September 9th, 2010
06:42 PM ET

FDA warns E-cig makers on stop-smoking claims

Distributors of 5 types of electronic cigarettes have been warned by the Food and Drug Administration that their products are considered unapproved new drugs and in violation of the Food, Drug and Cosmetic Act.

The FDA sent warning letters E-Cig Technology, Inc of Las Vegas, Nevada;  Gamucci America, Jacksonville, Florida; E-CigaretteDirect, LLC of Parker, Colorado; Johnson Creek Enterprises, LLC, Jackson Creek, Wisconsin; and Ruyan America Inc, of Minneapolis, Minnesota.

The letter reads in part: "Any product that bears labeling claims that it helps stop or reduce the cigarette urge, helps stop or reduce smoking, or similar claims is a smoking deterrent drug product."

"Products that are labeled, represented, or promoted as smoking deterrents, such as the electronic cigarette and cigar products marketed by your firm, are regarded as new drugs," the FDA letter continues.

The Electronic Cigarette Association also was alerted by the FDA.  It was told the devices need to go through the agency's new drug application process. The first step in that process is to file an investigational new drug application, which would require manufacturers to provide data on animal studies and even human clinical trials.

The companies were given 15 days to notify the FDA in writing what corrective actions they plan to take.

Keith King, sales manager for E-CigaretteDirect, said his  company would comply. "It's really unclear whether the FDA has any jurisdiction over electronic cigarettes. We do not promote the electronic cigarette as a stop smoking aid, but the FDA has misinterpreted some of the material on our website. We are going to have to meet their request and make some changes to our website."

Ruyan America president William Bartkowski said his company hadn't offered a nicotine product in the United States in more than a year. "We will promptly respond to the FDA."

soundoff (138 Responses)
  1. Penn Mason

    I use e-cigarettes everyday,. They helped me quit nasty tobaco for good! I wish the FDA would embrace this product is helping millions. If your looking make sure you look here http://www.smokepower.com

    October 14, 2010 at 07:23 | Report abuse | Reply
    • qst

      A recent survey found that 90% of e-cigarette users actually feel better! That is truly very encouraging!

      November 5, 2012 at 21:49 | Report abuse |
  2. tim

    it is just so funny how everyone talks about how tobacco kills and no one should be able to smoke but what about all the deaths from drinking, drinking and driving and pretty much everything to do with alcohol. I have know people that smoked til they died of natural causes so not everyone is going to die because they smoked. And if you have never smoked you have no idea how hard it is to quit and anything new to try and help us quit fda approved or not we will try seeing as the stuff that is approved does not work.

    October 20, 2010 at 16:58 | Report abuse | Reply
  3. Melissa

    I don't care if you smoke or not. We all have our vices. Even if you don't smoke you are still killing yourself and your family with processed food. Watch the movie Food Inc. and see what you are eating from the 4 main companies that produce all the food in America. It's a lot worse than second hand smoke. Fix them and yourself while we try to stop smoking.

    October 21, 2010 at 16:59 | Report abuse | Reply
  4. Jin

    Is FDA in bed with Big Tobacco? E-cigarettes offer an immediate benefit to millions of smokers by being an alternative to what is no doubt the biggest ill of our society - SMOKING. While E-cigarettes still deliver Nicotine to users, they do so without the 4,000 or so of other harmful chemicals found in your regular cigarettes. To blindly demonize E-cigarettes is to denounce a product that can potentially save countless lives of existing smokers. I have quit smoking regular cigarettes about a month ago when I discovered e-cigarettes and have regained the benefits of healthier "me." It's been over 20 years since I felt what it was like to breathe freely and to actually feel healthy and alive. I plan on giving up all forms of nicotine, including my e-cigarettes, and it would have been much tougher without this remarkable product.

    If it was this easy for me to "quit" smoking (normal cigarettes), I would imagine that the Big Tobacco companies AND the government are both losing sleep these days. Bankruptcy and lost tax-revenue can easily scare people into doing desperate things - like the FDA siding with tobacco companies. Get real, people. If you want to ban e-cigarettes, then why not simply ban ALL cigarettes everywhere (and lose the sin-tax in the process). Maybe the addiction to free money (from sin-tax) is more powerful than any addiction to cigarettes... yeah, that's it.

    January 19, 2011 at 19:52 | Report abuse | Reply
  5. StupidMyself

    As the child of two smokers, who happens to be allergic to nicotine, I'm glad there is an alternative. I've watched my father try fruitlessly to give up the habit. Every attempt has ended in failure. In some cases the side effects he experienced were terrible. I have friends that work in the same area as I work who have the product, and I haven't had a headache, my eyes haven't swollen shut, I don't feel like someone is holding a pillow over my head. I would hate to see this new product banned, especially with all the testimonies from smokers who have used it to stop.

    I haven't read every response here, but I would be interested in knowing what is exhaled. If there are any independent studies on the byproduct produced by these devices, I would be interested in knowing about them.

    February 9, 2011 at 18:32 | Report abuse | Reply
  6. SillyDebate

    I would just like to specify the misuse of the terms "right" and "choice". It's not your "right" to smoke. It's your choice. It is not my choice to breath in toxic carcinogens produced from your burning cigarette. "Rights" refer to race, ethnicity and religion. "Choice" refers to you knowingly polluting my lungs, and worse, children's lungs. Wake up to the reality people. Tobacco causes more deaths per year than AIDS, fires, car accidents, heroine, homicides, suicide, cocaine and alcohol COMBINED. That's a fact.

    February 22, 2011 at 11:22 | Report abuse | Reply
  7. gee

    not combined but close enough.

    March 23, 2011 at 10:04 | Report abuse | Reply
  8. Ian Juddy

    A look at the next year Blu-ray participants coming from kenmore and also Philips. Their email list regarding players can have 3d capability, Wi-Fi, DLNA plus more revolutionary functions that will increase ...SmokeStik

    January 12, 2012 at 19:07 | Report abuse | Reply
  9. Pablo Bernardo Rosa

    ... Lighting it and then the actual process itself of smoking the cigarette are all part... For our reviews of 3 of... Print this article E-mail to a friend...white cloud cigarettes

    January 14, 2012 at 13:00 | Report abuse | Reply
  10. Bruces

    I was a heavy smoker before, FDA didn't warn me on tobacco cigarette. I had switched to e-cigarette when my friend recommend me . E-cig is healthier than tobacco cigarette. Although there is unknown data, but I believe it is cleaner than nasty tobacco. I order stuff on http://www.novocig.com for 1 year and I really feel healthy everyday.

    August 2, 2012 at 04:56 | Report abuse | Reply
  11. Micheal

    After all this time and the FDA is still trying to monitor e cigs. Sources say in 2013 April they will introduce further regulation.

    April 8, 2013 at 06:40 | Report abuse | Reply
  12. Micheal

    After all this time and the FDA is still trying to monitor e cigs. Sources say in 2013 April they will introduce further regulation.

    April 8, 2013 at 06:41 | Report abuse | Reply
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