Fda To Regulate E-Cigs As Tobacco Products

[Christopher]

By MICHAEL FELBERBAUM AP Tobacco Writer

RICHMOND, Va. April 25, 2011 (AP)

The Food and Drug Administration said Monday it plans to regulate smokeless electronic cigarettes as tobacco products and won't try to regulate them under stricter rules for drug-delivery devices.

The federal agency said in a letter to stakeholders Monday that it intends to propose rule changes to treat e-cigarettes the same traditional cigarettes and other tobacco products.

The news is considered a victory for makers and distributors of the devices, which continue to gain popularity worldwide.

E-cigarettes are plastic and metal devices that heat a liquid nicotine solution in a disposable cartridge, creating vapor that the "smoker" inhales. A tiny light on the tip even glows like a real cigarette.

Users and distributors say e-cigarettes address both the nicotine addiction and the behavioral aspects of smoking — the holding of the cigarette, the puffing, seeing the smoke come out and the hand motion — without the more than 4,000 chemicals found in cigarettes.

First marketed overseas in 2002, e-cigarettes didn't become easily available in the U.S. until late 2006. Now, the industry has grown from the thousands of users in 2006 to several million worldwide, with tens of thousands new e-smokers every week.

No timeline has been set on the proposed rule changes.

The FDA said e-cigarettes could still be regulated as drugs or drug-delivery devices if they are "marketed for therapeutic purposes," — for example, as a stop-smoking aid.

Jason Healy, president of e-cigarette maker Blu Cigs, called the news a good first step, but said the pending rule changes will be more beneficial for "weeding out the shady companies."

Right now, "you can potentially sell snake oil," Healy said.

Nearly 46 million Americans smoke cigarettes. About 40 percent try to quit each year, according to the Centers for Disease Control and Prevention. But unlike nicotine patches or gums, e-smokes have operated in a legal gray area.

The FDA lost a court case last year after trying to treat e-cigarettes as drug-delivery devices, rather than tobacco products, because e-cigarettes heat nicotine extracted from tobacco. It had until Monday to appeal to the U.S. Supreme Court.

In December, a federal appeals court ruled electronic cigarettes should be regulated as tobacco products by the FDA rather than as drug-delivery devices, which have more stringent requirements such as expensive clinical trials to prove the products are safe and effective as a stop-smoking aid.

Some sellers of e-cigarettes sued the FDA in 2009 after the agency told 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.

Last September, the FDA issued warning letters to several makers of electronic cigarettes or its components, saying the companies are violating the law with unsubstantiated health claims and poor manufacturing practices.

The FDA also had said that its tests found the liquid in some electronic cigarettes contained toxic substances — besides nicotine, which is itself toxic in large doses — as well as carcinogens that occur naturally in tobacco. Most e-cigarettes are imported from overseas.

However, some public health experts say the level of those carcinogens was comparable to those found in nicotine replacement therapy, because the nicotine in all of the products is extracted from tobacco.

http://abcnews.go.com/Business/wireStory?id=13453151

*****

In short, this is great news - for now - essentially the FDA publicly announced that it is conceding to Njoy's victory in the lawsuit, and will NOT be filing a petition for review by the Supreme Court.

I'm sure there are other battles ahead, particularly what type of regulation they will conjure up. My guess is it's going to be very strict and the strong will survive the weak. I have no doubt the FDA will start targeting small operation liquid makers. Doesn't mean they'll be closed down, just mean they may have to setup facilities following strict FDA guidelines. (Which for the consumer is a good thing)

Regardless for now, this is good news.

Thanks to Mark for being the first one to make me aware this was in the press today.

[Beans]

That's great news, but I wonder when they will start taxing them like cigs.

[Christopher]

That's something that will be left up to the states to decide. The FDA cannot impose a tax.

[ThaLadyD]

YAY!

[Beans]

Well as broke as all the states are, I suppose we won't go un noticed much longer. But it also means I can stop hoarding now lol.

Edited April 25, 2011 by Beans

[Christopher]

Here is another article from the WSJ

http://online.wsj.com/article/BT-CO-20110425-707817.html

By Stephanie Gleason

Of DOW JONES NEWSWIRES

WASHINGTON (Dow Jones)--The Food and Drug Administration said Monday it won't appeal a federal court decision and will regulate electronic cigarettes as tobacco products.

The FDA wanted to regulate electronic cigarettes as drug devices, just as nicotine gum and smoking cessation products are regulated. Electronic cigarettes are battery-powered tubes that turn nicotine-laced liquid into a vapor.

However, a decision in January by the U.S. Court of Appeals for the D.C. Circuit stated the FDA instead should regulate electronic cigarettes as tobacco products, not as drug devices. Regulation as drug devices would have required e-cigarettes to go through a pre-market approval process.

The FDA, in a statement, said "The government has decided not to seek further review of this decision, and FDA will comply with the jurisdictional lines established by (the circuit court decision.)"

Monday was the deadline for the FDA to try to appeal the decision to the Supreme Court.

Regulated as tobacco products, e-cigarettes can't be marketed with other FDA-regulated products such as food, cosmetics, medical devices or dietary supplements. They will be subject to registration requirements, ingredient listing, good manufacturing practices and user fees, among other regulations.

[ripple]

This is a good first step, but as you note, the devil is always in the details and in this case in the regulations they end up proposing.

It is likely that production regulations and licensing of the producers of e-liquid are to follow and that could drive up the cost significantly as do most regulatory efforts.

For now its a positive first step for the FDA to stop fighting a battle they seem to have little basis to fight but where they go next should be closely watched.

[Christopher]

For now its a positive first step for the FDA to stop fighting a battle they seem to have little basis to fight but where they go next should be closely watched.

I couldn't agree more. We're already making adjustments. Our new liquid bottles have to contain an ingredient list. Something I don't think is a bad idea. What other regulations the FDA comes up with though have peeked suppliers curiosity.

[Brian]

So, if they intend to regulate them like tobacco, that could possibly be the end of internet/mail-order sales?

[johns]

So, if they intend to regulate them like tobacco, that could possibly be the end of internet/mail-order sales?

I was smilin till you said that.

[Natas]

not only that but I can see big money hungry

companies trying to get their piece of the pie smh !!

[Christopher]

So, if they intend to regulate them like tobacco, that could possibly be the end of internet/mail-order sales?

This indeed very possible and something we're looking into. Though the FDA will regulate ecigs as tobacco they will not have the same laws. Most of those requirments are not set in place by the FDA. We will have to fight state and federal regulation and that account. I have no doubt Big Tobacco may lobby for this. Unless of course they jump on the ecig bandwagon themselves.

[bizzyb0t]

A minor victory but a victory nonetheless. However, we must wait and see how the regulatory process will affect the market. I suspect the pharmaceutical conglomerate's lobbyists will be making some more frantic bids to squash e-cigs...

[JangoFett]

I have a friend who works for the FDA. He says they "gave up on those ecigs a long time ago"

Hopefully he's right.

[Phaseman66]

What about the bans already in place or proposed bans? Will proposed bans be dropped by individual states?

Could a ban on using one in public places happen? Since flavored tobacco products aren't allowed anymore, what about juice?

Such a soap opera for people to merely have a choice in their own lives.

Nanny state anyone?

Edited April 25, 2011 by Phaseman66

[Christopher]

Nanny state no doubt. It will be interesting to see this roller coaster ride unfold. The states should reverse the bans as the FDA now has regulations set in place but the laws would still need to be appealed.

[Jeffb]

I wonder what this means for Internet sales? You can't buy cigs online (legally )

[rwoodin]

Hooray for now!

Keep a watchful eye on what the FDA/Pharma/AntiSmoke/Big Tobacco vested interests try next. I'm sure all the motivations for money, power, control and zealous crusades are still there.

Advocate, Advocate, Advocate. The vaping community has made a difference by standing up for truth in the face of smear tactics, fear campaigns and coordinated spin campaigns designed to outlaw ecigarettes.

The FDA announcement is certainly good news!

[Sharon]

They will be subject to registration requirements, ingredient listing, good manufacturing practices and user fees, among other regulations.

This is going to affect everyone involved with e-cigs across the board. Even though it is a victory and the consumers will be more safeguarded from vendors suppling substandard products, it is going to drive prices higher and force some "Mom n Pop" vendors out of business. I agree with Beans. I am sure the individual states are already working their calculators over time regarding future tax revenue. I guess I am just being pessimistic!

[Christopher]

I love this part right here..back tracking are we?

The FDA also had said that its tests found the liquid in some electronic cigarettes contained toxic substances -- besides nicotine, which is itself toxic in large doses -- as well as carcinogens that occur naturally in tobacco. Most e-cigarettes are imported from overseas.

However, some public health experts say the level of those carcinogens was comparable to those found in nicotine replacement therapy, because the nicotine in all of the products is extracted from tobacco.

[jcamacho]

I agree prices will go up but at least e cigs won't be banned or classified as drug delivery devices. I wonder how hard it would be to get a prescription for an e cig?

[smokerevolutionusa]

Excellent news! As we know this is not over but what just happened is a HUGE step.

Congratulations to all people in the vaping community!

[Sharon]

I agree prices will go up but at least e cigs won't be banned or classified as drug delivery devices. I wonder how hard it would be to get a prescription for an e cig?

Hey JC, no problem! I'll print one right up for you from my word processing software. Would you like for me to fax that to your local pharmacy. LOL

[steeldragon]

I have a feeling this ruling is going to make for some interesting times. I also feel that this could be thorn in the smaller businesses. At the same token, it could cause a lot to clean up their acts. Being of a suspicious nature makes you wonder about Phillip Morris trying to get in the act of e-cig right before this ruling. Things that make you go hmmmm

Paul

[PADave]

Definitely a step in the right direction, but oh what a long and winding journey it will probably be. IMHO this will probably affect juice more than the hardware. If suppliers simply sell batteries, atomizers, and cartridges as separate pieces, couldn't that circumvent the e-cig designation? Juice I certainly see as becoming hugely regulated (and thus more expensive) but hopefully many suppliers can ride out the storm. I also forsee the day the 'juice underground' will arrive as an under the radar trading post for smaller suppliers. Just my thoughts, but at least we should be able to continue to get our vape on!