The Food and Drug Administration (FDA) - the lead federal agency which is in charge of regulating the safety of tobacco products which kill hundreds of thousands of Americans each year - is still not sure that these deadly products are any more hazardous than electronic cigarettes, according to a communication sent out by the FDA.
According to the communication: "There may be a perception that electronic cigarettes...are safer alternatives to conventional tobacco products. ... However, FDA is not aware of any scientific data to support those perceptions."
In other words, the FDA is not sure that cigarette smoking is any more hazardous than using a product (e-cigarettes) which contain absolutely no tobacco, does not burn tobacco, and delivers primarily nicotine and propylene glycol without the thousands upon thousands of chemicals - including more than 40 known carcinogens - that are present in cigarettes.
The FDA is not sure that cigarette smoking is any more hazardous than using a product which its own laboratory has shown contains only trace levels of tobacco-specific nitrosamines, carcinogens which are present at a concentration of about 1,400 times higher in your typical Marlboros.
The FDA is not sure that cigarette smoking is any more hazardous than using a product for which - with the exception of one brand - there is not a single known exposure (other than the nicotine) that has credibly been even postulated to significantly harm human health.
The FDA is not sure that cigarettes - which deliver nicotine along with more than 10,000 other chemicals and more than 40 known carcinogens - are any more dangerous than electronic cigarettes - which deliver nicotine without nearly any of the other 10,000+ chemicals and carcinogens.
The Rest of the Story
If this is the way the FDA is going to respond to its new authority to regulate tobacco products, then it's off to an unfortunate start. Is this really the way we want our federal health agencies to treat tobacco products? As a product that is of such little concern that it may be no more harmful than the combination of nicotine and propylene glycol in an electronic cigarette?
Is this the message we want going out to smokers? That their smoking is perhaps no more dangerous to them than if they quit smoking and instead used a product that only delivers nicotine without the tens of thousands of other chemicals?
The FDA is essentially saying that ex-smokers who have quit smoking using electronic cigarettes might as well revert back to smoking, since the Agency is not aware that vaping is any less hazardous than smoking. Is this the kind of scientific-based advice that we think is appropriate to be coming from a federal health agency?
The rest of the story is that this assertion by the FDA appears to be more politically-based than science-based. President Obama, in his inaugural address, called for a return of science to public policy. He asked that science be restored to its rightful place. However, the assertion that cigarette smoking is not known to be any more harmful than inhaling the vapors produced by putting an electric current through a solution of nicotine and propylene glycol is hardly something that can be viewed as science-based. Especially when the e-cigarette cartridges have already been studied in a number of laboratories and found to contain only trace levels of carcinogens and with the exception of one brand, no other toxic chemicals of any significant concern have yet been identified.
If the FDA is not sure that removing all of the carcinogens from cigarettes - and reducing their concentrations to no more than trace levels - is going to make "smoking" safer (even forgetting the fact that there is no smoke and no combustion associated with vaping), then one has to ask whether the FDA is basing its positions only on science, and not on any political or ideological concerns.
Think of it this way: Individual X has smoked 2 packs per day for 30 years. She has tried, unsuccessfully, to quit smoking using the nicotine patch and nicotine gum. Finally, she has successfully quit smoking using electronic cigarettes.
What the FDA is stating is that it does not believe that it would be any worse for individual X to resume cigarette smoking than for her to remain an ex-smoker by continuing to vape. The FDA is stating that it is aware of no evidence to suggest that returning to cigarette smoking would be an unwise decision for this individual.
That sounds like something the tobacco industry would say if asked to comment about electronic cigarettes. And to its credit, even the tobacco industry has not made any such statement.
Instead, the federal government has helped protect the tobacco market by making this unscientific statement for them.
Is this really the kind of pure scientific expertise - unclouded by any ideological or political concerns - that we want to be making the critical decisions about how to regulate tobacco products which are killing hundreds of thousands of Americans each year?
It doesn't take a rocket toxicologist to recognize that electronic cigarettes have to be a safer alternative to cigarette smoking. Based on the laboratory testing that has been conducted, the presence of the product on the market for more than 3 years without any recognized adverse effects, the demonstrated absence (or presence at only trace levels) of carcinogens present in high concentration in cigarettes, and the absence in of any suspected toxin or carcinogen that has been identified and thought to cause disease, how could it be opined that switching back to traditional cigarettes from this product is a reasonable decision?
There is plenty of research that needs to be done on electronic cigarettes. Clinical trials are clearly warranted. However, the need for such research does not equate to asserting that there is no evidence to indicate that vaping is as hazardous as cigarette smoking.
You don't need to make the latter statement to support the first opinion. Making it clear that further research is necessary does not necessitate that one also opine that there is no evidence that the novel product is any safer than cigarettes.
In fact, if there was no evidence to suggest that e-cigarettes are safer than cigarettes, then it would be unethical to conduct a clinical trial on this product. No IRB in its right mind would allow people to be used as guinea pigs to find out whether a company's whim that a product might be helpful is correct in the absence of any idea whether that product is safer than or potentially much more hazardous than the alternative products.
Of course we have evidence that electronic cigarettes are safer than traditional ones. That FDA fails to appreciate this is very concerning, especially given concerns over the politicization of the agency and the fact that the FDA is the agency that has been given authority over tobacco products.