Retracting My Support (?) for ECA

[WillPower]

First time I heard about ECA was when we were discussing the ways to stave off U.S. government intervention and keep e-cigs in the U.S. market, in one of the other threads in this forum. Lacey jumped in and indicated she was forming a industry self-regulatory organization. We were very glad to hear that.

As I learn more about the ECA, it is becoming clear to me that what ECA has in mind is quite different than what we envisioned in the thread discussion:

Recently, FDA allowed an unapproved drug (liquid morphine) to remain on the market, until an approved version become available. In the e-cig legal battle in the US, something like this would be, in my view, the best possible and realistic scenario for us.

To make this happen, I thought we needed an org with two goals:

1) Credible Self-regulatory Framework: liquid morphine is currently, even without FDA approval, regulated or controlled by DEA and AMA. We don't have anything equivalent to this. You need a board of scientific experts who can design standards that both FDA and Congress can buy into.

2) New Drug Application: non-profit cooperative to go though the NDA process. After the approval turn it into shared manufacturing / lab to produce product for each coop member for each members specs within the parameters of FDA approval.

In short, the org enables suppliers pool the resources to go through NDA, while you are continously funded through ongoing sales to customers like us. Also, you are gaining a storng foothold in the most likely to be multi-billion dollar U.S. e-cig market while you are going through NDA. This is a lot better deal that most pharmaceuticals get.

That's what I thought ECA is going to do. However, the more I read about ECA, it is not that (e.g. their self-regulaton is not what I thought). More of a trade association with guidelines. Nothing I said applies to international vendors (Canada, UK, etc), other than, maybe if any of these applies to their government, some might find it interesting. Why would Canadian venors pay for lobbying US lawmakers?

There is nothing wrong with ECA is what it is or it is going to be. It was just miscommunication and misunderstanding on my part. But, having said that,

I WOULD LIKE TO REQUEST SMOKEY JOE TO REMOVE THE ENTIRE THREAD "SHUT DOWN ALL VENDORS..."

Because the thread was closed, I can't even edit even though edit time is not expired. If ECA is just a trade association, what I said could be illegal nor I have that much passion to support them. On this ground I request that the thread is removed (or give me a chance to revise my posts).

Indeed, I would be quite mindful joining a lobbying organization that pays lobbyist and organizers for lobbying to keeping e-cigs legal. Without NDA?
Money now for what purposes in the future? Guidelines and talking with lawmakers? Personally it sounds somewhat fishy to me.

In fact if you make e-cig legal, wouldn't big pharma and tobacco jump in? What about revised Premiere or Eclipes coming in with national advertising? Well at least I guess ECA is better than nothing. Best wishes.

I am just a consumer, expressing my view. Sorry if anyone got offended. Even if e-cigs are pulled off the US market, I am pretty sure I can still buy them from China or Canada. Also, I am pretty sure many of the suppliers are smart enough to set up a online shop at sunny beach of Bahamas.

Good luck!

 

[yvilla]

Willpower, I'm sure you will remember my arguing with you about this in the other thread.

Well, because you and Tropical Bob, among others, are so wed to the idea that ecigs must be a "new drug" or "new drug delivery device" needing to go through the NDA process, I thought I'd try one more time to get my contrary point of view across.

Cigarettes are undoubtedly drug delivery devices. They contain and supply nicotine as their main drug ingredient. Sure, they are not under the control of the FDA, and never have been. However, that is for strictly historical/political/economic reasons. If anyone has any doubt about that, read the history and reasoning underlying the Supreme Court's decision in FDA V. BROWN & WILLIAMSON TOBACCO CORP.

Cigarettes contain nicotine, they contain PG, some VG, flavors, and many many other chemicals, as we all know. They are a veritable "drug cocktail".

Ecigs contain nicotine, they contain PG, some VG, flavors. In other words, they contain nothing not already found in cigarettes.

So the nicotine in cigarettes is extracted from tobacco at the point of use, by combustion, and is carried along to the user's lungs in smoke (although, I do seem to recall that some contain added or previously extracted and then re-added nicotine as well - but have not checked this to be sure).

The nicotine in ecigs is extracted from tobacco at an earlier point in time, not by combustion but by other chemical means, and is carried to the user's lungs in vapor.

But I believe it is specious to claim that the mere difference in the method and timing of the extraction is a difference of substance when it comes to deciding whether the nicotine in ecigs is a "new" drug as compared to the nicotine in tobacco cigarettes. Nicotine is nicotine, and no matter how it is extracted it is still going to have the same chemical properties, and the same action within the body.

So in reality I believe that ecigs are nothing more, in chemical reality, than a safer cigarette, one that accomplishes the exact same thing in terms of nicotine delivery, but without the exposure to the deadly carcinogens and toxins that are primarily a function of combustion.

Thus my argument that ecigs are not a "new drug" nor "new drug delivery devices". They are smoking or cigarette alternatives, nothing more.

If we characterize them and/or market them instead as smoking cessation devices or as NRT, then and only then do they become a "new drug" or "drug delivery devices" subject to the NDA process and the authority of the FDA (as the law stands now; if the Waxman bill passes, then things get more complicated to be sure!).

 

[LuckySevens4U]

Wow, Villa! You just expressed something I never really thought about and man is it true! Very well written!

 

[Tallulah]

yvilla, yours is a graceful hand, gently guiding us through the dark forest of fear to the clear, sunny meadow of a logical conclusion. You rock.

Yeah!!

 

[yvilla]

A PS: That's also why I've always felt that maybe being called ecigs is actually better - less a "new" drug device, and more just a safer cigarette.

 

[nitewriter]

yvilla, yours is a graceful hand, gently guiding us through the dark forest of fear to the clear, sunny meadow of a logical conclusion. You rock.

Yeah!!

I second this! You are a true asset to us all!

Thank you for all you do!!!

 

[V-V]

Cigarette manufacturers have to have their cigarettes tested regularly, to determine mg of nicotine (not sure about the other chemicals). This is the only issue I see with e-cigs, is the liquid and how much nicotine it holds, consistently.

 

[TropicalBob]

Yvilla, what I think or say means nothing. It's what the FDA says that means something. Neither Willpower nor I have made up concerns for the FDA. Let me quote the FDA:

Please be aware that electronic cigarettes that we have reviewed are drug-device combinations under section 503(g)(1) of the Federal Food, Drug, and Cosmetic Act (the Act) (21 U.S.C. 353(g)(1)) with their "drug" uses, as defined by section 201(g) of the Act (21 U.S.C. § 321(g)), as the primary mode of action.

The FDA then describes the electronic cigarette, quite accurately, and says:

And, like conventional cigarettes, they are intended primarily for the delivery of volatilized chemical substances to affect the body's structures and functions and/or to mitigate or treat the symptoms of nicotine addiction through a chemical or metabolic action on the body.

Can't argue with that, can we? So we read on:

Since we are not aware of any data establishing that such products are generally recognized among scientific experts as safe and effective for these "drug" uses, they are "new drugs," as defined by section 201(p) of the Act (21 U.S.C. § 321(p)) requiring approval of an application filed in accordance with section 505 of the Act (21 U.S.C. § 355) to be legally marketed in the United States.

Now that is really crystal clear to me. I didn't make it up. I just read it. The same official message has been sent to many sellers or importers from the FDA via Customs at stoppage of product. It's why we get this reason to confiscate e-devices:

None of these so-called "electronic cigarettes" is covered by an approved NDA.

So, please, stop posting the inaccurate notion that Tropical Bob and Willpower somehow faultily believe e-cigs are new drugs. What we believe means nothing! What you believe likewise means nothing. I have no feud with you, and I hope e-cigs find a legal crack to slide through. But this is certain: We'll soon know what the only agency with meaning really means.

 

[yvilla]

TBob, I have no feud with you either. As I said to Willpower previously, my point is that federal agencies have been and can be challenged on their interpretation and application of federal statutes. And sometimes even successfully.

What the FDA says in it's letters up to this point is nothing more than it's interpretation of the Food and Drug Act, as applied to ecigs. I simply submit that that interpretation can be challenged, and have offered a different interpretation.

 

[strayling]

TBob, I have no feud with you either. As I said to Willpower previously, my point is that federal agencies have been and can be challenged on their interpretation and application of federal statutes. And sometimes even successfully.

What the FDA says in it's letters up to this point is nothing more than it's interpretation of the Food and Drug Act, as applied to ecigs. I simply submit that that interpretation can be challenged, and have offered a different interpretation.

That's the key point. They can say the moon is made out of green cheese if they want - doesn't make it true, just means that they'd like it to be true. If they aren't challenged they'll get away with it.

 

[Kate]

Does the FDA ruling apply until a successful legal challenge overturns it?

 

[yvilla]

Bottom line - if the FDA does flex it's regulatory muscle and tries to shut down the supply here in the US then the issue will be decided in the courts (assuming of course we are talking about a retailer or retailers who decide to fight it and have the means to do so).

All I'm saying is there are valid arguments to be made!

Edit: I posted before I saw your post, Kate. There is no "ruling" as of yet, except for any shipments that have been stopped. So far, the FDA has not taken any action against any supplier. Only then would they have to be fought.

 

[strayling]

Does the FDA ruling apply until a successful legal challenge overturns it?

That's an interesting question. Also, if a challenge is made does it put a stop on any FDA actions until resolved?

I have a nasty feeling that I can guess.

Edit: Oops, I kinda repeated what you said. Must learn to read for comprehension.

 

[Kate]

From my understanding the FDA have issued a ban and are actively enforcing it in some cases.

To get them to allow all shipments through and for vaping products to be openly sold could take a while, even if successful.

Overturning their ban may be something that the ECA should discuss. A trader really needs to do the legal thing, maybe with the sponsorship of others.

 

[yvilla]

To my knowledge, Kate, the FDA has taken no enforcement actions at all, yet, again except for some shipments being disallowed entry.

 

[Kate]

That's selective enforcement. The question is not what their position is or if they have the power to act but whether and when they will choose to enforce their ban.

 

[kinabaloo]

For what it's worth, just like to give my support to the position expressed so well by yvilla. We wish to vape for enjoyment, not because we are ill. What next - chocolate is a drug?

How about other things people like to do. Ride a rollercoaster - that's thrill-seeking, a psychological disorder! Just do your work and pay your taxes! The pursuit of happiness must be crushed!

 

[tpboles]

Kate - I think the only shipments that have been stopped are the ones making health claims. Maybe someone could clarify this. It has been minimal at best considering all the shipments that have made it through just fine. I'm more of the opinion to let it go until the FDA takes a more aggressive approach. Why stir up trouble when there is none? Keep getting the word out there and ofcourse public support would be great, but I wouldn't be marching on the "hill" anytime soon.

edit: I am in no way saying that we shouldn't prepare. I think organizations such as RTV is great! Juice testing is probably the most important thing at this point. That would be a big step foward for our little e-cigs.

 

[strayling]

I'm a bit hesitant to suggest it, but how about a consumer pledge not to buy from suppliers who make unsubstantiated health claims?

 

[Tone]

How I understand it is if customs see them you lose them. if the happens to search your package you will lose it, and there is already a black list for certain manufactures coming in the US.