News story says 50 complaints submitted to FDA about e-cigs in past year

[Bill Godshall]

Article claims 50 complaints were submitted to FDA about e-cigs in past year, but said the complaints were obtained "according to data obtained through a public records request".
Reports of e-cigarette injury jump amid rising popularity, U.S. data show | Reuters

The complaints from the public filed with the FDA cited trouble breathing, headache, cough, dizziness, sore throat, nose bleeds, chest pain or other cardiovascular problems, and allergic reactions such as itchiness and swelling of the lips.
One person told the FDA that while eating dinner at a restaurant a customer at the next table was smoking an e-cigarette.
"The vapor cloud was big enough to come over my table and the e-cig smoker was 'huffing' it voraciously," the person, whose name was redacted, wrote. "I got dizzy, my eyes began to water and I ended up taking my food to go because of the intense heartbeat I began to develop."

and

Others complained of over-heating devices.
"The electric cigarette gets hot when you use it and alters the taste buds," wrote one consumer. "I just recently realized what was turning my taste buds black."
It is not possible to draw general conclusions from individual case reports, but there is a growing recognition that the inconsistent quality of the devices, aside from any risk inherent in the inhalation of nicotine vapor, poses potential safety risks.

While several of the cited complaints appear serious, it appears that most (and perhaps the vast majority) of the 50 complaints were relatively minor events, and I suspect that many complaints about e-cigs were submitted by ANTZ (or were prompted by fearmongering claims by ANTZ).

Regardless, 50 complaints about several hundred million e-cig products sold in the past year is a very good safety record.

And unlike any other product (that I'm aware of) the FDA established an e-cig complaint report site back in 2009, and has been urging healthcare workers to file complaints anytime they suspect that an e-cig may have been associated with an adverse event.

But of course, Logic's Miguel Martin used the opportunity to once again endorse FDA e-cig regulations, and to blame the complaints on other e-cig companies and their products.

Miguel Martin, president of Logic Technology, one of the biggest U.S. e-cigarette makers along with Lorillard Inc and privately held NJOY, said the spike in adverse event reports reinforces the importance of regulation, especially in areas governing manufacturing practices and labeling, where standards can vary dramatically.
"Clearly, because of the business opportunities, you have companies in an unregulated environment that are importing without checks and balances," he said, adding that while Logic pays attention to quality control, "some other companies just are not having the same diligence or focus."

 

[AgentAnia]

Bill, I haven't read the article yet, but:

The first quote sounds a lot like an anxiety attack to me. Could it have been caused by belief in ANTZ fearmongering?

Re the second quote: "I just recently realized what was turning my taste buds black." I may spend some time pondering "taste buds turning black" -- after I stop laughing...

 

[swampergene]

I can think of a lot of unregulated things we deal with every day that would probably generate 50 complaints an HOUR if they gave everything else the same attention.

 

[db13berry]

 

[Alexander Mundy]

Bill, I haven't read the article yet, but:

The first quote sounds a lot like an anxiety attack to me. Could it have been caused by belief in ANTZ fearmongering?

Re the second quote: "I just recently realized what was turning my taste buds black." I may spend some time pondering "taste buds turning black" -- after I stop laughing...

Sounds like black harry tongue to me caused when bacteria over multiply on the tongue. Harmless and good oral hygiene will alleviate it. Probably total coincidence.

 

[boog]

bismuth causes black hairy tongue, bismuth is found in pepto bismol

 

[kachuge]

I can think of a lot of unregulated things we deal with every day that would probably generate 50 complaints an HOUR if they gave everything else the same attention.

ARE YOU KIDDING?
ARE YOU KIDDING?

I can complain about nicorettes giving me rapid heartbeat..........
I can complain about that pill that's supposed to make you get off nicotine, making me want to kill people.....
I can complain about the patch not working.......

Everybody can complain about something......... holy crap..........
don't they have filters, or are they just accepting all the bogus complaints and treating them all as real?

propaganda is a machine.... usually a govt run one

g

 

[Frenchfry1942]

It is really good to get our personal stories out. Letters to the editor of newspapers, State and Federal Legislators, I just put two more items on my FB page, and I got a bite. Our success stories and our gratefulness are really needed.

 

[Jman8]

Regardless, 50 complaints about several hundred million e-cig products sold in the past year is a very good safety record.

I love Wisconsin sports teams (esp. Brewers and Packers), but during any given season, I could be heard spouting about 50 minor complaints.

IOW, if 50 complaints to a federal department of government is all we are up against, I expect some smooth sailing on the eCig boat.

 

[Rickajho]

One person told the FDA that while eating dinner at a restaurant a customer at the next table was smoking an e-cigarette.
"The vapor cloud was big enough to come over my table and the e-cig smoker was 'huffing' it voraciously," the person, whose name was redacted, wrote. "I got dizzy, my eyes began to water and I ended up taking my food to go because of the intense heartbeat I began to develop."

Oh great, now we are gonna have stories of "The dangers of e-cigarettes to the restaurant industry. Film at eleven."

Methinks some people are just too excitable to be venturing out into public at all. Unfettered social interaction can send them right over the edge.

Dwama... So much dwama...

 

[AgentAnia]

"Fifty complaints to the FDA" calls to mind "Calls to Poison Control Centers." Anyone can register a complaint w/ the FDA; anyone can call a PCC -- about any little thing. Doesn't mean squat without more information. But it sounds scary, no?

Seems to me like the FDA is jumping on the "question = run-for-the-hills toxic exposure" banwagon. So much for "science-based regulation"...

PS: PLEASE! No more black tongue images, okay?

 

[Rickajho]

Don'tcha mean science-fiction based regulation? That's all it takes to get a local ordinance passed.

 

[Fitzie]

If anyone is interested, you can read the actual adverse event reports on FDA's website. As I don't know how to post a link, just google "complaints to FDA about ecigarettes." Interesting reading ... I'll leave it at that.

 

[AgentAnia]

This is 114-page pdf file of "adverse event reports" to FDA.

http://www.fda.gov/downloads/AboutF...bouttheCenterforTobaccoProducts/UCM393323.pdf

After a quick scan, I agree with Bill's view:

While several of the cited complaints appear serious, it appears that most (and perhaps the vast majority) of the 50 complaints were relatively minor events, and I suspect that many complaints about e-cigs were submitted by ANTZ (or were prompted by fearmongering claims by ANTZ).

 

[NorthOfAtlanta]

Skim read through this, 5 of the "adverse events " were positive and asking the FDA why they were trying to kill them. Page # 55, 72, 78, 80 and 81 on the PDF. Many others seemed to be the normal symptoms of stopping smoking, new users with bleeding gums and coughing up multicolored phlegm.

Totally agree with Bill on some are serious and they should be followed up on. Most of them sounded like allergic reactions to something in
the vapor and would not be unexpected with the millions of people who have tried e-cigarettes.

For an interesting one start on page 108, disgruntled employee or whistle blower, I'm not sure which.

When you take millions of users and there are only 55 reports filed through 2013 10% of which are positive I'd say they have one heck of a safety record. I'd love to find a report like this on Chantix but I've only got a 500G drive and I'm not sure it would fit.

 

[badwolf91]

50 complaints in a whole year... what about the FDA approved drugs you see on tv that have caused cancer and death in the 1000s? just pathetic. im sure asprin has 50 complains a year, even pepsi lol

 

[NorthOfAtlanta]

Skim read through this, 5 of the "adverse events " were positive and asking the FDA why they were trying to kill them. Page # 55, 72, 78, 80 and 81 on the PDF. Many others seemed to be the normal symptoms of stopping smoking, new users with bleeding gums and coughing up multicolored phlegm.

Totally agree with Bill on some are serious and they should be followed up on. Most of them sounded like allergic reactions to something in
the vapor and would not be unexpected with the millions of people who have tried e-cigarettes.

For an interesting one start on page 108, disgruntled employee or whistle blower, I'm not sure which.

When you take millions of users and there are only 55 reports filed through 2013 10% of which are positive I'd say they have one heck of a safety record. I'd love to find a report like this on Chantix but I've only got a 500G drive and I'm not sure it would fit.

I don't usually quote myself but I came back to this post and clicked on AAs link looking for something that I thought I had seen on the pdf. The link took me to something that was not what I was looking at last night and made the above mean nothing as the pages referenced didn't match my comment. I had ended up on another PDF with photocopies of the original complaints like the last ones on AAs link. They're a lot more interesting than the cleaned up ones on the original link. I had bookmarked where I ended up, so here is the link that matches my post.

http://www.fda.gov/downloads/aboutfda/centersoffices/officeofmedicalproductsandtobacco/aboutthecenterfortobaccoproducts/ucm361437.pdf

 

[badwolf91]

man.. these are all people not considering their current health problems with something that may dehydrate you or pure stupidity. how many cell phones got too hot and started car fires? the lady smoking blu cigs should be an example that the cigalikes are the evil of this industry imo.. most costly and you get the least out of them (mostly are becoming owned by BT anyway so that would make sense)

could possibly be them using some very bad liquid too (you have to have common sense when buying..even such I have never come across a "bad" liquid, most vendors care enough to at least make it right... which because people do not have common sense we get stamped with BS regulations/laws that apply to everyone in a lot of cases) but I think most of these come from cigalikes, the breathing problems and stuff.

these cigalikes companies freak me out a bit lol.. I don't even think a lot of this is genuine. the kid just dying from using ecigs? id like to see what the "autopsy" ends up coming back with.

 

[Jman8]

The problem is all inside your head
Vaping said to me
The answer is easy if you
Vape continuously
I'd like to help you in your struggle
To be free
There only fifty complaints
Submitted to the FDA

I said it's really not my habit
To intrude
Furthermore, I hope my vapor
Won't be lost or misunderstood
But I'll repeat myself
At the risk of being crude
There only fifty complaints
Submitted to the FDA
Fifty complaints submitted to the FDA

You just vape with some tact, Jack
Avoid a new ban, Stan
Don't need to be coy, Roy
Just get yourself free
Take a few puffs, Gus
You don't need to discuss much
Just vape by the tree, Lee
And get yourself free

 

[Talyon]

O Macdonald has a Vape
Eieio
And on his Vape he has a Kayfun
Eieio
With a Vape vape here and a Vape Vape there
Here a Vape there a Vape everywhere a Vape Vape
O Macdonald had a Vape
Eieio

99 bottles of eLiquid on the bus
99 bottles of eLiquid
Open one up
Drip it on your Patriot
98 bottles of eLiquid on the bus

Feel free to continue...............