FDA Sued Over Electronic Cigarette Embargo

A Florida company that imports and distributes so-called electronic cigarettes filed suit yesterday against the Food and Drug Administration, claiming the agency is illegally blocking imports of its product into the United States.

The suit, filed by Smoking Everywhere in the U.S. District Court for the District of Columbia, argues that the FDA has overstepped its regulatory authority by banning shipments of the devices and insisting they need to go through the drug approval process.

Electronic cigarettes — often marketed as “e-cigarettes” — are a tobacco-free version of traditional smokes. Users inhale vaporized nicotine from a small, plastic tube that heats up with the help of a tiny battery. The whole contraption is designed to look and feel like a normal cigarette, minus the flame and smoke, and their makers market them as a risk-free way to get a nicotine buzz.

Smoking Everywhere’s lawyers from Thompson Hine point out that in 2000, the Supreme Court ruled that the FDA did not have the power to regulate ordinary cigarettes. Therefore, it shouldn’t be allowed to clamp down on their high tech counterparts, the lawyers argue.

“There are a series of laws and regulations pertaining to the advertising and distribution of regular cigarettes that we believe are more appropriate for this particular product, and those laws and regulations are largely administered by the Federal Trade Commission,” says Walt Linscott, an Atlanta-based partner at Thompson Hine.

Congress is currently considering the Family Smoking Prevention and Control Act, which would give the FDA explicit power to regulate cigarettes. Linscott notes that the law would probably give it the right to oversee e-cigarettes as well.

The case is being heard by Judge Richard Leon. The FDA did not return requests for comment.

Comments

[Jason Katzwinkel]

Recent Study Indicates That the FDA May Contain Trace Elements of Bos Taurus Egesta

"The U.S. Food and Drug Administration today announced that a laboratory analysis of electronic cigarette samples has found that they contain carcinogens and toxic chemicals such as diethylene glycol, an ingredient used in antifreeze."

Do you happen to have a beverage at your side? What is it? ... Wait, what? Are you serious? O'm'gawd, your drink contains an ingredient used in antifreeze! Yeah, that's right. Water. The term "... is an ingredient used in antifreeze" is the comestible, fear-mongering equivalent of "... then the terrorists win."

I must concede that diethylene glycol is indeed toxic. That much is true. But how toxic is it? It possesses one-tenth the toxicity of household aspirin, not to mention one-fortieth the toxicity of nicotine, the primary component in e-cigaratte vapor and administered in much higher doses. So why is the FDA focusing on diethylene glycol? Because if they told you that e-cigarettes contain trace amounts of aspirin and nicotine you'd stare blankly and shrug your shoulders. But when somebody starts throwing around a term like diethylene glycol, people pay attention because nobody knows what the hell it means and it doesn't sound like something you necessarily want a tall frosty mug of.

Or is it? Diethylene glycol is also an ingredient found in toothpaste, mouthwash, cough syrup, dog food, wine and cigars among plenty of other consumer products. Do you know what it is not an ingredient of? Antifreeze. Propylene glycol is used in antifreeze. Diethylene glycol is used in coolants. Let's get our scare tactics straight, shall we?

I'm reminded of city officials in Aliso Veijo, California who nearly proposed a ban on polystyrene containers because they heard that Styrofoam cups may contain dihydrogen monoxide, "a colorless, odorless chemical that is the primary component of acid rain and is lethal when inhaled." What is dihydrogen monoxide? H2O, more commonly referred to as water.

[Rookie]

I love that people freak out about ecigs and listen to to the news. Try reading the report yourself. Totally wicked has it. If you are going to complain against ecigs or for ecigs then get the facts first. Only the tobacco flavored cartridges had and cancer causing agents in them and everything else was clean. They said that some cartridges claiming to have no nicotine had nicotine in them but the report says none was detected. Read the report, get the facts, then do what you feel is right.

ps...It shows nicotine levels all over the place but doesnt state what the package says the nicotine levels for a high or low cartridge hold.

[James]

The FDA position is more about claims than the actual product. Although they lead the public to believe that they have regulatory control over nicotine, this is not necessarily the case. They do however have control over any health or quit smoking claims. This is where Smoking Everywhere may get into a bit of trouble. It is a good thing for the industry that Njoy has also entered the case as they seem to be free of any claims about healthier, safer, or quit smoking. For updates about this case you can visit my blog at http://www.e-cig.org

[Angela Muir]

I worked for a dermatologist in Birmingham AL who started distributing electronic cigarettes less than a week after I purchased mine. We purchase ours through Smoking Everywhere who (not 100% sure about this) is the only company that is receiving their shipments. I also talked to my primary doctor about these electronic cigarettes and he approves even though he doesn't know of any studies (in the US) that have been done. He says "it's got to be safer than smoking a traditional cigarette".

[Paul in PA]

As I see it... if the gov't gets 2/3 of the price of cigs as tax AND the FDA gets to cut the amount of nicotine per cig... a smoker will need more cigs and get to pay more tax.
MONEY MONEY MONEY

[Electric Mike]

I will make this as short as possible.

we have big pharma and big tobacco vs some small mostly online stores that sell e cigarettes in the US.

basically Money talks here, and there is lots of lobbying etc etc.

with that said... most of these stuff is made in China.... so.... they might have some sort of a point.

here is the bottom line.... I will take my chances with a Chinese made e cig vs a USA made cancer stick. If thats a problem... LETS bring production to the US... maybe big pharma and tobacco can even fund it. we make it here.. sell it here.. and collect taxes here... everyone WINS... and we move on. NO pun intended here.. but that would be thinking with a lot of REASON... and that will never happen.... so I will wait and see.....

Here is the website to the electronic cigarette association that is lobbying for e-cgarettes. http://www.ecassoc.org/

and here is a website where you can get the top of the line electronic cigarette.

http://www.electroniccigarettesource.com

[Dennis]

The F.D.A. won't let them through the borders because they're worried about lost tax revenue and are protecting the interest of pharmaceutical companies.

[Daniel Delarosa]

Clinical Trials
Clinical trials have now been carried out in New Zealand by Dr Murray Laugeson of Health New Zealand.
The test found that the E-Cigarette tested was:
"...very safe relative to cigarettes, and also safe in absolute terms on all measurements we have applied. Using micro-electronics it vaporizes, separately for each puff, very small quantities of nicotine dissolved in propylene glycol, two small well-known molecules with excellent safety profiles, – into a fine aerosol. Each puff contains one third to one half the nicotine in a tobacco cigarette’s puff. The cartridge liquid is tobacco-free and no combustion occurs."
Source: Safety Report by Health New Zealand (PDF)
Further research into electronic cigarettes continues to be carried out in New Zealand.

[George Walker]

Smoking Everywhere will lose this case because there arguments border on ridiculous. They claim they should be regulated like cigarettes, yet they do not pay the same taxes or fall under the scrutiny of the Dept. of Justice, BATF. They claim they should not be regulated by the FDA, but their main ingredient, propylene glycol, is regulated by the FDA in all of it's ingestiable forms.
If the electronic cigarette manufacturers had nothing to worry about, they would submit to FDA testing and then sue if the FDA did not honor the results.
And yes, as if it matters, I am a smoker.

[CJ Johnson]

Absolutely, keep fighting the good fight, SE. I am with you too. I don't want to lose this alternative. If drunks can change from beer to wine, and experience some increased heart health (or so we keep hearing) then why oh why can we smokers not step down the danger/inconvenience/environmental features of our addiction? I'm with you guys till the wheels fall off.

[Larry Miller]

Folks, tobacco cigarettes kill; nicotine does not (unless you eat a refrigerator full). Do not lose sight of that. There is no documented proof that the electronic cigarette (or personal vaporizer) has ever killed anyone, whereas, we can expect about 400,000 American smokers to die this year.

I fail to see the problem with a very small percentage of smokers to make an informed decision, as adults, to use a personal vaporizer for smoking cessation. As a user of a personal vaporizer, it has helped me to end a 30+ year addiction to tobacco. If you have never had an addiction or do not thoroughly understand the problem, anything I say below this sentance will likely fall on deaf ears.

Am I now addicted to another device, perhaps, but I am damn comfortable with my decision to inhale nicotine (think nicotine inhalers from drug companies) and theater fog (propylene glycol). I can control my nicotine intake, I have the option to gradually reducemy nicotine intake and will trust my body to tell me if I am doing something wrong or harmful. My other recourse was to continue to burn throusands of chemicals in tobacco while I wheeze and cough my way to death. I chose to make a change and the personal vaporizer provides significant harm reduction to my life.

Smoking cessation programs and products are a joke. The success rate 20 months out is less than 5%. This is a pretty dismal option for the tobacco smoker that wants to make lifestyle changes. If the Senate votes S. 982 into law, I will have lost whatever faith I had left in my government to protect me andmy right to choose. I will either have to use my vaporizer like a criminal on crack or return to smoking, which is what Altria would really like.

[Steven]

Good, post there I've smoked since I was 19 and very happy to be off the analog cigarettes. I love my electronic cigarette I feel healthier and noticed that I can actually smell things a again food tastes better to! I hope the FDA gets there just deserts and that this embargo stops!

[garrett moeller]

Lautenberg's main argument is that there are no clinical studies. Does anyone know of any studies that have been done already?

http://lautenberg.senate.gov/newsroom/record.cfm?id=310318

[Colleen Pridemore]

In response to Frances Boyde's earlier post: I went to http://www.be-smoke-free.com and the link to your survey doesn't work. But what a great site for product comparison and information!

Why all the concern about propylene glycol? It is used in the process of making regular tobacco cigarettes... So the FDA is full of crap -- the Big Tobacco and Drug Companies pay the FDA lots of money. Period.

[Frances Boyde]

I am a PhD Industrial Organizational Psychologist conducting the first research on 1000 electronic cigarette users to be sent to the FDA. I have been contracted by Be-Smoke-Free (who has all their inventory held by the FDA)to gather data and present a statistical analysis of any and all possible side effects felt by consumer. I need a random sample of 1000 e-cig users to log onto www.be-smoke-free.com and click on FDA survey. I will update regularly and publish the results using the format that FDA requires. We need to help Smoking Everywhere who has taken on a fight for all of us. Help gathering this data.

[Robert]

Regarding Sharon McEacherns comment:

Sharon, You really need to get your facts straight before posting recklessly like a loose canon on a ship at sea!
First, the non profits you speak of all get funding from pharmaceutical companies that want the e-cigs pulled off of shelves. The non-profits you speak of have not done any testing themselves and if they are truly saying this then they are just as you are throwing reckless words into the air like a spewing volcano.
Second, there has been scientific studies done, just not by the FDA.
Third, While inhaling nicotine is not good for your health you have to admit that inhaling an electronic cigarette which contains only nicotine and a food additive is a lot safer than inhaling nicotine, Benzene (petrol additive), Formaldehyde (embalming fluid), Ammonia (toilet cleaner), Acetone (nail polish remover), Tar, Carbon Monoxide, Arsenic (rat poison), Hydrogen Cyanide (gas chamber poison), plus thousands of other chemicals which regular cigarettes contain. Tell me, if you were a smoker which one would you rather smoke?
Fourth, I would like to see the proof of your claims that product-makers are committing fraud by using the WHO logo and name in advertising and packaging because I myself have not seen this. has anyone else?

Next time, watch what you say because this aint no Mr Rogers neighborhood! This is the real world!

Robert
invisismoke

[Sharon McEachern]

E-cigarettes are more than just suspect. Looks like they could be highly toxic. The American Cancer Society, Cancer Action Network, American Heart Assn. and American Lung Assn. -- all agree that electronic cigarettes should be pulled off the market.
Who should you trust -- nonprofits who've been around for decades and have earned respect or new for-profits trying to sell a product?

The World Health Organization says e-cigs may be highly poisonous and that the product-makers are committing fraud by using the WHO logo and name in advertising and packaging.

The makers of electronic cigarettes claim that they are safe but have absolutely no scientific studies to back up their claims. No evidence. No proof. Just their word: "Believe us, so we can make money."

Ethic Soup posted an excellent article on the subject at:

http://www.ethicsoup.com/2009/03/hey-hey-fda-whaddaya-say-are-ecigarettes-safe-eh.html

The cost of stopping your cigarette habit does not have to be breathing toxic poisons into your lungs from a pretend cigarette!

[amber]

sign the PETITION! WE MUST BE HEARD!!!!

http://www.e-cigarette-usa.com/Life_Saving_eCigarette.html

What UNEDUCATED people say about the
e-cigarette...
“Until this is approved by the FDA and proven to be safe, I would not in my right mind promote or encourage use of these products."

I am glad people out there have so much faith in our Government and FDA. I mean just think about all the other wonderful things they have already deemed "healthy" for us. Take rBGH for example. If you don't know what it is... LOOK IT UP or ASK A COW! That shit is being pumped into us Americans like sewage water and the FDA is WELL AWARE what it does to animals and what it will do to humans!
My point...! There are many products not approved by the FDA. MANY vitamins and supplements that may or may not be "healthy" but it is up to the consumer to have that choice whether or not they want to try or buy something not approved by the FDA.
Did the FDA ask us...? " hey fellow Americans look what happened to this cow after we injected it full of recombinant bovine growth hormone would you mind if we inject ALL of our farm stock with this horrible hormone and billions of antibiotics so we can keep them alive long enough to suck the very last drop milk and life out of them?... Then feed the rotten, poison left over meat to you as well?" NO! They never thought about us then so why take a product that OBVIOUSLY has already HELPED so many. I think we all know why. It’s all about what they can tax and "regulate".
Fine.
Figure out a way to tax e-cigs. But DONT DARE take a product that has helped so many Americans QUIT smoking and offer a healthier life style. As far as marketing the e-cig as a way to get around laws and being able to "smoke everywhere" That may be the name of some of the BIG distributors but that is NOT their message. They sell their product as a means to help people QUIT! The name is just a catchy title. Give it up. Let people have their freedom of choice!

[Nerdovision]

This is great news! I am an electronic cigarette distributor I currently have shipments being held by the FDA at customs. If anyone knows how I can help please contact me.

cheers,
robert
invisismoke

[Steve Miller]

FDA is a sham, working with the Tobacco and Pharma, lobbyists. I have been tobacco free for the first time in 40 years. 6 months without smoking a kool cigarette. I have stopped using Advair, and Albuterol. Feel great, breath great, lost weight, and vape at will. The Electronic Cigarette is a Miracle Product. Shame on the FDA, trying to kill us with Tobacco, Chantrix, welbutron, et.

I started smoking at 9, yeah, great job, policing tobacco. Nicotine, does NOT cause cancer, and studies show it is less harmful than Caffeine.

[WR Morris]

Thank you for starting the ball rolling. Hopefully we can get the rest of the distributors to join in, if needed. I pray not, let's just hope that the FDA sees 'the light' and backs off this insane practice of preventing us e-smokers the right to live free of the harmful effects of tobacco.
Thank you SE
Dr Morris

[Avi L.]

Help Us Keep Electronic Cigarettes On The Market!

ACTION NEEDED!!!!

Senator Lautenberg wants the FDA to completely Ban Electronic Cigarettes!
We need your VOICE!!! Sign The Petition To SAVE e-cigarettes
http://www.e-cigarette-usa.com/Life_Saving_eCigarette.html

[Rick Bar]

It seems that the only people benefiting from the FDA's involvement are the Tobacco and Drug companies. These companies stand to make a lot more forcing people to continue smoking regular cigarettes than if smokers were given a less expensive and less harmful way to continue with their habits. The irony of it all is that the FDA's motto is, "Protecting and Promoting Your Health". Wouldn't you think that if the FDA's wings were clipped by the Supreme Court over regulating regular cigarettes that they would be happy to promote a product that would be the healthier alternative to regular cigarettes by the sheer fact that you are only inhaling nicotine instead of the numerous other harmful chemicals that ordinary cigarettes produce. Further more the e-cigarette can also come with no nicotine. In not smelling smoke or cigarettes here but something real fishy instead.

[Sue]

I'm rooting for smoking everywhere. Although I have never personally tried their products, I use e-cigarettes every day. I do not smoke real cigarettes anymore and I only use my e-cig sometimes...not prolifically like I did with real cigarettes. I feel so much better. If the FDA bans then, I won't be able to get my fix and will turn back to cigarettes...my point...these things save lives! Even my doctors approve of my method.

[Rick Smith]

Good for the folks at Smoking Everywhere. It's high time a company stood up for the rights of Americans. Leave it up to the gov't., and we will only have one right, the right to PAY taxes. This is all a ploy for more taxes, which will be levied on the e cig and juice. What a fine establishment the fda is, they should be ashamed. They need to spend more time inspecting peanuts and red meat, not to mention chantix. Remember people, this is the same office that's supposed to keep us safe. The e cig is no different than nicotine gum or patches. If they want to ban something that is harmful, start with chantix, then move to tobacco.

[julia clarke]

Well done SE and i hope you win your case something needs to be done to stop e-cigs from being banned world wide they are saving hundreds if not thousands of lives

Jules
UK

[Kevin Brock]

This should have a very interesting outcome. Interesting to note about the FDA not having jurisdiction over cigarettes, so surely the same would (should) apply in this instance too...

[RB]

Go SE!!!