E-Cigarette or Drug Delivery Device?

Washington, D.C. – Devices marketed as “electronic cigarettes” are in reality crude drug delivery systems for refined nicotine, posing unknown risks with little new benefits to smokers, according to tobacco control experts.
In a “Perspective” published today in the New England Journal of Medicine, researchers from the Legacy’s Steven A. Schroeder National Institute for Tobacco Research and Policy Studies explore the current regulatory climate around electronic cigarettes (“e-cigarettes”) and their safety. The authors, Nathan K. Cobb, MD, a pulmonologist and assistant professor at Georgetown University Medical Center, and David B. Abrams, PhD, executive director of the Schroeder Institute, also question future implications for physicians, policy makers and e-cigarette users.
E-cigarettes are constructed to mimic real cigarettes in size and appearance, but contain no tobacco and are not cigarettes at all. In reality they are delivery devices for refined nicotine, having more in common with inhalers used to treat asthma or other delivery devices for both approved and illicit drugs. Though individual brands vary in construction, the products generally produce a propylene glycol mist containing nicotine along with flavorings and other chemicals.
Currently, three interrelated products are being sold: the delivery device itself; cartridges that can contain up to 20 mg of nicotine; and refill kits that allow consumers to fill used cartridges with replacement nicotine solution. Some refill bottles, easily obtained over the Internet, contain enough nicotine to kill an adult if accidentally ingested.
The U.S. Food and Drug Administration (FDA) announced April 25, 2011, that it would regulate e-cigarettes as “tobacco products” and not as “drug-delivery devices.” That action came after federal courts blocked the agency from regulating the products as drug-delivery devices. The courts maintained that, under the 2009 Family Smoking Prevention and Tobacco Control Act (FSPTCA), the FDA must regulate as tobacco products any product that contains nicotine from tobacco and that makes no claims to be therapeutic. These decisions together, the authors note, “upend[ed] the status quo” by having the effect of allowing the sale of unregulated refined nicotine directly to consumers, unless and until the FDA takes further action.
“The court’s decision that e-cigarettes should be regulated as tobacco products and not as drug-delivery devices has substantially delayed the FDA regulatory process that normally protects the public health. It has the practical effect of allowing manufacturers to sell potentially dangerous refined nicotine products directly to consumers,” said Cobb. “It is entirely possible that future modifications to the products will improve the efficiency of nicotine delivery and could dramatically increase the risks of addiction, abuse and serious overdose.”
While most devices and nicotine fluids are produced by small manufacturers, Cobb and Abrams note that the fact that leading cigarette manufacturers Philip Morris International and British American Tobacco recently purchased sophisticated nicotine inhaler technologies may be an indication that both companies are developing next generation nicotine delivery devices of their own.
Abrams, a professor at Johns Hopkins Bloomberg School of Public Health added “Any refined nicotine product, whether used for smoking cessation and tested and approved by the FDA (like the Nicotrol inhaler) or a new product designed for ‘reduced or modified’ risk, can and must be tested and strictly regulated before being introduced to the market”.
The authors argue that a comprehensive approach to regulating products containing refined nicotine is needed to protect the public’s health and should involve Congress, the courts and the FDA.
In this piece, Cobb and Abrams discuss several safety concerns:

  • Testing of cartridges reveals poor quality control, variability in nicotine content among brands, and deviations between label claims and cartridge content.
  • The devices do not reliably deliver nicotine, and have not been sufficiently evaluated in scientific studies the way the FDA requires of other drugs and devices used for smoking cessation. Smokers attempting to use e-cigarettes as quitting aids will most likely find them ineffective due to the fluctuating nicotine content and unpredictable delivery.
  • Manufacturers sell cartridges with a range of up to 20 milligrams of nicotine. However, refill kits allow consumers to fill used cartridges with replacement solutions at much higher doses. In fact, the devices are not limited to delivering nicotine. The paper notes that instructions for filling cartridges with marijuana hash oil can be easily accessed on the Internet.
  • The safety of inhaling propylene glycol over an extended period of time has not been studied in humans.
  • E-cigarettes may serve as a “bridge product” that smokers use in places where traditional tobacco smoking is prohibited, thus perpetuating their addiction and use of real cigarettes. Additionally, they may be used as a ‘starter’ product for young people considering smoking, especially since the cartridges can be purchased over the Internet with tempting flavoring like grape and chocolate.

In their conclusion, Cobb and Abrams counter the argument made by e-cigarette advocates that taking the devices off the market could mean current users would be forced to return to traditional tobacco products. Instead, the two researchers point to the multiple pharmaceutical-grade nicotine products on the market that have been regulated, approved and deemed safe and effective by the FDA, including patches, gums, lozenges, nasal sprays and even an FDA-approved inhaler. The two researchers also state that current users should pursue research-proven effective cessation tools, such as nicotine replacement products, telephone quit lines, and Web-based cessation services, as well as non-nicotine pharmacotherapies like bupropion and varenicline.
By Julia Cartwright, 202.454.5596, jcartwright@legacyforhealth.org
Karen Mallet, 215.514.9751, km463@georgetown.edu

Electronic Cigarettes Revisted: Public Health and Medical Opinion

A few weeks ago I posted a little essay here on “electronic cigarettes,” alleging that this relatively new nicotine delivery device might be more dangerous in various ways than some of the aggressive marketing of “e-cigs” might portray. Given the nefarious history of tobacco and smoking wars in this country and beyond, that one seemed fairly innocuous at the time.
However, the response from quite a few readers was vehement, and often less than complimentary – in fact, there was more angry response than anything I’d written on since gun control issues. Not all the input was critical – some readers had used e-cigs to quite or curtail tobacco smoking – a good thing, obviously, and evidence that the product can be used for “harm reduction” purposes in some cases. Some folks in the e-cig industry thanked me for critiquing the less ethical among their colleagues. Some clinicians were glad to see confirmation of their suspicion that e-cigs were being marketed to kids, who were using them and then wound up smoking regular cigarettes, as I had also noted.
But others accused me of all manner of perfidy, stupidity, and so forth. Others “yelled” at me in all caps while calling me things like “blowhard” – without sensing the irony, it seemed. I did learn new things from some of the comments, and would have written the original post differently in light of that information – in essence, the subtitle should have been “A Pack of Lies?” – with a question mark added, as I was trying to raise questions about safety, funding, regulation, and the so forth. I said nothing about favoring banning the product – at this time, anyway – but that we needed to be more cautious in allowing the open marketing, sales, and use.
But perhaps I should have just waited for our local health and medical authorities to weigh in, as they now have. The following policy statement has just been adopted by the San Francisco Health Commission, at the request of the San Francisco Department of Public Health, with the full endorsement of the San Francisco Medical Society’s board of (physician) directors. Clearly there are multiple sides to this story, and we have more to learn, but in the meantime, a cautious approach is warrented, as reflected in this new statement. It’s a long one (and for the record, I had no input on it), but for those interested, here it is.
Health Commission City and County of San Francisco Resolution No. 7-11
Endorsing the San Francisco Department of Public Health Proposal to Regulate Electronic Cigarettes
WHEREAS the United States Food and Drug Administration (FDA) has not yet issued any regulations regarding electronic cigarettes, also called e-cigarettes, and these products are available for purchase in this city; and
WHEREAS the U.S. Court of Appeals for the D.C. Circuit recently issued a decision that e-cigarettes and other products “made or derived from tobacco” can be regulated as “tobacco products” under the Federal Food, Drug, and Cosmetic Act, but that these products cannot be regulated as drugs/devices unless they are marketed for therapeutic purposes; and
WHEREAS electronic cigarette manufacturers and retailers are making unproven health claims about their products by asserting that they are safe or safer than traditional cigarettes and that they can be used as an aid to smoking cessation; and
WHEREAS the FDA has warned the public about the potential health risks of using electronic cigarettes; and
WHEREAS initial FDA studies found that electronic cigarettes contain known carcinogens; and
WHEREAS the FDA issued a statement on April 25, 2011 that it intends to propose a regulation that would extend the Agency’s “tobacco product” authority under the Family Smoking Prevention and Tobacco Control Act to other categories of tobacco products that meet the statutory definition of “tobacco product” under the Act; and
WHEREAS electronic cigarette packages do not supply any warnings about possible adverse effects on health comparable to FDA-approved nicotine replacement products or conventional cigarettes; and
WHEREAS there is no scientific evidence that electronic cigarettes can help smokers to quit smoking; and
WHEREAS the World Health Association does not consider electronic cigarettes to be a legitimate therapy for smokers trying to quit tobacco; and
WHEREAS FDA studies found that certain electronic cigarettes misrepresent nicotine content on their labels and sometimes contain far more nicotine than FDA-approved smoking cessation products; and
WHEREAS FDA studies found that certain electronic cigarettes emitted a markedly different amount of nicotine with each puff; and
WHEREAS the Surgeon General has found that the chemical nicotine is a powerful pharmacologic agent that acts in the brain and throughout the body and is highly addictive; and
WHEREAS withdrawal symptoms from nicotine include cognitive and attention defects, cravings, inability to sleep, and sleep disturbance; and
WHEREAS use of nicotine may cause or contribute to cardiovascular disease, complications of hypertension, reproductive disorders, cancer, and gastrointestinal disorders, including peptic ulcer disease and gastro esophageal reflux; and
WHEREAS electronic cigarettes may not be legally sold to minors in California; and
WHEREAS some electronic cigarette producers market their product to children by flavoring their products with candy, fruit, and other flavors popular with children; and
WHEREAS the FDA has raised concerns that electronic cigarettes, including but not limited to flavored electronic cigarettes, can increase nicotine addiction among young people and may lead youth to try conventional tobacco products; and
WHEREAS according to the 2009 San Francisco Unified School District High School Youth Risk Behavior Survey, 10.4% of San Francisco high school students reported current cigarette use; according to the 2009 California Health Interview Survey, 11.9% of San Francisco adults were current smokers, and according to the 2008 California Adult Tobacco Survey, 17.6% of California adults 18-24 years of age were current smokers; and
WHEREAS there is no evidence that the vapors released into the air through the use of an electronic cigarette do not present a danger to others who breathe them; and
WHEREAS electronic cigarettes’ resemblance to conventional cigarettes has caused the San Francisco Airport Health and Safety Office and Department of Public Health Secondhand Smoke Prevention and Enforcement Program to observe that the use of electronic cigarettes in places where smoking is prohibited increases the likelihood that people will break the law by lighting up cigarettes because they see what appears to be someone smoking, undermining compliance with existing smoking regulations; and
WHEREAS the use of an electronic cigarette in public is virtually indistinguishable from the use of traditional tobacco products in public, prompting confusion and concern by the owners of establishments seeking to comply with the City’s laws prohibiting smoking in certain locations; and
WHEREAS the Department of Transportation has banned the use of electronic cigarettes on U.S. carrier and foreign carrier flights in scheduled intrastate, interstate, and foreign air transportation; and
WHEREAS on April 5, 2011 the San Francisco Airport Commission amended its Rules and Regulations regarding smoking to include a ban on the use of electronic cigarettes due to the problems associated with electronic cigarette use in public outlined above; and
WHEREAS the American Cancer Society Cancer Action Network, American Heart Association, Campaign for Tobacco Free Kids, and American Lung Association support including electronic cigarettes in smoke-free laws; and
WHEREAS electronic cigarettes have been banned in indoor public places and workplaces by King County (Seattle), Washington, New Jersey and Suffolk County, New York while electronic cigarette sales have been banned throughout Canada; now therefore be it
RESOLVED, that the Health Commission endorses the policies proposed by the San Francisco Department of Public Health to
1. Prohibit the use of electronic cigarettes (and other nicotine delivery devices not approved by the FDA as smoking cessation aids) in those areas where smoking is prohibited in the San Francisco Health Code.
2. Require a tobacco permit for the sale or furnishing of electronic cigarettes and other nicotine delivery devices not approved by the FDA as smoking cessation aids.
– That’s it, although the many references are available in the online version:
http://www.sfdph.org/dph/files/hc/HCres/Resolutions/2011Res/ecig%20reso.pdf
I expect that many who have read this far – if anyone does – will include previous readers, and that some won’t like it. But some had asked for better information and what doctors think; here it is.
ps: If you intend to comment here, please do indicate who you really are, with a real name, and whether you have any financial or other stake in the sale or use of tobacco or e-cigs. Seems only fair to me (My name is above; I have no such conflict of interest).
pps: For other tobacco-related news, see:

PEDIATRICIANS CALL ON ALL MOVIE COMPANIES TO ADOPT SMOKE-FREE POLICIES THAT WORK
A new study in the CDC’s Morbidity and Mortality Weekly Report, “Smoking in Top-Grossing Movies, United States’ 2010,” shows promise for the ability of movie producers to positively affect young people’s health by reducing the number of teens who smoke. The American Academy of Pediatrics (AAP) calls on all movie producers to adopt policies that create a healthier movie experience for kids.
For more information, visit http://www.aap.org/richmondcenter/smokefreemovies.html
By: Steve Heilig

Regulation of E-Cigarettes and Other Tobacco Products

April 25, 2011
Dear Stakeholder:
The purpose of this letter is to provide stakeholders and the public with information, in light of a recent court decision, regarding the regulation of products made or derived from tobacco.
The Family Smoking Prevention and Tobacco Control Act of 2009 (Tobacco Control Act), which amends the Federal Food, Drug, and Cosmetic Act (FD&C Act), was enacted on June 22, 2009, and it provides the Food and Drug Administration (FDA) with authority to regulate “tobacco products.”  The FD&C Act, as amended by the Tobacco Control Act, defines the term “tobacco product,” in part, as any product “made or derived from tobacco” that is not a “drug,” “device,” or combination product under the FD&C Act.
Under the FD&C Act, the definition of “drug” includes articles intended:  (1) for use in the diagnosis, cure, mitigation, treatment or prevention of disease, or (2) to affect the structure or any function of the body.   Similarly, “device” is defined to include articles intended:  (1) for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, or (2) to affect the structure or any function of the body.
Between 2008 and 2010, the FDA determined that certain electronic cigarettes (e-cigarettes) were unapproved drug/device combination products and detained and/or refused admission to those offered for import by Sottera, Inc. and other manufacturers.  Sottera, Inc. challenged that determination in court.
The U.S. Court of Appeals for the D.C. Circuit, in Sottera, Inc. v. Food & Drug Administration, 627 F.3d 891 (D.C. Cir. 2010), recently issued a decision with regard to e-cigarettes and other products “made or derived from tobacco” and the jurisdictional line that should be drawn between “tobacco products” and “drugs,” “devices,” and combination products,  as those terms are defined in the FD&C Act.  The court held that e-cigarettes and other products made or derived from tobacco can be regulated as  “tobacco products” under the Act and are not drugs/devices unless they are marketed for therapeutic purposes.
The government has decided not to seek further review of this decision, and FDA will comply with the jurisdictional lines established by Sottera.
Under the Tobacco Control Act, “tobacco products” are subject to a number of controls.  Section 201(rr)(4),  for example, prohibits the marketing of a “tobacco product” in combination with any other article or product regulated under the FD&C Act (including a drug, biologic, food, cosmetic, medical device, or a dietary supplement).  FDA has already issued a draft guidance that addresses the status of such products.
Moreover, Chapter IX of the FD&C Act subjects “tobacco products” to general controls, such as registration, product listing, ingredient listing, good manufacturing practice requirements, user fees for certain products, and adulteration and misbranding provisions.   Chapter IX also subjects “new tobacco products” (i.e., products that are first marketed or modified after February 15, 2007)  and “modified risk tobacco products”  (i.e., products that are “sold or distributed for use to reduce harm or the risk of tobacco-related disease associated with commercially marketed tobacco products”)  to premarket review.  Although the statute places certain “tobacco products” immediately under the general controls and premarket review requirements in Chapter IX (i.e., cigarettes, cigarette tobacco, roll-your-own tobacco, and smokeless tobacco),  it also permits FDA, by regulation, to extend those controls to other categories of “tobacco products.”
FDA plans to take the following steps to ensure that appropriate regulatory mechanisms govern all “tobacco products” and all other products made or derived from tobacco after the Sottera decision:

  • The Agency intends to propose a regulation that would extend the Agency’s “tobacco product” authorities in Chapter IX of the FD&C Act, which currently only apply to certain specifically enumerated “tobacco products,” to other categories of tobacco products that meet the statutory definition of “tobacco product” in Section 201(rr) of the Act.   The additional tobacco product categories would be subject to general controls, such as registration, product listing, ingredient listing, good manufacturing practice requirements, user fees for certain products, and the adulteration and misbranding provisions, as well as to the premarket review requirements for “new tobacco products” and “modified risk tobacco products.”
  • The Sottera decision states that products made or derived from tobacco  can be regulated under the Tobacco Control Act unless they are “marketed for therapeutic purposes,” in which case they are regulated as drugs and/or devices.  The Agency is considering whether to issue a guidance and/or a regulation on “therapeutic” claims.
  • Section 201(rr)(4) of the Tobacco Control Act prohibits the marketing of “tobacco products” in combination with other FDA-regulated products. As mentioned, FDA has already issued a draft guidance on this provision, which it intends to finalize.
  • “Tobacco products” marketed as of February 15, 2007, which have not been modified since then are considered “grandfathered” and are not subject to premarket review as “new tobacco products.”  A “tobacco product” that is not “grandfathered” is considered a “new” tobacco product, and it is adulterated and misbranded under the FD&C Act, and therefore, subject to enforcement action, unless it has received premarket authorization or been found substantially equivalent.   FDA has already developed draft guidance explaining how manufacturers can request a determination from FDA that a “tobacco product” is “grandfathered.”

We look forward to working with all stakeholders to ensure that the existing authorities granted the Agency are harnessed to best protect and promote the public health.
Sincerely,
Lawrence R. Deyton, M.S.P.H., M.D.
Director
Center for Tobacco Products
Janet Woodcock, M.D.
Director
Center for Drug Evaluation and Research


New York bill would ban e-cigarettes until FDA action

A key New York Assembly committee has advanced a bill that could make the state the first to ban electronic cigarettes.e-cigarette
The devices advertised heavily on the Internet promise all the pleasures of smoking without the deadly health threat.
Health Committee Chairman Richard Gottfried (GOT’-freed) says the legislation passed Tuesday is a public health measure. It would ban e-cigarettes in New York until the federal government decides how to regulate their use.
Currently, children can buy the plastic devices, which contain nicotine and aren’t covered by indoor smoking bans.
Health officials say e-cigarettes are just another addictive habit, one that can hook kids early. But advocates say it helps people cut down or quit smoking tobacco.
THIS IS A BREAKING NEWS UPDATE. Check back soon for further information. AP’s earlier story is below.
ALBANY — New York lawmakers on Tuesday advanced a bill that would make the state the first to ban electronic cigarettes, devices touted on the Internet in ads promising all the pleasures of smoking without the deadly health threat.
Health officials say e-cigarettes are just another addictive habit, one that can hook kids early and legally on smoking.
But advocates who have used the devices to quit or cut down smoking tobacco call the battery-operated smokes a miracle.
“E-cigarettes are for some people a tool for enabling them to continue their nicotine addictions when they are someplace where they can’t smoke,” said Assembly Health Committee Chairman Richard Gottfried, whose panel passed the bill Tuesday. “I don’t think that’s good for public health.”
The Manhattan Democrat said the manufacturers should prove to the federal Food and Drug Administration that e-cigarettes are an effective smoking cessation aid in order to sell them to adults.
Brian Waterstripe has been selling e-cigarettes in central New York since December 2009, and a kiosk at Fingerlakes Mall in Aurelius is one of multiple retail vendors where he sells the product.
Waterstripe said on Monday that he’s aware of the talk in Albany, and said he believes the calls for a ban on the products are politically motivated. He plans to start a petition to stop any ban on e-cigarettes within the next two or three days on his website, waterstripeecig.com.
A ban would put his eight employees out of a job, he said. Waterstripe said he serves about 4,000 customers in the region.
“We definitely plan on doing something about it,” Waterstripe said.
He said he doesn’t have a problem with the state imposing some regulations on the product, and added that he expects some to go into effect soon. Some of those could include an age restriction, which he says he already imposes, as well as new requirements for the appearance of the fake cigarette and regulations on the liquid that contains nicotine.
Waterstripe went on to call an effort to take the products off the shelves an “avenue for the state to collect more taxes,” because the amount of money brought in through cigarette sales he said “adds up to huge revenue” for the state.
“There are certain regulations that are definitely going to pass, and I’m all for it,” he said. “Banning them completely, that’s definitely a political thing.”
Advocates – who say there is a nationwide grass-roots movement to keep e-cigarettes available – say the proof is in their health.
“I find it difficult to believe that my wheezing and productive morning cough would have magically disappeared sometime between March 2009 and now if I had continued smoking, waiting for someone to proclaim e-cigarettes 100 percent safe,” said Elaine Keller of Springfield, Va. She is vice president of the Consumer Advocates for Smoke-Free Alternatives Association.
“Why do politicians and organizations that claim to be protecting public health want to take away options that could save smokers’ lives?” she said Tuesday.
The bill’s sponsor was moved to act by the flood of Internet ads for the products and sales at shopping malls.
“So I did some research,” said Assemblywoman Linda Rosenthal, a Manhattan Democrat and 20-year smoker who quit more than a dozen years ago. “I found what is in the e-cigarettes is a mystery.”
She wants to ban them in New York until they are more thoroughly investigated and regulated.
Her bill was approved in the Assembly last year but stalled in the Senate, which was then controlled by Democrats. Senate Health Committee Chairman Kemp Hannon, a Republican, said the bill likely will be considered by his committee and a hearing may be held, but it’s too early to predict what will happen with the proposal.
E-cigarettes have prompted debate nationwide since they became widely available in the United States in 2006. But as either a tobacco cigarette substitute or a much more extensively tested and restricted drug-delivery device, the future of e-cigarettes will likely be decided by the Food and Drug Administration. 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.
“Maybe it stops some from smoking, but maybe it helps some kid start,” said Russ Sciandra, director of the Center for a Tobacco Free New York.
Powerful lobbies are involved. If treated as a tobacco product, e-cigarettes would avoid the research and trials required of competitors in the pharmaceutical industry, including anti-smoking patches and inhalers. As a medical device, e-cigarettes could draw opposition from that powerful lobby as a fresh and less expensive competitor.
The supporters of e-cigarettes are now watching New York “very closely. They kind of snuck up on us,” said Keller.
She said she has been tobacco free since March 2009 after 45 years of smoking. She said her group amounts to a grass-roots effort of those who feel the government has blocked this “miracle” product.
“There is no industry support on this thing at all,” Keller said of the organization. “We want to keep it this way so no one can say we are a shill for the tobacco, drug or e-cigarette industry.”
She also tries to recast the safety question.
“I can’t point to anything to say it’s 100 percent safe,” Keller said. “The thing is, it only needs to be safer. The only standard is that it’s safer than smoking.”

Electronic Cigarettes Require More Suction Than Conventional Brands

RIVERSIDE, Calif. – Stronger suction is required to smoke “electronic cigarettes” – marketed as tobacco-free nicotine delivery systems – than conventional brands, with possible adverse effects on human health, researchers at the University of California, Riverside report.
The researchers used a smoking machine to compare the smoking properties of eight conventional cigarettes with five e-cigarette brands. They examined the vacuum required to produce smoke (in the case of conventional cigarettes) or aerosol (in the case of e-cigarettes), and compared the density of the smoke/aerosol over time.
The researchers found that except for one brand (Liberty Stix), higher vacuums were required to smoke e-cigarettes than conventional brands.
The researchers also found that in the case of e-cigarettes, the aerosol density dropped after the first ten puffs, requiring still stronger suction thereafter to produce aerosol.
Study results appeared last week in Nicotine and Tobacco Research.
“It is too early to know exactly what effect stronger inhaling and diminishing amounts of aerosol will have on human health, but these factors are likely to lead to compensatory smoking, as has been seen previously with ‘light’ tobacco cigarettes,” said Prue Talbot, a professor of cell biology and the senior author of the research paper.
Talbot’s research team examined the following conventional cigarettes: Merit Ultra Lights, Marlboro Ultra Lights, Marlboro Lights, Marlboro Reds, Camel unfiltered, Camel Lights, Camel filtered, and Pall Mall unfiltered cigarettes. In the case of e-cigarettes, the researchers tested the following kits: Liberty Stix, Crown Seven’s Hydro Kit, NJOY, Smoking Everywhere’s Gold Kit, and a VapCigs starter kit.
“Our work shows that aerosol density decreases as e-cigarettes are used, requiring stronger puffs over time to sustain density,” Talbot said. “Manufacturers often claim that e-cigarettes cartridges are equivalent to a certain number of conventional cigarettes. However, this information seems misleading.”
Talbot’s lab found that while the first ten puffs of an e-cigarette are similar to a conventional cigarette, later puffs were highly variable in aerosol density and do not duplicate smoking of conventional brands. The researchers found that even though one e-cigarette cartridge may smoke for 200 puffs, cartridges do not smoke uniformly for those 200 puffs and therefore do not duplicate nicotine delivery of individual conventional cigarettes.
“Our results show that e-cigarettes smoke very differently than conventional brands,” Talbot said. “In preliminary trials, we observed that some brands of e-cigarettes were difficult to smoke possibly because they have relatively small air intake holes. Moreover, the interior of e-cigarettes is dense compared to the relatively porous tobacco-containing cigarettes.”
Talbot, who is also the director of the UCR Stem Cell Center, was joined in the research by Anna Trtchounian, the first author of the paper, and Monique Williams of UC Riverside.
The study was supported by the University of California Tobacco-Related Disease Research Program; the University of California Academic Senate; and the Hispanic Serving Institutions-California Cost Reduction and Access Act Science, Technology, Engineering, and Mathematics Pathway Project.
“This paper is the first detailed study showing that greater inhalation pressure is required to smoke e-cigarettes as compared to conventional cigarettes,” said Kamlesh Asotra, a research administrator at the University of California Tobacco-Related Disease Research Program. “An important implication is that users must exert greater inhalation pressure and, therefore, it may predictably cause the aerosol to reach deeper tissue in the user’s lungs. As in the case of conventional harm reduction cigarettes with lower nicotine content, users of e-cigarettes may also need to smoke greater number of puffs to receive sufficient amount of nicotine to satisfy their craving.
“Based on the results of this paper, not only do users become more aware of the vapor characteristics and smoking properties of e-cigarettes but also manufacturers of e-cigarettes will take notice of the functional inconsistencies of their products,” he said.
About electronic cigarettes:
E-cigarettes are marketed as a relatively new type of tobacco-free nicotine delivery device, consisting of a battery, a charger, a power cord, an atomizer, and a cartridge containing nicotine and propylene glycol.
When a smoker draws air through an e-cigarette, an airflow sensor activates the battery that turns the tip of the cigarette red to simulate smoking and heats the atomizer to vaporize the propylene glycol and nicotine. Upon inhalation, the aerosol vapor delivers a dose of nicotine into the lungs of the smoker, after which, residual aerosol is exhaled into the environment.
While produced mainly in China, e-cigarette use has rapidly proliferated worldwide. E-cigarettes do not burn tobacco and therefore do not deliver the numerous chemicals and toxicants found in conventional cigarette smoke.
To date, little has been published in the scientific literature about the health benefits and risks of e-cigarettes.
About the smoking machine:
The smoking machine consists of a puffer box connected via tubing to a peristaltic pump. The line between the puffer box and the pump contain two untapered T connectors. The connector closest to the puffer box holds the conventional or electronic cigarette. The second connector is attached to an upright U-shaped water manometer built at UC Riverside. The manometer measures the vacuum in the line drawing a puff from each cigarette.

E-cigarettes need FDA regulation, limits on sales

Chicago — Testing and safety information on electronic cigarettes is limited, the American Medical Association said, and the devices

Jonathan Klein
"There is an emerging social justice framework requiring us to protect others from secondhand smoke," says Jonathan Klein, MD, MPH, from the American Academy of Pediatrics.

should be restricted.
The AMA House of Delegates adopted policy at the organization’s Annual Meeting in June recommending that e-cigarettes be classified as drug delivery devices that are subject to regulation by the Food and Drug Administration. In addition, state legislatures should prohibit the sale of e-cigarettes and all other nicotine devices that are not FDA-approved, and the products should be covered by smoke-free laws, the policy says.
“I want them subject to [FDA] regulations so people know exactly what they’re inhaling,” said Atlanta internist Sandra Fryhofer, MD, a member of the AMA Council on Science and Public Health.
The FDA said it detected diethylene glycol, a chemical used in antifreeze that is toxic to humans, during examination of a small sample of cartridges from two leading e-cigarette brands. In several other samples, the agency identified carcinogens in the cartridges, including nitrosamines, which can be found in tobacco smoke.
FDA spokeswoman Siobhan DeLancey said the agency welcomes the AMA’s support. The FDA also wants the products regulated as drug delivery devices. She said the agency is in litigation with two e-cigarette firms over the regulatory status of the products. The companies did not return requests for comment as of this article’s deadline.
Also during the Annual Meeting, delegates debated whether individuals should be banned from smoking tobacco products in multiunit buildings because of the possible adverse health impact on other people who live there.
Jonathan Klein, MD, MPH, associate executive director of the American Academy of Pediatrics and an alternate delegate for the academy, from Elk Grove Village, Ill., noted that multiunit housing often has shared ventilation systems, meaning that smoke can filter into residences where children and nonsmoking adults live.
Tobacco smoke also can move through cracks in walls and floors, through elevator shafts, and along plumbing and electrical lines, according to an article in the June 17 New England Journal of Medicine that advocates a ban on smoking in public housing.
“I’m against smoking and secondhand smoke, and I don’t think people should be exposed to it in their apartments. But how do you tell someone they can’t smoke in their own house? Some individual rights are in conflict there,” said Daniel Koretz, MD, an Ontario, N.Y., internist and alternate delegate for the Medical Society of the State of New York, who spoke on his own behalf.
The Association moved in favor of the greater public health, adopting policy that recommends prohibiting smoking in multiunit housing.
“There is an emerging social justice framework requiring us to protect others from secondhand smoke,” Dr. Klein said.
Delegates also adopted policy that advocates for a tobacco-free school environment as defined by the Centers for Disease Control and Prevention. The CDC definition prohibits tobacco smoking, and use of spit or chewing tobacco, by students, faculty, staff and visitors in school buildings, on school grounds and in school buses or other vehicles that transport students. The tobacco ban also applies to off-campus, school-sponsored events.
The AMA policy recommends that the Association provide on its website resources that could help people implement tobacco-free school environments in their communities.
By Christine S. Moyer
Ama-assn, June 28, 2010.

E-cigarettes: A true remedy to quit or teen marketing tool?

SACRAMENTO, CA – Electronic cigarettes are offering smokers a cleaner, greener alternative. And for some, the alternative takes them one step closer to kicking the habit all together.
Ads for the “Smoking Everywhere” electronic cigarette claim the device “feels like a cigarette, looks like a cigarette, tastes like a cigarette.”
“It’s a lot cheaper than regular cigarettes, and it’s less dangerous,” said Aazi Sana with Natomas Cheaper Cigarettes.
Manufacturers claim that it’s a greener way to smoke with no tar, no ash, and no second-hand smoke. But there’s still plenty of nicotine.
Nicotine has kept Scott Whittlesey hooked for more than two decades. But, the idea of smoking less led him to switch to the e-cigarette last November.
“I do less and less puffing on this now,” Whittlesey said. “It’s healthier. It’s a healthier alternative.”
E-cigarettes run on a battery that could be charged in 30 minutes. Some even charge on your laptop. When the user inhales, the heating device converts the chemicals into a vapor that resembles smoke.
The e-cigarette comes in various nicotine levels– from zero to high and is offered in all sorts of flavors — from tobacco to chocolate to cherry.
“The place I go to has 100 flavors. They even have peanut butter,” said Whittlesey.
The flavors have reportedly been marketed to teens. While most stores strictly enforce the 18 and over rule, there are still questions about how a buyer’s age is verified when buying e-cigarettes online.
The California attorney general has filed suit against “Smoking Everywhere” for allegedly making misleading claims and for marketing to minors. They are one of the biggest e-cigarette retailers nationwide.
State Senator Ellen Corbett, D-San Leandro, is pushing a bill to prohibit the sale of electronic cigarettes to minors.
The Electronic Cigarette Association responded, “Electronic cigarettes represent a smoking alternative for adult committed smokers. We have no interest in marketing or selling our products to underage smokers and have taken numerous steps over the years to prevent youth access to our products.”
E-cigarettes can cost anywhere from $35 up to $200 for a starter kit. That includes a cigarette, nicotine cartridges, and a charger.
Electronic cigarettes have been popular in China. They’ve also been popular in Europe. But the FDA has not formally approved the devices in the U.S.
Even so, Whittlesey says e-cigarettes have brought him closer to kicking the smoking habit.
“If I smoke a regular cigarette now, I can’t handle it. I start coughing,” said Whittlesey.
By Suzanne Phan, 31 March, 2010

More research needed into safety of electronic cigarettes

The need for more research into the long-term health effects of electronic cigarettes has been highlighted by scientists in the British Medical Journal.
Andreas Flouris and Dimitris Oikonomou, from the Institute of Human Performance and Rehabilitation in Greece, are concerned that not enough research has been carried out into the safety – or otherwise – of so-called ‘e-cigarettes’.
Their position has been endorsed by Cancer Research UK, which is also concerned by the current lack of information.
E-cigarettes are battery-powered devices that simulate cigarettes by allowing the user to inhale a nicotine vapour.
Sales of the devices are thought to be increasing and a number of celebrities – including Kate Moss and Leonardo DiCaprio – have been spotted using them.
However, few studies have been conducted into the health effects of smoking e-cigarettes and those that have been published have reached differing conclusions.
One, carried out by the US Food and Drug Administration (FDA), found that the amount of nicotine provided with each puff often varies from the amount stated on the label, prompting the agency to express concern about e-cigarettes.
In contrast, a private enterprise called Health New Zealand (HNZ) found that the labelling on e-cigarettes reflected their actual nicotine content.
The FDA’s research also detected the presence of diethylene glycol – a highly toxic liquid – in one of the cartridges it investigated, while both the FDA and HNZ found cancer-causing chemicals called tobacco specific N-nitrosamines.
In its report, the FDA suggested that e-cigarettes may therefore be harmful, but HNZ recommended their use as they are likely to be less dangerous than tobacco products.
Meanwhile, a Greek organisation called Demokritos has maintained a neutral stance on the subject after conducting its own research.
Drs Flouris and Oikonomou note that this “represents all the knowledge we currently have about e-cigarettes” and that the European Centre for Disease Prevention and Control is yet to publish any research on the subject.
“Alternative smoking strategies aimed at reducing the threat to public health caused by the tobacco epidemic are always welcome,” the researchers conceded.
However, they observed: “To date, our knowledge about the acute and long-term effects of e-cigarette use is, at best, very limited.
“The scarce evidence indicates the existence of various toxic and carcinogenic compounds, albeit in possibly much smaller concentrations than in traditional cigarettes.”
Jean King, Cancer Research UK’s director of tobacco control, said: “There has been little research into how safe e-cigarettes are. And there’s also very little regulation to control these products or their marketing. The only way to be sure of any risks or benefits is through rigorous testing.
“Anyone trying to quit smoking should use medicinal nicotine products such as patches, gum or inhalators, because these have been tested and found to be safe and effective. We believe that e-cigarettes should undergo the same rigorous tests and meet the same standards as all other medicinal products containing nicotine.”
Reference: Flouris, A., & Oikonomou, D. (2010). Electronic cigarettes: miracle or menace? BMJ, 340
21 January 2010

Electronic cigarettes under fire for targeting Arizona kids

PHOENIX – In a hidden camera investigation, the ABC15 Investigators found Arizona electronic cigarette kiosk salesmen e-cigarettesselling their nicotine device to kids.
It is not illegal. But, there is controversy over what the devices do to our bodies.
Amir Hakak operates electronic cigarette kiosks in four Valley malls.
He said the e-cigarette helps people kick the real habit.
“It is the same as the patch or the gum. Actually, we add the vapor to it. The smoker gets the sensation, you feel you smoke; you trick the mind,” said Hakak.
It closely resembles a real cigarette. It blows smoke and has nicotine, but has no tobacco. The vapor is actually water.
It comes with a battery and filter in a variety of flavors.
And, it contains nicotine which not only makes it addictive; it also makes it come under the scrutiny of the Food and Drug Administration.
Last July, the FDA found dangerous chemicals in some electronic cigarettes they tested including diethylene glycol, a chemical used in antifreeze that is toxic to humans.
So then why are these e-cigarettes sold in a variety of flavors at kiosks in the mall — where teens regularly hangout?
That’s the question John Wickwire asked when his 17-year-old son came home from the mall.
“He come (home) excited and saying, ‘Oh yeah, there’s this new thing. It’s so cool. They have these flavors,’ and I’m like, ‘what is it?’ Oh, it’s this new kind of cigarette,” said Widkwire.
“We think this is cutting edge,” said former Arizona congressman, Matt Salmon, who helped push through one of the first public smoking bans.
He doesn’t smoke, but has seen devastating effects of smoking on his family members.
“Our product is marketed to long-term committed smokers who are killing themselves with combustible tobacco,” said Salmon.
Today, Salmon leads the Electronic Cigarette Association with very specific rules: they don’t make health claims, don’t sell to minors, and say they shouldn’t be sold at kiosks in the mall. And just like real cigarettes, they should not sell flavors targeting children.
But, we found just the opposite. Using a hidden camera, we went to a “Smoking Everywhere” kiosk in the Arrowhead Mall in Glendale.
Not only did the salesman make health claims saying the E-cigarette helps with influenza and pneumonia, but he sold it to our underage shopper.
With permission from his parent, Zach asked to buy the nicotine refills. They sold him 10. They never asked him for his I.D. and never even asked him his age. He is 16.
“This was a critical mistake,” said Hakak, “You can come and check at each of our locations again. There is no way that it could happen again. “
Well, 10 days later, we went back to the same kiosk in the same mall with the same child.
And the very same thing happened. Once again, Zach bought 10 nicotine refills. No one asked him his age or for his I.D.
The only difference this time was that they charged him half as much.
Wickwire thinks there’s a better place for this product than the mall.
“It’s nicotine. It’s addictive. It should be in a drugstore,” said Wickwire.
The FDA warns against the product being sold to minors because of limited testing.
Many countries have banned the cigarettes. But in the U.S., only one New York county bans them.
Visit the FDA’s website for more information about electronic cigarettes.
By: Joe Ducey, Abc15

Electronic Cigarette Association Urges Unbiased Evaluation of E-cigarettes

WASHINGTON–As the debate heats up concerning the use of electronic cigarettes, Electronic Cigarette Association (ECA) President Matt Salmon today encouraged those involved in this discussion to carefully and honestly study how these devices work and recognize that the more than one million adult committed smokers, who use electronic cigarettes, are seeking an alternative to combustible cigarettes that contain a multitude of toxic, harmful chemicals.
The debate on these devices has intensified in recent months as events have fueled and focused attention on electronic cigarettes, including a front-page story last week and a follow-up editorial in yesterday`s edition of USA Today and stories or editorials in other major newspapers such as the New York Times and Los Angeles Times. Governor Schwarzenegger`s veto of a bill that would have denied California citizens the right to purchase electronic cigarettes and a warning by the Food and Drug Administration (FDA) based on a flawed, narrow study have also contributed to the growing debate.
“Unfortunately, many of the arguments we`ve seen recently against electronic cigarettes have been driven by fear of the unknown, insufficient evidence, political agendas, and ignorance about our members` products,” said Salmon. “As in the case of California Governor Schwarzenegger, we`ve found that reasonable people, when willing to honestly and intellectually evaluate the information about electronic cigarettes, find that these products provide smokers a viable alternative to combustible tobacco cigarettes.”
Some legislators have taken a stance against electronic cigarettes as a result of an FDA study that Salmon says was extremely narrow in scope and failed to follow established scientific protocols. The Electronic Cigarette Association has called on the FDA to take a more scientific approach and to work with ECA members before making any hasty decision to ban electronic cigarettes altogether. Such a ban would leave smokers without an alternative to combustible cigarettes, whose toxic substances and life-threatening health effects are clearly documented and which the FDA has no intention of banning.
“We understand that to protect the public, some form of regulation may be necessary, and we welcome that. Our goal, nevertheless, is to ensure committed adult smokers the freedom of a clear, better alternative and to prohibit sales to minors,” said Salmon.
About the Electronic Cigarette Association
The ECA (www.ecassoc.org) is an association of private sector companies engaged
in electronic cigarette technologies. Its mission is to provide the tools and
information necessary for policy-makers, opinion leaders, media, and private
sector companies worldwide to make informed decisions about the management and
use of electronic cigarette technologies. The association institutes and
promotes industry-wide standards and a code of conduct, works to maintain sound
professional practices, educates the public and policy-makers on the industry`s
activities and potential, and works to ensure the ethical use of electronic
cigarette technologies.

Electronic Cigarette Association (ECA)
Media Contact:
Matt Salmon, 202-841-6729
msalmon@policyimpact.com
Copyright Business Wire 2009