Results of Evaluation of FDA’s Human Foods Programs

Results of Evaluation of FDA’s Human Foods Programs

December 14, 2022
Annette Maggi

By RDBA Executive Director, Annette Maggi, MS, RDN, LD, FAND

In July of 2022, the FDA Commission Robert Califf commissioned the Reagan-Udall Foundation to convene an expert panel to evaluate the Human Foods Program as related to culture, structure and leadership, resources, and authorities. The aim was to ensure the FDA is effectively carrying out its regulatory responsibilities, strengthen the agencies relationship with state, local, tribal, territorial and international governments, and support an abundant, nutritious, safe, and sustainable food supply.  The scope of the panel’s review included the Office of Food Policy and Response (OFPR), the Center for Food Safety and Applied Nutrition (CFSAN), and relevant parts of the Office of Regulatory Affairs (ORA). It’s important to note that dietary supplements cosmetics, which fall within CFSAN’s responsibility, were excluded from the review.

Key observations and recommendations from the report as related to the four areas evaluated are as follows:

Culture: The report indicated there is a lack of clear vision and mission as related to the overall Human Foods Program across FDA, competing priorities, use of a consensus government model, a culture of indecisiveness and inaction, lack of a supportive leader and ultimate decision maker, and risk aversion across the scope of work. The report acknowledges that culture change can be difficult but is necessary to create a culture that positions the FDA to achieve its goals and responsibilities as related to human food.

Structure and Leadership. The clear direction out of the report is to significantly realign the Human Foods Program within the FDA as well as making it more prominent within overall federal organizations. This includes separating food from drugs, separating functions related to food safety from nutrition and creating accountable leadership over each division, and elevating the importance of nutrition across the FDA’s work. The report provides several possible options for updating the structure to be more effective.

Resources. Interestingly, the Human Foods Program has been given one of the lowest priorities in funding and resource allocation across all FDA agencies. For example, staffing in CFSAN has remained flat since 1978 despite significant expansion of scope within this agency. To position the Human Foods Program to be most effective, recommendations are made to increase financial support, personnel, and IT resources.

Authorities. The food landscape has only become more complex over the past several decades and recommendations are made to increase the authority of the divisions under the Human Foods Program to achieve its goals. Some examples of suggested added authorities include tightening the Generally Recognized as Safe (GRAS) standards and oversight, data sharing across the supply chain on key food categories like infant formula, and better monitoring of industry and consumer behavior.

While the FDA has oversight of nearly 80 percent of the food supply, the report did not address USDA’s role in human foods management. It is also important to note that making significant changes to the FDA will likely be a slow and laborious process, starting with the need for appropriation of funds from Congress. But when combined with the significance of the White House Conference on Hunger, Nutrition, and Health, it’s likely that nutrition will be a national priority for the foreseeable future.