On January 31, 2023, Commissioner Robert Califf of the US Food & Drug Administration (FDA) announced the agency’s proposed plan to create a new Human Foods Program as the unified locus of oversight for the US food supply chain and safety. This proposal aims to better promote both food safety and nutrition in the US and to better align the food supply with the FDA’s public health and prevention-oriented goals. Under the proposal, the new program would draw from three key offices:

• The Center for Food Safety and Applied Nutrition (CFSAN), which is a product-oriented office that currently performs scientific analyses, provides services to external stakeholders regarding field programs, and handles critical issues related to food, supplements, and cosmetics
• The Office of Food Policy and Response, which currently helps lead and coordinate certain cross-cutting and high-priority food safety policy activities
• Certain functions of the Office of Regulatory Affairs, which leads agency field activities, including inspecting regulated products and manufacturers, conducting sample analyses of regulated products, and reviewing imported products

These offices currently have distinct leadership and would be united under a new Deputy Commissioner for Human Foods reporting directly to Commissioner Califf. The agency believes the new structure will streamline communication to key leaders when necessary and keep those leaders closely involved in food-related issues and policy changes as they arise.

Increasing Issues in the US Food Supply

Food and supplements are regulated very differently than medical products in the US. CFSAN works with state field offices to regulate domestic and imported foods (except for meat and poultry products, which fall under jurisdiction of the US Department of Food and Agriculture, or USDA) to ensure that they are safe, sanitary, and accurately labeled. Laws governing FDA’s food regulation have evolved since the agency’s creation more than 100 years ago. In 2011, the Food Safety Modernization Act (FSMA) was signed with the goal of preventing food safety problems rather than responding to problems after they occur. It also gave the FDA new enforcement and direction to build an integrated national food safety system in partnership with state and local authorities.

Critics argue that the food regulatory system is insufficient for a few reasons: implementation of FSMA has been very delayed, the FDA’s response capabilities are spread too thinly across multiple offices and agencies to be able to take sufficient regulatory action, and regulation in the food industry through both preventive and responsive actions has been underfunded in comparison to the FDA’s regulation of the drug industry. (While food regulation relies solely on discretionary funding appropriated by Congress, comprising about 18% of the agency’s budget, drug regulation receives the majority of its funding from drug and device user fees. Expansions of the FDA’s authority have historically not been accompanied by sustained increases in appropriations.)

Many recent issues in the food supply have led to calls from the private and public sectors to strengthen the FDA’s oversight. Roughly 46 million Americans experience foodborne illness each year, with an estimated 128,000 hospitalizations and 3,000 fatalities. Examples of specific issues include:

• Dangerous levels of heavy metals (such as arsenic and cadmium) in foods and supplements for both babies and adults
• Bacterial outbreak in an infant formula plant that led to its shutdown and shortages throughout the country
• Significant increases in the average size of food recalls in recent years
• Increasing evidence of harm caused by per- and polyfluorinated substances from food packaging and other sources that enter the food supply, leading to increased efforts to test and investigate their hazard

At the same time, continued increases in the prevalence of diet-related diseases in the US and abundance of ultra-processed, nutrient-poor foods are leading to calls for changes in the US agricultural subsidy systems through the farm bill, Dietary Guidelines for Americans, and various federal nutrition programs. The FDA has traditionally had fewer and less direct avenues to impact Americans’ dietary quality than other agencies and offices such as the Centers for Disease Control and Prevention and USDA. The FDA is also largely focused on food labeling and marketing, rather than food production or nutrition education. However, the agency released a proposed rule in September 2022 to redefine the term “healthy” used on food packaging. Also included in the proposed new Human Foods Program is the Center for Excellence in Nutrition, created in recognition of the burden of nutrition-related disease in the US.

Two other prominent calls for improvement were recently released. When FDA Deputy Commissioner for Food Policy and Response Frank Yiannas announced his resignation, he wrote that the agency’s many action plans, public communications, and other outputs have not yielded the necessary changes in outcomes to protect public health. Yiannas recommended a more integrated operating structure and an empowered deputy commissioner for foods. Additionally, a comprehensive evaluation of the food program conducted by the Reagan-Udall Foundation in December 2022 identified the need for a clear unifying vision, mission, and leader as well as more cooperation and accountability in field operations to fulfill the program’s potential. Thus, the new proposal was a response to these concerns and associated recommendations as well as other calls for enhanced regulation through effective responses and preventive measures.

Opportunities for Stakeholder Engagement

In light of these impending proposed changes, stakeholders in the food and healthcare industries have several opportunities to contribute to the development of the new program in the near term:

• Monitor upcoming events and presentations by the FDA and with other key stakeholders (such as the March 2 webinar by Principal Deputy Commissioner Janet Woodcock) as additional updates on the progress, design, and timeline are expected by the end of February.
• Provide input on the overall proposed plan before it is finalized, which can be done through both formal channels and  letters sent to FDA in the meantime (such as this recent letter).
• Contribute expertise to the new Human Foods Advisory Committee, which will comprise representatives of external organizations.

In the meantime, food and supplement companies, healthcare provider organizations, and other stakeholders can take action to optimize the safety and security of the food supply and consumers’ health by:

• Voluntarily testing and seeking third-party certification to ensure products do not contain unsafe levels of heavy metals, microplastics, and other chemicals
• Conducting research and disseminating findings on the effects of outbreaks and shortages on physical and mental health to inform future regulatory action
• Monitoring and responding to comment opportunities from other government agencies, such as the US Preventive Services Task Force, on issues related to food safety and nutrition interventions
• Entering new markets and developing new offerings to build redundancies into the food and supplement supply chains to prevent shortages

Avalere is well qualified to help stakeholders understand the many implications of this substantial proposed regulatory change based on our expertise in FDA regulation, human nutrition, and food systems issues. To learn more about how we can help your organization prepare and respond to the changes, connect with us.