Doing Less with More: FDA's Food Budget Ask
It’s that time of year again: the annual regulatory budget ask for federal agencies. Despite a year of public frustration with the way it handled vaccine approvals and hand sanitizers, the Food and Drug Administration is looking for more cash. And with COVID-19 becoming less pressing, we have a chance to look at some of the agency’s other goals and challenges. There’s much to be skeptical of, along with several potential public health game-changers.
The FDA is seeking $97 million in additional funds for food safety programs. The request for an 8 percent increase begins with two alarming statistics: First, an estimated 48 million foodborne illnesses occur every year. Second, an estimated 128,000 hospitalizations and 3,000 deaths result.
Okay, these figures should not be taken lightly. But they would be more alarming if the FDA didn’t report the exact same figures every single year since 2011 — and the numbers are even older than that. The Centers for Disease Control, which provided them, simply updated a faulty methodology in 2011 of the original estimate done over 35 years ago. In their justification, FDA analysts describe trying to bend the curve down, but it isn’t a curve, or even a straight line. It’s one number, and not a very good one at that.
Even if the statistics are right, why have they remained the same all these years? The FDA’s food budget for the last 10 years has been nearly $10 billion, growing from $835.7 million in 2011 to $1.1 billion in 2020 (according to yearly Congressional Research Service reports).
An additional claim in the FDA budget justification is that “The Foods Program addresses food safety risks at multiple points of the food supply chain.” Note that they do not claim to reduce food safety risks to consumers at those points, just “address” them. The Food Safety Dashboard tracks achievements under 2010’s Food Safety Modernization Act, citing “high rates of industry compliance,” seven new regulations, “enhanced collaboration,” and “cooperative agreements.” If any of these achievements had actual results, then there should be less than 48 million illnesses, and the numbers should not stay the same each year.
One report does hold promise for food safety. That’s the work the FDA has pursued for several years to promote blockchain-enabled tracebacks that will allow foodborne illness outbreaks to be quickly traced to the source.
Finally, the budget justification for the foods program claims that nutrition labeling “promotes a nutritionally healthy food supply to reduce the hundreds of thousands of deaths each year attributable to poor diet.” There is little evidence to show that labelling has ever reduced any deaths attributable to poor diet.
In fact, we are in the middle of an obesity crisis. Right now, the United States leads the Organization for Economic Co-operation and Development countries in obesity, at 36.2 percent (with another third of the country considered “overweight”). A recent Harvard study estimated that by 2030, half of the country will be obese. Obesity is the second-leading cause of preventable deaths. The FDA’s most notable response is more labelling, with calories now in bold letters.
Point being, obesity dwarfs the food safety problem. It won’t be the FDA’s Center for Food Safety and Applied Nutrition, my former employer, that will change this. It might be two other FDA centers: the Center for Biologics Evaluation and Research and the Center for Medical Devices and Radiological Health.
The former is responsible for regulating CRISPR — think cutting-edge DNA research — and there are solutions underway that might help with obesity. For example, two CRISPR experiments going on right now could turn fat into energy-burning cells, and others could make you feel full more quickly. No doubt, there are going to be other solutions that replace difficult dieting. Considered to be gene therapy by FDA, these new technologies will require clinical trials and approval.
The latter is overseeing other innovations, including genetic and microbiome tests and wearable health trackers. By monitoring what people eat, how much exercise they get, and testing for other personal characteristics, devices are coming onto the market that will help people to more easily choose foods to lose weight and improve other health characteristics.
The problem with both FDA centers is that these innovations require the FDA’s pre-market approvals, which may delay new products for years. Before automatically granting the FDA more resources, Congress should investigate all of the relevant laws and regulatory programs to make sure that forward-looking solutions, and not static or ineffective ways of doing things, are the priority.
Richard Williams is a senior affiliated scholar with the Mercatus Center at George Mason University and a former director for social sciences at the FDA’s Center for Food Safety and Applied Nutrition.