As the saying goes, you are what you eat. And, unfortunately, the food we eat is only solidifying America’s tragic title: We have the lowest life expectancy among large high-income countries.
The U.S. Food and Drug Administration is taking a number of steps to help people in the U.S. build healthy diets — including with respect to ultra-processed foods — and the food industry and research community should, too.
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Ultra-processed foods are usually characterized by industrial processing, the presence of food additives such as flavors or colors, and nutrients intended to make them appetizing (sodium, added sugars, and saturated fat). Research points to ultra-processed foods being associated with diet-related diseases such as heart disease, diabetes, obesity, and even dementia. These and other diet-related conditions account for at least half of all U.S. deaths, disproportionately impacting Black, indigenous, low income, and rural Americans, and contribute to $4.5 trillion in annual health care costs.
The clear association between ultra-processed food and negative health outcomes is cause for major concern. A groundbreaking clinical trial performed at the National Institutes of Health, published in 2019, raised the troubling possibility that ultra-processed foods may actually stimulate the appetite, creating a cycle of overeating and obesity. What we don’t yet fully understand is why and how.
If ultra-processed foods cause poor health, what factors are responsible? While ongoing research at NIH aims to help find out, most studies dominating medical journals and newspaper headlines are observational studies that can’t fully demonstrate causality. One study showed that while consuming more ultra-processed food was associated with higher rates of cancer, intake was also associated with higher rates of accidental death, raising questions about what’s truly causing the negative outcomes.
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Some research also indicates that not all ultra-processed foods pose health risks. Nutritious foods such as whole grain bread may be considered ultra-processed, but they are not necessarily associated with the same negative health outcomes and indeed have shown to be beneficial. Yet headlines would make readers think that all ultra-processed foods should be avoided — a near impossible task for average American families. In fact, up to 70% of our food supply would be considered ultra-processed based on some definitions. This leaves consumers with overly broad messages that may cause unnecessary fear and steer people away from affordable, convenient, and nutritious foods.
The FDA is taking steps to further open the public dialogue on the need to accelerate high-quality research on ultra-processed foods and help answer these important questions. In December, the FDA is convening a workshop with NIH and a key focus is to identify key priorities and critical next steps for research in ultra-processed food. During a public meeting in September, we also heard from a wide range of stakeholders regarding ultra-processed foods, the food additives they contain, and the potential role food chemicals may play in chronic diseases. The U.S. Department of Agriculture has even developed a research roadmap on ultra-processed foods with experts from academia, government, and industry. High-quality nutrition research adequate in size, duration, and consumption patterns will help us develop a clearer, science-based understanding of ultra-processed foods to inform food-related policies and regulatory decisions.
This research is also important for the food industry — some leading companies continue to aggressively market certain ultra-processed foods that raise nutritional concerns even as others have joined a growing movement focused on producing and distributing nutritious food.
It will take time to understand what characteristics of ultra-processed foods make them riskier for people’s health. But for some characteristics that are disproportionately present in ultra-processed foods — sodium, added sugars, and saturated fat — there is already substantial evidence of harm when these nutrients are consumed in excess. In fact, much of the potential harm from ultra-processed foods could be offset through acting on these factors.
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The FDA isn’t waiting to act on those characteristics of ultra-processed foods.
Most recently, we took the next step in facilitating lower sodium in the food supply by issuing draft Phase II voluntary sodium reduction targets after Phase I is showing encouraging progress. And, in the near future, we expect to finalize an updated definition for the “healthy” claim and we continue to work to propose front-of-package nutrition labeling. Such food labeling efforts can provide a quick signal to help consumers quickly and easily identify foods that can help them build a healthy dietary pattern.
The FDA also recognizes the clear nexus between our nutrition goals and chemical safety goals. As an example, in 2015, the FDA revoked the “generally recognized as safe” status of artificial trans fat. As a result, artificial trans fats have been removed from the food supply, likely averting tens of thousands of cases of heart disease and stroke. Under the new Human Foods Program, the FDA is leveraging its scientific expertise and developing a more nimble and systematic approach to evaluating chemicals in the food supply. The FDA will continue to evaluate new science, monitor the food supply, and take action when needed.
But we cannot fix this problem alone. Researchers, public health and health care groups, advocates, industry, and the public must put tackling diet-related disease at the top of their priority list. This includes pushing for high-quality nutrition research related to ultra-processed foods, as well as supporting and strengthening ongoing efforts focused on increasing consumption of nutritious foods that are limited in sodium, added sugars and saturated fat. In one way or another, we should all be invested in the health of our country.
Robert M. Califf, M.D., is the commissioner of the Food and Drug Administration. Haider Warraich, M.D., is the senior clinical adviser for chronic disease to the FDA commissioner. Jim Jones is the deputy commissioner for the Human Foods Program.
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