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After nearly a year without a permanent leader, Dr. Robert Califf is gearing up to serve as commissioner of the Food and Drug Administration. Though Califf is not new to the position given his time as head of the FDA under President Barack Obama, the agency he is returning to has drastically changed since he last held the position.

One issue in particular — tobacco harm reduction — has been the foundation of a series of scattered decisions by the FDA, which has yet to take clear and concise action in support of many products that would effectively reduce the number of smokers. [...]