The FDA Loses Appeal!

[Hygroscopic]

I think if you read the FTPCA along with bill authorizing it, the opposite appears to be true. The ecig industry will not be able to declare itself a safer tobacco product unless they can provide the testing to prove otherwise.

I should have clarified on that. Speculation: The benefit is that the industry can apply to have the safer label on the devices. If the FDA goes outside of it's scope of regulation (as someone keeps saying) then they'd be taken back into court. In order for the company to apply for the safer label, we would have had to supply the information to the FDA. If the FDA said no, we'd already have the information for a lawsuit. So the FDA would have to prove to the contrary. I put the cart before the horse on that one in regards to your answer. My apologies to you.

Now as far as looking into it:

The electronic cigarette was invented by a Chinese medicine practitioner Hon Lik in China in 2003 and introduced to the market the next year. The company he worked for, Golden Dragon Holdings, later changed its name to Ruyan (meaning "to resemble smoking") and started selling abroad.[2]

I hate using Wikipedia but there are a few articles via Google that are backing it up, but if 2004 is the accurate date, is it sufficient enough or are we talking US market introduction? I was speculating the FDA might go with the argument that it is new to the market. If it is the FDA's chosen path to get these banned under the Tobacco Act then we are looking at another lawsuit. It is only reasonable to challenge that if you ban one, then it is only appropriate to ban all. Which is unlikely to happen because the last thing the government wants to deal with is another prohibition.

Do we have any statistics or info on tobacco products released to the market since 2006/2007 that are not under attack by the FDA?

It isn't the fact that there could be endless litigation, or even a call for it. Just that the FDA isn't on stable ground if they are refusing to regulate and moving to ban. The point would actualy be to avoid litigation because the industry now knows which rules apply. The best option for all sides is they classify PV liquid as a lower risk class tobacco product, and regulate accordingly. Any lawsuits (if any) are going to be reactionary to the FDA's chosen action plan.

The disclosure that was resisted by some may suddenly become mandatory. And, since they are essentially a new tobacco product, it appears that the FDA may have the ability to refuse to allow any of them.

That all depends on if PVs qualify for the grandfathering clause. So on a technicality, if they were sold prior to 2007 on the market, then PVs are legal under the tobacco act. However I do see how the FDA could challenge that since I am not aware of any vendors prior to 2008.

Anyone aware of a vendor selling to the US prior to 2007?

 

[wv2win]

Here comes Phillip Morris !!!!

I can see no reason why the big tobacco co's do not get into the ecig business

I have my doubts about that happening. But if it did, it would be much better for BT to be the big player in the game than Big Pharm, that is for sure.

 

[Hygroscopic]

I have my doubts about that happening. But if it did, it would be much better for BT to be the big player in the game than Big Pharm, that is for sure.

I really can't find the lesser of the evil there. The only exception is that we have more interests aligned with big tobacco than big pharma. Only nicotine and the line ends there.
Phillip Morris flirted with Ruyan in 2009, but nothing happened from it.

I am going to only guess that they were aware of the potential FDA crapstorm and are perfectly fine sitting back using Sottera as their shield. I won't be surprised once the larger issues are challenged by smaller players, if Big Tobacco then looks to make manufacturer acquisitions.

Strategically and speculatively: That is the best option on their table for mitigating any losses from litigation. Once the current "big players" in the PV industry are drained, then big tobacco will jump in on the race.

 

[SimpleSins]

Actually, I suspect that the bigger tobacco companies already have warehouses full of ecigs ready to roll out...at the very least a factory (undoubtedly in China) ready to roll out the branded ecigs batteries and cute little mini-pack size boxes of Marlboro Red carts or cartos. I don't think they'll have to wait for the big PV players to drain. Much like TW brands an eGo with their own logo, I see no reason why the tobacco companies couldn't be the same- red for Marlboro "brand", green for Salem, titanium for Virginia Slims, etc. I don't think it will be long before you see them submitting the paperwork to the FDA to market them. And while we like to think we here on ECF represent the ecig market, in actuality there is a much larger number that patronize the mall kiosks and that sort of thing. I imagine any one of them would jump all over a Phillip Morris branded kit if it were (easily) marketed at a third the price of the mall one and available in 7/11. Not to mention all the people that think the mall ones seem a little shady and are hesitant about the on-line. They've got the name recognition and do know tobacco.

Time will tell, I guess. It remains to be seen what the FDA declares as the original marketing date of ecigs. I think, though, that they may still be able to limit the juices. If you go by an intro date of January 2007 (since they chose February 2007 as the cutoff), at the very best you had less than a handful of flavors, and so they may be able to state they may be forced to grandfather those tobacco flavors in, but to add the other flavorings would be a substantial change and prevent them.

But, as noted, at least they're not banned, and maybe everyone can start buying either no nic juice or mixing their own, and soak a patch in it*!!

*Tongue firmly in cheek- do not do not do not do not soak a nicotine patch in a bottle of flavored juice.

 

[JDSupreme]

score!!!!!!!!!!!!!!!!!

 

[kristin]

That all depends on if PVs qualify for the grandfathering clause. So on a technicality, if they were sold prior to 2007 on the market, then PVs are legal under the tobacco act. However I do see how the FDA could challenge that since I am not aware of any vendors prior to 2008.

Anyone aware of a vendor selling to the US prior to 2007?

I doubt Sottera's attorneys would have made the argument to be considered a tobacco product without first investigating whether or not they'd still be banned based on being a "new" tobacco product?

As far as the burden of proof (in other posts,) the burden of proof is on the manufacturer if they want to be a treatment/medicine or if they want to qualify as a reduced harm product. To qualify as a reduced harm product (under current guidelines) is next to impossible - apparently by design. E-cigarette merchants would fair best advertising that they are a substitute/alternative and avoid claims on health or safety. In reality, they don't need to make specific claims in order to get the message across - simply state what is in e-cigarette vapor vs. what is in tobacco smoke and most people can come to the right conclusion.

"Our e-cigarettes are a safer and healthier alternative to smoking" -> Bad

"Our e-cigarettes contain only food-grade propylene glycol, glycerin and artificial flavorings and USP-grade nicotine. Nicotine is not a known carcinogen. Cigarettes have been shown to contain over 4,000 toxic chemicals and dozens of carcinogens." -> Good

"Our customers quit smoking with e-cigarettes." -> Bad

"Our customers find our e-cigarettes to be a satisfying alternative/substitute for smoking." -> Good

The message can be clear without actually claiming to be safer or healthier or a smoking cessation device.

 

[BuzzKill]

Very good point Kristin , they are companies after all they will go after a market that will improve the bottom line $$$ , they are loosing market share with regular cigs they need an alternative market / product

 

[TJVapes]

This wouldn't be surprising.. The Chinese manufacturers are surely anticipating this or at least hoping. Mass production to BT would be a more sound plan than the smaller e-cig vendors were seeing now.

Actually, I suspect that the bigger tobacco companies already have warehouses full of ecigs bready to roll out...at the very least a factory (undoubtedly in China) ready to roll out the branded ecigs batteries and cute little mini-pack size boxes of Marlboro Red carts or cartos. I don't think they'll have to wait for the big PV players to drain. Much like TW brands an eGo with their own logo, I see no reason why the tobacco companies couldn't be the same- red for Marlboro "brand", green for Salem, titanium for Virginia Slims, etc. I don't think it will be long before you see them submitting the paperwork to the FDA to market them. And while we like to think we here on ECF represent the ecig market, in actuality there is a much larger number that patronize the mall kiosks and that sort of thing. I imagine any one of them would jump all over a Phillip Morris branded kit if it were (easily) marketed at a third the price of the mall one and available in 7/11. Not to mention all the people that think the mall ones seem a little shady and are hesitant about the on-line. They've got the name recognition and do know tobacco.

Time will tell, I guess. It remains to be seen what the FDA declares as the original marketing date of ecigs. I think, though, that they may still be able to limit the juices. If you go by an intro date of January 2007 (since they chose February 2007 as the cutoff), at the very best you had less than a handful of flavors, and so they may be able to state they may be forced to grandfather those tobacco flavors in, but to add the other flavorings would be a substantial change and prevent them.

But, as noted, at least they're not banned, and maybe everyone can start buying either no nic juice or mixing their own, and soak a patch in it*!!

*Tongue firmly in cheek- do not do not do not do not soak a nicotine patch in a bottle of flavored juice.

 

[Redrusty66]

Glad to see a bit mrore back and forth convo. I was quite panicky at first and a lot of the posts explaining further allt he rules, regulations and possible speculations have given me a bit of hope that things will work themselves out in the end without too much pain or anquish.

 

[Pav]

Even though this is only one step along the way, I'm not sure how it could be spun so negatively. I think it's one for the win column.

 

[shanagan]

Even though this is only one step along the way, I'm not sure how it could be spun so negatively. I think it's one for the win column.

I don't see it as spin (which is trying to make something appear in a way the "spinner" wants it to appear) so much as "ok, so what now..." I tend to look at any and all regulation as having the potential to wreck our flow, so to speak, and this is the first real step toward regulation - whether it's the "best" type of regulation or not. Realistically, though it is the "best" it is still going to come at a cost. So what's the tradeoff going to be? KWIM?

ETA: IMO, I guess realistically I believe the tradeoff will lie somewhere between "doom & gloom" and the "yay, we won! there's no stopping us now!" I just appreciate being able to explore what that might be.

 

[DC2]

For those of you asking about the grandfather clause and the February 2007 date...
http://www.e-cigarette-forum.com/fo...79.html?highlight=grandfather+2007#post356479

 

[Bigfoot1974]

Thats awsome. I guess I don't have to stock up on juice now. WOOOOOOOOOOOOOOOOOOOOOT!!!!!!

 

[Hygroscopic]

I doubt Sottera's attorneys would have made the argument to be considered a tobacco product without first investigating whether or not they'd still be banned based on being a "new" tobacco product?

As far as the burden of proof (in other posts,) the burden of proof is on the manufacturer if they want to be a treatment/medicine or if they want to qualify as a reduced harm product. To qualify as a reduced harm product (under current guidelines) is next to impossible - apparently by design. E-cigarette merchants would fair best advertising that they are a substitute/alternative and avoid claims on health or safety. In reality, they don't need to make specific claims in order to get the message across - simply state what is in e-cigarette vapor vs. what is in tobacco smoke and most people can come to the right conclusion.

That is where the strike down on the FDA trying to extend the limitation on what could be said about the products by the media, medical community, users, etc... was challenged to be unconstitutional. To apply the manufacturer/vendor would have to provide sufficient support for their request to the FDA. I would gander to suspect that the reason the medical community hasn't entertained the notion of embracing PVs as an alternative is due to trying not to royally tick off their regulation overlords.

It is something that again while speculative now, by that point in the race Big Tobacco will have their horses in it to win it. They have the armory to challenge that subsection. No mid-small vendor as of this time could challenge the actual law. - Thanks (honestly) for entertaining the speculation, I'm fascinated by what is up next and in the future.

DC2: Thanks for the link.

SS: I think they are more likely to be waiting for the Kiosk Kings to legally fend off the FDA and set the stage. When their horse jumps in the race, if anything they will look to acquire. Probably start as a test by partnering with one of the Chinese manufacturers. Goes well then they'd aim to acquire. Cheaper than starting from the ground up. The one advantage is that BT will have zero interest in getting into the mod market.

 

[SimpleSins]

That is where the strike down on the FDA trying to extend the limitation on what could be said about the products by the media, medical community, users, etc... was challenged to be unconstitutional. To apply the manufacturer/vendor would have to provide sufficient support for their request to the FDA. I would gander to suspect that the reason the medical community hasn't entertained the notion of embracing PVs as an alternative is due to trying not to royally tick off their regulation overlords.

Actually, the reason more physicians have not jumped on the ecig bandwagon is because it is untested. While an occasional physician may shrug and say it's okay in the privacy of the exam room, you are not going to find very many willing to go on record advocating the use of them until there has been testing done as to the safety. Physicians are funny creatures. They like science; real science, hard science, not the fluff. And most physicians also know how studies should be conducted, including peer-reviewed and double blind, understand a little bit about safe manufacturing standards and the potential problems when those things aren't in place.

So it's not a matter of fear of the regulatory overlord. It's adhering to "first do no harm".

 

[kristin]

Physicians are funny creatures. They like science; real science, hard science, not the fluff. And most physicians also know how studies should be conducted, including peer-reviewed and double blind, understand a little bit about safe manufacturing standards and the potential problems when those things aren't in place.

So it's not a matter of fear of the regulatory overlord. It's adhering to "first do no harm".

Physicians are also busy creatures and often don't do due diligence - they trust the "authorities" and the word of medical associations to give them a quick synopsis. Many don't look as deeply into e-cigarettes as CASAA'a medical director did.

The best doctors look at what is making their patients better - not at what is endorsed by the "powers that be." As Dr. Siegel pointed out recently on his blog regarding "do no harm,"

in the case of a product which is already on the market and which is reportedly providing immense benefits to thousands of people, the equation changes. Now, there are demonstrable benefits and the hypothesized harm is only a potential one. To remove the product from the market would cause harm. To cause definite harm merely to protect against a prospect that the product has adverse side effects violates the principle of nonmaleficence.

 

[SimpleSins]

Physicians are also busy creatures and often don't do due diligence - they trust the "authorities" and the word of medical associations to give them a quick synopsis. Many don't look as deeply into e-cigarettes as CASAA'a medical director did.

The best doctors look at what is making their patients better - not at what is endorsed by the "powers that be." As Dr. Siegel pointed out recently on his blog regarding "do no harm,"

I've asked repeatedly, as have others. Could you please point me to the studies that show that these are safe? Or even actually safer? As any pulmonologist can tell you, cancer is but one of the horrible things that can happen to your lungs. And I have yet to see one piece of proof that they are safe. As a matter of fact, the only scientific evidence seen is that some of the ingredients potentially cause an illness every bit as catastrophic as cancer. The PG studies were done in the 1940s; back then we thought cigarettes were safe, too. The New Zealand were looking for carcinogens and did not take into account other chemical toxicities, nor were they done on the extensive range of flavors that there are now.

If you have a physician that is too busy to educate himself, I am sorry for your bad luck. But they are not all like that, and, as any one who follows health information knows, they are often at odds with their regulating bodies, be it the AMA or the FDA.

 

[Trulee]

Thank heavens. I dont want to ever go back to analogs or the nicorette gum. I still think the big tobacco companies should just get with it and invest in making some electronic cigarettes themselves. Ecigs are truly wonderful. I feel great and another great thing is I'm already loosing the weight I put on while trying to stop smoking.

 

[kristin]

I've asked repeatedly, as have others. Could you please point me to the studies that show that these are safe? Or even actually safer?

Can you show the studies that prove they aren't safe or a least safer? I think it goes both ways.

In real-world use, there have been no reports of injury or illness related to e-cigarette use. Since when does a product that is currently on the market, which has displayed no serious adverse effects and yet is by almost all accounts helping thousands of people avoid a serious health risk, called to be pulled from the market?

The FDA testing was looking for ANYTHING they could find that would give them cause to pull e-cigarettes from the market. The worst they could find was trace amounts of carcinogens and one sample with a non-toxic amount of diethylene glycol. The lack of dangerous levels of carcinogens and/or toxic chemicals DOES show that they are safer than tobacco smoke. Just eliminating ONE of the toxic chemicals one would be inhaling from smoking makes it technically "safer" and e-cigarettes eliminate thousands. If one is inhaling 20 equally potentially deadly toxins and one switches to something with 5 equally potentially deadly toxins, one has still reduced risks by 75%. No one should be claiming that they are 100% safe regardless, but they need to be compared to the risks associated with smoking, not to breathing clean air. If someone wants "safe," then they shouldn't use e-cigarettes just for the known fact that e-cigarettes contain nicotine. If they are using 0mg and still concerned, they should quit altogether, because it's pretty much a certainty that inhaling anything other than clean air into one's lungs isn't going to be 100% safe.

Read Dr. Siegel's post. He makes the point that Chantix WAS proven to be deadly in some cases, yet the FDA felt that the fact that it was showing some benefit to allow people to quit smoking supported keeping Chantix on the market. The positives outweighed the negatives - even when people were actually DYING. Physicians still recommend Chantix to smokers - seemingly with the idea that the even the risk of death is better than continuing to smoke?? Yet e-cigarettes haven't even been linked to any reported serious illness, even with thousands of users, but because there have been no "official" studies (which were obviously so relevant with Chantix) they are afraid of them? Would lab studies have really painted the whole picture or as with Chantix, would they have to be released to the broader public and used long-term before we knew what the true adverse affects were?

I'm not saying that the continuing studies shouldn't be done and everything that can be found out about e-cigarettes be found, but to call for their ban or to tell people to use ineffective NRTs when e-cigarettes are working for them completely lacks logic.

The other problem is that politics makes unbiased safety studies nearly impossible. Researchers have had e-cigarettes in their hands and they have been testing them - for everything BUT safety. Have you noticed that? They've tested the effectiveness of nicotine delivery, how hard you have to suck on them, labeling accuracy and leaky cartridges - but not one has attempted to discover and document claims that these are a potential health risk. Why do you think that is? I believe it's because politics dictate that e-cigarettes must be stopped and because they KNOW that they aren't going to find anything in them more deadly than cigarette smoke they have to use all sorts of other ways to show how they are a "public risk." The same way the FDA was forced to play up DEG and carcinogens, because they couldn't find anything worse, researchers beholden to Big Pharma have to make e-cigarettes look dangerous without actually testing for human health risks.

I just don't see how further analysis of the chemicals in e-cigarettes are going to tell us any more about the safety of e-cigarettes than the fact that thousands of people have been using them to avoid smoking without serious adverse effects? For me the issue now, lacking any scientific evidence that e-cigarettes are causing harm to people and considering how much good they are doing, should be regulating the manufacturing, labeling and advertising of these products for quality control. The issue of safety is a moot point until or if we actually get complaints of serious illness or injury - and then those risks need to be evaluated compared to the health effects of smoking and how many people are actually affected - the same way they treated Chantix and hundreds of other products.

That's just how I personally see it, anyway.

 

[Trulee]

Seriously, simple, I'm not using the PG. I use only VG. The flavors I can do without if need be. PG is in the inhalers used by asthmatics. I have a nephew who has asthma. He's been inhaling PG since he was a child.