Commissioner Califf needs to put the F back in FDA

Robert Califf is taking the reins as commissioner of the Food and Drug Administration with the nation in a nutrition crisis. Americans are living shorter, less-healthy lives due to the foods they are being sold. The new commissioner can meet this challenge by harnessing the FDA’s effective but underused food-related regulatory powers, which were created with FDA itself for a similar food crisis more than 100 years ago.

At the turn of the 20th century, food was making Americans sick. Illnesses due to chemical and microbiological contaminants were among the top 10 causes of death. Food producers, eager to meet consumer demand for cheap, quick, appealing, and tasty food, were adding harmful ingredients without concern for people’s safety and were intentionally mislabeling food. Milk contained chalk and formaldehyde; canned foods had salicylic acid, borax, and copper sulfate; corn syrup was sold as honey; and colored animal fat from pig stomachs sold as butter. Food manufacturers were unchecked by government regulation, basic food safety, or labelling requirements.

Under the leadership of President Theodore Roosevelt and Harvey Wiley, a chemist working for the U.S. Department of Agriculture, the federal government was able to make the country’s food supply safer through research and policy. Wiley conducted groundbreaking research on food additives by testing them on a group of men that came to be known as “the poison squad.” This research culminated in sweeping food safety laws — and the founding of the FDA — through the 1906 Pure Food and Drug Act.

The resulting regulations and enforcement dramatically reduced the incidence of foodborne illness from chemical and microbiological contaminants.

Now, a century later, food-related illnesses are once again a leading cause of poor health, illness, and death. Today, more people die every day from diet-related chronic illnesses than die in a year from foodborne acute illness caused by contaminants the FDA and USDA regulate, making the food industry once again a major underregulated contributor to disease.

Food companies are making products that harm health not by adding acutely toxic ingredients, as was the case in the early 1900s, but by using highly processed ingredients that promote metabolic changes leading to chronic disease. As they were doing a century ago, food companies are creating cheap and convenient food using the technology of the day with little regard for health impacts because they have little incentive to consider the effects.

Research suggests that some of the ingredients that result from these technological processes have significant consequences for health. The way carbohydrates are being processed, for example, is making people sick. The American Academy of Pediatrics, which long recommended that children drink fruit juice, changed its recommendation in 2017 because the juice extracted from fruit is more similar to a sugar-sweetened beverage than the fruit itself.

The health and economic impact of nutrition-related chronic disease burden is irrefutable. Poor diet causes nearly half of all U.S. deaths due to heart disease, stroke, and diabetes, and only 12% of Americans over age 20 are considered metabolically healthy. The economic cost of nutrition-related chronic diseases has been estimated at $16 trillion over the period from 2011 to 2020.

Poor nutrition has also been an issue during the coronavirus pandemic, with a majority of adult Covid hospitalizations nationwide attributable to at least one of four diet-related, preexisting conditions: obesity, hypertension, diabetes, and heart failure. In other words, if the FDA had paid more attention to the shifting composition of our foods fueling the explosion of chronic illness, our Covid death toll might have been reduced by as much as one third.

Yet, the FDA uses just 7% of its food-related budget to protect Americans from processed-food driven chronic illnesses. And the agency has used its mandatory food regulatory powers only once to protect Americans from this modern food safety crisis when it ruled in 2015 that artificial trans fats were unsafe to eat and gave companies three years to eliminate them from the food supply. A 2021 report from the U.S. Government Accountability Office found that of the 200 actions the government is taking to address diet-related chronic disease, only six are regulatory. In addition to the trans fat ban, these include changes to the Nutrition Facts label, revisions to claims companies can make on food packaging, requirements for menu labeling, the Nutrition Innovation Strategy, and voluntary sodium reduction in packaged foods.

A major challenge the FDA faces in addressing this threat is that, unlike 100 years ago, the science needed to guide regulatory policy is lacking. This gap reflects a chronic underfunding of nutrition science in general and at the FDA.

Susan Mayne, the director of the FDA’s Center for Food Safety and Applied Nutrition, accurately summed it up like this in a briefing with the Alliance for a Stronger FDA:

“Our current nutrition funding accounts for 7 percent, I’ll just emphasize, 7 percent of the budget or 23.5 million dollars per year. This allows us to have 67 people directly supporting nutrition work in the center. By comparison, tobacco and nutrition similarly contribute to the chronic disease burden that I spoke about earlier. However, the Center for Tobacco Products budget is nearly 30 times larger than the budget allotted to our nutrition work. Considering the severity of the problem related to diet-related chronic diseases, there is no question that we could do more, much more, to move the needle with a more robust program.”

As Mayne points out, the public health consequences of the typical American diet are comparable to those of tobacco use, yet the size of the effort pales in comparison to that employed to successfully reduce tobacco use.

Under the leadership of former Commissioner David Kessler, the FDA met the challenge of the tobacco crisis in the 1990s with investigation, regulation, and ultimately through new powers authorized by Congress. With similar urgency, Califf should direct the agency’s launch of a robust investigation and rulemaking on the harms of today’s foods. Should the FDA need additional authority to make food safer, Congress should grant it, as it did for regulating tobacco and nicotine. The Biden administration and Congress should add $200 million to FDA’s nutrition budget, so it can provide today’s food industry a roadmap to produce the convenient, inexpensive, delicious foods that many Americans demand and need while also fostering good health.

Just as it did 100 years ago with food additives, and as it did 30 years ago with tobacco, the FDA should uphold its responsibility to ensure that the foods Americans consume make us well instead of sick.

Bill Frist is a heart and lung transplant surgeon, adjunct professor of cardiac surgery at Vanderbilt University Medical School, United States Senator for Tennessee from 1995 to 2007, and Senate Majority Leader from 2003 to 2007. Jerome M. Adams is an anesthesiologist, the 20th U.S. Surgeon General, and director of health equity initiatives at Purdue University. 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. All three are founders of Nourish Science, a nongovernmental organization focused on solving the country’s current nutrition crisis.