Sunday, August 9, 2009

Consumer Health Products Canada



Action Report - Spring/Summer 2009






Action Report Logo

SPRING/SUMMER 2009





Announcement: NDMAC has changed its name to
Consumer Health Products Canada. We are phasing in the change so look for a new masthead in
the next edition of the Action Report.


Modernizing the Food and Drugs Act



The Issue:

The intent behind the upcoming modernization of the Food and Drugs Act is to move towards a
relative risk framework for regulating therapeutic products. Consumer Health Products Canada supports this approach as it ties the
level of regulatory burden imposed on a product to the level of health risk posed by that product. The industry also sees this as
the opportunity to correct a long-standing inequity.


Currently, some consumer health products are regulated by the Natural Health Products Regulations,
while other consumer health products fall under the same regulatory framework as prescription drugs (i.e. Part C of the Food and
Drug Regulations
). While both sets of products are assessed to be of lower risk, requiring one set of consumer health products
to meet the regulatory burden of prescription drugs is contrary to the intent of the new legislation and creates unnecessary and
unfair regulatory hurdles for consumer health products.


Consumer health products - regardless of the source of their ingredient - are lower risk than
prescription drugs and should not be subject to the same regulations.


Consumer Health Products Canada is asking the federal government to ensure that the amended
Food and Drugs Act includes a provision that all consumer health products will be regulated separately from prescription drugs,
thereby allowing the consistent regulation of all products intended for self-care.


What's New:

The intent of the Government of Canada's Food and Consumer Safety Action Plan is to create a new
legislative foundation to better protect Canadians from unsafe consumer, health and food products.

Bill C-6: the Canada Consumer Product Safety Act
(formerly Bill C-52), and the upcoming bill to amend the Food and Drugs Act are two key components
of this plan.


Bill C-6, which passed third reading in June and is now being reviewed by the Senate, will allow for
prompt and effective action when a danger to human health or safety exists, as well as prohibiting the supply of consumer products
that pose an unreasonable danger to human health or safety. The Government is in the process of drafting legislation to amend the
Food and Drugs Act, which could be tabled in the fall.


While Bill C-6 does not apply to consumer health products, many of the provisions contained in the
bill will also be included in the bill to amend the Food and Drugs Act.


Consumer Health Products Canada in Action:

For over ten years Consumer Health Products Canada has been working closely with departmental and
elected officials on legislative renewal. The Association has been advocating for the development of regulations for consumer
health products that are distinct from those for prescription products, thereby ensuring the consistent regulation of all health
products intended for self-care.


Given that government is drafting a bill to amend the Food and Drugs Act, CHP Canada has turned
up the heat and is asking that a provision to provide consistent regulation for consumer health products that is separate from
prescription drugs be included in the bill.


Over the course of the spring, CHP Canada successfully executed a coordinated communications campaign
with advertising and direct mail components that culminated with two Association lobby days on Parliament Hill in May. In meetings
with key elected officials and senior civil servants, CHP Canada members and staff received support for our request, including an
endorsement by senior departmental officials in a meeting with Health Minister Leona Aglukkaq.


CHP Canada also appeared as a witness during the Standing Committee on Health's study of Bill C-6.
While consumer health products are explicitly exempt from this proposed legislation, the Association intervened because expected
amendments to the Food and Drugs Act are likely to contain similar provisions. CHP Canada was successful in getting
amendments made so that, in the event that the minister of health deems it necessary to release confidential business information
to third parties (eg., because of a recall or other such serious event), the minister must notify the affected companies within one
business day of the release of the information (the original Bill did not provide for any notice). The Bill was also amended to
ensure that only confidential business information that is crucial to the protection of public health can be released.


What you can do:

This is a once-in-a-generation opportunity to influence the fundamental structures underpinning the
regulation of our industry's products. It is critical that CHP Canada member companies and the rest of the consumer health products
industry become actively involved in supporting and asking the government to include in their amendments to the Food and Drugs
Act
a provision for ensuring that all consumer health products will be regulated separately from prescription drugs.


The bill is not expected to be tabled until the fall. Until then:

1. Write to and meet with your local MP at some point during the summer and
emphasize:





  • The consumer health products industry is very supportive of modernizing the Food and Drugs Act
    and are looking forward to seeing the bill tabled in the near future.


  • We are hopeful that it will set the legislative basis for implementing a risk-based regulatory
    framework (i.e., that the degree of regulatory oversight of a product will be appropriate to the degree of the potential risk of
    the product).


  • We also hope that the bill will provide the legislative basis for ensuring that all consumer health
    products will be regulated separately from prescription drugs.


  • We continue to be supportive of Parliament's actions in 2004 to remove natural health products from
    the prescription drug regulations. We wish to preserve the separate regulation of NHPs, and seek the creation of new regulations for
    other consumer health products that reflect their lower risk nature and are outside Part C of the Food and Drug Regulations.


CHP Canada has materials that you can use to visually demonstrate the current inconsistency in the
regulations. To obtain your "Know the Difference, Then Make a Difference" campaign kit, please contact
Mary McEwen.

Tip: The MPs will be in their ridings throughout the summer.
We recommend that you meet with them in their constituency offices to specifically discuss this need and that you watch for
opportunities to meet them in your community, such as at their fundraisers, community events, etc.


2. Spend the summer determining how other potential amendments, such as the
handling of confidential business information, the powers of the Minister and inspectors, product life cycle regulation, etc.,
could affect your company and the different corporate divisions of your companies (e.g. pharma and personal care product divisions)

and work on developing some general corporate positions on these issues. Please share your thoughts on these issues with
CHP Canada
by September.



Tip: Review Bill C-6
and the
former Bill C-51
for ideas of how the new bill on the Food and Drugs Act will stand such issues as the handling of confidential business
information, the powers of the Minister and inspectors, product life cycle regulation, etc.




Resources:



Background: How does Health Canada determine which regulations to
apply to which products?


Health Canada applies a series of criteria to determine whether or not a product requires the
prescription of a health professional in order to be used safely and effectively. If the product is captured by these risk criteria,
regardless of whether the active ingredients are naturally occurring or synthetic, it will be classified as a prescription drug and
regulated under Part C of the Food and Drug Regulations. If, on the other hand, the product falls outside those risk criteria,
the regulations to which it will be subject depends on whether or not the active ingredients are found in nature. Products that are
naturally occurring will fall under the Natural Health Products Regulations and those that are not will be placed under Part C,
just like prescription drugs.


Background: What is the problem with having some consumer
health products regulated by the same regulations as prescription drugs and others by the Natural Health Products Regulations?


Part C of the Food and Drug Regulations includes, under Division 8, a requirement that all "new"
drugs (using new chemical entities) be subject to extensive premarket authorization review in a New Drug Submission (NDS). New
consumer health products are not generally pulled into Division 8; however, there is one provision that indiscriminately pulls
low risk consumer health products into "new drug status," and that is when a company combines two or more well established
ingredients into a new formulation/product that has never been marketed in Canada before. For higher risk prescription drugs,
this provision makes sense as the potential for serious drug interactions is one of the criteria that can keep an ingredient in
prescription-only status. For consumer health products that combine ingredients that both have broad safety margins and have
already been established as having a very low potential for clinically significant interactions, it makes no sense at all. The
prohibitively high costs and excessive regulatory burdens are barriers to the development of new products for self-care, which is
proven to be one way to reduce costs on the formal health care system.


By contrast, the Natural Health Products Regulations take an approach to novel formulations or
uses that is far more appropriate to low-risk consumer health products. In fact, this particular issue was the single most important
factor behind the creation of the NHP regulations.


CHP Canada Contacts:











Copyright 2009 by Consumer Health Products Canada. Action Report is published four times a year. It is designed to increase awareness of specific issues that have a direct
impact on the consumer health products industry.






CHP Canada Logo



CHP Canada/NDMAC HOME PAGE



© Consumer Health Products Canada, 1111 Prince of Wales Dr., Suite 406,

Ottawa, Ontario, Canada K2C 3T2


Tel.: 1-613-723-0777 Fax: 1-613-723-0779 info@chpcanada.ca



Managing Editor: Kelly Tchorewski




Saturday, August 8, 2009

These postings are from

The Rest of the Story:

Tobacco News Analysis and Commentary

..Providing the whole story behind tobacco news.

By
Dr Michael Siegel Boston, Massachusetts

I am a physician who specialized in preventive medicine and public health. I am now a professor in the Social and Behavioral Sciences Department, Boston University School of Public Health. I have 20 years of experience in tobacco control, primarily as a researcher. My areas of research interest include the health effects of secondhand smoke, policy aspects of regulating smoking in public places, effects of cigarette marketing on youth smoking behavior, and the evaluation of tobacco control program and policy interventions.

Friday, August 07, 2009

Experiences of Electronic Cigarette Users Suggest that These Could Be Life-Saving Devices and that They are Effective for Smoking Cessation

While I agree that there is a need for research into the relative safety and effectiveness of electronic cigarettes, there is also a need for anti-smoking groups and the FDA to study the experience of electronic cigarette users with this product. The passionate testimonials of hundreds of electronic cigarette users suggest that these devices are effective in helping smokers to quit and stay off cigarettes.

I challenge the anti-smoking groups and the FDA to read all of these comments and then to reiterate their position that electronic cigarettes must be taken off the market.

These are all the comments from electronic cigarette users in response to Dr. Whelan's Washington Times op-ed piece. They are taken from the Washington Times site as well as the Digg site for this article. I have not omitted any comments from electronic cigarette users, which is remarkable because there is not a single comment from a user who has not found these devices to be effective in smoking cessation.

The Rest of the Story

"I smoked traditional cigarettes for 27 years.... 2+ packs a day. On June 11th, my first e-cigarette starter kit arrived in the mail. I opened it up and started using it. I have not had a traditional cigarette since that day!! Even if there are some risks associated with these products, it can NEVER be as dangerous as traditional cigarettes so WHY would the FDA (or anyone else) want to stop me and other smokers from using them??? THANK YOU Dr. Whelan for putting this in proper perspective!!"

"Do not allow this product to be taken off the market. It saved my life (my smoker's morning cough disappeared in 3 days after switching to an e-cig) and many thousands more. The FDA is being unbelievably hypocritical in this matter and it shows how politics and money, rather then genuine concern for public health, is behind everything they do. And this is coing from a registered Pharmacist."

"E-cigarettes (also known as Personal Vaporizers) got me off smoking after 20 + years. They're a miracle IMO. The deeply flawed FDA study is being used as a propaganda tool to mislead people about these devices. Their implication that e-cigarettes are just as dangerous as traditional smoking is absolutely incorrect. E-cigarettes save lives."

"E-Cigarette got me off 2 pack a day habit."

"I was a 30+ yr. smoker. None of the other stop smoking aids ever helped me. My blood pressure was out of control. After 8 days of use I was able to stop smoking entirely and my blood pressure has come down substantially. I've been smoke free for 3 months now. I think it would be a travesty to take these away from thousands of people and tell them to go back to smoking."

"I still have a pack of Marlboro cigarettes unsmoked since I took a first puff of these 2 weeks ago. To take them off the market would be a horrible idea and drive many smokers back. Of course tobacco companies and governments stand to lose billions in revenues if these catch on... and they will... so expect to see everything thrown at these new e-cigarette startups to stop this trend."

"I have smoked for nearly 20 years and NEVER went a day without smoking at least a full pack of smokes. Ever since I got my E-cig (3 weeks ago), I never had another reg cig since... I feel better, breathe better, sleep better and thats just to name a few. These are choices we made, please don't take these life changing choices from us!"

"I haven't smoked a tobacco cigarette in over 20 days thanks to the e-cigarette. Nothing else worked before. If this device becomes illegal, it will cause me to go back to using tobacco products or get a prescription to aid in my addiction which has more harmful side effects. Spread the word, this device is helping people lead healthier lives."

"Many of us, e_smokers, would have to go back to smoking regular cigarettes and harm not only yourself but non-smokers too with second hand smoke, increase health insurance cost and so on..."

"I use electronic cigarettes and have cut my consumption of tobacco cigs from a pack a day for 40 years to 1-5 cigarettes a day. I actually now prefer electronic cigarettes, and in the process have gone from thousands of chemicals in smoked tobacco to about 4 in e cigs. Do the math."

"I was smoking the traditional cigarettes for 20 years until I heard about the electronic cigarette. I have not touched a traditional CANCER stick in over 4 months, and I have slowly reduced my nicotine down to the lowest strength. I believe the FDA is working hard on this situation, my main question is, who are they working for. It makes no sense to stop an obvious safer alternative, for the ones they are trying to push us back on that kills over 450,000 people a year."

"I too smoked cigs for 25 years. I bought myself a kit, started "vaping" and haven't looked back."

"Almost 45 years a smoker at better than two packs a day. In less than two days I got rid of the wheezing, coughing and my tobacco cigarette intake dropped to less than five a day and falling. Someone in the FDA needs to see that there is a difference between trace elements of a carcinogen found in the e liquid (the vaporized liquid wasn't even tested by them) and the 60 some know heavy dosages of carcinogens found in cigarettes."

"I was a smoker for 10 years, tried to quit dozens of times. This product is the only thing that has made it possible for me to quit. Please don't ban e-cigs."

"I don't use e-cigs as a smoking cessation device. They are not for smoking cessation, although, many have quit smoking because they have this alternative. It is a much safer alternative, than inhaling 4000 chemicals the tobacco companies only recently admitted to. This is an alternative. I quit smoking over 3 months ago, prior to using an e-cig. I found that I missed the ritual, much like I'd miss having a cup of coffee in the morning. If for some reason I couldn't drink coffee anymore, I might have a cup of tea, or perhaps some other warm drink in my cup. Why on Earth couldn't I have an alternative to a deadly cigarette? Now I have come to know, after talking and listening to many people who have been using e-cigs, that they are very concerned over the safety of what is being inhaled, so much so, that they'd rather use this, than buy what they know is infinitely more harmful, tobacco cigarettes. Many are also not "vaping" nicotine at all!

When I smoked about 2 pack of cigarettes a day, I was wheezing, out of breath, and feeling horrible. The one room I smoked in was covered with tar, and smelled terrible. Since using the e-cig, there is no smell, I have no wheezing, I don't feel sick. There is no second hand smoke to keep from my family."

"I smoked for 25 years, and tried to quit (and failed) at least 5 times. My e-cig made it so easy. It took between 1 and 2 weeks, but the desire for a regular cigarette just melted away. You have to actually want to quit--but if you do, these things make it SO EASY!!! I haven't had a real one in 8 months and I don't miss them at all."

"I started smoking at age 19. From there, I smoked for 9 years until I was 28. I considered myself a casual / light smoker. A pack of lights or ultra-lights would last me about a week/week and a half. It was easy to switch over to e-cigs. Haven't touched a cigarette since. I love my e-cig."

"Massive Harm Reduction! 30 years of smoking cigarettes and now an alternative that works."

"I'll throw my 2 cents in to say e-cigs enabled me to quit after many many years of smoking. I thought I'd never be able to quit. These things are fantastic as a cigarette replacement. Still addicted to nicotine but nothing like the addiction I had when the delivery system was a cigarette."

"Great to read something positive about E-Cigarettes. I've been using this product for about 6 months and I have completely quit smoking cigarettes. I didn't even purchase this product for that- I was just curious. I found that the urge to smoke disappeared completely within a week of using this product. It makes me sick to think that the FDA could be so negative about a product that could potentially save millions of Americans from death."

"My wife and (Me 30yr smoker her 6yr smoker) have tried everything patches gums pills cold turkey and nothing has worked until now. We plan to quit within 3 months not long term."

"We are no longer smoking ANY tobacco cigarettes and feel great. We have already dropped from 24mg to 18mg and plan to keep going until finished with nicotine. we then may choose to use 0mg for as long as it takes to loose the psychological addiction. That is the real tough nut. I quit for a year once and went back. If I had the e-cig I would have used them and not gone back to the real cigarettes resulting in an additional 10 years of smoking."

"Thank you Dr Whelan. As corny as it sounds I almost cried when I read this. We as a people have been bombarded with the false claims of the FDA on this device, however, I truly feel it can save my life. I have tried every cessation method out there with no success until the ecig. I am a former two pack a day smoker and have not even looked back."

"I’ve been a life long cigarette smoker (35 years) whom has unsuccessfully attempted to quit many times. After the failure of the patch, nicotine gum, prescription drugs and cold turkey attempts; I have the e-cigarette to thank for my success."

"I have smoked for 20 years and have been 5 months now tobacco free because of e cigarettes. I have not touched a real cigarette since the day I received my electronic cigarette. Before that, NOTHING could get me off the tobacco cigarettes. I am taking in very low doses of nicotine and have reduced my nicotine immensely. The e cigarette has changed my life and I will never go back to smoking again. This is a crime to try and take this away from me. Without a doubt I know that what I am doing is WAY safer than smoking real cigarettes. SHAME on the FDA for what they are trying to do to us while they sit there and allow real tobacco known and proven cancer causing cancer sticks."

"These devices are a miracle. I tried everything to quit. Nothing worked. I quit cigarettes on the first day with ecigs. I am an adult. This is my choice and no one elses. Why would you force someone to go back to cigarettes?"

"After using an e-cigarette for 4months and 5 days, the only side effect I can report is I have been tobacco free all that time. I didn't buy it to quit smoking; I bought it to cut back my usage a little. NEVER would I have expected this to take the place of my tabacco cigarettes! And yes; I've used the patch, gum, drugs, candy sticks - all those APPROVED methods. I've 'suffered' with smoking for over 25 years. Is this the same as smoking? Well, when I asked my Dr, he said "*ell no! Congrats! you are now a NON SMOKER!""

"After 25 yrs of smoking, I have finally found something to get me off of the tobacco, tar, carcinogens and fire."

"I was an analog cigarette addict for 40 years. Forty Years. for Forty years, I was degraded and looked down upon by co-workers, even fired from one job by a boss who swore I 'smelled like cigarettes'. I've been subjected to restriction to designated smoking areas which are unsafe, poorly maintained, inconvenient and invariably exposed to the elements. I've been penalized by health insurance companies with higher premiums, even tho I've never been sick. I've been taxed exorbitantly by a government who capitalizes on my addiction. I've been lied to by Big Tobacco about what's in their product. I've been ripped off by Big Pharm with their snake-oil cessation products with alarming side-effects that invariably do more harm than good. And then I found the e-cigarette. And ended my days of paying up to $3/day/pack in taxes. For Forty Years. Ended my days of being analog cigarette dependent. My self-esteem is back. I haven't picked up a Big Tobacco cigarette in a month. for the first time in Fourty years. I may still die from 40 years of smoking, but at least I won't be surrounded by cigarette butts and ashtrays and I will have finally kicked my addiction. e-cigarettes save lives."

"I smoked for 25 years. Last year April I found out about the e-cigarette, started using them and I had my last real cigarette July 20th. of last year. So thankfully I am a nonsmoker now for over a year. I will never go back to smoking, will stick around for vaping. I feel better, I don't have a smokers cough anymore, I have more energy. Most people who quit smoking will gain weight. I have not even gained one pound. Also I have been saving a lot of money by not having to spend $ 4.00 on a pack of cigarettes. All in all it's a winner."

"I use a device called the electronic cigarette as a part of a personal harm reduction strategy, and it has helped me to break my 30+ year addiction to tobacco cigarettes. This device contains absolutely no tobacco and creates no smoke, yet provides some of the chemical, physical and psychological aspects of smoking without the deadly effects of a tobacco cigarette. I wish I had never made the foolish decision to smoke as a youngster. My wife of twenty years has never seen me without a cigarette in my hand. I can find very few family photographs that do not show me with a cigarette in my hand. I was completely addicted to tobacco. Two days after I chose to begin using an electronic cigarette with a fluid containing propylene glycol, water, flavorings and nicotine (optional component), I stopped smoking tobacco. I breathe easier, my sense of taste and smell has greatly improved and I no longer reek like an ashtray! Am I now addicted to another device, perhaps; but I am damn comfortable with my decision to inhale nicotine (think nicotine inhalers from drug companies) and propylene glycol (think theater fog). I can control my nicotine intake, I have the option to gradually reduce my nicotine intake and will trust my body to tell me if I am doing something wrong or harmful. My other recourse was to continue to burn thousands of chemicals in tobacco while I wheezed and coughed my way to death. I chose to make a change and the electronic cigarette has improved my life."

"I smoked for 45 years, tried to quit several times only to fail again. I discovered ecigs and within 14 days I quit, I have not touched a cigarette now for six months. I have no desire to smoke tobacco, in fact find it utterly repulsive now. This option could improve the lives of a lot of people not to mention health related cost savings."

"I have been perfectly content since stopping all analogs from day one after my e-cig arrived. A little on the jittery side for the first couple months, and after I switched away from PG to VG, I am now really content, no more jitters, if fact, so content that almost 3 weeks ago now I dropped the nicotine density of my juice from 24mg/ml down to 18mg/ml, with no side effects whatsoever! I find that fascinating, how can that happen when it never happened that way with analogs...if I cut down, I was a physical and mental MESS!!! So what is the secret? It's just a bad system? Tell that to the Doc that just published that article in the Wash Times! She seems to think it's a great idea. AND, that is why these tests have been valuable to me. I wanted to know the truth about what I was actually pulling into my body. And oh yes I was pulling nicotine into my body, and true to the testing done by Ruyan group, it is exponentially lower than when compared to a tobacco cigarette! That was the whole idea! And, if it quenches the god-awful withdrawal side effects of conventional and FDA approved NRT's (nicotine replacement therapy) PLUS gives the person using the options each individual needs to be able to stop smoking cigarettes, Lo and Behold, it has proven itself to be the very BEST kind of NRT. We're happy, this bunch, for some it may be just something new to do, but for me it was for quality of Life and removal of toxins and poisons that I knew and have known for a long time would eventually cause my death! That's pretty powerful, to me. I am now feeling more alive than I have at any time during my 44 years of smoking tobacco cigarettes."

"I have been using the e-cigarette for two months now with no side-effects and with almost no nicotine. I was almost a pack a day smoker and have no desire to go back to cancer sticks. Actually I take that back - I have had side effects, like being able to run without getting winded, more energy, and a better sense of taste/smell. I find the FDA's objections to the e-cigarette to be highly questionable."

"I smoked for 45 years one and half packs a day. Tried to quit numerous times and failed. I discovered ecigs and within 14 days I quit completely and have not had a desire to go back. This could improve the lives of many not to mention health related cost savings."

"I was a 1 1/2 to 2 pack a day smoker for over 40 years. When I first tried e-cigs it was to try to slow down on my tobacco cigarette smoking. My smokers cough was out of control. I coughed and hacked all the time, night and day. After about a week on e-cigs the cough was GONE!! I didn't start out to stop smoking, but it happened. I feel so much better! I can breath again. My sense of smell and taste have returned an I don't smell like cigarettes anymore. I don't need a lighter on me all the time and I don't need ashtrays either."

"I have been a smoker for 25 years and with the e-cigs I have been able to quit smoking real cigarettes. I am so grateful for this story I could really tear up."

"In this decade it's been nearly impossible to find honesty coming from a news source. Now that I can finally breath again since switching to e-cigs 5 months ago, I can truly appreciate a breath of fresh air."

"After 25 years of smoking, and at least 5 failed attempts to quit, I finally did it with my electric cigarette. And it was so incredibly easy, I didn't realize I was doing it--the urge to smoke real cigarettes just fell away over the first week or two I had it. Patches, gum, willpower, and Alan Carr all failed me, but this actually worked."

"I, too, smoked those "nasty stinkies" (tobacco cigarettes) for 40 years, tried all of the "smoking cessation" rip-offs, to no avail, until 9 months ago, when I bought my first E-Cig...2 1/2 weeks later, I had smoked my last tobacco cigarette! Now, 9 months later, I never would have imagined I would feel this good & healthy at the age of 60. I thank God for the invention of the electronic cigarette. Please, God, don't let them take THIS away from us. We want to live."

"I have not had a cigarette for 7 months. I detest the smell of them. I can't believe I smoked for so long. I started out with medium strength, then went to low, and I am now at extra low. I have not coughed in months. I no longer hear myself wheezing in bed. If the ecig has done all this for me, how can it be bad?"

"I have used e-cigarettes for over a year and have experienced health benefit from using them personally. I have had major health problems and the NRT's currently available, did not help and caused side effects. I hope more Doctors, join in this fight for harm reduction in using e-cigarettes."

"After 37 yrs of cigarette addiction, and many unsuccessful attempts to quit; it was only e-cigs that actually enabled me to give up smoking. This product has saved my life. It gets even better. Within a few weeks of using this product, I was down to level ZERO with the nicotine. There were no side effects. That suggests to me that my addiction was more in the mechanics of smoking."

"I smoked for 25 years, and tried to quit (and failed) at least 5 times. My e-cig made it so easy. It took between 1 and 2 weeks, but the desire for a regular cigarette just melted away. You have to actually want to quit--but if you do, these things make it SO EASY!!! I haven't had a real one in 8 months and I don't miss them at all."

"I smoked for 32 years and have been using the E-Cig for 2 months. I really needed to quit because I have Diabetes and other health problems. The Doctor said I was "a ticking time bomb" for stroke or heart attack. NOW? My blood pressure is back to where it was 32 YEARS AGO!! And my lungs were described by my Doc as "wonderful" I feel so much better. Thanks to a PV I have not polluted the air around me for almost 3 months. I did not buy this devise with the intention of quitting tobacco cigarettes, I was tired of being forced outdoors in all weather to feed my addiction. Within 2 weeks I was tobacco free by accident."

"I bought my first ecig last Friday. One week without a cigarette! I breathe better, I smell better, and I am excited and hopeful for a better future!"

"I quit smoking real cigarettes from the very first day after being a pack a day smoker. I can breathe again. I can smell again, I'm not as tired either."

There are many more posts on many different sites ... it's time to lift the ban.

eSmoke Cartridges - Lab Tested and Diethylene Glycol free!


Lab test and Diethylene Glycol (DEG) free


Precision Testing Labs - NJDEP Certified In response to the recent FDA report that found Diethylene Glycol in cartridges from our competitiors. We are pleased to announce that a recent third party analysis of the eSmoke cartridges was found to be free of DEG.

The FDA's report also backed up it's initial statement that e-cigarettes are no safer than real ones in an attempt to scare electronic cigarette users into returning to real cigarettes by alarming them about the carcinogens detected in the product, without telling them that that the levels were no higher than in nicotine replacement products and that they are 1400 times lower than in Marlboros.

Dr. Michael Siegel, a professor in the Social and Behavioral Sciences Department, Boston University School of Public Health with over 20 years of experience in tobacco control, primarily as a researcher stated in his blog titled "The Rest of the Story: Tobacco News Analysis and Commentary" the levels of carcinogens found in the Electronic Cigarette compared to traditional FDA approved NRTs and real cigarettes. His numbers based on scientific findings showed the following:

Maximum Tobacco-Specific Nitrosamine Levels in Various
Cigarettes and Nicotine-Delivery Products (ng/g, except for nicotine gum and patch which are ng/patch or ng/gum piece)
ProductNNNNNKNATNABTotal
Electronic Cigarette 3.87 1.46 2.16 0.693 8.183
Nicotine Gum 2.0 ND ND ND 2.0
Nicotine Patch ND 8.0 ND ND 8.0
Swedish Snus



2,400
Winston 2200 580 560 25 3365
Newport 1100 830 1900 55 3885
Camel 3100 1400 2800 150 7450
Skoal 4500 470 4100 220 9290
Marlboro 4300 1800 4900 190 11190

You can read the full article by Dr. Michael Siegel by clicking here

In another recent article in the Washington Times by Dr. Elizabeth Whelan who is the president of the American Council on Science and Health, Dr Whelan bashes the FDA's scare tactics about the electronic cigarette, stating it to be a very viable option for addicted smokers. You can read the full article on the Washington Times website by clicking here.

Friday, August 7, 2009

Media Coverage



_____________________________________________________________________________________

Firm wants e-cigarettes to be considered tobacco, not drug

Electronic cigarettes don't contain tobacco or tar, but a Florida company is fighting for its high-tech substitutes to be identified as tobacco products, not drugs.

Why struggle to be grouped with a product vilified for killing millions of people each year? At least for Smoking Everywhere Inc., it would be a step up from having its product regulated as a drug.

Smoking Everywhere distributes e-cigarettes, which can't be lit and don't have tobacco. They are battery-operated and contain cartridges filled with nicotine, flavor and other chemicals. The steel tube that is made to look like a cigarette turns nicotine and water into a vapor that is inhaled.

Company representatives will be in Washington, D.C., on Aug. 17 for a hearing in federal district court to challenge the U.S. Food and Drug Administration, which wants e-cigarettes labeled as drug devices under its jurisdiction. You can read the court documentation here.

You can read the remainder of this article here.

_______________________________________________________________________________

Friday, August 07, 2009

Experiences of Electronic Cigarette Users Suggest that These Could Be Life-Saving Devices and that They are Effective for Smoking Cessation

While I agree that there is a need for research into the relative safety and effectiveness of electronic cigarettes, there is also a need for anti-smoking groups and the FDA to study the experience of electronic cigarette users with this product. The passionate testimonials of hundreds of electronic cigarette users suggest that these devices are effective in helping smokers to quit and stay off cigarettes.

I challenge the anti-smoking groups and the FDA to read all of these comments and then to reiterate their position that electronic cigarettes must be taken off the market.

These are all the comments from electronic cigarette users in response to Dr. Whelan's Washington Times op-ed piece. They are taken from the Washington Times site as well as the Digg site for this article. I have not omitted any comments from electronic cigarette users, which is remarkable because there is not a single comment from a user who has not found these devices to be effective in smoking cessation.

The Rest of the Story

"I smoked traditional cigarettes for 27 years.... 2+ packs a day. On June 11th, my first e-cigarette starter kit arrived in the mail. I opened it up and started using it. I have not had a traditional cigarette since that day!! Even if there are some risks associated with these products, it can NEVER be as dangerous as traditional cigarettes so WHY would the FDA (or anyone else) want to stop me and other smokers from using them??? THANK YOU Dr. Whelan for putting this in proper perspective!!"

"Do not allow this product to be taken off the market. It saved my life (my smoker's morning cough disappeared in 3 days after switching to an e-cig) and many thousands more. The FDA is being unbelievably hypocritical in this matter and it shows how politics and money, rather then genuine concern for public health, is behind everything they do. And this is coing from a registered Pharmacist."



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eSmoke Cartridges - Lab Tested and Diethylene Glycol free!

Posted on 7th Aug 2009 @ 5:26 PM


Lab test and Diethylene Glycol (DEG) free

Precision Testing Labs - NJDEP Certified In response to the recent FDA report that found Diethylene Glycol in cartridges from our competitiors. We are pleased to announce that a recent third party analysis of the eSmoke cartridges was found to be free of DEG.

The FDA's report also backed up it's initial statement that e-cigarettes are no safer than real ones in an attempt to scare electronic cigarette users into returning to real cigarettes by alarming them about the carcinogens detected in the product, without telling them that that the levels were no higher than in nicotine replacement products and that they are 1400 times lower than in Marlboros.

Dr. Michael Siegel, a professor in the Social and Behavioral Sciences Department, Boston University School of Public Health with over 20 years of experience in tobacco control, primarily as a researcher stated in his blog titled "The Rest of the Story: Tobacco News Analysis and Commentary" the levels of carcinogens found in the Electronic Cigarette compared to traditional FDA approved NRTs and real cigarettes. His numbers based on scientific findings showed the following:

Maximum Tobacco-Specific Nitrosamine Levels in Various
Cigarettes and Nicotine-Delivery Products (ng/g, except for nicotine gum and patch which are ng/patch or ng/gum piece)
ProductNNNNNKNATNABTotal
Electronic Cigarette 3.87 1.46 2.16 0.693 8.183
Nicotine Gum 2.0 ND ND ND 2.0
Nicotine Patch ND 8.0 ND ND 8.0
Swedish Snus



2,400
Winston 2200 580 560 25 3365
Newport 1100 830 1900 55 3885
Camel 3100 1400 2800 150 7450
Skoal 4500 470 4100 220 9290
Marlboro 4300 1800 4900 190 11190

You can read the full article by Dr. Michael Siegel by clicking here

In another recent article in the Washington Times by Dr. Elizabeth Whelan who is the president of the American Council on Science and Health, Dr Whelan bashes the FDA's scare tactics about the electronic cigarette, stating it to be a very viable option for addicted smokers. You can read the full article on the Washington Times website by clicking here.

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Friday, July 31, 2009

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

The rest of this story


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Thursday, July 30, 2009

Comparison of Carcinogen Levels Shows that Electronic Cigarettes are Much Safer Than Conventional Ones

The FDA last week condemned electronic cigarettes on the basis that an FDA laboratory detected carcinogens (tobacco-specific nitrosamines) in the cartridges of several electronic cigarette manufacturers. The FDA held a press conference in which it attempted to scare electronic cigarette users into discontinuing e-cigarette use (and therefore a return to conventional cigarette smoking). In addition, a number of anti-smoking groups, including the Campaign for Tobacco-Free Kids and American Lung Association, have called for a ban on these products due to this carcinogen scare.

The FDA (and the anti-smoking groups), however, failed to do three important things:

First, they failed to disclose the levels of tobacco-specific nitrosamines that were detected in the electronic cigarette cartridges.

Second, they failed to test the control product (a nicotine inhaler) to determine the carcinogen level in that product.

Third, they failed to report the tobacco-specific nitrosamine levels in conventional tobacco products, including cigarettes.

The rest of this story

Name: Michael Siegel
Location: Boston, Massachusetts

Michael Siegel ... I am a physician who specialized in preventive medicine and public health. I am now a professor in the Social and Behavioral Sciences Department, Boston University School of Public Health. I have 20 years of experience in tobacco control, primarily as a researcher. My areas of research interest include the health effects of secondhand smoke, policy aspects of regulating smoking in public places, effects of cigarette marketing on youth smoking behavior, and the evaluation of tobacco control program and policy interventions.

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BOSTON, July 27


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.

The rest of this story



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October 21st 2008

E-Cigarette Clinical Trials

Clinical trials have now been carried out in New Zealand by Dr Murray Laugeson of Health New Zealand.

The test found that the E-Cigarette was:

"...very safe relative to cigarettes, and also safe in absolute terms on all measurements we have applied. Using micro-electronics it vaporizes, separately for each puff, very small quantities of nicotine dissolved in propylene glycol, two small well-known molecules with excellent safety profiles, – into a fine aerosol. Each puff contains one third to one half the nicotine in a tobacco cigarette’s puff. The cartridge liquid is tobacco-free and no combustion occurs."

Source: Safety Report by Health New Zealand http://www.ecigarettedirect.co.uk/extra%20info/e-cigarette-safety-report.pdf (PDF)

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Matt Salmon, former Congressmen and current President of The Electronic Cigarette Association

What's in a Cigarette