Part of the Food Policy Snapshot Series
Policy name: Restructure of FDA Human Foods Program
Overview: The United States Food and Drug Administration (FDA) has released a vision for unifying the food safety functions of multiple FDA offices by restructuring the Human Foods Program under one leader.
Location: United States
Population: 336.2 million
Food policy category: Food safety, nutrition
Program goals: To improve communications and efficiency in order to ensure a safe and nutritious food supply.
How it works: The Human Foods Program will combine the functions of the Center for Food Safety and Applied Nutrition and the Office of Food Policy and Response, as well as some functions of the Office of Regulatory Affairs, under a single leader. Food safety activities will also be closely coordinated with the Director of the Center for Veterinary Medicine. The Deputy Commissioner for Human Foods, who has yet to be selected, will report directly to the FDA’s Commissioner of Food and Drugs, Robert Califf, and will provide executive leadership and strategic direction for the program.
The redesigned Human Foods Program will also include the creation of:
- A Center for Excellence in Nutrition to help consumers make more informed food choices, which includes working with industry to offer healthier food products,
- An Office of Integrated Food Safety System Partnerships that will focus on coordinating and enhancing food safety and response activities with state and local partners, and
- A Human Foods Advisory Committee to advise the FDA on issues of food safety, nutrition, and innovative technologies.
Progress to date: In July 2022, in response to issues that were highlighted during the Abbott baby formula recall and resulting nationwide shortage, Commissioner Califf requested a comprehensive evaluation of the Human Foods Program. The Reagan-Udall Foundation completed the evaluation and published its findings and recommendations in December 2022. One recommendation was to make the Human Foods Program more prominent within the FDA and to give it a distinct leader and decision-maker. The FDA’s vision for the redesigned program was released on January 31, 2023.
Why it is important: In 2022, a widespread infant formula recall was deemed necessary because of unsanitary conditions at an Abbott Nutrition factory that had contaminated formula products and caused illness and death among babies. The company stopped formula production, which led to nationwide shortages and created significant hardships for millions of families across the country.
Therefore, it was important to make the proposed changes to the Human Foods Program so that the FDA is better equipped to adapt to an ever-changing environment and able to respond more quickly and efficiently if a similar crisis arises.
Program/Policy initiated: The restructured Human Foods Program was announced on January 31, 2023. The Deputy Commissioner and Advisory Committee members have not yet been appointed.
Point of contact:
FDA Press Inquiries
Similar practices: The overhaul of the Human Foods Program is aligned with the FDA’s New Era of Smarter Food Safety blueprint, which was announced in July 2022. These changes will allow the FDA to fully realize the preventive vision laid out in the FDA Food Safety Modernization Act, elevate the importance of nutrition, strengthen state partnerships, and embrace innovative food and agricultural technologies that will allow the agency to supply the nation – and the globe – with ample safe and nutritious food.
Evaluation: Evaluation has not yet been conducted.
- FDA Announces Overhaul of Food Program to Protect Consumers and Food Supply (PBS News Hour)
- FDA Proposes Overhaul in Wake of Baby Formula Shortage (The Wall Street Journal)
- FDA Report Details Agency Fumbles During Infant Formula Investigation that Hampered Response (CNN)
- Here’s What the FDA Says Contributed to the Baby Formula Shortage Crisis (NPR)
- Infant Formula Information and Ongoing FDA Efforts to Increase Supply (U.S. Food and Drug Administration)
- Is the US Infant Formula Shortage an Avoidable Crisis? (The Lancet)
- New Report Calls for FDA Overhaul to Strengthen U.S. Food Safety (Consumer Reports)
- FDA Evaluation of Infant Formula Response (U.S. Food and Drug Administration)
- FDA Proposes Redesign of Human Foods Program to Enhance Coordinated Prevention and Response Activities (U.S. Food and Drug Administration)
- FDA to Review Food Program Structure for Potential Overhaul (Food Dive)
- Following Criticism, FDA Proposes Redesign of its Human Food Program (CNN)
- The National Baby Formula Shortage and the Inequitable U.S. Food System (Center for American Progress)
- New Era of Smarter Food Safety (U.S. Food and Drug Administration)
- New Era of Smarter Food Safety Blueprint (U.S. Food and Drug Administration)
- Operational Evaluation of the FDA Human Foods Program (Reagan-Udall Foundation)
- Vision for a Reimagined FDA Human Foods Program (U.S. Food and Drug Administration)
- What Led to the U.S. Baby Formula Shortage − and How Officials are Trying to Prevent it from Happening Again (CNBC)