FDA's partial truths and exaggerations endanger health
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FDA's partial truths and exaggerations endanger health

Rockville : MD : USA | Mar 26, 2012 at 3:03 PM PDT
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The Public Health Impact of Tobacco Product and Advertising Regulation

After the U.S. Food and Drug Administration (FDA) held a press conference in July, 2009 to announce the results of their testing of 18 samples from two brands of electronic cigarettes, several countries responded by banning sales of the devices. For example, Uruguay, Colombia, Panama, and Argentina are countries that ban sales altogether, while Canada and Australia do not ban sales of hardware, but do ban sales of liquid containing nicotine.

The FDA press release announced that cartridges "contain carcinogens, including nitrosamines, and toxic chemicals such as diethylene glycol." Apparently the goal was to make the audience believe that e-cigarettes are quite likely to cause cancer and might even poison users. The trick worked.

The "trick" involved saying nothing that was untrue, but leaving out just enough facts to make the audience draw an incorrect conclusion. Yes, there were "carcinogens", detected, but "including nitrosamines" is a red herring, because the ONLY potential carcinogens detected were Tobacco-specific Nitrosamines (TSNAs). The wording selected by the FDA made it appear as if several different types of carcinogens were detected. Even more important is the fact that the FDA neglected to mention the quantity of TSNAs measured.

We know from testing conducted by other researchers that there are 8 nanograms in 1 gram of liquid that contains 1.6% nicotine. A 4 mg. nicotine patch also contains 8 nanograms. There are no cancer warnings on nicotine patch containers because 8 nanograms is such a miniscule quantity that it has never been shown to cause cancer. In contrast, a pack of full-flavor cigarettes can contain 126,000 nanograms of TSNAs.

So, ironically, the governments that responded by banning e-cigarette sales "protected" their smoking citizens from exposure to 8 ng of TSNAs instead of allowing them to switch, which would have protected them from exposure to hundreds of thousands of ng of TSNAs, plus many more types of carcinogens, in cigarette smoke!

The press release mentioned "toxic chemicals" [plural] implying that several different types of such chemicals were found. Yet the report cites only one toxin. And this chemical was found in a non-toxic concentration of 1% in one cartridge. The cartridges being tested hold at most 0.5 g of liquid. If users drank the liquid from the cartridges, an average weight adult would need to drink the contents of several thousand cartridges that contained diethylene glycol in a single day to be exposed to a fatal dose.

But users don't drink the liquid. They vaporize the liquid and inhale the vapor. What did the FDA find in the vapor? "Nicotine was detected in both products for all cartridges containing low, medium and high levels of nicotine but was not observed in cartridges identified as containing no nicotine. Screening for the possible tobacco specific impurities cotinine, nicotine-N-oxide, nornicotine, anabasine and myosmine was negative. β-Nicotyrine was detected in all Njoy cartridges but was not detected in the Smoking Everywhere cartridges." http://www.fda.gov/downloads/Drugs/ScienceResearch/UCM173250.pdf

The report does not mention finding any TSNAs at all in the vapor. β-Nicotyrine is neither toxic nor carcinogenic.

Here is the bottom line: Smokers who switch to e-cigarettes are exposed to nicotine if they use cartridges that contain nicotine. Health New Zealand found that cartridges with 1.6% nicotine deliver from 1/10 to 1/3 the amount of nicotine per puff that a puff of smoke delivers. Smokers who continue lighting up tobacco cigarettes are exposed to nicotine, plus tar, particulates, poisonous gasses, plus thousands of chemicals created by the process of combustion. Hundreds of these chemicals are toxic and dozens are carcinogenic.

If someone you loved was a smoker who is unable to quit, would you prefer that they switch to an e-cigarette or that they continue inhaling smoke?

True, there has not been enough testing to prove beyond a shadow of a doubt that e-cigarettes don't present any new types of health risks, and the only quality control practices are the voluntary measures put in place by manufacturers. But given the high risks of continued smoking, a replacement doesn't need to be 100% safe--it only needs to be less hazardous.

How long will it take before there is a government stamp of approval on an e-cigarette?

After 45 years of smoking, I didn't have time to wait around. I was being kept awake at night by loud wheezing. I had a productive morning cough. I couldn't enjoy a good laugh because by the third "ha" I was going into an embarrassing coughing jag. Maybe the next cigarette I lit would be the one that started a tumor growing in my throat or in my lungs.

On March 27, 2009, I switched. The nightime wheezing has disappeared along with the productive morning cough, and I can enjoy a good hearty laugh, without being interrupted by a coughing jag.

I pity the citizens of the countries where e-cigarettes have been banned. How many smokers kept inhaling smoke who might have been able to switch to vapor? How many of those continuing smokers have developed cancer, COPD, or had a heart attack or stroke, thanks to their government being fooled by the FDA's partial truths and exaggerations?

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Elaine Keller is based in Springfield, Virginia, United States of America, and is a Stringer for Allvoices.
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Posted By mhatter99 Martin Kloess | about 1 year ago
well written - thank you
Posted By hmichaelharvey Harold Michael Harvey, J. D. | about 1 year ago
So glad I gave up smoking way back in 1975 as a New Year resolution.
Posted By Bruno24 Bruno24 | about 1 year ago
This illustrates that the FDA has not yet really accepted the principle of harm reduction. It looks like we should ban the security-belt in cars under the pretext that it does not eliminate *all* dangers. This is a ridiculous, sad, and an harmful attitude.
Thank you for the information both on the e-cigarette and on the FDA.
Of course, as long as cannabis is not approved as an healthy product by the FDA, we might continue to expect them saying anything to protect their own interest. What a shame.
Reply By wdstckdr wdstckdr | about 1 year ago
It illustrates that the FDA can reiterate the same may, should and possibly antics with ultimately no outcome. They have a nice website and very pleasant ideas. Wonderful caring and somewhat mothering overview of all of this material. There is a lot of money in the Tobacco Settlement and a safer anything will decrease government revenue from the Settlement.
Posted By Namma Namma | about 1 year ago
I have used e-cigarettes and vaped my way to better health.

This April I will be free of tobacco and paper burning cigarettes for one year.

Not only that, I have gone from 21 milligrams of nicotine e-liquid to 5 milligrams and my next order will be 0 milligrams. My plan is to be free entirely before summer.

It's disgusting that the FDA slants and skews it's research and reports based upon how much they're vested in the tobacco companies (in times past) and now into big pharma.

I think that it's past time that the citizens of the world mandate that any sitting politician, or government agency employee or committee member, MUST give up any and all form of investment into public companies.

This is a horrible offshoot from Congressmen and Senators NOT being banned from insider trading.

It's time to ban insider trading by Congress
http://finance.fortune.cnn.com/2011/11/18/insider-trading-congress/

Senators propose rules stopping insider trading by Congress members
http://thehill.com/blogs/on-the-money/801-economy/194521-senators-propose-insider-trading-rules-for-congress
Posted By wdstckdr wdstckdr | about 1 year ago
This illustrates the power and the influence of the Fourth arm of the U.S. government, in Orwellian terms they would be Ministries. The power to effect a change rests to a great extent in the agendas of these non-elected officials and their actual existence. The legislative bodies are certainly able to mandate that an agency undertake jurisdiction of a subject, but after that it is lobbyists and special interest groups that push for agendas. This is a well formulated piece that is at this time a concluding statement that will retire this old and frankly tiresome news. The FDA (a fourth branch of gov't) has made no effort to remove the postings or correct their assertions. The rhetoric continues as pseudoscience that is made more credible by the continued lack of correction by a governmental agency. I would look at that as criminal neglect and misinformation is much more damaging than no information. At stake here are Pharma and Big Tobacco interests (an interesting pairing that are on opposite sides of the agenda, one producing tobacco products and one tobacco cessation medications (now OTC and prescription). The advent of a viable and possibly more effective alternative that sprung from the grassroots of the populous is just not right and must be causing many ripples with the fabric of corporate time. Electronic cigarettes and other Tobacco Harm Reduction materials (SNUS for example) are like a black hole in the space time continuum of the FDA-Pharma-Big Tobacco triad. Money for smoking cessation, combustible tobacco and the Tobacco settlement money (which appears for the most part to be used primarily for non-tobacco related actions) are jeopardized by these new technologies. Nicotine a word associated with death and destruction is now a promising agent to treat senility, not a tumor initiator and may be helpful in attention and task related activities. Arguments that it may be this or could be that are the arguments of an entity that does not have available data to show any effect. Not even to detect trends. Yet the real issue is that there are trends and one is the billions spent on decreasing childhood smoking have shown very little effects and may show none if you factor the higher taxes and less use portion out of the equation.
What I see in the workplace is a decrease in people having cigarettes to share, smoking half and keeping the other half for later and the increase in the use of smokeless alternatives. If increasing taxes helps decrease total tobacco consumption on a kg/smoker basis, that would say this is a great policy. Well check the outdoor ashtrays, there may be a few less cigarettes, but there certainly are many, many more cigarettes smoked to the filter line and beyond. Nobody stubs out a two puff smoke anymore. Consumption and use may be on the supply demand curve, increase cost then one increases the percent of the product consumed with the ultimate outcome being that there is a pseudo-reduction in amount purchased with more efficient use of the product the reason.
Great article.
Posted By BenjaminGrant BenjaminGrant | about 1 year ago
I have NO doubts that vaping has saved my life. I can breathe again and my blood pressure is normal for the first time in over 20 years. E-cigs may not have 'caused' this directly, but they have kept me from inhaling thousands of cubic feet of deadly smoke. I may still be an addict, but least I am no longer dying for a cigarette.
Posted By crashinbrn crashinbrn | about 1 year ago
excellent article Elaine. thank you for those very truthful words.

after that press conference, it makes me wonder how many other products the FDA has lied to us about.

i used the numbers put out by the FDA to build a spreadsheet with graphs. and i put the results here:

http://crashinbrn.net/pages/Maximum%20Tobacco-Specific%20Nitrosamine%20Level.htm

for those that do not want to try to decipher the FDA's results i thought a graphical report would do them better.
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