In a warning letter to the Electronic Cigarette Association, the Food and Drug Administration (FDA) announced it intends to regulate electronic cigarettes as drugs.
Most disturbing to the FDA was the fact that at least five electronic cigarette makers were claiming that use of their products would help users quit smoking regular cigarettes. Under the Food Drug and Cosmetics Act, companies cannot claim that their products are effective in treating diseases, like nicotine addiction, unless those claims have been proven. "Yet all five companies claim without FDA review of relevant evidence that the products help users quit smoking cigarettes," stated the FDA.
Electronic cigarettes are products designed to deliver nicotine or other substances to the user in the form of a vapor. Typically, they are composed of a rechargeable, battery-operated heating element, a replaceable cartridge that may contain nicotine or other chemicals, and an atomizer that, when heated, converts the contents of the cartridge into a vapor. This vapor can then be inhaled by the user.
Typical claims of the "curative" powers of electronic cigarettes cited by the FDA included, "If you've tried the patch, gum and other methods that haven't worked for you, try the electronic cigarette," and "E-cigarettes Reducing 400,000 American Deaths per year to 10,000."
The FDA also found that some of the manufacturers were including other drugs in their electronic cigarettes without FDA approval. The drugs included tadalafil, an erectile dysfunction drug, and rimonabant, a weight loss drug not approved for use in the United States.
The companies receiving FDA warning letters were: E-CigaretteDirect LLC, Ruyan America Inc., Gamucci America (Smokey Bayou Inc.), E-Cig Technology Inc. and Johnson's Creek Enterprises LLC.
As early as July 2009, the FDA announced that it had determined that electronic cigarettes contained cancer-causing toxic chemicals such as diethylene glycol, an ingredient used in antifreeze.
Also See:
Electronic Cigarettes Worry FDA
The Politics of Smoking: Menthol Cigarettes
FDA Further Restricts Tobacco Sales
Comments
This just shows how STUPID the U.S. GOVERMENT really is. They want people to quit smoking, but don’t want them to use something that will help them stop. Maybe they fear the tax money they will lose if people quit. Before they try to stop the common citizen from smoking, they need to work on our great President who buys his with our tax dollars. WHEN HE QUITS, I’LL QUIT!!
This sort of idiocy is why the FDA is trusted less than the IRS.
A preliminary ruling from the federal court in January informed the FDA in no uncertain terms that it had overstepped its boundaries with e-cigarettes and ought to regulate them as tobacco products.
The FDA’s insistence that e-cigarettes be classified as a drug delivery device is what’s keeping them unregulated. Even unregulated, however, in the 7 years e-cigarettes have been on the market–with around a million former smokers using them in the U.S. now–there have been no reported serious adverse effects.
Can the FDA say the same for Chantix? (More than 10,000 adverse events and more than 350 deaths so far, yet FDA leaves it on the market.)
The FDA can bite me. I’ve been using an e-cigarette since March of 2009 instead of traditional cigarettes. I’m not treating an illness any more than I was when I smoked. If e-cigarettes are a drug delivery device, then so are Marlboros. Will we be seeing an FDA-approved Marlboro any time soon?
The drug companies must have complained about the competition and the politicians about tax revenue.
It’s about money and not health!
It is probably both. I am also always complaining about several mindless decisions made by the US or EU regulating agencies and I also think that there is a strong pressure from the pharma companies to do so.
On the other side, the “money thing” is not only an important goal for the big pharma, but also for the sellers of (just as an example) E-cigarettes. So they have their reasons to make exaggerated claims, which are not really always true. Nicotine on itself is not totally harmless, diabetes and blood pressure, just to mention.
I believe that inhaling a few ingredients in vapor form is a lot less harmful than inhaling smoke from burning tobacco leaves with thousands of harmful chemicals. Unfortunately, I’m sure that governments see this as a threat to tobacco tax collection, which has lead to the trend of banning sales in certain states. The government doesn’t always look out for the people’s best interest, but often times the revenue to support their paycheks. If they were really worried about our health, tobacco would have been banned already.
Gimme that axe, Ima fuhk somebody up!
I keep seeing the statement that diethylene glycol is in antifreeze, as an argument that it is somehow dangerous. Water is also an ingredient in antifreeze, so by this logic is water also dangerous? Diethylene glycol is also in many toothpastes and a large number of food products, all approved by FDA.
The FDA is a unconstitutional agency of the federal government to begin with! The Feds are freaked out about the tax money they are loosing and the big tobacco companies are freaked out about loosing customers. The e-cigarette culture is still in is infancy. I just bought my first e-cigarette 7 days ago, after smoking for 12 years and guess what? My pulse and blood pressure are back to normal, I can smell and taste again, and best of all, no tar, smell, ashes, or cigg butts anymore!!! My teeth are finally turning white again! Yep I am e-cigarette customer for life. FDA – how about we elect a president that will have guts enough to abolish you, and leave what you do to the state governments? How much money would that save the federal government? billions a year? You’ve already lost this battle FDA! Good Bye!!
So if the electronic cigarette is supposed to be considered a drug delivery device, does that mean that my coffee cup will soon be regulated by the FDA?
Sorry had more to say. I think we the people should have our say given back to us. We should VOTE on what should be legal and illegal. We should VOTE on every law made, instead of having government officials that can be paid off under the table be the ones that determine our laws.
Voting is the way back to where we can have our choices back. I know it sounds idiotic and unreal. But I have a vision of a government for the people, by the people, not a government for the people with the most money.
Thank God for the electronic cig! The FDA needs to focus on bad eggs in Iowa. We do not trust an agency that is unable to recognize the first real solution that helps people QUIT SMOKING!!! These are so much better than that stupid patch. It takes private industry to make such an innovative product. Government would never endorse anything that actually helped people stop smoking. Tobacco is still big business in the US. Think of the people’s lives these electronic cigarettes are saving. No second hand smoke, no tar, no carbon…. Wake UP FDA.
The FDA are MURDERERS. WAKE UP. FIGHT BACK.
Very interesting article and very interesting comments from everyone! I’ve been contemplating on trying e-cigarettes for a while now but have been so curious as to why the public has not been more informed about something that seems like such a revelation in the fight to quit smoking. I have literally wondered all the things you all have commented on…how much would a product like this (especially if it’s proven an effective method to get people off cigarettes) affect the tobacco industry as well as the government’s tax collection from tobacco products? Does everything have to revert back to some sort of hidden agenda or conspiracy? Perhaps in today’s American society…more so than not! In all of the FDA’s reports that I’ve found about e-cigarettes, they all mention that these products would likely influence and encourage kids to START smoking real cigarettes over their being used as a tool to help people QUIT smoking. But yet, no evidence was cited as to why or how this could happen. I think I’m going to just go for it and try the e-cigarette. I appreciated everyone’s insight into this topic
one more thing…check out Dr. Vapor on youtube (not the marijuana guys – unless that’s what you’re looking for – HA). The post in which he critiques Rachel Ray is pretty informative. He’s a little corny but I definitely got a few giggles out of his posts, along with some great info and clarity on e-cigs!
I only hope that the FDA will take this issue seriously and complete the necessary studies. The people here in Kentucky and everywhere deserve a safe alternative! It isn’t easy to quit something that has been an addiction for many years for many people. Now that we have a safer alternative, of course it will have insurmountable controversy associated with it! To those that are trying to reduce their smoking habit or quit all together, I highly recommend trying any of the reputable e-cig companies out there. You don’t have to spend a fortune to try an electronic cigarette. I first tried what is called a disposable e-cig from http://www.vaporconcepts.com and after being impressed, I ordered a starter kit and haven’t looked back since.
Totally! I have been a smoker my entire adult life. I tried to quit, but electronic cigarettes were the definite ‘right’ move for me.
Started using SmokeTip brand e cigarettes on 1/1/11. Haven’t had a single cigarette since. Because our socialist government want’s to regulate (tax) EVERY aspect of our lives, they will regulate (TAX) e cigs as well. Government does NOT want you to quit smoking because the make big money off of every pack of cigarettes you buy. They want you to die before 65 so they won’t have to pay social security. Now that we are finding e cigs to be a comfortable smoking alternative, the gov’t feels threatened by this and will tax e cigs to compansate for the lost taxes on standard cigarettes. By the way, if you don’t know this by now, Obama…that is President Obama, SMOKES…MENTHOLS !!!!!!
It’s not diethylene glycol that makes up the base of the ejuice it’s propylene glycol and vegetable glycerin, and propylene glycol is recognized by the FDA as generally safe to consume and handle, it is in many other product’s that we eat and use every day. As far as I have seen all sales are only allowed to 18 yrs and up, just like tobacco.