mdi ConsultantsA new report on the FDA’s food safety program just came out. One of the recommendations is to break up the Agency into 2: one for food and another for medicine. – READ ON
Protecting the nation’s food supply is one of FDA’s primary charges. While affirming that Americans generally have access to safe and nutritious foods, U.S. Food and Drug Administration Commissioner Robert Califf acknowledged that the Agency has “confronted a series of challenges that have tested our regulatory frameworks”.
FDA came under heavy criticism for their handling of a baby formula shortage. FDA did not act fast enough on complaints about sanitation issues at the formula manufacturing facility as well as triggered the formula shortage when the plant could not fix deficiencies identified by the FDA.
In July 2022, Dr. Califf requested that the Reagan Udall Foundation convene an Independent Expert Panel to conduct a comprehensive evaluation of the FDA Human Foods Program with the aim of strengthening FDA’s food regulatory role. The Reagan-Udall Foundation for the FDA is an independent 501(c)(3) organization created by Congress to advance the mission of the Agency.
An Independent Expert Panel was convened to evaluate the FDA Human Foods Program and provide recommendations to the Agency in four primary domains:
- culture,
- structure,
- leadership, resources and
- authorities
On December 6, 2022, the Independent Expert Panel for Foods submitted its report to FDA Commissioner.
The report stated FDA is the oldest comprehensive consumer protection agency in the U.S. federal government. Since 1938, Congress has passed significant legislation giving FDA more authority over the food supply.
Some of the more notable laws include:
- The 1958 Food Additives Amendment required manufacturers to establish the safety of new food additives before going to market;
- The 1980 Infant Formula Act required manufacturers to follow quality, nutrient and stability protocols;
- The 1990 Nutrition Labeling and Education Act required nutrition labels and regulated health and nutrient claims;
- The 1994 Dietary Supplement Health and Education Act created a new regulatory framework for dietary supplements;
- The 2004 Food Allergen Labeling and Consumer Protection Act required food labels to include key allergens, and;
- The FDA Food Safety Modernization Act focused on preventing food safety problems before they occur and recognized the importance of strong foodborne illness and outbreak surveillance systems.
The Human Foods Program has clearly expanded over time however, it was not accompanied by sustained increases in FDA funding. The report indicated an estimated 46 million Americans are sickened by foodborne illness each year and, of these, an estimated 128,000 are hospitalized and 3,000 die. A significant proportion of foodborne illnesses are attributed to FDA-regulated products. For example, in 2019, produce was implicated in 46% of foodborne illness outbreaks.
Today’s food industry is estimated to be worth $1.5 trillion, accounting for approximately one-fifth of the U.S. economy. The food industry is also more global, with approximately 32% of the fresh vegetables, 55% of fresh fruit, and 94% of seafood that Americans consume annually being imported from other countries.
The COVID-19 pandemic exposed how supply chain gaps can cause havoc for industry, regulators overseeing the food supply, and consumers. These supply chain challenges were also illuminated during the infant formula crisis that began in late 2021. That crisis demonstrated what can happen when a significant, food-safety related production problem occurs in a food industry sector in which few competitors have the capacity to meet consumer needs.
The Independent Panel found the FDA Human Foods Program has an opportunity to turn today’s challenges into tomorrow’s success. However, to fully accomplish its public health mission as an effective food regulatory agency, FDA requires adequate resources, sufficient authority, and a structure and culture that breeds success.
The Panel recommended sweeping structural changes within the FDA. The first option proposed to create separate Food and Drug Administrations within HHS. In other words, a Federal Food Administration would be separate from a Federal Drug Administration, each with a Commissioner reporting directly to the HHS Secretary.
The other option proposed to separate medical products and foods but keep both within FDA. Other FDA reorganization plans were also suggested.
The Independent Panel provided improvement recommendations in the cultural, leadership and recourses domains. The report concluded that to strengthen the FDA Human Foods Program as a premier public health regulator, necessary resources must be provided. Sufficient authority to fulfill its mission effectively is required.
Leadership must embrace a proactive, prevention-driven strategy that is action-oriented and fosters effective and efficient decision-making. Leaders must also make their support clear to staff as they make decisions.
The full report of the Human Foods Independent Expert Panel can be reviewed here:
Operational Evaluation of the FDA Human Foods Program: A Report of the Human Foods Independent Expert Panel. Henney, et. al; 2022. https://reaganudall.org/operational-evaluation-fdas-human-foods-programs.
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