially with a set of talking points/script) but may at least get counted and the # pros/cons be passed to an on-the-fence legislator. Letters are even better since someone physically sees them (and hopefully responds). The *VERY* best thing someone can do as a citizen to make their voice heard in congress (outside of throwing money around) is to visit *their* legislator *in person*. That does not always mean DC, part of the year they are in their local offices at home.

Of course the really laughable thing is I am vaping 100% VG at 0 nic with flavorings that have been through the FDA process. The FDA says they have not approved their vapors. Does anyone seriously think they would not test that something would not turn into a poison when you baked with it?

 

[twgbonehead]

A few points:

1. The FDA has indicated that it will regulate "flavored hookah charcoal". I believe they already regulate cigarette papers. Neither of these contain any form of tobacco, or nicotine, or anything derived from a tobacco plant.

2. The 2008 court victory wasn't free. It was very expensive. The original plaintiff dropped out because of the costs; fortunately the case was picked up by another vendor. Justice isn't free.

3. The FDA doesn't have to ban anything. They can just deny the applications for whole classes of products. They deny lots of applications on very vague grounds, such as "insufficient information provided". The FDA can categorically decide, for example, that since there are no long-term scientific studies on the use of e-cigarettes, that NONE of the applications include sufficient information. Once your application is denied, you can re-apply, but in the mean time you have to stop selling the product. How many manufacturers, vendors and products (besides Blu and Vuse) would survive?

4. I would never have tried e-cigarettes if they didn't contain nicotine. Yes, they might have worked for me, but I would have felt as ridiculous puffing on "fake smoke" as I would sucking on a lollipop. The fact that e-cigs provide nicotine was the convincer that got me to believe these would work, and to try them.

Logic and science, sadly, are not in play here. We are in deep doo-doo unless popular opinion and pressure on our legislators becomes strong enough to win the day.

 

[zoiDman]

...

3. The FDA doesn't have to ban anything. They can just deny the applications for whole classes of products. ...

This is Something that I Think many people are Not Considering.

 

[dragonpuff]

3. The FDA doesn't have to ban anything. They can just deny the applications for whole classes of products. They deny lots of applications on very vague grounds, such as "insufficient information provided". The FDA can categorically decide, for example, that since there are no long-term scientific studies on the use of e-cigarettes, that NONE of the applications include sufficient information. Once your application is denied, you can re-apply, but in the mean time you have to stop selling the product. How many manufacturers, vendors and products (besides Blu and Vuse) would survive?

As CASAA called it, this is a "de facto ban." So it is a ban, just not in the sense of the product being outright illegal. It is a ban in that they require approval for the product to be sold legally, but never give approval, therefore it is never legal to sell them. So it is a ban, just a much sneakier one than passing a law against it.

As a matter of fact, this is how "other stuff" became illegal to begin with. Back in the 30's when lawmakers were toying with the idea, they realized that they could not pass a law against it outright for various reasons. Instead they passed a law requiring anyone who intended to distribute it to buy a special stamp before sale, which would act as tax collection. However, the required stamps were never produced or sold anywhere, and thus distributing the product was simply illegal. This is how a de facto ban becomes a legal ban.

 

[bigdancehawk]

Unless you have some secret psycho-epistemological method of knowing exactly what each person in the community 'needs' - your comments regarding that have no validity. And also that you would have a 'field day' with someone opposing, is a bit of posturing more suited to a sports event. lol.

You're forgetting that on field day everyone gets a ribbon.