The Corner

FDA Can’t

I’m no fan of cigarettes, but the Senate’s just-passed tobacco regulation bill is a problem area for the Food and Drug Administration for two reasons. First, the FDA’s role is to regulate food and drugs and deem them safe for use. Tobacco, which would be regulated by the FDA under the bill, is neither food nor drug, and thus constitutes uncharted territory for the FDA. Given how dangerous tobacco is, it’s extremely difficult for the FDA to declare tobacco in any way to be safe and maintain its public-health credibility. In addition, the FDA’s resources are already stretched thin by its oversight over food, drugs, and devices. Getting new drug approvals alone from the FDA is a 10-year, billion-dollar endeavor. Adding tobacco to the FDA’s responsibilities would stretch the agency‘s capabilities and complicate the commissioner’s arduous job.  As a former FDA commissioner’s chief of staff told me, “they could give us all the responsibility in the world, but there’s still only one commissioner and there’s still only 24 hours in the day.”

 — Tevi Troy, deputy secretary of health and human services from 2007 to 2009, is a visiting senior fellow at the Hudson Institute.


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