The U.S. Food and Drug Administration issued warning letters to five electronic cigarette distributors, saying the products are being marketed illegally as safer alternatives to smoking and even as smoking-cessation aids. In addition to making unsubstantiated claims, other violations include poor manufacturing practices.

Letters were sent to E-CigaretteDirect, Ruyan America, Gamucci America, E-Cig Technology and Johnson's Creek Enterprises. The FDA also sent a letter to the Electronic Cigarette Association, alerting the group that it intends to regulate electronic cigarette products to protect the public health. The FDA is already involved in a separate lawsuit with other e-cigarette companies that involves the agency's jurisdiction over the products, according to The Wall Street Journal.

Electronic cigarettes often look like cigarettes. They're designed to deliver nicotine or other substances in the form of a vapor, by heating a cartridge containing the substance. This vapor can then be inhaled. Cleverly, some e-cigarettes are made to look like everyday items such as pens and USB memory sticks, to avoid being noticed.

Just Smoke and Mirrors?

The FDA is concerned about the products' safety and effectiveness, especially in light of claims that e-cigarettes can safely help people quit smoking.

E-Cig Technology, for example, writes on its website: "Why choose E-Cig? . . . E-Cig can help you reduce or quit smoking habits." In the instruction manual it claims: "It can refresh the smokers and satisfy their smoking addiction, making them happy and relaxed, so as to relief [sic] the suffering of quitting smoking." All the companies that the FDA sent letters to make similar claims. But so far, none of the claims have been supported by any scientific evidence.

There is much that scientists and the public don't know about e-cigarettes, the FDA explains. "They are being promoted as a safe alternative to smoking, and we don't know that," says Dr. Janet Woodcock, director of the FDA Center of Drug Evaluation and Research in a video.

Other than impurities that could be dangerous, as well as cancer-causing chemicals already found in limited testing the FDA has conducted, another issue is delivering highly addictive nicotine to the body. Plus, e-smokes are readily available to teenagers because there are no age restrictions on their sale.

Experts from such organizations as the World Health Organization and the American Academy of Pediatrics Tobacco Consortium have previously raised similar concerns.

E-Cigs Must Seek FDA Approval

For a drug product to gain FDA approval, a company must demonstrate to the agency that the product is safe and effective for its intended use. The company must also demonstrate that manufacturing methods are adequate to preserve the strength, quality and purity of the product. At this point, the FDA says it doesn't believe that adequate quality controls have been put in place. For now, the companies have 15 days to respond. Depending on their response, the agency could act to remove the products from the market, but it would likely involve a court fight.

In 2006, U.S. consumers spent approximately $83.6 billion on cigarettes. Between 2000 and 2004, cigarette smoking was estimated to be responsible for $193 billion in annual health-related economic losses in the U.S. Cigarette smoking results in 5.1 million years of potential life lost in the U.S. annually. For those who want to quit smoking, the FDA suggests a number of FDA-approved smoking cessation aids.

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timix941@gmail.com

Dear Melly, Thank you for your article. I join the others who have commented. I add that in honor of 9-11, let's step back and attempt more perspective in yet another emotionally charged issue: The behavioral ideology of nicotine addiction. You did not mention the recent CDC report on American smoking: I believe that 46 million Americans continue to smoke, and that number has remained about the same for many years and so far is expected to do so. Why? I would conjecture it's that nicotine is a very, very powerful behavioral problem. The FDA is doing its job as best as it can. No effort is perfect. We're humans, not gods. The electronic cigarette was invented and brought to market several years after the national tobacco settlement. That timing is unfortunate. I believe we're witnessing the grind, shocks and jerks of a broken clutch in our socio-economic manual transmission. One or more of our senators or representatives must introduce legislation to modify the tobacco settlement for electronic cigarettes or any inhaler for nicotine to help nicotine addicts. The FDA needs guidance. The four-fifths of the people in the general population who have never been addicted to nicotine must show compassion for the one fifth who are struggling with this terrible problem. Do it in honor of the Native Americans who we mistreated upon the conquest of this continent. None of us will get out of this life alive, and so it doesn't make sense to adopt an immortal attitude toward people struggling with nicotine addiction. Bear in mind that tobacco smoke has a trace of a monoamine oxidase inhibitor that activates the nicotine dependency pathway that is not present in electronic cigarette liquids, something I haven't found mentioned in the debates. Isn't this electronic cigarette struggle an opportunity for people to adopt a more loving attitude to living in general? Another chance to act in hope, put fear behind? Thank you.

September 11 2010 at 2:18 PM Report abuse -1 rate up rate down Reply
Sharon

I think it is funny that the FDA has this mentallity that just because they say it is safe we are supposed to accept that. Look at all the drugs that have been recalled that the FDA said was safe and put their stamp of approval on them. I don't know anything about the e-cig other that what I have read. The problem the FDA has is they are not making money off of them.......

September 10 2010 at 2:39 PM Report abuse +1 rate up rate down Reply
Ron

I guess the main concern is, what's in the water vapor that's inhaled? Is it safe to utilize a delivery system and inhale additives/chemicals that were designed and manufactured to replace cigarettes? Have the additives/chemicals been tested and approved for safety? Evidently not. And you know who's going to end-up using this "replacement addictive alternative" to smoking........children, that's who. This E-Cig product should never have been released to the market- place without rigorous scrutiny, advance testing by the medical/scientific community, and authorization by the Food and Drug Administration. This isn't a free enterprise and capitalism issue, it's a public health and safety matter.

September 10 2010 at 1:35 PM Report abuse -1 rate up rate down Reply
2 replies to Ron's comment
nsarmento

So you also believe that nicotine patches, gum, lozenges, and NICOTINE INHALERS that ARE FDA approved should also be banned? In the water vapor, there is either vegetable or proplyene glycol (food grade) that is also used in inhalers for asmhatics, in various food products, and in coatings for medications. Then there is nicotine liquid, flavor and water. Compare that to the chemicals in tobacco and there IS NO QUESTION that e-cigs are a FAR SAFER ALTERNATIVE to tobacco. There is NO health or safety issue to the non-smoking public....because THERE IS NO SMOKE. I'm all for more testing and I'd even go for regulation and tax...but like someone else said, they'll have to pry my e-cig from my cold, dead hands if the FDA bans this perfectly GOOD device.

September 10 2010 at 1:48 PM Report abuse +1 rate up rate down Reply
nsarmento

And BTW, e-cigs fall under the SAME LAWS as tobacco...they cannot be sold to children. If any vendor DOES sell to a minor, they are subject to the same laws as a cigarette vendor who does the same thing because of the nicotine content.

September 10 2010 at 1:50 PM Report abuse +2 rate up rate down Reply
Truwriter

I always wonder why the FDA does not deal with the many weight loss scams, the herbal medicines, etc. If you record the commercial and stop it and watch on a big screen TV you can see the disclaimers for the products but you cannot read them any other way. Why does the FDA allow that to go on?

September 10 2010 at 1:20 PM Report abuse +3 rate up rate down Reply
JEANNETTE

I just started using e- cigarettes two days ago. I failed to quit with the patch- twice, and even chantix twice. As a matter of fact the chantix had me adverse effects. So, far this e-cig is great. I feel like I am smoking and I dont have the urge to run a buy a pack as I did with the other products. I use the 6mg - the lowest amount of nicotine. This cig.seems just like the patch, step down from nicotine withdrawel. What is there problem??

September 10 2010 at 1:11 PM Report abuse +1 rate up rate down Reply
lthrnck68

The only 100% safe cigarette is the one you don't smoke.

September 10 2010 at 12:57 PM Report abuse rate up rate down Reply
1 reply to lthrnck68's comment
nsarmento

Therefore, e-cigs are fine because you do NOT smoke them! THERE IS NO SMOKE PRODUCED FROM AN E-CIG.

September 10 2010 at 1:12 PM Report abuse rate up rate down Reply
Kookabird

If the FDA wants to protect the public health, why don't they do away with selling tobacco products ? I smoked cigarettes for 40 years and I tried everything the FDA has approved to quit. I finally got an E Cig and it has helped me quit smoking tobacco cigarettes for 1 year now at 0 nic. They will have to pry the e-cig from my dead cold hands as I never want to go back to smoking tobacco cigarettes.

September 10 2010 at 12:22 PM Report abuse +3 rate up rate down Reply
Richard

For e-cigs you can make your own liquid using: Water 10%, Flavoring 15%, vegetable glycerin (VG) used as an additive in thousands of food and drink products or propylene glycol (PG) 60% commonly use in many food products such as cake mixes as well as soft drinks and salad dressings and nicotine liquid 20% (lower dose or no nicotine). If I used the FDA approved nicotine patches or gum...I receive nicotine in my system. So I am assuming this is not the issue. The list of "599 additives approved by the US Government" for use in the manufacture of cigarettes submitted by the five major American cigarette companies to the Dept. of Health and Human Services in April of 1994 had long been kept a secret. Most e-cigs starter packs come with ready to use cartridges (in low to high dose nicotine or no nicotine). These cartridges are sold separately or you can buy separate bottles of liquid to replenish the cartridges. What is it that the FDA is trying to ban? Is it the e-cig itself or the cartridges (sold separately pre-soaked with liquid) or the liquid? I don't see that the e-cig on it's own should be the concern. If they want to test and approve the liquid that people put in it - then I don't have a problem with that. What I would have a problem with is the goverment placing an extreme tax on it - as they do on regular cigarettes.

September 10 2010 at 12:16 PM Report abuse +2 rate up rate down Reply
1 reply to Richard's comment
nsarmento

The FDA wants to ban both the delivery devices and the liquid. They have already begun siezing shipments of the e-cigs (the electronic devices) that come to the USA from China. Many distributors have had their shipments siezed and lost thousands of dollars. I do not understand WHY this is being done, as the devices without the liquid is useless. I do not mind one bit if the FDA wants to regulate the liquid or if they want to tax it....for me, it is STILL a far better alternative to smoking tobacco. But I believe their goal is an outright ban so they don't lose the big money from tobacco and pharm. companies.

September 10 2010 at 12:38 PM Report abuse +3 rate up rate down Reply
nsarmento

For folks who do not know what an e-cig is, here is an actual description (not the government mantra): E-cigs consist (in general) of a battery, an atomizer, and a cartridge. The cartridge contains a liquid that contains nicotine (although 0 nicotine liquid is available as well). Once the battery is turned on, it provides heat (NOT FIRE) to the atomizer. The atomizer heats the liquid in the cartridge, producing an oderless vapor when the user inhales. There is no fire, nothing is burning, no smelly tobacco smoke, no need for lighters, no threat of burning down your house or starting a forest fire, no stinky clothes, houses, and cars. So many benefits...and yet the fight is on because of MONEY.

September 10 2010 at 12:09 PM Report abuse +4 rate up rate down Reply
1 reply to nsarmento's comment
Richard

Could you please explain the ingredients which are used in the liquid to create the vapor produced by an e-cig.

September 10 2010 at 2:30 PM Report abuse rate up rate down Reply
suntanatoo

I have smoked for almost 50 years. I was smoking 2 to 2 1/2 cartons of an ultra light cigarette a week. I have tried numerous times and methods to quit smoking and was unsuccessful. In June I started with the electronic cigarette and have successfully quit smoking without so far gaining any side effects or weight. I am very impressed with the e-cigarette. It is a shame that a product that works is being scrutinized by the FDA.

September 10 2010 at 11:38 AM Report abuse +4 rate up rate down Reply