Following recommendations from a five-member expert panel convened by its independent 501(c)(3) Reagan-Udall Foundation last year, the U.S. Food and Drug Administration (FDA) announced a “new, transformative” vision for the agency’s human foods program. As part of that vision, functions of the Center for Food Safety and Applied Nutrition (CFSAN) and Office of Food Policy and Response (OFPR), along with certain elements of the Office of Regulatory Affairs (ORA), now will be unified under the human foods program. The ORA, for its part, will also undergo structural changes, essentially transforming into an enterprise-wide organization that supports the human foods program and other FDA regulatory programs through inspections, lab testing and investigative operations.
To oversee the revamped human foods program, FDA is opening a search for a deputy commissioner of human foods. Reporting to FDA Commissioner of Food and Drugs Dr. Robert M. Califf, the new deputy commissioner will be tasked with removing redundancies to oversee human food in a more efficient, effective way.
FDA announced other internal changes on the heels of the panel’s December report, such as the creation of a Center for Excellence in Nutrition aimed at helping consumers make more informed food choices. As part of that center, a new Office of Critical Foods will be established. In tandem with that effort to improve nutrition, FDA is also focused on food safety, launching an Office of Integrated Food Safety System Partnerships to improve collaboration with state and regulatory organizations.
A Human Foods Advisory Committee is another novel group stemming from FDA’s new vision. That committee will consist of a team of external experts who will share their views on emerging issues in nutrition, food safety and food technologies.
To navigate these and other updates to the agency, FDA is engaging an implementation and change management group, according to Dr. Califf. “Our ability to continue our work means consistently evolving and adapting with the constantly changing, complex industries we regulate and the emergence of new technologies,” he declared, adding, “While details of this proposal continue to be developed, CFSAN, ORA and OFPR will continue to operate under their current structures, with my direct oversight.”
Organizations within the food industry swiftly reacted to FDA’s announcement. “FMI welcomes the announcement today by Commissioner Califf to enact reforms within the FDA to strengthen the administration of the human foods program, specifically through the creation of a deputy commissioner for human foods with clear authority and a clear reporting line to the commissioner,” said Jennifer Hatcher, chief public policy officer for FMI – The Food Industry Association. Hatcher added that FMI will work with FDA leadership and other stakeholders to ensure that the reforms will improve and promote public health and a more efficient supply chain.
The Consumer Brands Association (CBA) welcomed the changes, especially the creation of the deputy commissioner role, but noted that more efforts are needed. “While today’s announcement is a positive first step, it fails to provide the deputy commissioner with direct line authority over all major foods program components or fully integrate the agency’s policymakers with its inspection force,” remarked Roberta Wagner, VP of regulatory and technical affairs for the CBA. “We are concerned that anything short of this and a fully empowered deputy commissioner will make it difficult to truly unify the program and deploy the prevention mindset envisioned under the Food Safety Modernization Act.”
Ahead of FDA’s Jan. 31 statement, a coalition of industry groups likewise underscored the need for an empowered deputy commissioner with direct authority. The coalition included American Frozen Food Institute, Association of Food and Drug Officials, CBA, Consumer Reports, Environmental Working Group, International Fresh Produce Association, STOP Foodborne Illness and Western Growers.
Together, they wrote: “Reframing the culture within the foods program is a prerequisite to the success of its structural reform. The current fragmented structure and lack of central authority and leadership contributes to a culture of silos, indecision, inaction, and delay in implementing the prevention mindset called for in the Food Safety Modernization Act (FSMA). The deputy commissioner should also be mandated to modernize the program in a way that facilitates transparency, timeliness, and meaningful stakeholder engagement as part of its decision-making process.”
According to Dr. Califf, FDA will release an update by the end of February on the progress, organizational design and timeline of the sweeping reforms.