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Electronic Cigarettes and the FDA

Electronic cigarettes, the FDA, anti-freeze and teenagers… how are these four connected?

Apparently the FDA found small traces of diethylene glycol, an ingredient used in antifreeze, in one sample of electronic cigarette solution they analyzed. They are also concerned that teenagers will get addicted to electronic smoking. How serious are these issues? Are e-cigarettes harmful devices that should be banned? Lets get the facts straight and put all this information into perspective.

Diethylene glycol may be a toxic ingredient but exactly how toxic is it?

1. It is has one-tenth the toxicity of aspirin.
2. It has one-fortieth the toxicity of nicotine (the primary ingredient in electronic cigarette vapor).

Diethylene glycol is also found in everyday consumable products like:

- Toothpaste
- Mouthwash
- Cough syrup
- Wine
- Dog food
- And many others…

You have to wonder why the FDA is focusing so much on the minute traces of diethylene glycol found in one sample when clearly this is a very common ingredient many of us are ingesting regularly.

That’s not to say that diethylene glycol is totally harmless and we shouldn’t have any concerns about it. But when the FDA starts focusing on words like ‘diethylene glycol’ and ‘anti-freeze’ it sure does sound scary. However, a little bit of education on the facts puts it back in perspective doesn’t it? By the way, water is another ingredient found in anti-freeze!

The FDA tends to give the impression that they have regulatory control over nicotine. That is not always the case. They regulate smoking cessation products and claims. That’s why electronic cigarettes are marketed as a smoking alternative and not as a means to quit smoking.

Another “concern” expressed by the FDA is that electronic cigarettes target underage kids. Here is an FDA quote from one of their reports:

“These products are marketed and sold to young people and are readily available online and in shopping malls. They are also available in different flavors, such as chocolate and mint, which may appeal to young people”.

There is absolutely zero evidence that e-cigarettes target teenagers. Just the opposite… the marketing is focused on adults who already smoke and are searching for a healthier alternative they can use in public places. And here is some breaking news: Adults like to shop in malls and enjoy a variety of flavor choices too! Besides, the initial cost of entry for a top of the line electronic cigarette is not practical for most teenagers.

I encourage you to do your own due diligence and research the electronic cigarette to see if this is something that will benefit you. Look at all sides of the story and try to get unbiased information. Right now the FDA appears to be biased against electronic smoking for some reason. Do they have a hidden agenda? Who knows… but I think I detect trace elements of BS in the FDA reports!

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FDA Can’t Regulate ‘Electronic Cigarettes’

The Food and Drug Administration can’t block tobacco distributors from importing “electronic cigarettes” into the United States, a federal judge in Washington, D.C., ruled in a decision that could save at least one domestic distributor from going under.
U.S. District Judge Richard Leon rejected the FDA’s ban on importation, saying electronic cigarettes are regulated by the Tobacco Act, just like regular cigarettes.
The FDA detained more than 35 shipments headed for the distribution companies Smoking Everywhere and NJOY, saying the products qualified as drug-device combinations under the Food, Drug and Cosmetic Act. In the FDA’s view, the electronic cigarettes weren’t simply therapeutic; they also affected the structure or function of the body.
Judge Leon disagreed.
“[A]ll they purport to do is offer consumers the same recreational effects as a regular cigarette,” he wrote, calling the FDA’s argument “bootstrapping run amuk.”
Leon said the FDA’s rationale would force him to exclude traditional cigarettes from the list of acceptable tobacco products.
“Congress did not intend tobacco products to be drugs merely because they deliver nicotine,” Leon wrote.
Smoking Everywhere touts the product as an “alternative to traditional cigarettes that delivers the same sensation as smoking,” but “without combustion or the use of cancerous byproducts.” Electronic cigarettes vaporize liquid nicotine, allowing the user to inhale nicotine without the tar, carbon monoxide, ash and smell of traditional cigarettes, according to the ruling.
But they are not meant to affect the body in any way different from regular cigarettes, Leon wrote. And the companies never touted them as having therapeutic effects, such as treating nicotine addiction, the ruling states. Instead, the companies were promoting nicotine use by encouraging consumers to use the product as often as they would traditional cigarettes.
The court granted the distributors’ motion for a preliminary injunction blocking the enforcement of the FDA’s ban on the importation of electronic cigarettes.
Electronic cigarettes are the sole product line for Florida-based Smoking Everywhere, according to the ruling. The distributor’s inventory is “already near depletion,” and no domestic electronic cigarette makers exist. Smoking Everywhere has sold more than 600,000 electronic smoking kits since it began operating more than a year ago. Competitor NJOY has sold more than 135,000 since its opening in 2007.
Leon said the case demonstrates the FDA’s “drive to maximize its regulatory power” – another example of its “aggressive efforts to regulate recreational tobacco products as drugs or devices.”

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Special Interest Deceptions Continue to Rampant About Electronic Cigarettes

As the battle continues over the electronic cigarette, more deceptive practices are being used to send out dangerously misleading information on the popular product.

GAINESVILLE, Fla., Dec. 17 /PRNewswire/ — Over the last few weeks there has been an increase of the amount of scare language that is used by e cigarette opposition in an attempt to scare the population concerning the electronic cigarette. Many are questioning the tactics of these groups when the evidence clearly shows that the product is indeed a safer alternative to tobacco according to several studies, lab reports and opinions from top medial and harm reduction specialist around the world.

Special interest groups appear to have no legitimate argument against the electronic cigarette and have stepped up the use of catch phrases like “an ingredient found in anti-freeze” to describe propylene glycol, when it is an that ingredient is also found in the food supply and asthma inhalers that children use on a daily basis.

There have also been statements from special interest on the dangers of nicotine and less than accurate information about this substance stating that nicotine in a vapor, even in low concentrations can cause cancer in bystanders. These statements are in direct contradiction of current scientific evidence.

“Nicotine is probably the second most used drug after caffeine.” Amazingly, no one thinks of caffeine as a harmful drug. Nor should they. “The possible dangers of nicotine are dwarfed by the dangers associated with tobacco. Pure nicotine has not been associated with the risk of cancer.” States The International Harm Reduction Association. “If one could entertain the unrealistic assumption that all tobacco users would switch to clean nicotine tomorrow, we would see an immediate effect (for the better) on cardiovascular disorders, and a delayed effect on respiratory and cancer disease.”

Produced by E Cigarettes National

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Anti-Electronic Cigarette Campaign Funding Revealed

(OfficialWire)

LONDON, ENGLAND

Public health groups carrying out a health campaign against electronic cigarettes have been bankrolled by the very organisations whose products are most threatened by the innovative new device.

That’s the claim being made by Jean Rasbridge, Managing Director of E Cigarette Direct, who has published a list of direct and indirect grants made by large pharmaceutical companies to these health groups.

“These organisations, with the help of a $99 million dollar grant from the Robert Wood Johnsong Foundation, helped bring about the current anti-smoking environment which exists today – an environment which helps fuel the three billion nicotine cessation industry.

“Given that, it’s perhaps not surprising that the same organisations are campaigning hard against the electronic cigarette – despite the fact that some respected scientists maintain that the electronic cigarette carries between one percent and one tenth of one percent of the risk of cigarettes.”

Attacks on the electronic cigarette have focused on the existance of carcinogens in electronic cigarette and on the use of propylene glycol.

The FDA, which receives hundreds of millions of dollars from the pharmeceutical industry every year, stated in a press release that the electronic cigarettes contained carcinogens – without mentioning that the carcinogens found were both thousands of times lower than that found in cigarettes and at a similar level to that found in nicotine cessation aids.

In total, the carcinogens found in electronic cigarettes measured 8.3 per trillion, somewhat lower than the 20 parts per trillion allowed in many food products.

One public health organisation, ASH, has argued that electronic cigarettes should be withdrawn from sale based on the fact that they contain carcinogens.

As Proffessor Siegel, a scientist with over 20 years of experience in the field of tobacco control, noted on the Tobacco Analysis blog, banning electronic cigarettes on those grounds alone and without taking into account the quantity would also mean the banning of nicotine gum, nicotine inhalers – and peanut butter.

“We believe that the total lack of science in the anti-electronic cigarette campaign can be much more easily explained when the funding of the campaign is taken into account,” concluded Jean Rasbridge.

To see the full details of the financial links please visit Anti-Electronic Cigarette Funding.

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Health New Zealand: Cancer risk reduced by e-cigarettes

Health New Zealand have gone public with their findings of research into Electronic Cigarettes and have stated that “Cancer risk reduced by e-cigarettes.”

New Zealand has, for a long time been inquisitive about electronic cigarettes and is one of the few countries in the world which has investigated deeply the health benefits rather than producing biased and inaccurate reports and banning them. They have spent time studying not only the ingredients involved in the operation of an e-cigarette but have also probed deeply into what health benefits can be gained from their use.

In a release on their website (http://www.healthnz.co.nz/cancerrisk.htm) they report that “Using e-cigarettes INSTEAD of smoking tobacco cigarettes is bound to reduce the risks of lung cancer, because the cancer-causing gases such as 1,3 butadiene found in the smoke of all cigarette brands, are no longer inhaled.”

“Switching to e-cigarettes with nicotine continued, can be expected to reduce lung cancer risk the same as altogether quitting cigarettes without e-cigarettes.”

The report also details how Health New Zealand feels the future of electronic smoking should go and asks the question ‘Is the nicotine delivered via the e-cig going to promote cancer in already existing pre-cancerous cells?’ to which the simple answer is “Not likely and not in the next 10 years.”

To progress, the industry needs governments around the world to support electronic cigarettes and not be scared of the unknown. These products are still significantly under the radar and rarely get mainstream media attention even though they offer so many benefits to so many different aspects of a users life. These products have the potential to save millions of lives every year but because the idea is new, there are very few politicians who will support them, except for governor Schwarzenegger of course who recently vetoed a bill which would have banned the sale of electronic cigarettes in California.

This latest group of medical professionals who support electronic cigarettes only strengthens the potential of e-cigs in our society.”

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New Electronic Cigarette Study Shows Exciting Results

LONDON, UNITED KINGDOM–(Marketwire – Dec. 3, 2009) – A groundbreaking new survey into the electronic cigarette, smokers’ health and smoking cessation, carried out by NJOY retailers E Cigarette Direct and analysed by tobacco harm reduction scientists, has shown encouraging results.

An article by researchers in the Carl Phillips research group, TobaccoHarmReduction.org research group at the University of Alberta School of Public Health, concluded:

“The majority of the respondents indicated that their general health, smoker’s cough, ability to exercise, sense of smell and sense of taste were better since starting to use e-cigarettes”.

Nearly all of those questioned had previously tried to quit smoking using pharmaceutical products, but had been unable to do so.

They had, however, been able to replace cigarettes with electronic cigarettes.

The study pointed out that the respondents were “highly motivated and passionate e-cigarette users who may have different experiences than average e-cigarette users or smokers.”

However, it also suggested that “very few e-cigarette users are not using them to replace cigarettes and there are many switchers and current smokers who could have the reported experience.”

“While we believe further research is necessary, these initial results are very encouraging,” said Jean Rasbridge, Managing Director of E Cigarette Direct.

“Previous research in New Zealand has shown that electronic cigarettes can help alleviate nicotine cravings and increase the level of nicotine in the blood.

“This new study suggests both that electronic cigarettes can both help smokers replace cigarettes, and improve health in the short term.

“We now need longer term research into the effects of the electronic cigarette to see if these results are consistent over time.”

Electronic cigarettes are devices that deliver nicotine by vaporizing a gel that also contains water, propylene glycol and flavourings.

In contrast to cigarettes, there is no combustion involved.

Combustion is, according to experts such as Dr. Phillips, the main cause of harm in smoking.

The TobaccoHarmReduction.org Project at University of Alberta School of Public Health is the leading source of information of safer alternatives for smokers who cannot or do not wish to quit using nicotine. Professor Phillips and his work group are leading advocates of tobacco harm reduction, and Dr. Phillips advises and works with many other organizations who are trying to promote it, some of which are companies that hope to profit from selling low-risk nicotine products. The TobaccoHarmReduction.org research group at the University of Alberta School of Public Health is partially supported by an unrestricted (completely hands-off) grant from U.S. Smokeless Tobacco Company.

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Do Electronic Cigarettes Reduce Harm?

Encouraging results from new E-Cigarette study

LONDON, ENGLAND

E cigarettes could be a useful harm reduction tool according to a survey carried out by UK e-cigarette company E Cigarette Direct and analysed by researchers in the Carl Phillips research group, the TobaccoHarmReduction.org research group at the University of Alberta School of Public Health.

The survey questioned several hundred e-smokers, many recruited from e-cigarette-forum.com, about their smoking habits and health prior to and after using the electronic cigarette.

“The majority of the respondents indicated that their general health, smoker’s cough, ability to exercise, sense of smell and sense of taste were better since starting to use e-cigarettes,” concluded the report.

Encouragingly, the survey also found that all those questioned had smoked prior to taking up the electronic cigarette, and many were using it as a complete replacement to cigarettes.

Researchers at the Tobacco Harm Reduction Project believe that the main cause of harm in tobacco use is caused by combustion.

Electronic cigarettes work by vaporising a gel that also contains water, propylene glycol and
flavourings. In contrast to cigarettes, there is no combustion involved in the process.

“While we believe further and longer-term research into the electronic cigarette is needed, these initial results are very encouraging,” said Jean Rasbridge, Managing Director of E Cigarette Direct.

For more information please view the abstract of the study or download the full article: Electronic Cigarettes as Potential Harm Reduction Products: Results of an Online Survey of E Cigarette Users.

The TobaccoHarmReduction.org Project at University of Alberta School of Public Health (link to be inserted here) is the leading source of information of safer alternatives for smokers who cannot or do not wish to quit using nicotine. Professor Phillips and his work group are leading advocates of tobacco harm reduction, and Dr. Phillips advises and works with many other organizations who are trying to promote it, some of which are companies that hope to profit from selling low-risk nicotine products. The TobaccoHarmReduction.org research group at the University of Alberta School of Public Health is partially supported by an unrestricted (completely hands-off) grant from U.S. Smokeless Tobacco Company.

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Prominent Tobacco Researchers Expose Double Standard in FDA’s Study of Electronic Cigarettes and Challenge FDA’s Alarmist Attitude Toward the Devices

electronicsigaret

The press release can be found here.

I have copied it below, as well:

Prominent Public Health Physicians and Tobacco Researchers Expose Double Standard in the FDA’s Recent Study of Electronic Cigarettes and Challenge the FDA’s Alarmist Attitude Toward the Devices

Contact: Thomas R. Kiklas, Director of Media, inLife LLC, 949-250-9600 ext 108,
tkiklas@myinlife.com

BOSTON, July 27 /Standard Newswire/ — The FDA recently went public with misleading information about the safety of electronic cigarettes and the marketing of the devices, not only using its clout but recruiting other prominent organizations to demonize a product that has great public health benefit potential.

A group of prominent doctors and tobacco researchers, including Dr. Michael Siegel at the Boston University School of Public Health, Dr. Joel Nitzkin of the AAPHP Tobacco Control Task Force, and Dr. Brad Rodu, Endowed Chair, Tobacco Harm Reduction Research University of Louisville, challenge the FDA to provide the full quantitative data of the study upon which the FDA has based its warning against electronic cigarettes. They are concerned that the FDA’s disingenuous targeting of electronic cigarettes through a biased presentation of the scientific data has had significant negative impact upon the public perception of electronic cigarettes, when the best available evidence suggests that these have shown that the devices offer great potential to reduce serious health issues among traditional tobacco smokers.

In a July 22 news release, the FDA cited the detectable presence of carcinogens and “toxic chemicals” in a “small sample” of electronic cigarette cartridges as reason for alarm, singling out nitrosamines as particularly toxic. What the FDA fails to inform the public is that detectable amounts of carcinogens are also present in nicotine replacement products such as NicoDerm CQ and Nicorette gum, both approved by the FDA, and nitrosamines that can be also found in food items such bacon and beer. This double standard and alarmist attitude has had the significant and unfortunate effect of inducing hysteria among the public, discouraging tobacco smokers from using a product which is thought to be a significantly safer alternative to traditional tobacco.

Regrettably, the FDA has used biased reporting of this small and inconclusive study, the complete results of which have not been made public, to secure the vocal support of groups such as the American Academy of Pediatrics Tobacco Consortium, the Institute for Global Health, and the American Lung Association in their attack on electronic cigarettes. These researchers argue that it is absurd to consider taking electronic cigarettes off the market when it is the conventional ones which have been shown to be killing people. Further, the electronic cigarette community calls for accurate and fair reporting relative to the findings and statements of prominent medical professionals in favor of this new and important technology and challenges the media to tell the other side of the story.

“The FDA’s laboratory findings actually indicate that electronic cigarettes are much, much safer than conventional cigarettes,” says Dr. Michael Siegel. “The traces of carcinogens present are also present in nicotine replacement products. The FDA and the anti-smoking groups have fallen into a huge analytical trap as they have failed to ask the appropriate question. The question they are asking is: ‘Are electronic cigarettes safe?’ That is not the right question. The right question is: ‘Are electronic cigarettes much safer than traditional ones?’”

Dr. Rodu states, “The FDA tested e-cigarettes for TSNAs using a questionable sampling regimen, and the methods that were so sensitive that the results may have no possible significance to users. The agency failed to report specific levels of these contaminants, and it has failed to conduct similar testing of nicotine medicines that have been sold in the U.S. for over 20 years. These are not the actions of an agency that is science-based and consumer-focused. These pseudo-scientific actions are clearly intended to form the justification for banning a category of products that are probably 99.9% safer than cigarettes.”

Dr. Joel Nitzkin speaking as individual states, “The newly adopted FDA/Tobacco legislation will give full FDA approval to currently marketed conventional cigarettes. The new law encourages cigarette companies to produce new “reduced exposure” cigarettes to be marketed as reduced exposure products, with no scientific evidence that such reductions in exposure will reduce risk of future tobacco related illness and death. In the context of these provisions of the newly adopted FDA/Tobacco bill — FDA should be encouraging, not maligning the manufacture and sale of electronic cigarettes, and working with manufacturers to assure the highest possible quality control.”

For more information and interviews, contact:

Michael Siegel, MD, MPH
Professor
Department of Community Health Sciences
Boston University School of Public Health
617-638-5167

Joel L. Nitzkin, MD, MPH, DPA
Chair AAPHP Tobacco Control Task Force
Phone: 504 899 7893 or 800 598 2561
Fax: 504 899 7557

Brad Rodu
Professor of Medicine
Endowed Chair, Tobacco Harm Reduction Research
University of Louisville
Phone: 502-561-7273

Thomas R. Kiklas
Director of Media
inLife LLC
Phone: 949-250-9600 x108

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List of Identified, Known Carcinogens in Electronic Cigarettes vs. Conventional Cigarettes

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List of Identified, Known Carcinogens in Electronic Cigarettes vs. Conventional Cigarettes, and Which Anti-Smoking Groups are Telling Smokers to Smoke

Based on the best available scientific evidence, I have compiled a list of the identified, known carcinogens present at greater than trace quantities in electronic cigarettes compared to conventional cigarettes.

Below that list is a table listing a number of anti-smoking organizations and which of the two products they have stated or implied they would prefer that smokers smoke.

Table 1. List of Identified, Known Carcinogens in Electronic Cigarettes, Present at More than Trace Levels (defined as 1 nanogram per cigarette)

None

Table 2. List of Identified, Known Carcinogens in Tobacco Cigarettes, Present at More than Trace Levels (defined as 1 nanogram per cigarette)

Benz(a)anthracene
Benzo(b)fluoranthene
Benzo(j)fluoranthene
Benzo(k)fluoranthene
Benzo(a)pyrene
Dibenz(a,h)anthracene
Dibenzo(a,l)pyrene
Dibenzo(a,e)pyrene
Indeno(1,2,3-cd)pyrene
Quinolineb
Dibenz(a,j)acridine
Benzo(b)furan
Furan
N-Nitrosodimethylamine
N -Nitrosoethylmethylamine
N -Nitrosodiethylamine
N -Nitroso-di-n-butylamine
N -Nitrosopyrrolidine
N -Nitrosopiperidine
N -Nitrosodiethanolamine
N -Nitrosonornicotine
4-(Methylnitrosamino)-1-(3-pyridyl)-1-butanone
2-Toluidine
2,6-Dimethylaniline
2-Naphthylamine
4-Aminobiphenyl
AaC
PhIP
Formaldehyde
Acetaldehyde
1,3-Butadiene
Isoprene
Benzene
Styrene
Acetamide
Acrylamide
Acrylonitrile
Vinyl chloride
DDT
DDE
Catechol
Caffeic acid
1,1-Dimethylhydrazine
2-Nitropropane
Nitrobenzene
Ethyl carbamate
Ethylene oxide
Propylene oxide
Methyleugenol
Hydrazine
Arsenic
Nickel
Chromium
Cadmium
Lead
Polonium-210

Source: http://tobaccoanalysis.blogspot.com/2009/07/list-of-identified-known-carcinogens-in.html

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ASH in UK Comes Clean on Electronic Cigarette Health Debate

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COLLEYVILLE, TX, October 20, 2009 /24-7PressRelease/ — “e-cigarettes, which deliver nicotine without the harmful toxins found in tobacco smoke, are likely to be a safer alternative to smoking.”

Action on Smoking and Health (ASH) In their October briefing, ASH in the United Kingdom has released a favorable position on electronic cigarettes which is nearly 180 degrees to the position ASH in the United States has taken.

ASH’s UK Position on E-cigarettes

“ASH supports a harm reduction approach to tobacco, that is, we recognize that whilst efforts to help people stop smoking should remain a priority, many people either do not wish to stop smoking or find it very hard to do so. For this group, we believe that products should be made available that deliver nicotine in a safe way, without the harmful components found in tobacco. Most of the diseases associated with smoking are caused by inhaling smoke which contains thousands of toxic chemicals. By contrast, nicotine is relatively safe. Therefore, e-cigarettes, which deliver nicotine without the harmful toxins found in tobacco smoke, are likely to be a safer alternative to smoking. In addition, e-cigarettes reduce secondhand smoke exposure since they do not produce smoke.”

Kyle Newton of eCigarettesChoice.com is elated at the release. “This is the second piece of good news for the E cigarette industry this week. The first was Governor Schwarzenegger’s refusal to ban E cigarettes in California. It is a David vs. Goliath battle for us against organizations that are well-funded by companies who stand to lose a huge market share to the E cigarette.”

On the other side of the big pond, ASH, USA has hammered the electronic cigarette industry unmercifully in its public claims against the product. But throughout this entire finger pointing, they have failed to produce any scientific research which tested the electronic cigarette and could trump the positive data “real” tobacco researchers have published.

ASH, USA and spokespersons of other health organizations continue to make weak accusations stating that they “don’t know what’s in them” and that, because flavors are involved, “children may be attracted to them”. While a spec of truth may be found in any of these statements, they appear to lean more towards gross exaggeration or pure fiction. Kyle claims, “Not one US electronic cigarette dealer I know of would knowingly sell to those under the legal age of smoking.”

Misleading statements continue to be made by health organization PR representatives who are well-educated on this subject, yet choose to ignore the widely publicized Health New Zealand’s tests on the Ruyan electronic cigarette that list the ingredients and give the electronic cigarette the green light. When confronted with Health New Zealand’s report, they claim that the study was not independent because it was paid for by the electronic cigarette maker which is the industry norm.

Prominent doctors and tobacco researchers, including Dr. Michael Siegel at the Boston University School of Public Health, Dr. Joel Nitzkin of the AAPHP Tobacco Control Task Force, and Dr. Brad Rodu, Endowed Chair, Tobacco Harm Reduction Research University of Louisville continue to publish unbiased scientific benefits of the electronic smokes that counter the misleading information

It may be impossible to please these health organizations since their resistance to e cigarettes may be affected by their addictive funding from the manufacturers of smoking cessation products. A better harm reduction alternative to smoking tobacco does not appear to be their priority or they would be partnering with the e cigarette industry.

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