Source - Food & Beverage Litigation and Regulatory Update | Issue 789

Evaluation of FDA Human Foods Program Finds Culture of “Constant Turmoil”

An independent review commissioned by the U.S. Food and Drug Administration (FDA) of the Human Foods Program has reportedly identified several issues with the agency’s culture. The key findings of the Reagan-Udall Foundation for the FDA’s report were:

  • “FDA has dedicated staff who are committed to protecting public health, but the current culture of the FDA Human Foods Program is inhibiting its ability to effectively accomplish this goal.”
  • “While the Human Foods Program has specified functions, a clear unifying vision and mission for the entire program is not apparent.”
  • “The lack of a single clearly identified person to lead the Human Foods Program has adversely impacted the organizational culture and led to overlapping roles and competing priorities that result in what is perceived as constant turmoil.”
  • “The Human Foods Program approach of relying on consensus has significant drawbacks for making decisions about taking regulatory action.”
  • “A culture of cooperation and accountability in the Human Foods Program’s field operations needs to be reestablished to fulfill the potential of program alignment and to optimize the performance of the Human Foods Program.”
  • “The Human Foods Program culture appears to foster an aversion to risk that undercuts its ability to meet its public health mandate.”

The report makes a number of recommendations for improvement, including (i) nurturing “a culture where regulatory decision-making is rooted in scientific evidence”; (ii) establishing “an organizational structure with a clear leader”; and (iii) committing to “transparency, timeliness, and predictability in decision-making, with a preference towards action.”

FDA Commissioner Robert Califf responded in a statement, noting that he will form a “group of agency leaders to advise me on how best to implement and operationalize these findings.”

“The Human Foods Program is a top priority for the agency,” Califf said in the statement. “America’s food supply is as safe as it’s ever been, and our Foods Program experts have significantly contributed to the availability of more safe and nutritious food options for consumers. That said, over the past several years, the program has been stressed by the increasing diversity and complexity of the nation’s food systems and supply chain, the ongoing impacts associated with climate change and rapid advances in the science underlying many of the foods we eat today.

“Each of these factors point to the need to evolve our existing Foods Program leadership and structure and identify new ways to fund these mission critical activities. In addition, the agency’s inspectional activities, including those conducted in collaboration with our state and international partners, are critical in order to assure a safe and high-quality food supply. And finally, the need to maintain upgraded digital technology systems that allow us to stay ahead of the vast and growing food system, are essential components of any future plan.”

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