Remarks by Commissioner Robert M. Califf to the Food is Medicine National Summit: “Transforming Health Care” April 26, 2023

Speech | Mixed

• Speech by: Robert M. Califf, M.D., MACC

(Remarks as prepared for delivery)

Thank you for inviting me to be with you today.  I know that everyone at this summit has deep knowledge and great appreciation for the enormous and critical connections between health and nutrition and the complementary roles that consumption of healthy food and the health care system can play.  

I thought I’d focus today on the interaction of the regulatory system, the research enterprise, commerce, clinical care, and public health.   My vantage point is that of a regulator and a public health official, but also an intensive care and outpatient clinician for decades and, for a good part of my career, a health system leader. The goal is, hopefully, to stimulate you to a re-energized state of activism.  The stakes are enormously high, with the potential for significant gains in health through the redirection of forces in our society towards nutrition, health, well-being and a common view of our interdependence.  

I’m sure that we almost all agree in a goal of a world in which every person has access to plentiful, nutritious food, beginning in utero – and even before conception – and continuing until death.  And that blissful, ideal food state should happen in an ecosystem designed to provide biodiversity that is climate friendly, humane to animals and generates meaningful and rewarding jobs for many people.  Unfortunately, as I have delved deeply into the food world over the past year since returning to the FDA, I see a worrisome pattern that is analogous to the world of health care in which our knowledge and technology continue to advance rapidly, but our health outcomes are failing.

There is an increasing divergence between the pace of knowledge generation about fundamental science and our translation of that science into policies and clinical strategies that improve the health of our population.  Indeed, at some level the beneficiaries of our advanced knowledge are people like us in this room—well educated, relatively wealthy, or both.  The overall, aggregate health trends in the U.S. are moving in the wrong direction, and the disparities are accelerating both in ways that involve persistent, historical patterns and others that signal relatively new trends in our society.

The overall patterns are clear. We’re experiencing an unprecedented decline in life expectancy so that the U.S. now has a life expectancy between three and five years shorter than our peer high income countries.  This difference is partly due to Covid-19, but also gun violence, overdose, and suicide, which are linked to societal trends.

Unfortunately, we’re also experiencing a broader backsliding relating to many diseases that we once had a handle on controlling or were seeing real progress in treating—most painfully for me as a cardiologist, we are facing a tsunami of diabetes and cardiovascular disease that has already started with the uptick in stroke mortality and flattening of other parameters related to cardiovascular disease where we were making so much progress.   And the risk factor profile of our youth and young adults predicts a much larger wave of premature disease and death.

Much of this negative trajectory is driven by ongoing disparities as a function of race, ethnicity, education, and wealth.  But we’re also experiencing a dramatic shift in rural populations.  Our university towns and cities continue to experience improvement in health statistics, but just a few counties away in more rural areas the statistics are quite different.   And the gap between the life expectancy of women and men is once again growing, with more than a five-year advantage for women—something we don’t discuss enough.  

If we accept these epidemiological facts, it seems obvious that we need to do something different.  Given the unique perspective of the FDA as a regulatory and public health agency directly dealing with over 20% of the U.S. economy and with a seat at the table with the other major public health agencies, the role of the FDA as a part of the solution deserves consideration. 

The overlapping issues of science, biomedicine, food, and public health at the FDA come together in the practical issues we encounter in the exercise of our regulatory responsibilities.  In one sense we are doing our part: the U.S. is clearly the number one innovator in medical products, producing drugs, biologics, tests, and devices that fuel healthcare around the world.  The Economist ranked us in the top three worldwide in food safety and also very high in nutrition policies and, as part of the science enterprise, we probably all agree that we know more about healthy food than we could have imagined several decades ago.  

But America’s translation of these developments into practice in both health care delivery and nutrition is, well, not delivering.  As I look at the agenda for this meeting, it’s good to see that you are engaged in the translation we need — directly addressing the integration of nutrition into the fabric of everyday life and making sure it is directly addressed as we take on the social determinants of health that are driving the negative trends I have discussed.

The work of the FDA to ensure the safety of the U.S. food supply, provide American consumers with key nutrition information, and support industry reformulation toward healthier products, is a key part of our mission to protect and promote public health. We regulate the labeling and safety of about 80 percent of the U.S. food supply, and our statutes and regulations require that American consumers are provided directly with key nutrition information. The iconic Nutrition Facts label that is on packaged foods, as well as additional labeling requirements for restaurant menus and menu boards, empower consumers by giving them the opportunity to make informed choices about the products they are eating and identify healthier foods.  We’ve also seen how manufacturers can respond by reformulating their foods to create healthier products, thereby helping to foster a healthier food supply. In short, food labeling can be a powerful tool for change.

When a food or food ingredient does not meet our safety standards, we can take definitive action, as we did with unhealthy artificial trans fats, which have now been effectively removed from the food supply. We have taken other actions to facilitate reducing the intake of sodium and added sugars, by issuing voluntary targets for industry on sodium, and by requiring that added sugars be listed on the Nutrition Facts label. We’re also planning to hold a public meeting to assess what more can be done to help reduce added sugars intake. And consumers also can have a significant influence on these essential areas of nutrition through their purchasing power.

In addition, the FDA recently proposed an update to the nutrient content claim, “healthy.”  An updated “healthy” claim would align use of the claim on food packages with current nutrition and dietary guidelines and help consumers more easily identify foods that are consistent with healthy eating patterns.  We hope and expect that manufacturers may reformulate and produce new foods in order to bear the “healthy” claim.  And we are developing a front-of-package labeling system that consumers can use to quickly and easily identify foods that can help them build a healthy eating pattern. Front of package labeling systems can promote equitable access to nutrition information, particularly for those with less nutrition knowledge.

As we work on these policies, your voices will be critical.  Contrary to what many people seem to believe, the FDA does not unilaterally dictate these sorts of policies.  They go through periods of interagency review and public comment, sometimes taking years because of different perspectives, and they often include detailed economic analyses.  The trade-offs are adjudicated by the little-known Office of Information and Regulatory Affairs, or OIRA, which is part of the Office of Management and Budget and independent of the FDA.  To the extent these policies influence the underlying substrate for your work, I urge you to watch which policy documents we put into the OIRA process and when — it’s a matter of public record.
 
We’re also working within the FDA to strengthen our Food oversight.  Earlier this year, as many of you are aware, we announced our vision for a unified Human Foods Program that will combine previously distinct parts of the FDA into a new organization under the guidance of a Deputy Commissioner for Human Foods.  In addition, we are creating a Center for Excellence in Nutrition, which will elevate and strengthen FDA’s nutrition portfolio. All of this will allow us to focus even more on food policy and, more specifically, on helping to improve nutrition and supporting the principles of Food is Medicine.  

And we’re excited to play an important role in the Biden-Harris Administration’s National Strategy on Hunger, Nutrition, and Health -- along with the HHS Assistant Secretary for Health Admiral Levine, who will address you shortly, and many others -- to help improve dietary patterns, better integrate improved nutrition within healthcare through Food is Medicine initiatives, and much more. 

I want to emphasize four specific priorities for the FDA where you can also make a difference.  First, across the board we should be entering a new era of evidence generation, stimulated by digitization and the capacity to deal with big data to analyze complex patterns in ways that were, until recently, simply impossible.  We talk about real world evidence in health care a lot, but it may be even more important in food safety and nutrition.  And we need the participation of people in the real world.

It’s essential that we strengthen the study of diet and nutrition and broaden the collection of data in this area, including more effective use of electronic health records, or other real-world evidence that can give us greater insights into topics such as the impact of genetics or personalized diets on health. What people eat is a critical part of their “exposome” and we need both intake data along with genetics to have the types of high-quality real-world evidence to support healthier dietary patterns. We also need information on the implementation of innovative initiatives, like Food is Medicine, at the community and systems level -- integrating activities, services, sectors, information, and science.  We’re a collaborator on a recently announced NIH initiative on Food is Medicine with many other federal agencies that will help generate more of the data and knowledge we need.  The possibilities are truly limitless, and we must build this capacity. 

Second, as we improve knowledge through evidence generation, it’s also critical that we educate our health professionals.  In collaboration with the American Medical Association and the American Academy of Pediatrics, we’ve created free programs in nutrition and food safety.  For example, we have developed an education program to help physicians and other healthcare professionals understand the Nutrition Facts label and counsel adult patients about using the label to make informed food choices that support healthy dietary practices and can help reduce the risk of developing some health conditions.  More is needed. Health professional schools, including for medical, dental, pharmacy, nursing, social work, public health, physician’s assistants, physiology, exercise science, and others, as well as licensing boards, should expand nutrition education in graduate education curriculums, board exams, and postgraduate training.

Third, we need to strengthen advocacy for nutrition, including resources and policies that can better support nutrition.  Nutrition is significantly under-resourced at the FDA, despite the fact that our calculated return on investment for funding in nutrition exceeds that for food safety.  Our resources reflect Congress’s priorities. With the stunning prevalence of diet-related chronic disease, politicians need to understand the devastating impact of chronic disease and support the means for better prevention and management. 

And fourth, we need to strengthen our ability to provide information and education, not just for medical professionals but the public at large.  This is especially important today as we confront the rampant misinformation and disinformation that is destabilizing communication, undermining confidence in science and the work we do and, and weakening faith in governmental and other institutions, including the FDA.  It is something that is affecting not just our work on nutrition and food policy, but every area of public health.  

This kind of misinformation, spread largely through social media and on-line and cable entertainment, is leading people to make plainly uninformed and adverse choices regarding their health. We see this across the spectrum -- from continuing use of tobacco products or vaping, to spurning effective and lifesaving medicines such as vaccines, to continuing to eat an unhealthy diet.  Each of these decisions is made in the face of definitive facts that make clear these actions are harmful, Unfortunately, the information ecosystem increasingly linked to the social determinants that are so important for health is very susceptible to manipulation by people trying to sell adverse choices through persuasion and social identity.

Misinformation about how foods can fit within a health dietary pattern is a distinct, but important category of misinformation.  It can confuse consumers who have many other issues to focus on in their daily lives, leaving them susceptible to influences that lead them to make uninformed food choices for themselves and their families.   And it often is targeted to certain populations, including children or members of specific geographic, ideologic, racial, or ethnic groups who may be at increased risk. 

We have an enormous opportunity to use the knowledge and technology at our disposal to increase access to safe, healthy, and nutritious food for all Americans and to provide them with information that can help them identify healthy food choices.  Nutrition is a central building block as we attempt to change the devastating effects of social determinants on health outcomes, and it bridges the health care delivery system and social networks.  I look forward to strengthening the efforts of the FDA to this cause and working alongside you to realize the enormous opportunity we have to improve health and quality of life in the US through improved nutrition.

Thank you for your good work and partnership in nutrition advocacy.