With the reelection of President Obama, the U.S. Food and Drug Administration (FDA) is likely to continue its current high level of regulatory oversight and enforcement. Current levels of appropriations, if not reduced under a proposed sequestration reduction of 8.2% across-the-board ($320 million), which is unlikely, also provides the agency with necessary resources to implement the 5-year agenda contained in the recently enacted prescription drug user fee bill, the “Food and Drug Administration Safety and Innovation Act” (FDASIA). New FDA regulations, which were delayed or stalled before the election, will likely be published in proposed or final form, potentially provoking a Congressional response, along with the potential expansion of existing authorities including regulation of cigars, e-cigarettes, pipe tobacco and dissolvable tobacco products under the Tobacco Control Act. On the Hill, the recent fungal meningitis outbreak associated with bulk pharmacy compounded products and extensive news coverage of food safety issues may drive additional FDA reform legislation in the next Congress, and the prospect of new, unfunded mandates.