FDA sends warning letters to e-cigarette companies

Infernal

Infernal

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FDA sends warning letters to e-cigarette companies
By MICHAEL FELBERBAUM (AP) – 2 days ago
RICHMOND, Va. — The Food and Drug Administration is lighting a fire under the electronic cigarette industry to work with the agency to legally market the devices and is cautioning other companies that their sales and manufacturing practices violate federal law.
The FDA said Thursday it sent warning letters to five companies that make e-cigarettes or components for the plastic and metal devices that heat a liquid nicotine solution in a disposable cartridge, creating vapor that the "smoker" inhales.
In the letters, the FDA said the companies are violating the Federal Food, Drug and Cosmetic Act, including unsubstantiated claims and poor manufacturing practices.
One of the companies, Las Vegas-based E-Cig Technology Inc., the agency said, is even selling liquid forms of erectile dysfunction and weight loss drugs that can be used in an e-cigarette. The FDA is asking the companies to let the agency know within 15 business days how it plans to correct the violations.
The other companies receiving warning letters are: E-CigaretteDirect LLC of Colorado; Ruyan America Inc. in Minneapolis; Florida-based Gamucci America; and Wisconsin-based Johnson Creek Enterprises LLC.
But in a letter to the Electronic Cigarette Association, the FDA said the actions against the companies were not meant to be seen as a larger effort to ban e-cigs. The agency encouraged the industry group to work with the FDA to ensure the safety and effectiveness of the devices to help people quit smoking traditional cigarettes through usually expensive clinical trials.
"We are interested in finding out whether e-cigarettes can be proven safe and effective," FDA compliance lawyer Michael Levy said in a conference call.
Levy added that there are several FDA-approved smoking cessation aids available on the market and the agency is working with several some manufacturers for approval as a drug-delivery device, but did not provide further details.
Representatives with the Electronic Cigarette Association and the companies issued warning letters did not immediately return messages seeking comment.
The battery-powered electronic cigarettes have become the center of a fight over how risky they are compared with traditional smokes, whether they're legal and, if they are, how they should be regulated.
The FDA and public health groups have sounded the alarm, saying they contain dangerous chemicals and are being marketed to children, and the federal agency has halted shipments of e-cigarettes at ports nationwide.
Some sellers of e-cigarettes sued the FDA last year after the agency instructed customs officials to refuse entry of shipments into the U.S. A federal judge ruled that the FDA can't stop those shipments, saying the agency had overstepped its authority. The FDA appealed, and won a stay of that ruling, pending oral arguments that are set to begin later this month.
The FDA would not comment on how Thursday's actions relate to the pending lawsuit.
While the FDA claims it has the authority to regulate e-cigarettes as drug-delivery devices, some sellers contend the products should be regulated as a tobacco product, which would follow the same restrictions as traditional cigarettes and tobacco products.
First marketed worldwide in 2002 as an alternative to regular cigarettes, e-cigarettes didn't become easily available in the U.S. until late 2006.
Now, the industry has grown from the thousands in 2006 to several million worldwide, with estimated 20,000 to 30,000 new e-smokers every week, according to Jason Healy, the president of e-cig maker Blu Cigs, which was not among the companies sent warning letters.
Copyright © 2010 The Associated Press. All rights reserved.
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Seems the FDA is up to its tricks again in the e-cigarette business approaching it from the standpoint e-cigarette as "a drug delivery device."
 
these people are making insane claims though. completely unsubstantiated claims.
 
Infernal said:
Link

Seems the FDA is up to its tricks again in the e-cigarette business approaching it from the standpoint e-cigarette as "a drug delivery device."
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So very true.







They are sick of people getting off of traditional tabacco, small chinese comanies manking money. All the while americans, who's health is the number 1 priority...have to stoop to those "sub par standard e cig factory cigarettes" - real wholesome American tobacco. We know what conditions the tobacco had been growing in, and each filter is checked twice.

I support this decision.
 
Infernal said:
Seems the FDA is up to its tricks again in the e-cigarette business approaching it from the standpoint e-cigarette as "a drug delivery device."
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It delivers nicotine (and perhaps other chemicals) through inhalation, does it not?

I don't know much about these devices, other than to know that my own State's DOJ initiated such action many months ago.
From what I understand, seems like any other nicotine product (patch, gum, etc) ... tobacco-less tobacco, essentially.
As I am not a fan of nerve toxins I am rather impartial.
 
the government's selfishness never ceases to amaze me. not only will they sacrifice their people's health by selling cigarettes and profiting off of our pain and suffering, but'they'll sacrifice our chances to recover or switch to an alternative because the other companies might profit off of something they have no control over...

so what do they do? ban the fuckin' things, or gain some sort of seniority in the companies so they can profit themselves.
 
SilverFeniks said:
It delivers nicotine (and perhaps other chemicals) through inhalation, does it not?

I don't know much about these devices, other than to know that my own State's DOJ initiated such action many months ago.
From what I understand, seems like any other nicotine product (patch, gum, etc) ... tobacco-less tobacco, essentially.
As I am not a fan of nerve toxins I am rather impartial.
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The basic "science"(for lack of a better term) behind the E Cigarette is that a liquid form of nicotine is inhaled as a water vapor hit. The liquid nicotine solution is said to be free from tar and an array of carcinogens that are present in tobacco. I am very interested in this subject as I am placing my order for a custom design Electronic Cigarette from Cigarti later today.

Here is some basic information on the Cigarti brand that I chose,after Googling the top 10 E-cig companies on several sites as an outline for my personal research.

http://www.cigarti.com/jApp/index.jsp?inc=42&lang=en

I hope that as news develops on this subject that I will have 1st hand experience to weigh along the facts and contributing a more apropos reply.

I will,however,say that after the FDA banned flavored tobacco and cigars last year, I would not be surprised to see the FDA placing this product under a microscope,keeping close tabs and up to date criticism on the budding E-Cig industry. I still find myself shocked that at age 34 I cannot purchase a pack of clove cigarettes. Luckily most flavored tobacco companies turned there now banned cigarettes into a legal cigar version and so I have gotten by on well enough. I look forward to the benefits I that I believe the E-Cig possesses.
 
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