FDA thinks e-cigarettes may be an unapproved drug

The FDA appears to be trying to halt distribution of so called e-cigarettes by curbing imports.

The makers of the cigarettes, which are white with a brown filter and tip that glows red, say the cigarettes are safe because they don’t contain tar or other chemicals. They do, however, contain liquid nicotine.

A major distributor of electronic cigarettes compared the cigarettes to a nicotine patch. “There are no ingredients in our e-cigs that can cause cancer. However, it is a pretty new product, so we are not 100 percent sure of the side effects at this point,”

The World Health Organization has called for clinical studies and toxicity analysis to determine the safety of the cigarettes.

23 comments ↓

#1 FDAGuru on 03.18.09 at 6:09 AM

Yes, FDA has always treated nicotine (qua nicotine and as distinct from nicotine contained in tobacco as a drug)… That means if you want to sell nicotine as a product, you need there approval. FDA 101.

#2 Bill Godshall on 03.18.09 at 11:56 AM

Perhaps FDAGuru can reveal which drug company he/she is funded by.

If the FDA bans e-cigarettes, the ensuing headlines and editorials (e.g. “FDA tells smokers to drop dead” “FDA bans least hazardous nicotine products, but can’t ban cigarettes” should help efforts to amend Waxman’s tobacco bill with sound tobacco harm reduction product and policy amendments that protect public health instead of Big Pharma’s profits.

It should also be interesting to see what Ms. Sebelious (appointed to head DHHS) Drs. Hamburg and Sharfstein (appointed to head FDA) say (during their confirmation process) about FDA’s tobacco/nicotine harm reduction policy.

#3 FDAGuru on 03.18.09 at 7:12 PM

Bill, I don’t question your personal motives — I am merely trying to describe FDA’s stance relative to unapproved drug products. Personally, I think the harm reduction movement is a great thing. I think the low tsna smokeless products are a great thing. But, you have to realize that nicotine is viewed as a drug by FDA and you’ll spend many, many years trying to persuade the FDA otherwise. Once they see it (because they see it) as a drug, they want to regulate it like they regulate other drugs.

I am merely arguing that people who think the e-cigarette is going to be a commercial success are betting on the wrong horse…. FDA will pull product, like Australia has and China is in the process of doing.

Sorry!

#4 Bill Godshall on 03.24.09 at 9:40 AM

Sen. Lautenberg wants to snuff out electronic cigarettes

By Jordy Yager
The Hill
03/23/09
http://thehill.com/leading-the-news/sen.-lautenberg-wants-to-snuff-out-electronic-cigarettes-2009-03-23.html

Sen. Frank Lautenberg (D-N.J.) wants to ban a smoking device that several House Republicans have trumpeted for helping them quit smoking.

The battery-operated device, known as an electronic cigarette, looks like a normal cigarette, but contains no tobacco and instead of smoke emits a nicotine vapor when the user inhales. Reps. Cliff Stearns (R-Fla.), Duncan Hunter (R-Calif.) and Collin Peterson (D-Minn.) have all been spotted using the device on Capitol Hill.

But the device, which is sold over the Internet and at select mall kiosks, needs to be tested by the Food and Drug Administration (FDA) before it is deemed safe for general use, Lautenberg wrote in a letter to the FDA on Monday.

“Manufacturers and retailers of these products claim that e-cigarettes are safe, and even that these products can help smokers quit traditional cigarettes,” he wrote.

“However, there have been no clinical studies to prove these products are effective at helping smokers quit, nor have any studies verified the safety of these products or their long-term health effects.”

Stearns shot back at Lautenberg on Monday, saying that there is no evidence that the device is harmful.

“Before the FDA takes any immediate action, it should put forward scientific evidence that these products are harmful or unsafe,” he said in a statement.

“These e-cigarettes are smokeless and do not produce carcinogens. The nicotine in e-cigarettes is controlled in a capsule that can help in smoking cessation by allowing the user to reduce gradually the nicotine level, hopefully to zero.”

Stearns has sent electronic cigarettes to House Minority Leader John Boehner (R-Ohio) and President Obama to help them quit smoking. He’s been seen using the device in the Speaker’s Lobby, where Speaker Nancy Pelosi (D-Calif.) banned smoking two years ago. Her office did not respond to a request for comment by press time.

A longtime opponent of smoking, Lautenberg authored the law that banned smoking on airplanes and a law that banned smoking in federal facilities that serve children.

#5 Adrian on 03.25.09 at 12:53 PM

American Cancer Society Action Network, ALA, CFTFK and AHA also want to snuff out e-cigarettes

http://news.prnewswire.com/DisplayReleaseContent.aspx?ACCT=104&STORY=/www/story/03-24-2009/0004993931&EDATE=

Statement of the American Cancer Society Cancer Action Network,
American Heart Association, American Lung Association and the Campaign for
Tobacco-Free Kids

WASHINGTON, March 24 /PRNewswire-USNewswire/ — The American
Cancer Society Cancer Action Network, the American Heart Association, the
American Lung Association and the Campaign for Tobacco-Free Kids applaud
Senator Frank Lautenberg of New Jersey’s call for the Food and Drug
Administration to exert its authority and immediately remove e-cigarettes
from the market.

FDA officials have been quoted numerous times in many
publications during the past few weeks saying that e-cigarettes are “new
drugs,” which require prior approval from the FDA before they are allowed to
be sold. Without this approval, e-cigarettes are illegal to market or sell.
Despite these statements, no action has been taken to remove e-cigarettes
from the market.

Currently, e-cigarettes are being sold in 62 kiosks at malls
across the United States, with plans to expand to another 55. E-cigarettes
are also being marketed towards young people, who can purchase them in fruit
flavors and online, without having to verify their ages.

Makers and retailers of these products have been making unproven
health claims about their products, claiming that they are safer than normal
cigarettes and asserting that they can help people to quit smoking. Absent
scientific evidence, these claims are in blatant violation of FDA rules.

In fact, no studies have been done on e-cigarettes to date
regarding their health effects or their effectiveness as cessation aids.
Like the “light” and “low tar” cigarettes that tobacco companies claimed
were healthier for consumers, there is no evidence to back up the claims
made by e-cigarette makers. In September of 2008, the World Health
Organization stated that they have “no evidence to confirm the product’s
safety or efficacy.”

Our organizations thank Senator Lautenberg for his leadership in
urging the FDA to remove these products from the market and echo his call
that the FDA move quickly to remove these products from the marketplace.

While the FDA currently does not have jurisdiction over tobacco
products, it does have jurisdiction over other products that contain
nicotine including e-cigarettes, which have been marketed as delivering
nicotine without tobacco.

SOURCE American Lung Association

#6 Adrian on 03.27.09 at 2:51 PM

In the latest twist to the e-cigarette debate, Health Canada has advised Canadians not to use electronic cigarettes (see: http://www.hc-sc.gc.ca/ahc-asc/media/advisories-avis/_2009/2009_53-eng.php). According to their press release, ‘Persons importing, advertising or selling electronic cigarette products in Canada must stop doing so immediately. Health Canada is providing information to interested stakeholders on how to apply for the appropriate market authorizations and establishment licences’

One wonders what those smokers who might have switched to e-cigarettes are supposed to do in the meantime – go back to smoking cigarettes???

#7 FDAGuru on 03.27.09 at 8:06 PM

Australia and Canada both have american-style regulatory agencies…. In many respects they are more on the ball than the US FDA… Please note, I am not advocating a ban of the e-cigarette — merely predicting US FDA will follow the lead of Canada and Australia (you’ll even see it banned in China imo) irrespective of whether Congress specifically bans the e-cigarette.

#8 jancascascade on 03.27.09 at 10:41 PM

Government can ban them but people will get them anyway. The Genie is out of the bottle and smokers have an alternative to smoking and paying the ever increasing taxes on cigarettes.

The best thing the government can do is leave them on the market and allow people to have them as an alternative to smoking tobacco cigarettes.

#9 jancascascade on 03.29.09 at 12:10 AM

This certainly puts the politicians and anti tobacco cartel between a rock & a hard spot

http://www.associatedcontent.com/article/1601882/doctor_tells_sen_lautenburg_cancel.html?cat=3

#10 TAZ on 03.31.09 at 2:52 AM

Chair of Tobacco Control Group Asks Senator to Reconsider Ban
In a fax dated March 27, the Chair of the Tobacco Control Group for the American Association of Public Health Physicians, Dr Joel L. Nitzkin, stated that he “vigorously” opposed Senator Lautenburg’s proposal that the Electronic Cigarette be withdrawn from sale.

In the letter to the Senator, the doctor agreed that there needed to be stricter controls over both the manufacture of electronic cigarettes and the claimsDoctor Tells Sen. Lautenburg: Cancel Your Opposition to the Electronic Cigarette made by e-cigarette retailers.

However, he also stated that, given the low smoking cessation rates amongst habitual smokers both with and without smoking cessation aids, alternatives to smoking should not be banned.

Available evidence, the doctor argued, appears to indicate that alternatives to smoking, including the electronic cigarette, are far safer than smoking cigarettes.

“Alternative nicotine delivery devices, including, but not limited to electronic cigarettes, have no products of combustion and none of the toxins in cigarette tobacco… As best we can tell, on the basis of currently available research data, these products promise a risk of illness and death well under 1% of the risk posed by cigarettes.”

Senator Lautenburg, who received over $126,000 in campaign funding from pharmecutical companies, recently wrote a letter to the Food and Drug Administration (FDA) requesting that the electronic cigarette be taken off the market until proven safe.

#11 Adrian on 04.02.09 at 12:55 PM

For those of you still following the e-cigarette controversy, you might be interested in the views of David Sweanor, as expressed in a recent interview for e-Cigarette Direct (see link below). For those of you who might not know him, and as the preamble to the interview explains, David has worked with numerous companies and organisations, including the International Union Against Cancer, World Health Organization, World Bank and the Pan American Health Organization, on the issue of tobacco harm reduction. He has received both international recognition and prestigious prizes for his work. Well worth a read!

http://www.ecigarettedirect.co.uk/interviews/david-sweanor.html

#12 Troubadour on 04.03.09 at 11:58 AM

Adrian,

Great article from David Sweanor. Your right it’s worth reading!

#13 rick smith on 04.05.09 at 3:15 PM

Why is nicotine now considered a drug? Anyone can buy nicorette gum and nicotine patches over the counter. Amazing that when e cigs come to mind it is a drug that needs to be tested. As a gum chewer, I am sure I have inhaled some of the nicotine from the gum. The fda needs to concentrate more on peanuts and leave the nicotine to the user. Nicotine has been proven addictive as is caffiene. No one talks of a caffiene ban. I don’t think you have to be a genius to figure out that big tobacco is worried as is our own gov’t. not to mention big pharm, after all, they may lose some serious revenue. To all the anti smoking groups, you should all be happy with the arrival of the e cig.. Tobacco smoking could soon be on the endangered list.
Rick Smith

#14 Bill Godshall on 04.06.09 at 4:50 PM

Per Rick Smith’s comment, some of us anti smoking advocates support the use of smokefree tobacco/nicotine products (as alternatives to cigarettes) and have been urging Congress to amend Waxman’s FDA tobacco bill to:
- allow all smokefree tobacco/nicotine products (including e-cigarettes and smokeless products) to remain on the market,
- truthfully inform smokers (and the public) that smokefree tobacco/nicotine products are less hazardous alternatives to cigarettes, and
- allow/encourage manufacters to develop and market smokefree tobacco/nicotine alternatives to smokers.

Our biggest challenge has been that increasingly more organizations (in the tobacco industry and the health arena) have publicly endorsed the Waxman legislation.

Altria, UST, Swedish Match, NACS and small manufacturers endorsed Waxman’s legisaltion after aach negotiated changes in the legislation that protected their self interests.

Several hundred health organizations have endorsed the Waxman bill (with most never reading the bill) simply because CTFK (which first negotiated and agreed to the legislation with Altria in 2004) convinced the directors of ACS, AHA, ALA to endorse the bill (which they did without reading or understanding it), and those four organizations then solicited hundreds of otehr health organizations to also endorse the bill. Most endorsing groups did so simply because lots of other groups did (the blind leading the blind).

We have an opportunity to convince the Senate HELP Cmte and/or the full Senate to amend the legislation with tobacco harm reduction amendments.

#15 Jason on 04.09.09 at 4:39 PM

I would like the opportunity to make my own decisions in life about what I believe to be beneficial / harmful to me without the government’s approval.
It seems more and more that the gov’t is taking our individual freedoms to decide for ourselves what is healthy and unhealthy. These product being developed offer an alternative nicotine delivery system that so closely resembles the actual smoking of a cigarette the migration for analogue smokers will be seamless. This product needs to be manufactured and marketed in USA because, quite honeslty, we need a market for something in USA. Times are changing and technology will continue to evolve. The potential for job creation is enourmous if the USA would just step out of the past and lean into the future. We as Americans can not allow this opportunity to pass us by. Just imagine this -
Walking into Walmart – E – ciggs behind the counter with analogue ciggs…but analogue ciggs are 10 bucks a pack and an E-cigg nicotine cartridge, equivalent to 1 pack, is 1 buck. A safer, non toxic, delivery system for nicotine that offers you your oral ciggarette fixation for 10% cost of a cancer giving, smelly, teeth staining, skin ruining, ashes everywhere, fires starting, etc analogue nicotine delivery system. What is the chatter all about people. It’s not our saftey they have at interest, it’s the bottom dollar. If the FCC says we have to switch to digital TV by June, then why can’t we swith to digital ciggs ?

#16 FDAGuru on 04.09.09 at 8:12 PM

I am waiting for Bill G. to give me props for calling out the FDA ban in advance — :)

#17 Bill Godshall on 04.10.09 at 5:47 PM

What FDA ban is FDAGuru citing? During the past three years (as many folks have told me the FDA would ban e-cigarettes), sales of the products have skyrocketed.

Had the FDA truly desired to ban the products, it would/should have done so before 100,000 of the products were sold, and before tens of thousands of smokers quit smoking by switching to the products.

But if FDA does decide to ban the products, it should make it easier to convince the US Senate to amend the Waxman/Kennedy FDA tobacco legislation with harm reduction provisions (including allowing the e-cigarette to be reasonably regulated as a tobacco product.

#18 john rolfe on 04.10.09 at 5:56 PM

Following Bill’s thoughts, the eBan provides a perfect opportunity for everyone seeking more liberal tobacco harm reduction provisions to show the Senate why Waxman-Kennedy is misguided. Lautenberg’s anti-liberal ban request may be just the spark that could get this thing going as the petition on the web site petitionwebsite.com shows. Go sign up and tell the Senate they are misguided. Why doesn’t someone draft a petition on THR in general and load it to the site and then load it here and have all the twitter people run it up their social network flag poles?

#19 Anonymous on 04.19.09 at 3:15 PM

United States: Analysis Says E-Cigarettes Represent Good Investing Opportunity
An analysis in Seeking Alpha says that electronic cigarettes can be considered the kind of “disruptive technology” that can revolutionize the US tobacco industry, given their cost advantage and purported health benefits over regular cigarettes, adding that they could create fortunes for early investors, provided major cigarette makers, pharmaceutical companies, whose smoking cessation drugs face a potential threat from e-cigarettes, and the government allow the product to remain on the market. The article noted while Big Tobacco views e-cigarettes as direct competition, Big Pharma also has a big stake in the fight against the product, given that the $3 billion nicotine replacement segment is a major cash cow for drug makers. US Sen. Frank R. Lautenberg (D-New Jersey), who, the article noted, has received $128,250 in campaign contributions from pharmaceutical/health product companies, recently urged the Food and Drug Administration to remove e-cigarettes from the market until proven safe by the Federal agency, a call supported by the American Cancer Society Cancer Action Network, the American Heart Association, the American Lung Association and the Campaign for Tobacco-Free Kids. There is, however, some support among the public health community for e-cigarettes, the article said, quoting harm reduction expert David Sweanor, who in a recent interview said that “[i]f there is anyone who believes cigarettes are no more hazardous than e-cigarettes I’d recommend a remedial course in basic sciences.” The article also noted that Dr. Joel Nitzkin, chair of the Tobacco Control Task Force for the American Association of Public Health Physicians, recently sent a letter to Sen. Lautenberg, saying currently available research data show that electronic cigarettes “promise a risk of illness and death well under 1% of the risk posed by cigarettes” (Seeking Alpha 4/12).

#20 OTP Kid on 04.20.09 at 2:04 PM

What are the thoughts on the new E-SNUS? I understand it looks like a small watch battery that fits between your cheek and gum and emits an electronic simulated taste of tobacco but with actuall liquid nicotine. Does anyone actually believe the FDA will approve such a device, even insofar as it might become a choking hazard?

#21 FEDUP on 04.22.09 at 8:42 PM

Why not OTP Kid, they approve other products that make no sense!

#22 TAZ on 04.29.09 at 10:15 PM

FDA Sued Over Electronic Cigarette Embargo

By Jordan Weissmann
Blog of the LegalTimes
April 29, 2009
http://legaltimes.typepad.com/blt/2009/04/fda-sued-over-electronic-cigarett
e-embargo-.html

A Florida company that imports and distributes so-called electronic cigarettes has 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.

#23 josh wilkins on 03.10.10 at 3:06 PM

Government can ban them but people will get them anyway. The Genie is out of the bottle and smokers have an alternative to smoking and paying the ever increasing taxes on cigarettes.

The best thing the government can do is leave them on the market and allow people to have them as an alternative to smoking tobacco cigarettes. ”

NAILED IT!!! its out of the bottle and people will now see they have some HOPE……

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