FDA Miscalculates Real Danger to Smokers

[kristin]

Ok everyone, here is a rough draft of my latest article. I would appreciate reviews for accuracy and grammar! I know some won't be happy with the smoking cessation angle, but I think that horse has already left the barn and we need to address it.

FDA Miscalculates Real Danger to Smokers

By Kristin Noll-Marsh

The FDA is at a loss.

It knows why people want to quit smoking tobacco cigarettes – exposure to first and second hand smoke is proven to cause numerous health problems, from heart disease to cancer.

Up until now, the only way thought to quit smoking was to cure nicotine addiction. Beat the nicotine cravings, beat the urge to smoke – or so the theory goes. Consequently, the term “smoking cessation” has become synonymous with curing nicotine addiction with the use of Nicotine Replacement Therapies or NRTs.

However, focusing solely on nicotine addiction has been proven to be ineffective.

FDA-approved medications are tested in clinical trials and the enthusiasm of participants, close monitoring and counseling may all inflate the success numbers found in those studies, according to a report released in a 2002 edition of Journal of the American Medical Association (Vol. 288, No. 10: 1260-1264). "These products are designed to help with the cravings associated with smoking, but not the behavioral aspects," stated co-author Professor Elizabeth Gilpin, of the University of California. The report also pointed out that NRTs were originally by prescription only, giving patients trying to quit access to a physician’s support and behavioral counseling.⁽¹⁾

In the 2006 study, “Nicotine replacement therapy for long-term smoking cessation: a meta-analysis,” the authors wrote, “Due to relapse, the overall efficacy of NRT treatment in terms of additional ex-smokers declined from 10.7% over and above placebo (6.6% to 14.8%) after one year to 7.2% (3.8% to 11.3%) at an average of 4.3 years follow up. “

“Because the long-term benefit of NRT is modest," the study concluded, "tobacco dependence treatment might be better viewed as a chronic disorder, requiring repeated episodes of treatment.” ⁽²⁾

So, why the extraordinary failure rate?

What Nicotine Replacement Therapy and other medications designed to solely treat nicotine addiction fail to address is the basic human tendencies of habit and ritual. Smokers don’t just crave the nicotine. The physical act of smoking becomes integrated into their everyday activities to the point where the smokers are essentially lost without it. They become loyal to their cigarette brand. They find just the right holder and the best lighter.

Certain activities trigger the desire to light up, mostly common activities such as morning coffee, driving or after a meal. Just as people may bite on pen caps, twirl their hair or chew their lip, the act of taking a cigarette out, fiddling with it, lighting it, the sensation of inhaling the smoke, the feel of the smoke at the back of the throat and seeing the smoke swirling in the air are all part of the comfort mechanism for a smoker. That comforting ritual and habit is far and away the greatest reason why treatments that focus solely on nicotine addiction fail. After a year, there shouldn’t be any more cravings for nicotine. Ask smokers why they started up again and they’ll most likely point to a stressful event or period that caused them to seek out the comforting ritual of smoking, giving them a sense of control over their stress, not the craving for nicotine.

Nicotine is already acknowledged by the FDA and medical professionals to be one of the safer ingredients in tobacco cigarettes, as it’s commonly used medically to assist smokers in the attempt to quit. Therefore, the FDA and medical professionals must agree that the greater danger in cigarettes is contained in the actual smoke, the known source of the tar, ammonia, acetone, carbon monoxide and other toxins and carcinogens.⁽³⁾ So, why isn't the urgency to improve the smoker’s health focused on removing the exposure to smoke, rather than the addiction to nicotine? Up until now, there hasn’t been any alternative.

Enter the Personal Vaporizer or "electronic cigarette," a device whose growing popularity has left the FDA at a loss of how to properly categorize it.

For the first time in history, there is a device which, when used in lieu of tobacco cigarettes, targets the smoker’s ritual and habit instead of the nicotine addiction. Nicotine is still present in the electronic cigarette and smokers are still comforted by the look and feel, as if they are still smoking, but the component most lethal to tobacco cigarette smokers and bystanders – the smoke – is absent.

Unlike NRTs, the consumer decides when and if they will reduce or eliminate their nicotine intake. The nicotine liquid sold by reputable manufacturers is available in measured levels of nicotine content, chosen by the consumer to match their former tobacco use. It consists of water, propylene glycol, nicotine and flavoring. Propylene glycol, a substance which is generally recognized as safe and approved for human inhalation by the EPA ⁽⁴⁾, is often confused with diethylene glycol, which is a toxic ingredient found in tobacco cigarettes (and antifreeze.) Propylene glycol is actually FDA-approved for human consumption and is used as a base for consumable products such as imitation vanilla and toothpaste and is the same substance used to create theatrical fog.

In July 2009, the FDA announced that laboratory analysis of two brands of electronic cigarettes found traces (approximately 1%) of diethylene glycol in one cartridge and certain tobacco-specific toxins, which are also found in tobacco cigarettes and FDA-approved NRTs. ⁽⁵⁾ However, the agency's analysis was also quite positive in the fact that researchers did not find the dangerous levels of toxins and carcinogens, such as the tar, carbon monoxide, ammonia, etc., that is found in tobacco smoke. ⁽⁶⁾

The FDA, however, objected to some manufacturers' claims that the electronic cigarette is a smoking cessation device - falling back on the now outdated view that smoking cessation must involve nicotine replacement therapy - and electronic cigarettes have not been proven effective as NRTs through the proper studies. Electronic cigarette companies countered that their products are not intended for use as an NRT smoking cessation device, but rather as a smokeless alternative - one that mimics the habits and rituals of tobacco smoking, without giving up the nicotine. An FDA rebuttal cited numerous reports, including testimonials on vendor web sites, that consumers were using the device as a way to quit smoking and that indicated "intended use." As all NRTs fall under FDA jurisdiction, electronic cigarettes, the agency maintained, must be tested and shown to be as effective as other medicinal drugs.

Another July 2009 press release stated, “The FDA has been examining and detaining shipments of e-cigarettes at the border and products it has examined thus far meet the definition of a combination drug-device product under the Federal Food, Drug, and Cosmetic Act. The FDA has been challenged regarding its jurisdiction over certain e-cigarettes in a case currently pending in federal district court. The agency is also planning additional activities to address its concerns about these products.” ⁽⁷⁾

Most would agree that the FDA has some valid points. The nicotine liquid does need to be regulated for consistency in ingredients, labeling and safe packaging. Studies should be done for the long-term effects of its use. Laws should be passed limiting the use and sale to legal adults. However, in its zeal to gain control over the regulation of electronic cigarettes, the FDA insisted that the product be removed from the market altogether, rather than cautious use while the studies are being made. This caused a snowball of misinformation in the media and gave the general public the impression that electronic cigarettes have all of the same dangers of tobacco cigarettes, if not worse. These concerns have prompted several anti-smoking groups and legislators to call for a complete ban of electronic cigarettes, ignoring the undeniable fact that, in the absence of an alternative, most electronic cigarette owners will return to smoking deadly tobacco cigarettes.

Because the FDA is at a loss as to how to categorize electronic cigarettes as a smoking cessation device without classification as an NRT and furthermore, by insisting that a smoking cessation device must address nicotine addiction, many believe the agency has miscalculated the greater danger facing current tobacco smokers – the actual smoke.
_____________________________________________________________________________________________________________
1. ACS :: Smoking Cessation Aids Use Increases, Success Rate Declines
2. http://eprints.ucl.ac.uk/6622/1/6622.pdf
3. Smoking Effects | Effects of Cigarette Smoking
4. http://www.epa.gov/oppsrrd1/REDs/propylene_glycol_red.pdf
5. FDA Warns of Health Risks Posed by E-Cigarettes
6. Summary of Results: Laboratory Analysis of Electronic Cigarettes Conducted By FDA
7. FDA and Public Health Experts Warn About Electronic Cigarettes

 

[HaploVoss]

"As all NTRTs fall under FDA" --> [NTRT - typo?]

Really well written once again. Very professional and easy to read. Honestly I meant to say this before but aside from the subject matter, I really like your writing style.. you really do well on making your articles take the reader 'with' the story instead of forcing them to re-read it several times to make sure they understood it

My wife says great job also. And you must be good if I can get it in one read

Take care,
- Hap

 

[Madness008]

wow NRTs are a joke. What a pathetic success rate. Time to pull the plug on that garbage. That percentage probably could have quit without it.

 

[HaploVoss]

Oh the one I tried eons ago was a joke. I think it was called Nicotrol Inhaler and it was so disgusting!! It was a little white 'thingy' that you cracked open and put a cartridge in. snapped it shut and could inhale nicotine 'vapor. It tasted nasty, it burned your throat like no tomorrow, and after a few pulls on it... if you put it in your pocket then pulled it out for another pull - it was rank!! I hated it, and it cost me a fortune. What a bunch of crap.

 

[olderthandirt]

to be able to tell you how comfortable I am in having you around to speak for me Kristin! So much of what you put down rambles round in my head but when I try to write it out, ferp!

Thanks!

 

[SheerLuckHolmes]

Loved it except for the reference to second hand smoke, "...exposure to first and second hand smoke is proven to cause numerous health problems..."

To my knowledge there has never been any acceptable science proving second hand smoke a danger. It has been stated as such and become accepted to be true, but it is not. In another post in this forum is was stated, "Michael Crichton wrote a interesting essay entitled "Aliens Caused Global Warming' About 4/5th's of the way thru, he discusses how the FDA used politically-twisted science {my bold} to turn second-hand smoke into a hysterical 'for the children' issue..."

I don't like to see this false but accepted idea that second hand smoke is dangerous repeated once again.

Other than that I thought it, again, well written, well thought out and kudos to you Kristin

 

[kinabaloo]

Haven't read it all yet; but I will. Some cuts to the quotes i'll mention later.

But first, and no criticism btw because it's hard to write such as article - but i would use the term tobacco addiction r.t. nicotine addiction. The addiction to tobacco is much stronger than that to nicotine.

Hence: with effective levels of nic (e-cig r.t. NRTs) peole can give up tobacco much easier - and then also / from there cut / give up the nicotine (some people).

But the chemical addiction is more than just nicotine.

 

[kinabaloo]

I suggest cutting the red parts to keep the text more focused.

"FDA-approved medications are tested in clinical trials and the enthusiasm of participants, close monitoring and counseling may all inflate the success numbers found in those studies, according to a report released in a 2002 edition of Journal of the American Medical Association (Vol. 288, No. 10: 1260-1264). "These products are designed to help with the cravings associated with smoking, but not the behavioral aspects," stated co-author Professor Elizabeth Gilpin, of the University of California. The report also points out that NRTs were originally by prescription only, giving patients trying to quit access to a physician’s support and behavioral counseling.(1)

In the 2006 study, “Nicotine replacement therapy for long-term smoking cessation: a meta-analysis,” the authors concluded, “Due to relapse, the overall efficacy of NRT treatment in terms of additional ex-smokers declined from 10.7% over and above placebo (6.6% to 14.8%) after one year to 7.2% (3.8% to 11.3%) at an average of 4.3 years follow up. “

“Because the long-term benefit of NRT is modest, tobacco dependence treatment might be better viewed as a chronic disorder, requiring repeated episodes of treatment.” (2)"

 

[kinabaloo]

"Nicotine is already acknowledged by the FDA and medical professionals to be one of the safer ingredients in tobacco cigarettes, as it’s commonly used medically to assist smokers in the attempt to quit. Therefore, the FDA and medical professionals must agree that the greater danger in cigarettes is contained in the actual smoke, the known source of the tar, ammonia, acetone, carbon monoxide and other toxins and carcinogens.(3) So, shouldn’t the urgency to improve the smoker’s health focus on removing the exposure to smoke, rather than the addiction to nicotine? Up until now, there hasn’t been any alternative.

Enter the Personal Vaporizer or "electronic cigarette," a device whose growing popularity has left the FDA at a loss of how to properly catagorize it."

First para is very good.

I'd change the second. The FDA know well how they wish to classify it (as a drug) although the appropriate category is 'reduced harm tobacco alternative/replacement'.

 

[kinabaloo]

Suggested additions in CAPS.

"It consists of water, propylene glycol, nicotine and flavoring. Propylene glycol, a substance which is generally REGARDED known as safe (GRAS STATUS) and approved for human inhalation by the EPA, is often confused with diethylene glycol, a toxic ingredient found in tobacco cigarettes (and STANDARD antifreeze.) Propylene glycol is actually COMMONLY used as a food base for products such as imitation vanilla and toothpaste and is the same substance used to create stage AND DISCO smoke. IT IS ALSO USED IN COSMETICS AND MEDICINES, AND IS THE KEY INGREDIENT IN RESTAURANT HAND SANITIZERS."

 

[kinabaloo]

"Because the FDA is at a loss as to how to categorize electronic cigarettes as a smoking cessation device without being an NRT and furthermore, BY insisting that a smoking cessation device must address nicotine addiction, it miscalculates the greater danger facing current tobacco smokers – the actual smoke."

 

[TropicalBob]

Nicely done and very smooth writing style, Kristin.

Do not cut one word! Stand by what you wrote. People here could not agree that the sky is blue, much less specifics about e-smoking. Good job.

 

[Sun Vaporer]

Ok everyone, here is a rough draft of my latest article. I would appreciate reviews for accuracy and grammar! I know some won't be happy with the smoking cessation angle, but I think that horse has already left the barn and we need to address it.

Kristin--I am going with TB all the way here--stick with what you wrote---great job as usual.

Sun

 

[kinabaloo]

"The FDA, however, cited numerous reports, including testimonials on vendor web sites, that consumers were using the device as a way to quit smoking and that indicated "intended use." As all NRTs fall under FDA jurisdiction, electronic cigarettes, they maintain, must be tested and shown to be as effective as other medicinal drugs."

A NOTICE TO DESIST FROM THAT CLAIM COULD BE ADDRESSED TO THE FEW VENDORS THAT MAKE IT.

AS FOR THE E_CIG CLASSIFICATION< IT IS NOT DESIGNED TO HELP PEOPLE STOP NICOTINE BUT STOP SMOKING. SO IT IS NOT A DRUG THERAPY, IT IS A REDUCED HARM PRODUCT, A LONG TERM REPLACEMENT THAT ELIMNATES THE DANGERS OF SMOKE.

 

[laurieok]

Add another me too!! Its PERFECT!! Love the way you write!!

 

[kinabaloo]

Nicely done and very smooth writing style, Kristin.

Do not cut one word! Stand by what you wrote. People here could not agree that the sky is blue, much less specifics about e-smoking. Good job.

I believe the idea is to get feedback. I took the trouble to do just that.

 

[kinabaloo]

Kristin--I am going with TB all the way here--stick with what you wrote---great job as usual.

Sun

What a surprise.

Ok, forget everything I suggested. It's wonderful and perfect. Go with the thought controllers ('those nice FDA guys aren't bad, just misunderstood' - yeah right).

(I only made some suggestions as that's what you asked and because it's basically very good)

 

[kristin]

Thank you everyone.

No worries, Kinabaloo - I take very seriously every suggestion you made and will place careful consideration of each. Thank you for your time and effort!

 

[BigJimW]

Looks good Kristin. When you're done, I'll toss it in the pressroom if you want.

We also miss you over at the other place.

 

[~Gazoo~]

Good article..but

"Propylene glycol is actually used as a food base for products such as imitation vanilla and toothpaste and is the same substance used to create stage smoke."

Its not smoke. It's fog but could be classified as artificial smoke.