March 17, 2015

Stanton A. Glantz, PhD

A sensible plan for effective FDA regulation of e-cigarette marketing (almost) now

Eric Lindblom, who headed the Office of Policy in the FDA Center for Tobacco Products and is now on detail at the Georgetown University School of Law, just published "Effectively Regulating E-Cigarettes and Their Advertising— and the First Amendment" in Food and Drug Law Journal.  This paper is the  an amazingly creative and incisive analysis of how to get out-of-control e-cigarette marketing under control as soon as the FDA achieves authority to regulate e-cigarettes.
Lindbloom notes that there are two possible justifications for allowing e-cigarettes on the market:

  1. The might help current smokers quit cigarettes.
  2. The might be an effective harm reduction strategy for current smokers.

He notes that there are several ways in which e-cigarettes could result in increased harm:

  1. Kids who would not otherwise have smoked addicts start using e-cigarettes.
  2. Former smokers take up e-cigarettes.
  3. Former smokers relapse to smoking cigarettes again.

While the first two points about the potential benefits of e-cigarettes are controversial, the last three are not.  Indeed, the major challenge to e-cigarette enthusiasts is how to craft a policy/regulatory environment in which the possible benefits of e-cigarettes can occur without the collateral damage of promoting increased nicotine addiction in never or former smokers.
Lindbloom presents a sensible and practical solution:  Limit e-cigarette advertising and promotion to highly targeted direct-to-consumer contact materials that only go to confirmed current smokers.
This is something that companies can do given their databases of current smokers. 
This highly focused advertising would get e-cigarette advertisements out of mass media (including the internet) and greatly reduce exposure to nonsmokers.
Lindbloom carefully assesses the First Amendment issues and shows how the FDA could do this discretionary enforcement authority without any new rulemaking.
This approach would not only allow action much faster – years faster – than using rule making, but it would also be easier to defend in court.
If it turns out that e-cigarettes do not help smokers quit, keep people smoking (which I think is their actual effect) or that they turn out to be a lot more dangerous than the optimists think (i.e. if assumptions 1 and/or 2 turn out to be wrong) , the FDA can adjust its rules.  But the damage will only be done to current smokers and the significant collateral damage listed in items 3, 4, and 5 will have been avoided.
Everyone at the FDA needs to study this paper with an open mind and see that the deeming rule which is now being finalized does not inadvertently make it harder to implement this plan.
And, while the technical details of Lindbloom’s plan are written for the US, the ideas can be easily implemented in other countries.  Indeed, they may be easier to implement in countries that do not deify commercial speech the way the US Supreme Court does.
Probably even more important, public health advocates need to read this paper and start pressing the FDA, their keepers in the Obama Administration, and pro-health members of Congress to make sure that this plan gets implemented.

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