Friday, July 24, 2009

The FDA Crusade Against E-Cigarettes


On July 22, 2009, the FDA released the results of laboratory tests of e-cigarettes, which were conducted by the Division of Pharmaceutical Analysis at the FDA’s Center for Drug Evaluation and Research. In a press release, the FDA said: “These tests indicate that these products contained detectable levels of known carcinogens…” The FDA report can be downloaded here.

For many years, I have investigated the cancer risks of cigarette smoking and smokeless tobacco use. As I wrote in a recent post, the FDA has never regulated nicotine effectively, and the agency had previously signaled its intention to ban e-cigarettes. So while the agency’s new analysis of e-cigarettes comes as no surprise, it does undermine the assumption that the FDA bases it oversight activities purely on scientific principles.

The FDA analyzed 18 cartridges from two e-cigarette manufacturers, Smoking Everywhere and Njoy (there are many other manufacturers). With respect to “carcinogens,” the agency looked at four tobacco-specific nitrosamines (TSNAs) with very long chemical names; I’ll abbreviate the agents here as NNN, NNK, NAT and NAB.

I have some experience with TSNAs, since I participated in a project with a scientist at the Swedish National Food Administration to measure the levels of these agents in smokeless tobacco products. Our research showed that TSNAs are present in most American tobacco products at extremely low levels, about 0.1 to 12 parts per million by weight. At this level of TSNAs, someone who puts 1 gram (about 1/28th of an ounce) of smokeless tobacco in his mouth is exposed to, at most, about 10 one-millionths of a gram of TSNAs. There is abundant scientific evidence that exposure at this minuscule level is not associated with ANY cancer in smokeless tobacco users.

The FDA analyzed 14 products from Smoking Everywhere, but the agency only reported the TSNA levels for 7 of those products. Why did the FDA test only half of the company’s products for carcinogens? And how did they choose those products? There are some clues in the report. First, the products that weren’t tested simply had blank boxes in the results chart. A footnote says, “Open boxes indicate the sample was not available for testing.” Another note in the methods section admitted that “…not all sample lots were available for analysis…as they were consumed in other testing.” In other words, the FDA didn’t purchase enough of the products to conduct the testing in a systematic and scientific manner. Maybe it’s a budget problem. On the Smoking Everywhere website cartridges are $9.99 each.

The FDA tested 3 out of 4 Njoy products for TSNAs.

What the FDA didn’t test is even more important than what the agency tested. The report noted that the “Nicotrol Inhaler, 10mg cartridge was used as a control for some test methods.” That inhaler is a pharmaceutical nicotine product that is regulated by the FDA, but the agency didn’t test the product for TSNAs. This is a critical omission, because in 2006 a published research study revealed that pharmaceutical nicotine products contain TSNAs. In fact, it’s been known for almost 20 years that nicotine medications contain TSNAs.

Why did the FDA analyze e-cigarettes for carcinogens, when there is no evidence the agency ever conducted carcinogen studies of products that they have regulated for over 20 years? Is it possible that the FDA approved medicines that contained TSNAs, but the agency is now disapproving e-cigarettes because they contain the same contaminants? To answer this important question, we have to know how high – or how low – the TSNA levels are in these products.

Unfortunately, the agency did not report TSNA levels. Instead, it reported that TSNAs were either “Detected” or “Not Detected,” which is entirely inadequate. For hundreds of years, one of the basic tenets of medicine has been “the dose makes the poison.” Mere detection of a contaminant is meaningless; the critical question is: At what concentration is it present?

So what does “Detected” mean in the FDA analysis? In other words, what was the lowest TSNA concentration that the test detected?

As I noted earlier, many tobacco products have TSNA levels in the single-digit parts per million range, a level at which there is no scientific evidence that TSNAs are harmful. According to the report, the FDA used an analytic method published in 2008. The report notes that “the published method is quite sensitive for the TSNAs…” and it goes on to explain that the level of detection is 40 parts per TRILLION.

The implications of this are astounding. Apparently, the FDA tested e-cigarette samples using a method that detects TSNAs at about 1 million times lower concentrations than are even possibly related to human health.

In summary, the FDA tested e-cigarettes for TSNAs using a questionable sampling regimen, and 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. According to Dr. Murray Laugesen, a respected New Zealand researcher, “Simply banning e-cigarettes will simply consign thousands of e-smokers back to smoking tobacco and an early death.”

The FDA and anti-tobacco extremists who support it should be held accountable for their prohibitionist actions.

The FDA has a legitimate interest in two matters involving e-cigarettes: assuring that cartridges contain the advertised quantity of nicotine, and that they do not contain contaminants.

I welcome the FDA to correct any errors in this critique. I attempted but was unable to reach the scientist who conducted the analyses.

14 comments:

Michael said...

Brad--

This is most disturbing, and is clearly an example of politics at work at FDA--and not science.

Left to its own devices, the agency generally does good work.

electronic cigarette said...

Over 400,000 American Citizens Die every year! So if the FDA really cares about it's citizens then it should Ban Traditional Tobacco smoking before Closing it's Doors on a Simple device called an Electronic Cigarette which Has not yet harmed a single human since it was introduced in 2004. I've been a tobacco smoker all my life and this simple device made me quit smoking Tobacco for good so I can freely suggest to those who are considering a much better & safer alternative to give an electronic Cig a try. Please care about your health & the environment, :) I purchased my electronic Cig from http://www.ElectronicCig.com

Tony- electronic cigarette vapour said...

You guys made great comments for this subject. I think politics should not interact with the use of an electronic cigarette since conventional tobacco smoking has proved on breing the most deadliest product know to man kind for centuries. Our new generation needs a much safer alternative to smoking, a solution has been invented that's calledelectronic cigarette which has not killed nor harmed a single human in 5 years of it's making! So please choose what's safe for you & the environment!!!

Johnny Blaze said...

My big issue with the FDA is that they only tested Chinese smoke juice, and made a blanket statement that all Electronic Cigarette products are dangerous. So what if they found antifreeze in Chinese e-liquid, did we forget that they also put lead in our kids toys!? Why didn't the FDA test any American Made
electronic cigarette e-liquid like Halo or Johnson Creek? I bet these would have came back without any incriminating issues.

Johnny Blaze

Sally E said...

I simply can not understand why the governmant would want to regulate the e-cigs. Like Dr. Murray Laugesen said above “Simply banning e-cigarettes will simply consign thousands of e-smokers back to smoking tobacco and an early death.”

Anonymous said...

Duh People. Let's look at this. Cigarrets are addictive. It's a hard habit to break. And they are outragously expensive (taxed). And they cause cancer. E-cigs have helped people quit. They are giving them away. And they appear to be harmless.

So, smoke regular cigs, pay lot of money to the Government, get cancer and die young. OR Smoke E-cigs, pay little money to the Government, possibly quit and live a full and happy life.

This is why they want them banned! Wake Up Sheeple!

respiratory therapy job chicago said...

FDA could just be doing it's job, they said repeatedly that E-cig contains harmful chemicals maybe we should give them the benefit of the doubt. Hopefully FDA's finding will be publicly released

Veppo said...

Seriously, give the FDA the benefit of the doubt? This is obviously some noob who isn't well educated on the history of the FDA. Funny comment REspiratory Therapy!

Anonymous said...

The cigarette companies and the government taxes are the ones to lose to the ecig. THE ECIG HAS SAVED MY LIFE. I no longer get sick and cough up nasty stuff. One day we will value life over money.

Luv2bfishin said...

Whatever they find in an e-cig most likely is contained in a real tobacco cigarette. So, it seems basic. Ban e-cigarettes and you'll have to ban real cigarettes. That will never happen, because there is too much money at stake in profits, and taxes.

Anonymous said...

I have been historically a supporter of government regulation. It has done good for a number of people. But, this is a clear case of fraud and not science. I'm not saying ecigs are safe. But I would like to know. I can only guess that tax revenue and lobby money is playing into the FDA and the lack of true peer reviewed research. What a scam. I say regulate the ecig companies and test their products -- if they don't contain what they say, fine them, take away a license or whatever. Imagine if a safe alternative to smoking is at hand that allows people to enjoy the pleasure of nicotine! The government can tax nicotine, who cares? Lets get to the science.

Francesco said...

there is only one way to close this discussion: to perform a prospective study in which the risk for cancer, lung disease and cardiovascluar events are compared between traditional smokers and e-cig smokers. Why such a trial has not been performed or proposed by FDA? Maybe it is because someone fears it will clearly show e-cig safety? And then, what will happen to tobacco brands like Marlboro?

Anonymous said...

it is not about health it is about greed, lies, and politics. e cigs help and are better than cigarettes. the tax money alone that will be lost if we all switch is unreal not to mention the tobacco company will fall if they don't switch too. it is jobs and more. its not about saving lives like me. E cigs are the new way to quit and the new way to keep enjoying.E cigs need to be properly regulated and taxed correctly and not considered a tobacco product. nicotine is not tobacco. it is a byproduct. cigarettes have more addictive things other than nicotine. i have felt that since i switched and have fought threw them and now feel good. now just have to get off the nicotine.

Tronic Vape said...

Looks like things are about to change with the way FDA handles e-cig regulation. Now that big tobacco is on board...