FDA Acts Against 5 Electronic Cigarette Distributors

[PurKat]

FDA Acts Against 5 Electronic Cigarette Distributors
http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm225224.htm

Sept. 9, 2010

The companies receiving warning letters today are: E-CigaretteDirect LLC, Ruyan America Inc., Gamucci America (Smokey Bayou Inc.), E-Cig Technology Inc. and Johnson’s Creek Enterprises LLC.

E-CigaretteDirect, LLC Warning Letters
E-CigaretteDirect, LLC 9/8/10


Ruyan America, Inc. WARNING LETTER
Ruyan America, Inc. 9/8/10


Gamucci WARNING LETTER
Gamucci 9/8/10


E-Cig Technology Inc. WARNING LETTER
E-Cig Technology Inc.


Johnson Creek Enterprises, LLC WARNING LETTER
Johnson Creek Enterprises, LLC 9/8/10


FDA is telling them, they have to file a New Drug Application to sell E-cigs in the USA.

 

[cozzicon]

Well, I've read all this material.

Of course the FDA is going to act in this manner. If any of the retailers react as if it's a drug, they can walk into court saying- "See they admit it's a drug".

This is standard manipulation during a court case. Nothing new here.

I'll be willing to bet this action gets attention during oral arguments of the court case.

 

[PurKat]

Well, I've read all this material.

Of course the FDA is going to act in this manner. If any of the retailers react as if it's a drug, they can walk into court saying- "See they admit it's a drug".

This is standard manipulation during a court case. Nothing new here.

I'll be willing to bet this action gets attention during oral arguments of the court case.

I would like to see some consistency in juice strength and other ingredients. It worries me when reports show there is a discrepancy in strength verse what the label says.

 

[trying]

THE key point of these FDA letters is the FDA wants to require a full NDA ( Nation Drug Application) and not the much simplier and cheaper ANDA ( Abbreviated Nation Drug Application).
That way they can say they are not going to ban E-cigarettes, yet doing so since the FDA relizes that none of the current E-cigarette companies has the 10's of millions of dollars for an NDA nor the finacial resources to wait at least 5 years for the NDA to be completed.

 

[trying]

If the FDA is going to demand NDA's there is no way that simply changing or eliminating claims will satisfy the FDA.
The only company I see surviving this is Ruyan America with their herbal supplement RAPP. The FDA standards for nicotine approval are just to expensive and time consuming
for any current e-cigarette company to meet.

 

[PurKat]

If the FDA is going to demand NDA's there is no way that simply changing or eliminating claims will satisfy the FDA.
The only company I see surviving this is Ruyan America with their herbal supplement RAPP. The FDA standards for nicotine approval are just to expensive and time consuming
for any current e-cigarette company to meet.

Herbal Supplement is another area, that FDA is trying to take control over. Plus many people are allergic to Herbal products. Maybe the E-cig could survive, if they took the Nicotine out of it, and just left the flavors of tobacco and ect. That way people could still use them to stop smoking, without the Nicotine ingredient. Just a thought.

 

[ad356]

some of us like inhaling nicotine. its a personal choice and so should be the inhalation method. i do not want to see them remove the nicotine, it would render it completely ineffective and many would simply return to cigarettes. nicotine is a prime component of the habit of smoking and to remove it will make it useless. of course, this may be exactly what they want.

if they are going to remove the nicotine from the e cig lets remove it from the patch and gum as well. its no different

 

[PurKat]

some of us like inhaling nicotine. its a personal choice and so should be the inhalation method. i do not want to see them remove the nicotine, it would render it completely ineffective and many would simply return to cigarettes. nicotine is a prime component of the habit of smoking and to remove it will make it useless. of course, this may be exactly what they want.

if they are going to remove the nicotine from the e cig lets remove it from the patch and gum as well. its no different

You make a very good point. I feel for the E-cig to be a more effective means, of quitting smoking, that the Nicotine Levels do need to be regulated, so we know exactly how much we are inhaling. According to the FDA, the samples they examined, did not have the level of Nicotine content, as the label stated. Even the juices that were suppose to be zero Nicotine content still had Nicotine in them, and that is not right! Someone who just wanted to vape, and never smoke cigarrets, could become addicted, without even knowing it. So something needs to be done, in regulating the Nicotine content in the juices, so we can trust what the labels say.