M401 fda aprroved claim by smoore

[Palestine]

they are claiming to me that they are FDA approved as a medical device please people what does this site mean


PLEASE EMAIL ME FOR THE FDA LINK I CAN NOT POST ON HERE FOR SOME STUIPED REASON

 

[wegster]

PM me the link in the next 30 or so mins and I'll happily post it for you, although this sounds...odd.

 

[wegster]

Here we go, here's the link:
Establshment Registration & Device Listing

 

[wegster]

Huh, it does indeed to be 'the' Smoore, but...no reference to what specific device is registered, nor if this is actually an 'approval for anything'?

haven't dug further yet, but it's possible it's just a record of the FDA being aware of Smoore as a company, and may even be a 'hold' versus an approval of any sort?

Did anyone try contacting the US FDA contact listed on that link to clarify?

Sure would be nice if it's an 'approved medical device e-cig,' though. (possibly depending on the 'new price' if so..)

 

[happily]

it seems SCHENZEN is affililiated with either central trade or dekang..........I'll look

dekang is located in the city of schenzen.........my bad

 

[willsgirlie]

I deleted it ..

 

[yvilla]

It looks like this may be a case of "registration" indeed, but that does not equate to "approval". See this explanation on the FDA site:

Device Registration and Listing

Johnson Creek is also "registered" with the FDA, but not "approved".

This is not to say that Smoore may not be going through the process and trying for actual approval as a new device - they may well be making that attempt. I hope they are and good luck to them if so!

 

[happily]

It looks like this may be a case of "registration" indeed, but that does not equate to "approval". See this explanation on the FDA site:

Device Registration and Listing

Johnson Creek is also "registered" with the FDA, but not "approved".

This is not to say that Smoore may not be going through the process and trying for actual approval as a new device - they may well be making that attempt. I hope they are and good luck to them if so!

they are affiliated with alibaba.......can anyone clarify because I have always been under the impression that the FDA does not ever approve an item. They simply register it if it does as it claims

my guess is these people went at this from the right angle, as a disposable(or other) to not make claims that were unacceptable

 

[Zaxx]

I've also wondered if the fact that they are dropping 36mg is a concession that is being offered to the FDA.

 

[happily]

I've also wondered if the fact that they are dropping 36mg is a concession that is being offered to the FDA.

most of the suppliers did in fact say we no longer carry 36mg as we are seeking approval of the fda

I think the cig suppliers simply need to not register as medical devices

 

[yvilla]

As to Smoore not being approved yet, here is a customs refusal from March 5, 2009, and the reason is given as "505(a), 801(a)(3); UNAPPROVED NEW DRUG"

Import Refusal Report=

 

[boxhead]

my dig into that site with a search at the site brought up holds on their products...hrmmm...yet at the web site for the companys products say FDA aproval...hrmmm...anybody?

 

[boxhead]

yeah same one yvilla, that i saw, there is one more also...

 

[klum]

The same FDA site from the link originally posted has a disclaimer:

This database includes establishment registration and device listing information current as of the last updated date shown at the bottom of this page. Firms who wish to modify, add, or delete information should log on to their FURLS account and make the appropriate changes. The changes will not appear in this database until it is updated again, usually around the fifth of each month. Registration of a device establishment or assignment of a registration number does not in any way denote approval of the establishment or its products. Listing of a medical device is not approval of the establishment or a device by FDA.

The last two sentences are the key. Registration does not mean approval. It may be the first step though. We'll see.

kevin