Matt Salmon is now president of NJOY (Sottera, Inc)

[Bill Godshall]

Former US Congressman and former ECA president Matt Salmon is now president of Sottera, Inc.

The hired him a week ago, but hadn't publicly announced it yet.

However, the updated Business Week article below (on the DC Court of Appeals ruling against FDA) has now made it public.

FDA Loses Appeal, Can’t Regulate E-Cigarettes as Drug - BusinessWeek

 

[AngusATAT]

Interesting...

 

[kevbow]

Very interesting

 

[markarich159]

Everyone, I HOPE, does realize what is going on here. Matt(who had been mysteriously AWOL from ECA for some time) and njoy are now going to go about the process of having FDA squash all the other smaller suppliers being that njoy is , technically, the only ecig supplier in compliance with current Tobacco Control Act(i.e. no flavors, correct labeling, etc...). Everyone is making it like this appeals win is such a huge Victory day for vapers. I see it as the complete opposite; it gives njoy AND the existing Big Tobacco companies(who are now going to use there huge stores of capital to start manufacturing and marketing ecig products that are also "in compliance" with the Tobacco Act). As I said in another thread, we are now, ostensibly, smokers again & the industry will now be just another offshoot of Big T. At least the small basement "homebrew" suppliers will be put out of business.

 

[kristin]

As far as I know, flavors are only banned from SOME tobacco products, not all of them. There is no law banning flavors from e-cigarettes.

As I mentioned in another thread, being a user of a "tobacco product" does not automatically make one a "smoker." I doubt snus or Orbs users are considered "smokers" by anyone.

 

[markarich159]

There is no law banning flavors from e-cigarettes.

Yes there is, In CA.And I'm sure NJOY was following that model as that IS most likely HOW the FDA will regulate ecigs(being they now have the full authority under the FSPTC Act) Why would NJOY voluntarily do this. Ecig flavors (besides tobacco and Menthol) are definitely going to be out. With all the hoopla over ecig flavors tempting kids, flavors are out. NJOY wasn't stupid in joining and remaining in this suit(they saw they would win either way). They just eliminated a good portion of their competition(other then Large Companies that can meet the FSPTC requirements). All the small to midsize players have just been pushed out. No internet sales. No advertising(meaning no ECF). It's now a LEGAL entity(although not as highly regulated as drugs) and carries all the legal requirements and restrictions that imposes. The salad days are over.

 

[Petrodus]

No advertising (meaning no ECF). It's now a LEGAL entity (although not as highly regulated as drugs) and carries all the legal requirements and restrictions that imposes. The salad days are over.

No ECF... Interesting.

No question about it...All those opposing E-cigarettes and Truth would do a "Happy Dance" if the ECF was shut down.

Food for Thought: Sometimes we discuss things...
as if "THEY" are not listening (or have moles)

 

[markarich159]

No ECF... Interesting.

No question about it...All those opposing E-cigarettes and Truth would do a "Happy Dance" if the ECF was shut down.

Food for Thought: Sometimes we discuss things...
as if "THEY" are not listening (or have moles)

Most, if not all, of the registered and/or approved supplier on ECF are going to be put out of business because of this decision anyway; So ECF really isn't going to have many suppliers to advertise for. I can't see ECF being a great place to come with only NJOY, Philip Morris & RJR Reynolds as the approved suppliers.

 

[Petrodus]

Most, if not all, of the registered and/or approved supplier on ECF are going to be put out of business because of this decision anyway; So ECF really isn't going to have many suppliers to advertise for. I can't see ECF being a great place to come with only NJOY, Philip Morris & RJR Reynolds as the approved suppliers.

There's a lot more questions than answers.
I hate "Limbo" and waiting for the "other shoe to drop"

The next few months will be very interesting.

 

[cozzicon]

Most, if not all, of the registered and/or approved supplier on ECF are going to be put out of business because of this decision anyway; So ECF really isn't going to have many suppliers to advertise for. I can't see ECF being a great place to come with only NJOY, Philip Morris & RJR Reynolds as the approved suppliers.

That is a really sweeping statement. And a dangerous one to make, for your own credibility.

This fight isn't over. And the next step is another lawsuit challenging the FDA's ability to actually regulate e-cigarettes as tobacco product. And then another over nicotine. And another. And another.

This whole thing is going to go on for a long time.

 

[mauzey]

This fight isn't over. And the next step is another lawsuit challenging the FDA's ability to actually regulate e-cigarettes as tobacco product. And then another over nicotine. And another. And another.

This whole thing is going to go on for a long time.

I agree, How can they regulate a product that is to be used for vaping No Nic flavored juice, at least that may be the way they market in the future world anyhow. DIY Rules, I just need hardware I can make my own software.

Jeff~

 

[markarich159]

The decision has been made. It was either drug or tobacco. The appeals court decided. The FDA now has control under the FSPTC Act. Like it or not, this is what everyone wanted. And if you think my credibility is questionable, READ THE ACT!!

The question of how the industry was to be regulated is now over. There is not going to be any challenges to the appeals court decision from the ecig side(NJOY got exactly what it wanted - it's business model is already in compliance with the FSPTC). The only possible challenge will be if the FDA decides to take this to the Supreme Court and continue arguing for drug regulation. And there is no court in the USA that is going to entertain a lawsuit on behalf of the ecig industry that argues for continued disregulation.

And just to address the "hardware" issue. The whole product(ecig and Eliquid) is now going to be regulated by FDA under the FSPTC Act. I don't know where this idea that this decision applies only to the eliquid is coming from.

 

[mauzey]

If what you say comes to its worst fruition, then it is indeed time to "stock up" .

 

[cozzicon]

The decision has been made. It was either drug or tobacco. The appeals court decided. The FDA now has control under the FSPTC Act. Like it or not, this is what everyone wanted. And if you think my credibility is questionable, READ THE ACT!!

The question of how the industry was to be regulated is now over. There is not going to be any challenges to the appeals court decision from the ecig side(NJOY got exactly what it wanted - it's business model is already in compliance with the FSPTC). The only possible challenge will be if the FDA decides to take this to the Supreme Court and continue arguing for drug regulation. And there is no court in the USA that is going to entertain a lawsuit on behalf of the ecig industry that argues for continued disregulation.

And just to address the "hardware" issue. The whole product(ecig and Eliquid) is now going to be regulated by FDA under the FSPTC Act. I don't know where this idea that this decision applies only to the eliquid is coming from.

If your right, I'll buy you dinner.

If you are wrong- I'll never let you forget it

 

[Our House]

(NJOY got exactly what it wanted - it's business model is already in compliance with the FSPTC)

So what? Every other supplier whose business model intends to comply with tobacco laws will get the same thing as well. What exactly is your problem?

You keep insisting that a 3rd route should have been taken. My opinion is that you live in la la land. This battle could never have been won unless NJOY/SE aligned their products with tobacco. Never. You also keep insisting that manufacturers and suppliers should have been conducting their own studies. How exactly did you expect that to happen? Studies paid for by the ecig industry are considered biased and unacceptable. Studies conducted outside the US are inadmissible here. Studies paid for by government grants only support pharmaceutical ends. Studies conducted by the government are not going to happen. Even studies that have already been conducted haven't gone anywhere. NJOY commissioned (what was to us) the most famous ecig study from Exponent, a top-10 FDA sanctioned independent lab, and the study was STILL largely ignored by the opposition.

Your comments in this thread (and others today) indicate that you have some sort of axe to grind. Either that, or you're rooting for us to lose to big pharma. If you're not happy with the outcome of this appeal, I don't understand what realistic solution would appease you.

 

[markarich159]

If what you say comes to its worst fruition, then it is indeed time to "stock up" .

No you'll still be able to "get" ecigs and eliquid. It just will be in a radically different marketing state. The FDA will, most likely, only approve ecig models that have been UL, FCC approved/listed and meet set consumer protective guidelines(mod days are likely over). The eliquid will have to meet fairly stringent Quality control standards(probably not as stringent as cGMP but their will need to be in-process and batch product testing, probably stability testing as well, standard operating protocols will need to be established and approved, inspections, etc...), the allowable nicotine level will be set by FDA, flavors will likely be severly limited to tobacco and menthol, formulations will have to be approved by the FDA, you'll have to purchase in a retail store(no internet or mail order sales), it will be taxed, etc.... It will be a typical government regulated industry. We've(and when I say we've, I mean the ecig/eliquid consumer AND vendors) have gotten used to a completely unregulated marketing envronment. We knew this day would eventually come, we just didn't know exactly what incarnation the regulation would take. Just reading the FSPTC Act should give one some type of idea of what the industry will look like. I personally don't like this fairly new act. The tobacco industry doesn't like this act &, most likely, the ecig industry isn't going to care for it much either. But coming from a state of absolute non-regulation, the ecig industry isn't going to like any act being imposed. There are definitley going to be a great deal of vendors(mostly the smaller & mid-sized ecig/eliquid producers that have had pretty much free reign to do anything they wanted for the past 3 years) that are definitely not going to be around once these regulations are implemented.

 

[markarich159]

You keep insisting that a 3rd route should have been taken. My opinion is that you live in la la land. This battle could never have been won unless NJOY/SE aligned their products with tobacco. Never. You also keep insisting that manufacturers and suppliers should have been conducting their own studies. How exactly did you expect that to happen? Studies paid for by the ecig industry are considered biased and unacceptable. Studies conducted outside the US are inadmissible here. Studies paid for by government grants only support pharmaceutical ends. Studies conducted by the government are not going to happen. Even studies that have already been conducted haven't gone anywhere. NJOY commissioned (what was to us) the most famous ecig study from Exponent, a top-10 FDA sanctioned independent lab, and the study was STILL largely ignored by the opposition.

This is going to be my last post for the day. Being a graduate with a Pharmacy degree, I understand the whole clinical process a bit more than most. #1. Manufacturers are the ones financially responsible for clinical testing of THEIR product for approval(not the government)- that's how it is that's how it's always been(at least since the Kefauver-Harris amendment to the FD& C act in 1962) #2. We haven't seen a REAL,scientifically rigorous peer-reviewable safety analysis(not a full clinical study mind you - an animal model safety analysis) in 3 YEARS since the industry moved into the USA(that's deplorable for any product intended for human consumption - and don't quote the Ruyan Health NZ study, it's a non-published joke)#3. The industry certainly has made enough money(last year it was quoted as being 100 million dollar industry in the US) to put together a basic animal model safety/toxicity analysis as a start. #4 Government grants/subsidies/exceptions aren't given to pharmaceutical companies to fund "for profit" research except in special cases(such as orphan drugs); they're given to research entities working in studies to further public health in general. Finally #5. I've never heard of the NJOY study, but I'd love to see it. I'm going to venture a guess that it wasn't accompanied by a properly filed IND(investagational new drug) application, in which case, the FDA CAN'T legally give it any attention OR if it was, it didn;t contain the necessary requirements to make it leaglly reviewable . Unfortunately , there are protocols and processes in place that have to be followed(for public safety) that can't just be run end around. Here's some info:

Investigational New Drug (IND) Application

There was no battle won today either & that is, unfortunately, going to become painfully apparent to vapers that are accustomed to the way things are currently run. And , frankly, as a healthcare professional, I don't necessarily agree with the way things are currently run as they are dangerous. I've already explained what could have occured had the industry started this process 3 years ago, and it is not unheard of for new, novel products , when marketed properly, to create new regulating schemes.

 

[SharonLM]

Wow, thank you so much for this thread. It's helped me understand the legalities and what really might be going on.

 

[Our House]

Markarich,

Ecigs are NOT drugs, and should not be positioned as drugs (if we know what's good for us), yet you are requiring that they be held to the same standard as drugs. That is inherently inconsistent. I'm really beginning to wonder what side you're on.

EDIT: In addition, the FDA has already announced several times that the types of studies you mentioned would not be accepted. The FDA has already ignored NDAs from several ecig suppliers while, at the same time, denied having received any. Secondly, if you have not heard of the NJOY/Exponent study, then I suggest you stop looking only at the media hype and information which helps you tear us down, and start brushing up on ALL of the information. The Exponent study is very well known around here. CASAA has a link to it.

EDIT2: There is also the VCU study showing promising results, which also got very little mainstream media attention...unlike the bogus, negative "study" from UC Riverside which is taking over the news lately.

 

[xg4bx]

i love njoy, i have always loved njoy. >_>