FDA approved ecig???

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Lyndale

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Oct 5, 2009
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This site ticks me off for because of the numerous false claims this jerkwad is making. The device is FDA approved as a medical device? That's some seriously fraudulent false advertising right there. E-cigs have been proven to help people stop smoking? I'm not aware of any studies that have been done on the long term smoking cessation results of an e-cig smoking cessation program.

Who can we lobby some complaints with to get this douche shut down? That FDA claim should be good for a hefty fine against this tool. :mad:
 

BigJimW

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May 17, 2009
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www.moonport.org
*cough*

You know James I don’t appreciate threats. I do have a law degree and will prosecute to the fullest extent of the law for defamation. We are doing the world good with helping people quit smoking. I don’t understand your hostility towards what we are doing.



Here is our FDA number:



FDA#: 3007697818

At least I got something out of them. And I never threatened the douchbag. I sent him the same message verbatim I quoted here. Talk about hostility.

My response

I honestly don't care about your little "law degree" and your threat of a "lawlsuit". You make a claim that your little e-cig is "FDA Approved", which it is NOT.

You will be in for a world of **** if your claim is not true.

People like me are trying to make e-cigs acceptable. People like YOU making false claims make us all look bad.

I'll be contacting the FDA tomorrow.

- Jim

I'll e-mail the FDA tomorrow to see if this is up and up. I tend to doubt it tho.

The heat is on. ;)
 
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BigJimW

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They replied:

I am doing the same as you with making e-cigs acceptable. Actually probably much more than you. I have a lot of legal connections

My reply

More than me? Ok, lets see. YOU claim that the FDA approved your electronic cigarettes. Your FDA number is nothing more than registering with them as a business. Johnson Creek (who makes e-juice) had to do the same thing. That does NOT make you "approved". It only makes you registered so they know you exist. Nobody is impressed.

Your blatent false advertising of your e-cigs as being FDA "approved" is going to bring a tidal wave of ****.

Trust me, you're not helping with the fight. It's bad enough Smoking Everywhere is screwing things up, the LAST thing we need is another fly by night operator who makes false claims like this.

You're not fooling anyone.

- Jim

Worth staying up all night for. :D

And notice that he went from having a law degree to "have a lot of legal connections"? Sweet.
 
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Eric in AK

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Sep 30, 2009
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My neighbor's husband has a bunch of legal connections, too: various public defenders over the past 10 years or so. Anyway....

If this guy's business is licensed in a state with any kind of consumer protection law, you can report his false advertising to the enforcement agency. You can also report it to the FTC, since this involves interstate commerce. If he's running banner ads on web sites, you can report his deceptive trade practices to the web sites, though most sites would probably rather have the ad revenue.

Go get 'im, Jim.
 

Eric in AK

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Sep 30, 2009
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Look at this information on their "News" page:

"Smoking has a wide variety of negative health effects and can affect nearly every organ in the body. But the organs that are most adversely influenced are your lungs. Of course, as everybody knows, your lungs help you breathe."

I always wondered where the air went when I inhaled, and now I think I know.....the lungs....who would have guessed?

See? Who needs TV or newspapers when you can get that kind of news on the internet?!?
 

Ryle

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ramblingrose

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Apr 8, 2009
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Their registration does NOT allow them to make any claims as a smoking cessation device (and is a load of BS). This is what they registered as:

TITLE 21--FOOD AND DRUGS CHAPTER I--FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES SUBCHAPTER H--MEDICAL DEVICES PART 874 -- EAR, NOSE, AND THROAT DEVICES
Subpart F--Therapeutic Devices
Sec. 874.5220 Ear, nose, and throat drug administration device. (a)Identification. An ear, nose, and throat drug administration device is one of a group of ear, nose, and throat devices intended specifically to administer medicinal substances to treat ear, nose, and throat disorders. These instruments include the powder blower, dropper, ear wick, manual nebulizer pump, and nasal inhaler.
(b)Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in 874.9. If the device is not labeled or otherwise represented as sterile, it is exempt from the current good manufacturing practice requirements of the quality system regulation in part 820 of this chapter, with the exception of 820.180, with respect to general requirements concerning records, and 820.198, with respect to complaint files.
[51 FR 40389, Nov. 6, 1986, as amended at 59 FR 63009, Dec. 7, 1994; 66 FR 38801, July 25, 2001]


Uh huh, we're all being treated for ear, nose or throat disorders.
 

TnA

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Apr 19, 2009
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I've only read the first page of this thread, but wanted to chime in that in the past 2 months, I've received close to 100 offers to supply products from Chinese manufacturers. In the process of researching the companies and their products (boy is this tedious :rolleyes:), I recently came across one (I'm sure there were others before, but was just so inundated that my head was spinning too much to notice) manufacturer with health claims and claims of FDA approval. I responded back about my concerns of health claims and that I was not aware of any e-cig that was approved by the FDA.

Their manager quickly responded back with this: "thanks for your kind reply about FDA problem.
well,about the health claims,pls do not worry,all our product get approved CE,ROHS,SGS,FDA on Medical Device.

espercially the FDA,maybe you are a little confused,exactly FDA on Medical Device is for the e-cigarette,except the e-liquid,you know,now nobody have get e-liquid FDA.but do not worry,about the liquid,we have get approved SGS,it is healthy."

So, while the FDA claim is not wholey legit, I think the way they've managed to word-smith might be keeping them fairly safe. I would definitely like to know more about their ability to be legit under the eyes of the FDA as a "medical device"!!

On a side note, I just recently clicked on a hyperlink in a thread in this forum that took me to a US vendors website where it is specifically stated, "PENSTYLES are THE MOST successful way to QUIT Tobacco. This is how I started and quit Tobacco myself!" Obviously, we still need to do some house-cleaning of our own US vendors. :mad:
 

ichaya

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Mar 26, 2009
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Well here is what that docket number shows as when you go to FDA.GOV.

I believe you are correct this is the registration of a business. NOT a approval of a device.

Skip to Main Content









-
Establishment Registration & Device Listing




510(k)|Registration & Listing|Adverse Events|Recalls|PMA|Classification|StandardsCFR Title 21|Radiation-Emitting Products|X-Ray Assembler|Medsun Reports|CLIA
New SearchBack To Search Results
Establishment:
SHENZHEN YANQU ELECTRONICS CO., LTD.
room 502, building 6,wangtang industrial
nanshan district
shenzhen, CHINA 518055
Registration Number: 3007697818
Status: Active
Date of Registration Status: 2009

Owner/Operator:
Shenzhen YanQu Electronics Co., Ltd.
room 502, building 6,wangtang industrial
nanshan district
shenzhen, CN-44 CHINA 518055
Owner/Operator Number: 10029223

Official Correspondent:
yumei jin
room 502, building 6,wangtang industrial
nanshan district
shenzhen, CN-44 CHINA 518055
Phone: 086-0755-33010358

US Agent:
Peter Yu
250 e gun hill road, apt 3i,
bronx, NY 10467
Phone: 646 4653085 ext
Fax: 267 3163911
Email: info@ayuglobal.com
 

ramblingrose

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ECF Veteran
Apr 8, 2009
464
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New Jersey USA
correspondence with ElectrikBlue:
How do you justify your claims? All you have is FDA registration as an ENT inhaler, and its not legitimate as related to your claims. I'll be filing a complaint with the FDA. You're giving the industry a bad name at a time when it can do permanent damage.

Elektric Blue reply: Hence why we say medical device and not the cartridge. We are just trying to sell a product to help people stop smoking. This product will be regulated in the near future at no fault to me or you, just like nicotine water, gum, patch, etc… If you feel you must try to harm one of us out there, then I guess do what you need to do. That really isn’t a positive or nice thing to do as I would never wish ill will on anyone. It isn’t our company that is giving the industry a bad name. It is Lobbyists from the Tobacco Industry. This will be a regulated industry because of the nicotine in the cartridges, as we do have an application in for the nicotine cartridge also and expect an approval in less than a year.

My reply:
It's one thing to sell a device that may help smokers quit, but another to make claims that haven't (at least not yet!) been proven. This is a very sensitive issue for legislators, lobbyists and the FDA. The sad truth is manufacturers and suppliers making these claims without controlled studies are feeding into the prevailing 'anti' attitude, which may make approvals more difficult to obtain. Use of these unproven claims is one of the FDA's complaints with the e-cig industry. We have enough to deal with in a society with strong anti-anything-that-resembles-a-cigarette sentiment, compounded by Big Tobacco and Big Pharmaceutical lobbyists. We shouldn't also have to contend with manufacturers and suppliers amplifying the problem.

I don't wish you ill will, and hope you get your approval. But I believe that how you and others in the business handle yourselves at this point in time is critical to the industry's survival.
 

LaceyUnderall

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Dec 4, 2008
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USA and Canada
I just wanted to stop in and let everyone know that nycsublime girl has commented (not regarding the ECA's position, but Bloogs) and being on the board, she is aware, but I also have forwarded this thread onto the ECA for review.

With more and more suppliers showing up, making claims that are obviously not on the up and up... my concern too grows for how this looks on the industry and what can be done regarding suppliers making such claims who are not ECA members.
 
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