FDA-2014-N-0189-0644
This proposal conflicts with Executive Order 13563 of January 18, 2011 (the "EO") in two key ways in its initiation of a minimum age of purchase for nicotine delivery products.
First, the proposed rule relies on weak evidence for the proposition that nicotine has unique effects on the adolescent brain. The EO § 5 requires an agency to "ensure the objectivity of any scientific and technological information and processes used to support the agencys regulatory actions." Yet, FDA relies on a single study using a rat model to support the proposition that nicotine has effects on adolescent brains, in particular to assert an increase in impulsivity. But the evidence that rat models can provide such information is poor, with studies showing that rats are poor models for comparing the effects of psychostimulants on humans. Mary C. Olmstead, Animal Models of Drug Addiction: Where do we go from here?, 59 Q. J. of Experimental Psychology 255, 263 (2006).
Second, while FDA notes the potential for harm reduction by substitution of cigarettes for electronic nicotine devices, Proposed Rule at 3, it neglects to consider whether allowing adolescents to choose electronic nicotine would dissuade them from smoking cigarettes -- thereby resulting in population harm deduction. Failure to consider this option violates the EO's mandate to "maxify net benefits."