FDA sends letter to e-cigarette company(ies) requesting info on adverse events

[Vocalek]

Back when I first started using an e-cigarette, I had an njoy NPRO, which looks very much like a real cigarette. Just to socialize with my friends, I would go outside with my gadget when they would go out to have a smoke. One day a guy walked up to me and asked me for a light! *Giggle*

 

[N rustica]

This is a heads up to cover your ... if you already haven't done so. The tobacco companies can provide a summary of adverse effects and consumer complaints when requested, the ecig companies should be prepared to do so also. The tobacco companies have been been pretty successful at keeping the FDA off them. I don't see them moaning and .....ing and playing the victim.

Wise up and follow their lead!

 

[sailorman]

This is a heads up to cover your ... if you already haven't done so. The tobacco companies can provide a summary of adverse effects and consumer complaints when requested, the ecig companies should be prepared to do so also. The tobacco companies have been been pretty successful at keeping the FDA off them. I don't see them moaning and .....ing and playing the victim.

Wise up and follow their lead!

Uh...Duh... When your products contain whole tobacco, which is known to cause adverse effects, it's easy to provide accounts of them. What adverse effects should ecig companies be prepared to supply? Complaints about bad tasting e-juice, dead batteries and DOA attys? Accounts of PG sensitivity? Increased thirst? Horror stories about WNA withdrawl and strangely clear phlegm? Or, should they just make some up?

The FDA wants complaints of medical problems they can attribute to e-cigs. They want accidental overdoses, nicotine poisoning, respiratory emergencies, abnormal heart functioning, allergic reactions and stories of contamination poisoning.
I somehow doubt the e-cig companies have very thick files containing accounts of these adverse effects.

The tobacco companies have been successful in keeping the FDA off of them because of the massive political influence gained through hundreds of millions of dollars in political contributions and fielding armies of high powered lobbyists to tailor legislation in their interests.

Cigarettes have never been considered medical devices but the new tobacco products will, and do, have the FDA on them. So, the tobacco companies have not been so successful in keeping the FDA completely off of them when it comes to non-traditional forms of tobacco, despite their massive expenditures. But, OTOH, they've only just begun to wield their influence on behalf of those types of products, so we'll see.

I'l make you a friendly wager that when the TPSAC convenes to consider e-cigs, they'll get a lot more hositle treatment than did the dissolveable tobacco products they recently discussed.

You don't see them moaning and .....ing now because, as regards their mainstay products, they have paid up for their protection, largely by bribing states via their concession to the MSA. They did plenty of moaning and .....ing in the past, before they succeeded in their PR and political protection campaign.

When a panel like TPSAC is convened to take up the issue of e-cigs, I wonder if the e-cig industry will be granted space for 3 members of their industry to provide input. When will we see a House Leader walking around the House floor, passing out checks from the e-cig industry?

 

[calsax]

The FDA has specific definitions for everything, and "Adverse Event" is no exception. In their world, bad taste, dead batteries, doa attys, etc, are not adverse events. For a clearer explanation of the term, check this link: What is a Serious Adverse Event? It should help.

And yes, they do want to build a case against us, based on their reports. However, I am not sure they have the right to request this reporting. Their power is very clearly defined in the CFR. I would certainly consult with a (very) good and (very) knowledgable attorney before responding to any request for data from the FDA.

 

[tommy2bad]

Thanks for the link calsax. Most of the listed adverse affects are so far non existent for vapers but one little line in the other serious paragraph....
"The development of drug dependence or drug abuse would also be examples of important medical events."
Thats hard to answer as most users would already be addicted but addiction is a hazard for someone who takes up vaping from non smoking. Possibly a weak link in our defenses.

 

[sailorman]

The FDA has specific definitions for everything, and "Adverse Event" is no exception. In their world, bad taste, dead batteries, doa attys, etc, are not adverse events. For a clearer explanation of the term, check this link: What is a Serious Adverse Event? It should help.

And yes, they do want to build a case against us, based on their reports. However, I am not sure they have the right to request this reporting. Their power is very clearly defined in the CFR. I would certainly consult with a (very) good and (very) knowledgable attorney before responding to any request for data from the FDA.

Yeah, I was sure that none of that trivial stuff would be what they were looking for. I wonder if they delineate exactly what they were looking for in their letter to the vendors or manufacturers. Would vendors be expected to know the criteria of a serious adverse event? If not, a good tactic would be to flood them with thousands of positive testimonials containing any small complaint that could possibly construed as adverse.
Of course, if the FDA had provided a definition of "adverse event", then this wouldn't be applicable. But since the mfg's aren't engaged in making medical devices, the FDA shouldn't assume they know what constitutes a "serious adverse event". If they don't enlighten them, they deserve to get a flood of extraneous crap to sift through.

 

[sailorman]

Thanks for the link calsax. Most of the listed adverse affects are so far non existent for vapers but one little line in the other serious paragraph....
"The development of drug dependence or drug abuse would also be examples of important medical events."
Thats hard to answer as most users would already be addicted but addiction is a hazard for someone who takes up vaping from non smoking. Possibly a weak link in our defenses.

Is it a credible scenario for someone to inform a manufacturer that he was a non-smoker and became addicted to nicotine because of that manufacturer's product? Why would someone even do that? I could see a parent relating such a story regarding their child, but really. "Dear Joytech. I was a non-smoker and bought an e-cig with 24mg nicotine juice. Now, I'm addicted and it's your fault. Why didn't you warn me this could happen" Really????

 

[suzyslegs]

Vape with a vv box mod, but something tells me there's something wrong with the picture of the e-cig on the FDA's 'informative' page on electronic cigarettes - kinda ruins their credabilityl


Image of an e-Cigarette inserted into a charger. (looks like they plugged the carto in )

And, here is the response:

Thank you for your email.

The following web address will help explain the current information regarding e-cigarettes and FDA. Electronic Cigarettes

As for information on FOIA request. Your request would need to be submitted under the Freedom of Information Act (FOIA). The following link provides more details regarding FOIA requests, Freedom of Information.

We encourage you to visit our website (Tobacco), which includes up-to-date information about the regulations that have been promulgated and actions CTP is taking regarding requirements for industry. You can sign up for automatic notification when there is any new information on the website (Sign Up for E-mail Updates on Tobacco Products).

Center for Tobacco Products/FDA
CTP Call Center: 1.877.CTP.1373 Tobacco

 

[sailorman]

Vape with a vv box mod, but something tells me there's something wrong with the picture of the e-cig on the FDA's 'informative' page on electronic cigarettes - kinda ruins their credabilityl

View attachment 86054
Image of an e-Cigarette inserted into a charger. (looks like they plugged the carto in )

ROFLMAO!! Oh man. I thought you were spoofin' us. Freaking FDA. What a bunch of maroons. I guess when you have zero credibility in the first place, you don't worry about little details. I wouldn't be surprise if that wasn't an e-cig at all. Looks like a Pall Mall 100 to me.

 

[Thulium]

ROFLMAO!! Oh man. I thought you were spoofin' us. Freaking FDA. What a bunch of maroons. I guess when you have zero credibility in the first place, you don't worry about little details. I wouldn't be surprise if that wasn't an e-cig at all. Looks like a Pall Mall 100 to me.

No, that is the actual picture the FDA included in their report on preliminary tests on 18 e-cigarette cartridges from SmokingEverywhere & Njoy. I think they've tried to claim it was a joke--I'm pretty certain it was not intentional, but I do have to admit it cracks me up every time!

 

[Bill Godshall]

Perhaps someone could explain what's the big joke about the picture used by the FDA.
Is it because the product pictured isn't any of the SE or NJOY e-cig products the FDA tested back in 2009?

 

[Maestro]

It's because they didn't take the cartridge off before plugging it into the charger.

 

[LeDean]

So if you felt inclined to answer this request, what would you say were the adverse effects?
Cotton mouth, mod envy, postman stalking?
How could any vendor know the adverse effects without conducting the research? Surely this should be aimed at manufactures, oh wait their in China and would bin this piece of spam.
My sugestion ! "Call me back in 20 years, we will know more then, in the mean time theirs lots of info on ECF, Thank you for calling"

Our poor postlady. She looks shell-shocked every time she pulls into the driveway. We've put some miles on that old girl.

 

[sonicdsl]

Perhaps someone could explain what's the big joke about the picture used by the FDA.
Is it because the product pictured isn't any of the SE or NJOY e-cig products the FDA tested back in 2009?

It's because they didn't take the cartridge off before plugging it into the charger.

So no way it's actually charging, see, because it won't fit that way. Definitely an in-joke.

 

[Thulium]

Perhaps someone could explain what's the big joke about the picture used by the FDA.
Is it because the product pictured isn't any of the SE or NJOY e-cig products the FDA tested back in 2009?

The entire e-cigarette is jammed into the charger by the cartridge, rather than the battery. Anyone who knows anything about using e-cigarettes knows that you don't recharge the atomizer and cartridge, but just the battery. The picture is evidence of how little the FDA understands about the product they are warning might possibly be dangerous even though they failed to detect anything at any level known or expected to cause serious risk of death or disease.

I think they took the picture this way thinking that it would show both the fact that it looks like a cigarette and that it is plugged in, but this picture looks like something that should have a big red "DON'T" sign above some poorly translated Chinese instructions about how NOT to recharge your new e-cig.

 

[MattZuke]

Perhaps someone could explain what's the big joke about the picture used by the FDA.
Is it because the product pictured isn't any of the SE or NJOY e-cig products the FDA tested back in 2009?

I don't know my classic 901 gear, I don't know who made the "mini cigarette" 901. The charger though looks like a Desan DSE901-C.

 

[D103]

RE: to the picture erroneously depicting the recharging of an e-cig.

How about an analogy - a picture depicting jump-starting a car showing a legitimate power source with the cables leading to the car in need of "charging" and the cables are clamped to the bumper! Pretty stupid and silly to anyone who knows better - like Thad said, the battery is rechargeable, NOT the whole unit.

The fact that the FDA got that wrong is important I believe. If they, in fact, did not know they were in error, that alone is pretty glaring and should go a long way in discrediting much, if not all, of what the FDA has to say about e-cigs (i.e. if you don't understand the very simple basics of the product, how can you and more importantly, why should you be considered reliable and competent regarding more complex issues such as safety/risk analysis?)

If, however, they knew better but used that particular depiction for any other reasons, which frankly would be deceiving and manipulative, it goes a long way towards discrediting the FDA's motives, credibility and integrity.

 

[Tom09]

Just adding some history to what has been said about the FDA picture: In 2009, already, this picture was used in a consumer leaflet intending to discourage use. In late 2011 it was advanced to be THE representative picture on FDA’s remolded official e-cig page. So, that’s the impressive progress achieved by FDA on the e-cig issue within the course of several years...

 

[Angi2299]

Just adding some history to what has been said about the FDA picture: In 2009, already, this picture was used in a consumer leaflet intending to discourage use. In late 2011 it was advanced to be THE representative picture on FDA’s remolded official e-cig page. So, that’s the impressive progress achieved by FDA on the e-cig issue within the course of several years...

Those poor kids at the FDA are a little slow. Maybe in two more years they will finally figure out how to charge that thing and be able to begin doing a few studies. That may be the reason for their dislike of our PVs. I can hear the conversation now....... "Those e-cigarette things are junk, I mean, its been on the charger for two years and it still isn't charged."

DUH?! HERE'S YER SIGN!

 

[sailorman]

Can anyone say for sure that the e-cig in the picture is even an e-cig at all??

To me, it looks like it could be an analog. In that case, the pic could be a satirical photo or meant to convey a subliminal message to the uninitiated masses.
Like "E-cigarette or real cigarette. No difference".
Or am I giving the FDA more credit than it deserves?