The most damaging revelation in the FDA's proposed deeming regulations is the fact that the agency is not sure that smoking is any more hazardous than vaping.
This is worth repeating: the nation's federal regulatory agency with jurisdiction over cigarettes is not sure that smoking - which kills more than 400,000 Americans each year - is any more dangerous than vaping, which involves no tobacco and no combustion and has not been shown to cause any harm. The FDA is not convinced that inhaling nicotine plus tens of thousands of chemicals and more than 60 known human carcinogens is any worse than inhaling nicotine plus propylene glycol and low levels of a few other chemicals.
To make matters worse, the deeming regulations would prohibit electronic cigarette companies from informing their consumers that vaping is less hazardous than smoking. In fact, e-cigarette companies would not even be allowed to inform consumers that electronic cigarettes are free of tobacco, or that they have much lower levels of a number of carcinogens and are free of thousands of harmful chemicals that are present in tobacco smoke.
In the deeming regulation proposal, the FDA states: "Many consumers believe that e-cigarettes are "safe"
tobacco products or are "safer" than cigarettes. FDA has not made such a
determination and conclusive research is not available."
Clearly, the FDA does not believe that there is sufficient evidence at the present time to conclude that cigarette smoking is any more hazardous than vaping.
Futhermore, one of the problems noted in the deeming regulations is the fact that: "The vast majority of the respondents who were aware of these products indicated that they believed e-cigarettes were less harmful than traditional cigarettes...".
Once again, the FDA is stating that smoking may not be any more hazardous than vaping.
The Rest of the Story
Frankly, I find it horrific to learn that the FDA - the agency which is going to supposedly be using science to make informed, evidence-based decisions regarding tobacco products - is not sure that cigarette smoking is any more hazardous than the use of fake cigarettes that contain no tobacco, involve no combustion, produce no secondhand smoke, have much lower levels of carcinogens, and have been found to acutely improve the health of smokers who switch to them.
Fortunately, the vast majority of the public appears to have better scientific judgment than the FDA and to recognize that cigarette smoking is far more hazardous than the use of an electronic nicotine delivery system that merely aerosolizes nicotine from a propylene glycol solution that is completely free of any tobacco or any combustion.
While the FDA sees the problem as being that the public believes electronic cigarettes are safer than smoking, I believe the problem is that the FDA fails to grasp the clear science and to appreciate that cigarette smoking is far more hazardous than vaping.
Is this really the way we want our federal health agencies to treat
cigarettes? 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, including more than 60 known human carcinogens?
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?
With this disregard for the basic principles of science, the FDA is undermining literally decades of public education about the severe hazards of cigarette smoking. The FDA is negating the benefits we have accrued from the tobacco companies halting their own undermining of the public's appreciation of smoking's hazards because the agency is now doing that work for the tobacco companies.
The rest of the story is
that this assertion by the FDA - that cigarette smoking may be no more hazardous than vaping - 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 aerosol produced by heating a solution of nicotine
and propylene glycol is hardly something that can be viewed as
science-based. Especially when e-cigarette vapor has been extensively characterized and shown to be far less toxic than cigarette smoke.
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
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
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.
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?
While the deeming regulations pretend to acknowledge that there is "a continuum of nicotine-delivering products" in terms of their health risks, the truth is that the agency fails to acknowledge that the most hazardous product along that continuum - cigarettes - are any more hazardous than the least dangerous product (non-tobacco electronic cigarettes).
If this is the kind of "scientific" reasoning that is going to guide the nation's decisions on how to handle tobacco products which are killing hundreds of thousands of Americans each year, then we may actually be better off reverting back to the "wild, wild west" that Stan Glantz keeps talking about. At least in that wild west, consumers are able to make reasonable judgments about the relative safety of different products. In the FDA-regulated "east," consumers are going to be kept hidden from even the most basic truths: that electronic cigarettes do not contain tobacco and that they are much safer than the real thing.
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