Former F.D.A. Chief Backs Kennedy’s War on Ultraprocessed Food

A former head of the Food and Drug Administration who led the charge against tobacco companies in the 1990s is aligning himself with Health Secretary Robert F. Kennedy Jr.’s war on ultraprocessed foods, offering a path to take on the industry while testing President Trump’s willingness to enter the fray.

In a citizen petition filed late Wednesday and shared with The New York Times, Dr. David Kessler, who held an advisory role in the Biden administration, argued that the agency he ran more than 30 years ago has the authority and the scientific evidence to declare that some of the core ingredients in ultraprocessed foods are no longer “generally recognized as safe.”

That includes sweeteners like high-fructose corn syrup and certain refined flours and starches like maltodextrin, dextrose and corn solids, which are used by the food industry but not in home cooking. A citizen petition is a formal request to the F.D.A.; the agency is obligated to respond in 180 days.

“This is the great public health challenge facing us,” Dr. Kessler said in an interview. “Twenty-five percent of American men are going to develop heart failure. Thirty to 40 percent of us are going to be diabetic. Twenty-five percent of us are going to have a stroke.”

“And the primary driver of that,” he added, “is our diet and what we are eating.”

The petition is both a gift and a shot across the bow to Mr. Kennedy, who has made no secret of his desire to restrict ultraprocessed foods, which account for more than half the American diet, and which he blames for the nation’s chronic disease epidemic.

Dr. Kessler is challenging the Trump administration to do what it has so far been unwilling to do: use government regulations to force the industry to change. So far, Mr. Kennedy’s major food initiative, removing artificial dyes from foods, has relied on the industry’s voluntary cooperation. The strategy outlined by Dr. Kessler, who ran the F.D.A. under presidents of both parties, would put Mr. Kennedy and Mr. Trump squarely at odds with interests that have traditionally backed Republicans.

“If they go down this road, they are going to hear from industrial agriculture in a big way — all the corn and soybean farmers who are growing these ingredients, and then he’s up against these big food manufacturers,” said Michael Pollan, a journalist who has written books and produced documentaries about the nation’s food system.

“It’s a big fight, it’s a powerful tool to bring that fight,” Mr. Pollan said, referring to Dr. Kessler’s petition. “But does the administration really want to wage that fight?”

A spokesman for Mr. Kennedy had no immediate comment.

If the petition is ultimately successful — and that is a big if — the food industry might be forced to either reformulate or put warning labels on some of America's most familiar grocery store items, including certain types of breakfast cereals, protein bars, breads, yogurts and plant-based meats.

“This would cover an extraordinarily large percentage of foods that are ultraprocessed,” said Marion Nestle, a professor emerita at New York University and an expert on nutrition policy. She has reviewed Dr. Kessler’s petition, which she called “an extraordinarily impressive document.”

The petition also underscores the bipartisan appeal of the secretary’s campaign against the food industry and Americans’ poor eating habits. Dr. Kessler, the architect of the Biden administration’s vaccine distribution policies during the Covid-19 pandemic, said he was willing to set aside his profound differences with Mr. Kennedy, the nation’s most prominent vaccine skeptic, on this one issue.

Food safety legal experts, however, are divided over Dr. Kessler’s approach.

His petition relies on the argument that modern scientific research has found a close link between consumption of refined carbohydrates — sweeteners, flours and starches — and weight gain, heart and kidney diseases, certain cancers, and other serious health conditions.

He asserts that body of evidence means the F.D.A. can no longer allow such ingredients to be “generally recognized as safe,” or G.R.A.S., which is a designation that allows companies to circumvent a cumbersome and lengthy approval process for food additives.

Some say that Dr. Kessler’s strategy is a silver bullet, because it does not require the F.D.A. to determine that the ingredients are unsafe — only that their safety is in doubt. It would also put the onus on manufacturers to prove their ingredients aren’t harmful.

“It’s an opportunity for a major change in how these products are regulated,” said William B. Schultz, a partner at Zuckerman Spaeder, a law firm. Mr. Schultz, who previously held senior roles at the Department of Health and Human Services and the F.D.A. under Dr. Kessler, praising the proposal as innovative.

But others aren’t so sure of Dr. Kessler’s arguments about the lack of consensus on the safety of certain ingredients.

“I don’t know that at the end of the day, one can establish that the laundry list of ingredients that he’s attacking are inherently unsafe or aren’t generally recognized as safe,” said Stuart Pape, chair of the food and drug practice at Polsinelli, a law firm, who previously held senior roles at the F.D.A.

He noted that an important consideration would be if the ingredients “are inherently unsafe, or if when they’re consumed to excess they become unsafe because of the excess.”

Early Thursday, the Centers for Disease Control and Prevention released a study showing that, on average, people over the age of 1 get 55 percent of their calories from ultraprocessed foods. Sandwiches, including hamburgers, sweet bakery products, savory snacks, and sweetened beverages were four of the top five sources of calories from ultraprocessed foods, the study found.

Ultraprocessed foods tend to be high in sugar, salt and fat. Researchers typically define “ultraprocessed” foods as those using industrial ingredients and often manufacturing methods, including so-called “extrusion technology,” in which core ingredients are broken down and then reconstituted to make foods that are profitable, convenient, shelf stable and taste so good consumers often want to eat more.

Mr. Pollan explained ultraprocessed foods this way: “It’s food you couldn’t make at home, it’s food you need a factory to make.”

He noted that not all such foods are inherently unhealthy, citing Cheerios, “which we see as kind of a benign food.”

But there is no precise scientific definition for ultraprocessed foods, which makes them difficult to regulate. Last month, Mr. Kennedy and Agriculture Secretary Brooke Rollins issued a public call for information that would help establish a “federally recognized uniform definition” — a definition that many experts said would be unwieldy, if it could even be divined.

Dr. Kessler argues that no definition is needed. By going after core components of ultraprocessed foods, like refined sugars and starches, the F.D.A. can effectively regulate them, he said. He argues that such “refined carbohydrates” are “conducive to rapid eating, rapid digestion,” and thus lure people into overeating to the point of suffering health complications.

“Speed eating is no accident,” Dr. Kessler writes. “The food industry designs food to go down in a whoosh.”

Mr. Kennedy’s personal animus against ultraprocessed foods suggests Dr. Kessler’s petition is not likely to be ignored, experts noted. But if the F.D.A. tries to institute changes that are too sweeping, they added, it could inspire a backlash from Congress, which has stepped on the F.D.A.’s efforts to restrict other ingredients in the past.

The F.D.A. “is not going to walk into a large grocery store and put yellow police tape over yards of shelves,” Mr. Pape said.

Dr. Kessler, who is also a lawyer, said he had “no illusions” that food manufacturing would change overnight and added that ultimately, Congress might have to get involved. He sees a parallel to the tobacco wars, which have lasted for decades.

In 1994, under Dr. Kessler’s leadership, the F.D.A. responded to a citizen petition by announcing it would consider regulating nicotine as a drug. Congress followed up with hearings exposing the industry’s deceptive practices; the companies sued to block F.D.A. regulation and won at the Supreme Court. It took years, but in 2009, Congress passed legislation giving the agency authority to regulate the marketing and sale of tobacco products.

“We still don’t regulate nicotine, but the world has changed,” Dr. Kessler said. “Congress came up with a framework, in part because we raised that question.” Similarly, he said, his petition “should generate a rethinking of how we make food in this country and what we’re eating.”