The Food and Drug Administration has commissioned an external review of its food and tobacco programs in the wake of high-profile debacles—including bungled oversight of e-cigarettes, most notably of Juul products, and a dire nationwide shortage of infant and specialty formulas that left many parents scrambling and some babies in the hospital.
“The agency has confronted a series of challenges that have tested our regulatory frameworks and stressed the agency’s operations, prompting me to take a closer look at how we do business,” FDA Commissioner Robert Califf said in a statement Tuesday.
Califf commissioned The Reagan-Udall Foundation, which will work with unnamed outside experts, to conduct evaluations of the agency’s Human Foods Program and the Center for Tobacco Products. The foundation is a private nonprofit tasked by Congress to support and advise the FDA. The foundation’s evaluation will scrutinize the two FDA programs’ “processes and procedures, resourcing, and organizational structure,” and the foundation will report initial findings to the agency within 60 days, Califf said.