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FDA to transform Human Foods Program
FoodBev Media

FoodBev Media

1 February 2023

FDA to transform Human Foods Program

The US Food and Drug Administration (FDA) has proposed plans to transform its Human Foods Program and the Office of Regulatory Affairs (ORA, the FDA's field-based operations) to enhance coordinated prevention and response activities. The redesign for both groups will focus on protecting and promoting a safe, nutritious US food supply that is able to quickly adapt to “an ever-changing and evolving environment”. These efforts follow careful reviewing from the FDA, which noted that there were "several areas of need, including modernising data systems, providing more resources and authorities, improving emergency response systems, and building a more robust regulatory programme". FDA commissioner, Robert Califf, said in a statement: “I believe this proposed approach addresses the recommendations outlined in both reports, and takes into consideration feedback from stakeholders, as well as the voices of employees working in the Human Foods Program who had an opportunity to share input through numerous interactive and listening sessions over the past month”. He continued: “Creating a Human Foods Program under a single leader who reports directly to the Commissioner unifies and elevates the program while removing redundancies, enabling the agency to oversee human food in a more effective and efficient way”. Under the new plan, the functions of the Center for Food Safety and Applied Nutrition (CFSAN), Office of Food Policy and Response (OFPR) and certain functions of ORA will be unified into a newly envisioned organisation, titled Human Foods Program. The FDA will hire a deputy commissioner to oversee the programme and its main elements, including decision-making for policy, strategy and regulatory programme activities within the organisation. Under the new organisation, plans include creating a Centre for Excellence in Nutrition that supports US consumers in making “more informed food choices”. Additionally, the FDA plans to establish Office of Integrated Food Safety System Partnerships that will support the coordination and integration of its food safety and response activities. Califf added: “...there will be an emphasis on strengthening our enterprise information technology and analytical capabilities to fulfil the promise described in the New Era of Smarter Food Safety and support the improvement in workflow that will accompany these changes. This area of focus will support the work of the Human Foods Program by enabling more facile communication, more efficient operations and enhanced empirical risk algorithms to guide the priorities of the programme and the work in the field.” ORA's operating structure will be transformed into an enterprise-wide organisation that supports the Human Foods Program and all other FDA regulatory programmes. The realignment will allow ORA to be singularly focused on “excellence in its core mission,” which includes inspections, laboratory testing, import, and investigative operations. The FDA intends to provide further updates on the programme by the end of the month.

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