ENSURING FOOD SAFETY: Don’t Rely on the FDA

James J. Jones sounded the first alarm. Explaining why he resigned as head of the Human Foods Program (HFP), the food division in the Food and Drug Administration (FDA), on March 2, 2025, he wrote that he had been “looking forward to working to protect the Department’s agenda of improving the health of Americans by reducing diet-related chronic disease and risks from chemicals in food.” But the previous weekend DOGE had laid off 189 of HFP’s 2,000 staff. The fired employees included those with “highly technical expertise in nutrition, infant formula, food safety response and even 10 chemical safety staff hired to review potentially unsafe ingredients in our food supply.” Moreover, many were recent hires, who represented the program’s future. Jones singled out Robert F. Kennedy, Jr, the newly appointed Secretary of the Department of Health and Human Services (DHHS), for his “comments impugning the integrity of the food staff, asserting they are corrupt based on falsities.” Jones had been appointed as a reformer after an infant formula scandal at Abbott Laboratories in 2022 led to a nationwide formula shortage.

The appointment of Kyle A Diamantas as Jones’s replacement did little to restore trust in the program. A corporate lawyer, Diamantas recently had defended Abbott Laboratories in a lawsuit charging that it had failed to warn parents that its formula for premature babies could cause a deadly bowel disease. Rep. Rosa DeLauro (D. CT.) who had worked on infant formula issues, protested: “The FDA’s job is to protect our babies, not the corporations that poisoned them. Appointing an Abbott lawyer to oversee food safety which includes infant formula, is letting the fox guard the henhouse.” It is likely that Diamantas came to the administration’s attention because he often hunted with Donald Trump, Jr.

RFK Jr’s statements in the middle of March may have assuaged some fears about HFP’s future. On March 10, he directed the FDA to revise the Generally Accepted as Safe (GRAS) rule, issued in 1958, that allowed companies to add new substances to food products without informing the agency. “For far too long,” Kennedy wrote, “ingredient manufacturers and sponsors have exploited a loophole that has allowed new ingredients and chemicals, often with unknown safety data, to be introduced into the US food supply without notification to the FDA. Eliminating this loophole will provide transparency to consumers, help get our nation’s food supply back on track by ensuring ingredients introduced into food are safe, and ultimately Make America Healthy Again.”

Announcing Operation Stork Speed eight days later, Kennedy said, “The FDA will use all resources and authorities to make sure infant formula products are safe and wholesome for the families and children who rely on them. Helping each family and child get off to the right start from birth is critical to our pursuit to Make America Healthy Again.”

A year after launching both initiatives, however, Kennedy could point to few accomplishments. In the CBS News program “60 Minutes” in February 2026, he reaffirmed his intention to remove chemicals from ultra-processed food. But when asked whether he would issue regulations, he followed the Trump administration line, placing the sole responsibility for health on individuals. “I’m not saying that we’re going to regulate ultra-processed food,” he remarked. “Our job is to make sure that everybody understands what they’re getting, to have an informed public.” (What single mother with three children and two jobs can find the time to read food labels when she stops by the grocery store? What if English is not her first language? How would she find a list of contaminants?)

In March the Environmental Working Group (EWG), a nonprofit organization, reported that the FDA had failed to review more than 100 substances commonly used in food. Melanie Benesh, a co-author of the report, called it “a wake-up call for every American who assumes the FDA is reviewing the safety of chemicals in their food.”

Operation Stork Speed did not fare much better. In June 2025, the FDA promised to convene an expert panel. Helena Bottemiller Evich, a food policy journalist, reported that within months she began to “hear experts privately worry that things were not actually moving forward with any urgency. Where was the momentum? Where was the plan?” In November 2025, there were reports of an outbreak of botulism caused by the pathogen Clostridium botulinum in the infant formula manufactured by ByHeart, Inc. By December, 51 hospitalizations had been reported. In response, the Safe Food Coalition, a group of advocacy organizations, sent a letter to Kennedy, Martin Makary, the FDA Commissioner, and Jim O’Neil, Acting Director of the Centers for Disease Control and Prevention, stating, “Consumer protections against contaminated infant formula remain woefully inadequate, with infant formula production and packaging facilities typically inspected at most once a year.” The authors urged the FDA to inspect baby-formula manufacturers more frequently, fill inspector vacancies, strengthen regulation, and require companies to test for Clostridium bolulinum.

On March 3, 2026, Consumer Reports published the result of its study finding that 26 of the 49 tested formulas had “potentially concerning levels” of contaminants. Andrew Nixon, a DHHS spokesperson, stated, “FDA testing of infant formula is ongoing as part of Operation Stork Speed and results will be released as soon as this spring.

It is tempting to place the blame for HFP’s inaction solely on the Trump administration’s contempt for public health. But long before the regime took office, the FDA’s food division had failed to act in a timely manner. For example, the 2004 Food Allergen Labeling and Consumer Protection Act directed the FDA to propose a rule to define the term “gluten free” within two years and to issue a final rule within four. In 2007 the FDA, the agency responsible for establishing the standard, finally proposed that products could be labeled gluten free if ingredients containing wheat, barley, and rye represented no more than twenty parts per million. The FDA asked for comments and launched a safety assessment.

And then nothing happened. While the gluten-free market exploded, the FDA failed to act. People who could not eat gluten without serious consequences had no way of knowing whether the products contained any gluten and, if so, how much. In August 2013, when the FDA finalized the rule it had first proposed six years earlier, The New York Times editorial board wrote that it was “not clear why it has taken the food agency almost seven years to come up with a limit of 20 parts of gluten per million in products sold as ‘gluten free,’ a level similar to what is required in Canada and the European Union.”

The most compelling answer may be that this was business as usual. A 2022 Politico investigation of the Center for Food Safety and Applied Nutrition, the FDA division then responsible for food issues, provided numerous examples of unacceptable delay. Because the center had long argued that reducing sodium in food was a critical public health concern, the Institute of Medicine (a nonprofit group now known as the National Academy of Medicine) in 2010 urged the center to establish mandatory sodium standards. Instead, it set voluntary standards; a decade later it still had failed to issue them. The Center established a work group to study toxic elements in 2017 but then ignored the group’s suggestions. In response to pressure from health organizations and Congress, the Center announced that it would set standards for the presence of heavy metals in some baby foods.

According to Bottemiller Evich, the author of the report, gross underfunding explained the failure of the FDA food division to act quickly. In addition, the report stressed that the Center suffered “from a deep-seated culture of avoiding hard decisions and a near-paralyzing fear of picking serious fights with the food industry.”

Rather than addressing the FDA’s pattern of long delays, Kennedy has made a bad situation much worse. When regime change finally arrives, the new leaders will have to fix not only the problems the Trump administration created but also those that existed long before it took office.

Sources:

“Read the Resignation Letter from FDA Food Director Jim Jones,” Washington Post, March 6, 2025.

“HHS, FDA Initiate Comprehensive Review of Nutrients in Infant Formula,” www.hhs.gov/press.

Christina Jewett, “He Fought Claims of Harm from Infant Formula. Now He Regulates It,” New York Times, March 4, 2025.

Bill Whitaker, et al., “RFK Jr. Says Ultraprocessed Food Manufacturers Hijacked GRAS ‘Loophole’ to Use Questionable Ingredients,” CBS News, February 15, 2026.

Safe Food Coalition to Robert F. Kennedy, Jr., Martin A Makary, and Jim O’Neill, December 8, 2025, https://www.cspi.org/resource/letter-safe-food-coalition-re-byheart-infant-formula-outbreak-secretary-kennedy

Lauren Kirchner, “We Tested 49 More Baby Formulas for Lead and Arsenic,” Consumer Reports, March 3, 2026.

Patrick Rhonemus, “EWG Analysis Flags 111 Ingredients Added to Foods through GRAS,” Quality Assurance & Food Safety, March 13, 2026.

“4 Takeaways from Our Investigation into the FDA’s Byzantine Food Arm,” Politico, April 9, 2022.

Emily K. Abel is Professor Emerita at the UCLA Fielding School of Public Health. Her forthcoming book is Listening to Dementia: Advocating for Dignity and Autonomy (NYU Press, August 2026)