April 23, 2014

Stanton A. Glantz, PhD

First reaction to e-cigarette deeming (based on press reports): FDA leaves ecigarette marketing unscathed

I could not find the actual rule on the FDA website.  This is my first reaction based on what was in the NY Times the evening of April 23, 2014.
While establishing minimum age to purchase e-cigarettes at 18 is sensible, the FDA's proposal does nothing to reign in the wild west marketing of e-cigarettes to kids  (that the FDA itself recognizes). 
It does not ban flavors that are well-dcoumented to appeal to kids in cigarettes.  It does not apply the same restrictions on television and radio advertising of ecigarettes that apply to cigarettes.  The FDA's failure to act to reign in youth-rated marketing will allow the ecigarette companies to continue building the youth market for years.
Press reports indicate that there will be a warning that ecigarettes contain the addictive drug nicotine.  The specific size and placement of the warning is important.  We need to see details.  Simply saying "nicotine is addcitive" probably does not inform youth of the risks very well because the idea of "addiction" is so abstract.
The FDA says that there will ingredient disclosure.  It is not clear what "disclosure" of what is in ecigarettes means.  Is this disclosure to FDA, which will then keep it secret from the public, or is it public disclosure?
There was no mention in the Times story about the the FDA doing anything to prohibit health claims until there is evidence to support these claims.  Is the FDA requiring evidence to support the health claims -- both implicit and explicit made to sell ecigarettes?
Is the FDA doing anything to prohibit claims that e-cigarettes help people quit smoking? (The population studies consistently show that ecigarettes as associated with less quitting cigarettes.)
While every journey begins with a single step, the reality is that the promotion of ecigarettes -- including promotion to kids -- will continue unabated for years.  It is the marketing not the product, that needs to be controlled.
The real meaningful action of e-cigarettes will remain at the state and local level, especially including them in clean indoor air laws.  Myabe local governments will start prohibiting sales of flavored ecigarettes.  Any FDA action is years away.  (I hope that state and local policy makers do not swallow the inevidable arguments that they don't need to do anything because the FDA is taking care of it.)



The FDA proposal on e-cigarettes is pretty astounding for how little it seems to do.  It's late in the game (with a $2 billion US annual market) for merely foundational regulation of these products.  But maybe that is all the White House would let Mitch Zeller do.  I would strongly suspect he would prefer to take a more responsible course of action.  Because the youth issue has been the most problematic for e-cigarette makers and the under 18 market is so tiny, this FDA rule is the best possible ruling by the FDA for the e-cigarette companies.  A gift, really.
The FDA doesn’t need a huge evidence base to regulate a new tobacco product.  It should be up to the manufactures to demonstrate safety and public health impact.  Not the other way around. This is basically like grandfathering a product that has only been on the market for about 6 years!
I was a little bothered by Matt Myers’ comment to the NY Times implying that it was better for the established companies to be selling e-cigs rather than "fly by night" operations.  At least the "fly by night" companies haven't already committed large scale fraud resulting in the deaths of millions. But maybe he is right that established tobacco companies are easier to regulate. Hey, it's been a breeze for FDA so far, right?
A key question is whether this will have a chilling or motivating effect on state and local e-cigarette regulations.  Youth access regulation of e-cigarettes was often the foot-in-the-door for examining the question of whether to include e-cigarette use in smoking bans. An FDA federal minimum sales age may reduce local incentive to act. On the other hand, this lack of strong action by FDA will only help to grow the market and may force consideration of the issue at the state and local level as increased e-cigarette use frustrates enforcement of existing smoking bans. 
In any case, this is no way to tap into the much-touted harm reduction potential of these products . . . unless dramatic restrictions on combustibles were to follow.  I'm not holding my breath
-Mark Gottlieb
Public Health Advocacy Institute
Northeastern University School of Law
Boston MA

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