On Jan. 31, the Food and Drug Administration proposed a redesign of its human food program in response to several ongoing food crises impacting public safety and the health of millions of Americans.
The redesign attempts to solve leadership and funding problems identified by an expert panel in December.
Unfortunately, the proposal does little to fix the most urgent or fundamental problems within the agency and the safety of our food. Only Congress has the necessary tools to do that.
The festering food leadership failures at FDA were brought to public attention in part by the recent shortage of infant formula. In response to criticism over their role in the shortage, FDA appointed an expert panel to investigate the root causes of the problems and to recommend solutions, sparking a broader conversation about the various ways FDA’s food programs have recently fallen short.
Largely left out of the conversation though, is perhaps the most compelling reason for reconstructing FDA’s — and our nation’s — food safety program: its inability to handle the country’s crisis of chronic food-caused illness.
More Americans, 1,600, die each day from chronic food diseases such as obesity, diabetes, high blood, pressure, heart failure and cancer than die in a year, 1,400, from microbial and chemical contaminants the FDA and the United States Department of Agriculture also regulate. Additionally, tens of millions of Americans are suffering daily from sickness and disability caused by these diseases. Americans were more vulnerable to COVID because of food-caused diseases; one study found two-thirds of COVID hospitalizations were caused by four food-caused conditions. It is also an enormous drain on our personal and the nation’s finances. The economic cost of nutrition-related chronic diseases has been estimated at $16 trillion over the period from 2011 to 2020. We must make both acute and chronic food illness food safety priorities.
Over the last decade, the U.S. Government Accountability Office has identified both acute and chronic food illness regulatory issues in need of urgent reform. GAO has repeatedly recommended that a government-wide approach led by a single entity is needed to address the fragmentation in the federal food safety regulatory and oversight system. The executive branch agencies have tried responding from their respective silos with little impact. While distressing, this is not surprising. The regulators at FDA, USDA and other agencies are mostly doing their best under trying circumstances, but it is only Congress in its oversight role that can effectively drill down into organization and resource issues that are hindering an effective food safety program.
There are many causes of the FDA food crisis, but a key cause that stands largely unaddressed is that Congress has been reactive and rarely proactive in its food-related oversight and legislative responsibilities. Congress has an obligation to ensure that nutrition-related issues are properly regulated by an accountable FDA, the Department of Health and Human Services and the USDA. Congress established the foundation for the current crisis in 1940 when it added human drugs and cosmetics to FDA’s sole food responsibilities and moved the agency out of USDA to the Federal Security Administration which became today’s HHS. Meat safety remained at USDA. Over the ensuing years, Congress provided USDA the resources it needed to ensure meat safety, but only provided FDA the needed resources for new drug, biologics such as vaccines, medical device and even tobacco control programs, leaving the food program with a growing shortage of budget and leadership to do its job.
As a result, today USDA regulates the safety of 20 percent of our food supply and receives about half the food safety budget. FDA regulates the safety of the remaining 80 percent of our food without the needed budget, laws, or leadership to do so.
This current moment of increased scrutiny of the FDA’s food program is Congress’s opportunity to take action. Simply put, our food and its impact on our health have fundamentally changed since the current system was created, and Congress needs to conduct a bipartisan, bicameral intensive review including in-depth hearings this year on how food safety and related issues should be regulated in today’s world to protect the public health and safety and who should be in charge.
We have a USDA secretary who is able to do his job in large part because he is an accountable Cabinet member. The same is not true with the FDA, whose leaders must navigate layers of bureaucracy to reach its Cabinet member, and whose attention is largely currently focused on pharma approvals, sick care and tobacco — not on food. Without prejudging the outcome of a thorough review by Congress to solve the problem, options Congress might consider include improving coordination and collaboration across federal agencies with increased authority to address hunger, nutrition and health, creating an independent food agency, or merging FDA’s food program into USDA, creating a food, nutrition and health mission area. At a minimum, Congress must address the leadership and resource gaps in the operation of our food safety agencies and give that the priority it deserves.
What’s clear is Congress must act now. We recognize these problems exist because they are difficult to solve, involving turf concerns that frequently paralyze government action. But Congress has effectively dealt with comparable structural problems before and must do so now. It can start this year by providing the needed oversight, authority and budget. The president can help by proposing solutions in his budget on March 9.
We need food that is safe, delicious and affordable and that promotes optimal health and well-being. That is among Congress and the government’s most essential roles. Our lives literally depend on it.
Senator William H. Frist, MD is a heart and lung transplant surgeon and former United States Senate Majority Leader, representing Tennessee in the U.S. Senate from 1995 – 2007. He currently serves as Chair of the Global Board of the Nature Conservancy, the largest conservation organization in the world. Dan Glickman is the former secretary of Agriculture from 1995 until 2001 and member of Congress from 1977 until 1995. Jerold Mande is an adjunct professor of nutrition at the Harvard T.H. Chan School of Public Health and former senior adviser to the FDA commissioner and deputy undersecretary at the U.S. Department of Agriculture, and CEO of Nourish Science.