FDA Loses Appeal, Can’t Regulate E-Cigarettes as Drug

http://www.businessweek.com/news/2010-12-07/fda-loses-appeal-can-t-regulate-e-cigarettes-as-drug.html

23 comments ↓

#1 01outside on 12.07.10 at 2:54 PM

Unfortunately there is a huge difference between avoiding an FDA ban and a safe and effective E-cigarette that is available to the public.

First E-cigarette manufacturers must prove what is a “safe” amount of inhaled nicotine.
FDA will counter wih years and millions of dollars worth of clinical testing that shows, in FDA’s opinion, that 4mg of inhaled nicotine is an Rx level.

Can a sub-4mg E-cigarette be efffective?
Even that question will only come after FDA required safety test is completed and some level of tobacco tax is applied.

Not banned but a tough road ahead…………

#2 jersey boy on 12.07.10 at 3:05 PM

YEAH BUT WHERE ARE ALL THOSE THAT SAID THE PRODUCT WOULD BE BANNED! HEY OTP KID LOOKS LIKE BILLY BOY WINS! WHAT YOU GOT TO SAY NOW???

#3 01outside on 12.07.10 at 6:09 PM

Jersey Boy – best to find out how the ruling is defined, because thanks to Congress and it’s giving tobacco to FDA, the nanny state now can set the nicotine content of tobacco as low as it wants just so long as it is not zero.

#4 Bill Godshall on 12.09.10 at 2:17 PM

The DC Court of Appeals decision is at:
http://www.casaa.org/files/ct%20app%20opinion%20on%20injunction.pdf

#5 Bill Godshall on 12.11.10 at 3:26 PM

Court Rejects FDA Bid To Regulate Nicotine Products Outside Tobacco Law

By Alaina Busch
FDA Week
December 9, 2010

A federal appeals court ruled that nicotine products, including electronic cigarettes, are to be regulated as tobacco, reaffirming previous decisions while going against recent FDA actions to regulate the products as drugs and devices. While opponents of the decision are raising safety concerns saying it will lead to an uptick in nicotine items and be detrimental to public health, some anti-smoking advocates have long pushed for the products to be regulated as tobacco, not requiring safety and efficacy data, to keep them on the market for former smokers who rely on them as cessation aids.

One opponent of the decision, which reaffirmed that FDA cannot ban electronic cigarette imports, equated the ruling to the creation of a “wild west” of nicotine products, while a longtime anti-smoking advocate lauded it as a public health victory saying FDA’s attempt to strictly regulate the products has bolstered the tobacco industry.

The U.S. Court of Appeals for the District of Columbia Circuit on Tuesday (Dec. 7) affirmed a January ruling that tobacco-derived products are subject to the Family Smoking Prevention and Tobacco Control Act, which brought tobacco under FDA’s power in 2009.

The ruling comes three months after FDA announced that it would regulate the products as drugs and devices under the Food, Drug and Cosmetic Act, requiring safety and efficacy studies. The agency sent letters to five distributors and a trade group announcing its intentions. The distributors received warning letters for making unsubstantiated claims and poor manufacturing practices (see FDA Week, Sept. 10).

Citing FDA v. Brown & Williamson Tobacco Corp., a Supreme Court case that denied FDA’s efforts to regulate cigarettes as a drug-device combination in the 1990s, the court ruled that the tobacco law that has since passed further established that other tobacco products cannot be regulated as such either.

“To the extent that Congress believed Brown & Williamson left an insufficiently regulative environment for cigarettes, smokeless tobacco, cigars, and other tobacco products, it found the Tobacco Act an adequate remedy,” according to the court decision, written by Circuit Judge Stephen Williams.

A federal judge had previously ruled that electronic cigarettes are not drug-device combinations and FDA could not block their shipment. The agency had been taking action against the products since 2008 (see FDA Week, Jan. 22).

Groups like Campaign for Tobacco-Free Kids said the decision will lead an unsafe level of nicotine in products. The group’s president, Matthew Myers, said the ruling will have harmful implications for public health.

“While the court found that the FDA could regulate electronic cigarettes as tobacco products, it will take the FDA time to assert jurisdiction over these products and issue regulations governing them, leaving these products unregulated in the meantime,” he said in a statement. “This ruling invites the creation of a wild west of products containing highly addictive nicotine, an alarming prospect for public health.”

Other anti-smoking advocates, like Smokefree Pennsylvania, have lauded the decision as a public health victory. The group, in addition to the Washington Legal Foundation, filed an amicus curae brief on behalf of Sottera, Inc., the company listed in the lawsuit. The American Association of Public Health Physicians has also filed citizen petitions requesting the agency reclassify electronic cigarettes as tobacco products.

Bill Godshall, executive director of Smokefree Pennsylvania, said FDA’s move to strictly regulate the products, which are mostly used by former smokers, has bolstered the tobacco industry because the most harmful products are still on the market. The majority of the e-cigarette companies, he said, were not making therapeutic claims, which would have made them subject to stricter regulations.

By reclassifying the products as tobacco, the 2009 tobacco law allows for safety monitors, he said. Quality concerns about the products, which are primarily imported, were cited when FDA announced its regulatory plans earlier this year.

“A lot of these things people are claiming are problems with the products can be resolved,” Godshall said. The Tobacco Control Act would give FDA power to regulate health claims and require manufacturer registration as well as laboratory analyses of the products.

Depending on whether FDA appeals the decision, he said he expects tobacco companies to get into the product’s market. Other nicotine products that had previously been banned, like lollipops, water and skin cream, will likely resurface, he said. “And that’s good because these are all far less hazardous tobacco alternative products,” he said.

The ruling comes as a collaborative study on the safety of electronic cigarettes was released by Legacy, Georgetown University School of Medicine and Johns Hopkins Bloomberg School of Public Health. After an analysis of several electronic cigarette brands, researchers found that there was no consistency in the delivery of nicotine, suggesting poor quality controls.

Nathan Cobb, a researcher at Schroeder Institute for Tobacco Research and Policy Studies at Legacy, said the poor standards present a new set of risks associated with e-cigarettes. “These devices and accessories present a new and wholly different set of risks apart from those of tobacco, including the real risk of inadvertent nicotine overdose,” Cobb said in a release. “The variation in design and poor quality control emphasizes that they should not be on the market until and unless regulation to ensure device safety has been established.”

#6 jersey boy on 12.12.10 at 3:14 AM

So here is the next challenge for these e-cig companies.

Philip Morris & Reynolds America!!!!!

Good luck!

#7 jersey boy on 12.12.10 at 3:15 AM

hey otp kid cat got your tongue!!!!

#8 OTP Kid on 12.14.10 at 6:36 PM

Please see my previous comments Jersey Boy. I believe you are looking at this ruling the exact opposite way as you should be. This ruling is no “free lunch” to the ecig companies. In fact, what the ruling DID SAY is that they can regulate it as a tobacco product – note the word regulate them. So what does that mean, we will see. But it would mean they would have to have approved packaging, they could institure a minimum of 20 per pack (expensive), they could require list of ingredients, along with warnings.

Ask Kretek about what regulating tobacco means!

#9 OTP Kid on 12.15.10 at 11:26 AM

Never doubt me, ever, Jersey Boy!

KING COUNTY, Wash. – Washington state has had a law banning pipes, cigarettes and cigars in public places since 2006. Now, King County would like to expand that ban to include electronic cigarettes, the Seattle Post Intelligencer reports.

Even though proponents of e-cigs point out that the devices only emit a smoke-free mist, public health officials worry that e-cigarettes look too much like the real tobacco products and could make it harder to enforce the current law.

“The idea is that even though they’re not exactly identical to cigarettes, people see folks using e-cigarettes, and they think somebody else is smoking,” said Bud Nicola, a King County Board of Health member. “It makes it very difficult for inspectors.”

Nicola pointed out that the devices attract the interest of teenagers. “These are something that can potentially get kids hooked on nicotine. … E-cigarettes have a high appeal to youth. They come in candy flavors,” he said

#10 texas tommy on 12.20.10 at 11:30 PM

saw today that the fda is not quitting and is going to fight this

#11 OTP Kid on 12.21.10 at 2:08 PM

By DAVID KESMODEL
The Food and Drug Administration, dealt a blow this month in its effort to regulate electronic cigarettes as drug devices, isn’t walking away from the fight.

The agency on Monday filed a petition to ask the entire U.S. Court of Appeals for the District of Columbia Circuit to hold a new hearing and review the FDA’s appeal, which was rejected Dec. 7 by a three-judge panel.

At issue is how the FDA should regulate a nascent industry whose products have caught on with thousands of smokers who are seeking an alternative to their daily habit. E-cigarettes are battery-powered tubes that turn nicotine-filled liquid into a vapor mist.

The appellate panel ruled that e-cigarettes should be regulated as tobacco products by the FDA, unless marketers make specific claims that the devices help smokers quit or provide other remedies.

The agency contends that e-cigarettes are drug or medical devices that require preapproval from the FDA, much like nicotine gums, patches or sprays. The agency began intercepting shipments of e-cigarettes from China two years ago, which triggered a lawsuit by the fledgling industry.

Sottera Inc., an Arizona e-cigarette distributor that joined the lawsuit as a plaintiff and some of its rivals say their products are merely recreational alternatives to cigarettes and that they haven’t marketed them as tools to wean people off nicotine. The industry’s annual sales are estimated at more than $100 million.

The appeals panel upheld a January ruling by a district judge, who granted a preliminary injunction to the e-cigarette distributors who sued the FDA.

On Monday, the agency asked the full appellate court to reinstate a stay of the preliminary injunction, pending its request for a rehearing of the case.

In its court papers, the FDA argues that the three-judge panel’s decision “rests on a clear error of law and will undermine” objectives that were laid out by Congress when it passed legislation in 2009 that empowered the FDA to regulate tobacco products for the first time.

#12 texas tommy on 12.22.10 at 8:50 PM

The FDA just has nothing better to do. I mean come on how do they think this will work out. They are just trying to save their asses on a whim!

They are making a very big mistake! Just go regulate them. Tax them! FDA – you ever think what the FDA stands for? ……. dumb …..

#13 James on 12.28.10 at 3:35 PM

I’m glad they lost the appeal. Since quitting smoking and switching over to e-cigarettes and snus, I have felt so much better. I can breath without coughing again!

#14 Copenhagen Charlie on 12.30.10 at 4:03 PM

The FDA is grandstanding as usual. If your goal is to save lifes than stop fighting a product that is possibly a game changer. OH maybe that’s it. Wouldn’t want to upset Big Pharma and Altria.

#15 fireguy on 01.12.11 at 11:37 AM

New news on the e-cigg.
Looks like they said “hey USA take care of the FDA bit and o by the way………..”

Chinese electronic cigarette manufacturer and marketer Dragonite International Limited (formerly Ruyan Group Holdings), which trades on the Hong Kong Stock Exchange and was the first company to develop the battery-powered alternative nicotine delivery device in 2004, announced that it will file a patent infringement lawsuit on January 13th in a Los Angeles court in California against all major e-cigarette manufacturers and distributors in the US. (South China Morning Post 01/12

#16 Joe on 01.12.11 at 1:23 PM

Pretty interesting. Been waiting for this to happen. Very interesting. Just read the entire release and it’s obvious they did their homework!

#17 Candy Girl on 01.12.11 at 3:26 PM

“. . .will file a patent infringement lawsuit on January 13th in a Los Angeles court in California against all major e-cigarette manufacturers and distributors in the US.”

Patent litigation not likely to have near term impact on importation of non-Dragonite/Ruyan product, but it could influence certain distributors and retailers. Most won’t want to get stuck in the middle of what is usually lengthy and difficult litigation.

#18 Texas Tommy on 01.13.11 at 1:42 AM

I had read recently in a magazine that this possibly would be an issue in the future. It was a good article. I recall a wholesaler saying they were not worried about this but from what i know about these suits they really do need to be concerned. Any idea which major manufacturers will feel the sting?

#19 01outside on 01.13.11 at 1:44 AM

WOW !!! That’s a big deal……
Isn’t Ruyan 3 and 0 in patent cases so far………

#20 Vapor Vixen on 01.14.11 at 1:53 AM

I found this to be very informative –

The company’s patent application for the “electronic atomisation cigarette” was recently approved by the US Patent and Trademark Office and covers all the main components, including the battery, vaporisation mechanism, activation switch and flavour cartridge

#21 Vapor Vixen on 01.25.11 at 12:33 AM

And the FDA loses AGAIN!!!!!

#22 Candy Girl on 01.25.11 at 11:45 AM

COURT OF APPEALS AGAIN DENIES FDA

by David Kesmodel and from THE WALL STREET JOURNAL

The fledgling electronic-cigarette industry scored another victory against the Food and Drug Administration in federal court Monday, potentially setting the stage for the battery-powered devices to be regulated like conventional tobacco products.

The U.S. Court of Appeals for the District of Columbia Circuit rejected the FDA’s request to have the entire court review a December decision by a three-judge panel that went against the agency.

The FDA, which contends that the products should be regulated as drug devices, now has the option of asking the U.S. Supreme Court to take up the case. An FDA spokesman said Monday that the agency is evaluating the latest court ruling “and considering its legal and regulatory options.”

E-cigarettes are battery-powered tubes that turn nicotine-laced liquid into a vapor mist. The devices have caught on with thousands of smokers who want an alternative to their daily habit, leading to annual industry revenue of at least $100 million.

On Dec. 7, a three-judge D.C. appeals panel ruled that e-cigarettes, which are sold online and in malls, should be regulated as tobacco products by the FDA unless marketers make claims that the devices help smokers quit or provide other remedies.

The agency has argued that e-cigarettes are drug or medical devices that require pre-approval from theFDA, much like nicotine gums, patches or sprays. The agency began intercepting shipments of e-cigarettes from China in 2008, prompting a lawsuit from the industry.

Sottera Inc., an Arizona e-cigarette distributor that joined the suit as a plaintiff, and some other e-cigarette purveyors say their products are simply recreational alternatives to cigarettes and should not be subject to the onerous pre-approval process required of quit-smoking aids.

The agency has regulated nicotine-replacement products for years and gained authority to regulate the production and marketing of cigarettes and other tobacco prodcuts for the first time in 2009. If the government decided to regulate e-cigarettes as tobacco products, manufacturers would still face significant regulations, but it would be easier to bring the devices into the market.

“We are very pleased with the court’s decision not to rehear the case,” Gregory Garre, an attorney who represents Sottera, said in an email Monday. “The fact that the full court unanimously declined the government’s rehearing request underscores the force of the panel’s original decision.”

The appeals court Monday also refused to reinstate a stay of a preliminary injunction that was granted to the e-cigarette distributors by a U.S. district-court judge in January 2010. The injunction blocked the agency from intercepting their product shipments from China.

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#23 01outside on 01.26.11 at 8:09 PM

the New York E-cigarette ban progress is getting more media attention.
Most likely because it is now were as the FDA court case will like drag on and on.

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