FDA approved ecig???

[Snarkyone]

Give people like this douchbag enough rope and they generally will hang themselves.

[Ryle]

https://esos.state.nv.us/SOSServices...YBgA%253d%253d

look at their financial information

and their "parent company" or whatever you'd like to call it (also the company the url is actually registered to)

looks like their Inc. registration has been revoked
https://esos.state.nv.us/SOSServices...kMtw%253d%253d

[ramblingrose]

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.

[Ryle]

I wonder how effective it would be if people started filling out ripoffreport.com reports on companies like this. I know ROR never removes a complaint from their site and it's very common for the report to show up right next to the company name on google if you type their name into the search.

[halopunker]

You know, I don't encourage anyone to make false claims. It sounds like he is another seller that jumped on the bandwagon and believed everything that the Chinese told him.
With ecigs, it seems that there is always a learning curve due to all the misinformation out there.

[TnA]

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 ), 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.

[ichaya]

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

• FDA Home >
• Medical Devices >
• Databases

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]

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.

[CJsKee]

I was just wondering if anyone with ECA has contacted this guy? Maybe he could be directed to their web site for information.

[LaceyUnderall]

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.