July 17, 2013

Stanton A. Glantz, PhD

FDA will never regulate where you can use e-cigs ... because it can't

At the same time that the the e-cig companies (which are increasingly the conventional cigarette companies) are vigorously fighting FDA regulation of e-cigarettes, they are telling state and local officials they should not act to protect people from secondhand e-cig "smoke" because the FDA will take care of it.

The fact is that, while the FDA could and should regulate the e-cigarette product  and how they are marketed, the fact is that the FDA has no authority to regulate where e-cigarettes are smoked.

The e-cig companies know this and are hypocritical in using the FDA's inaction on e-cigs to justify fighting sensible laws, such as California's SB648, to prohibit the use of e-ciagrettes anywhere that you cannot smoke conventional cigarettes.

This argument reminds me of when the cigarette companies were telling local and state officials that they should not enact smokefree laws because OHSA was working on doing so at the same time that they were aggressively (and successfully) fighting to block OSHA action.

In this case the hypocracy is even greater, since the FDA has no authority to regulate where e-cigs are used.



Stan - This is an important point and you are absolutely correct.  Where e-cigarettes can be used and how they are taxed is beyond the scope of potential regulatory authority at FDA and must be addressed at the state or local levels. States and, quite often,municipalities may also determine and where to whom and even whether e-cigarettes can be sold.
What FDA must (and, I think, soon will) do is to issue a deeming regulation that includes e-cigarettes and then develop a dual track application process for manufacturers to enter the market as either new products or modified risk products (for which health claims may be made).  The latter process will be much harder for the manufacturers obtain approval for, so it is likely that e-cigarettes will mostly be marketed as new tobacco products.  If that is the case, any express or implied health claims would be prohibited.  If the manufacturers wish to market their products for smoking cessation purposes (which they seem to imply), then that is outside the scope of even the FDA Center for Tobacco Products and would be handled like any other therapeutic drug delivery or combination device through normal FDA channels. 
The challenge will be to implement a federal regulatory regime on a class of products with domestic 10 figure domestic annual sales. 
-Mark Gottlieb
Public Health Advocacy Institute at
Northeastern University School of Law

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