The former head of the US Food and Drug Administration is testing the Trump administration’s commitment to “Make America Healthy Again” with a challenge to crack down on some of the key ingredients in ultraprocessed foods.
In a petition filed Wednesday, the former FDA commissioner, Dr. David Kessler, argued that the agency has the authority to declare that certain sweeteners, refined flours and other additives are not “generally recognized as safe.” Removing that designation, known as GRAS, would force makers of ultraprocessed foods to remove products from the market and reformulate recipes — or try to prove that those ingredients are not harmful.
It would be a sweeping change to the food industry and a significant shift in the Trump administration’s MAHA strategy. So far, US Health and Human Services Secretary Robert F. Kennedy Jr. has relied on popular food brands to volunteer to remove artificial dyes and other additives from their products.
“Kessler has given the FDA a way to define the vast majority of ultra-processed foods. In doing so, he has handed RFK Jr a huge gift on the path to regulating these products. It’s just what MAHA has asked for. I hope they take it seriously,” Marion Nestle, the Paulette Goddard professor emerita of nutrition, food studies and public health at New York University, said in an email.
Kessler proposed that companies have 12 months to submit a petition to keep those food additives in their products and then go on to prove they are safe.
“It’s a very appropriate, worthy step to shift the burden of proof where it belongs and have the industry meet that burden, or stop using the substances.” said Michael Taylor, a former FDA food regulator and current co-chair of the nonprofit STOP Foodborne Illness. “It’s using the GRAS tool to really drive a serious safety conversation.”
HHS did not respond to a request for comment.
Federal health officials announced last month that they are looking for input on how to define ultraprocessed foods, a first step in eventually setting up new regulations, which could take months to years to establish. Kessler’s petition could put pressure on that ultimately lengthy timeline; the agency is required to respond to the request within 180 days.
Kessler, a physician who served as FDA commissioner under presidents Bill Clinton and George H.W. Bush, and advised President Joe Biden during the Covid-19 pandemic, oversaw the agency when it began requiring nutrition labels on food products.
He also spearheaded efforts for FDA to regulate tobacco in the 1990s and sees parallels to that fight.
“What was key in tobacco was finding the regulatory hook,” Kessler told CNN. “It was about asking the right legal question that would frame the issue.”
That has been the tricky part of setting up any regulatory standards for sugary and starchy foods, he said.
The term ultra processed foods has resonated with the public, he said, but “it’s going to be hard to define, legally, what’s in it.”
But there is a pressing need to do that, he argues. The FDA allowed these ingredients under GRAS regulations four decades ago, and rates of obesity, diabetes, and heart disease have climbed in the years since, he wrote in his petition. The argument echoes Kennedy’s own case for MAHA reforms to food policy.
Former FDA commissioner, Dr. David Kessler speaks during a Senate Health, Education, Labor, and Pensions hearing on Capitol Hill, on May 11, 2021. – Jim Lo Scalzo/AP
A ‘brilliant’ move on processed foods
The petition focuses on refined flours and starches — which the body breaks down into sugars — that are subjected to food extrusion technology, including wheat, corn, tapioca, oat and potato flour. It also references refined sugars, including corn syrup, corn solids, dextrose, xylose, maltose, and high-fructose corn syrups. Finally, the petition targets any manufactured sugars, flours and starches that contain additives commonly used in today’s ultraprocessed foods.
Tackling the issue of too much sugar is a key to better health, experts CNN spoke with agree, but they say the real genius of Kessler’s petition is his focus on additives.
“The food industry uses the emulsifiers, the stabilizers, the gels and the rest to make inexpensive, high volume, industrially processed foods,” said Christopher Gardner, director of nutrition studies at the Stanford Prevention Research Center.
“If you take those tools away from industry it’s not that foods will taste bad and icky,” Gardner said. “They won’t be as addictive, as flavorful, as tasty — and industry has made these foods as manipulatively flavorful and manipulatively tasty. That’s the problem.”
Several food and nutrition experts heralded Kessler’s petition as a bold move that would, if enacted by FDA, reshape the food industry.
“This is an important proposal that is based on the true meaning of GRAS, which would exclude the majority of foods on our grocery shelves,” said leading nutrition researcher Dr. Walter Willett, professor of epidemiology and nutrition at Harvard T.H. Chan School of Public Health and professor of medicine at Harvard Medical School in Boston.
The GRAS standard, created in 1958, was originally intended to narrowly apply to commonly used ingredients in the nation’s food supply, such as oil, vinegar and baking soda. Manufacturers that used those products could rely on existing research to show their safety but are supposed to file GRAS petitions for newer ingredients like refined sugars.
FDA updated its system in the late 1990s — amid a backlog of petitions for new additives — allowing companies to voluntarily notify the agency that they had determined their ingredients were generally safe.
A 2022 analysis conducted by the Environmental Working Group found that nearly 99% of new chemicals used in food or food packaging since 2000 were green-lit for use not by the FDA but by the food and chemical industry.
During that period, food manufacturers asked the FDA’s permission to introduce a new substance only 10 times, according to the analysis.
Barry Popkin, the W. R. Kenan, Jr. Distinguished Professor at the Gillings School of Global Public Health in Chapel Hill, North Carolina, called Kessler’s petition “a brilliant move.”
“Knowing the FDA like he does – he’s put industry in a real bind,” Popkin said. “They have to show that without a reasonable doubt that carbohydrates, along with additives, are healthy, and do not hurt health. And that’s next to impossible.
“It’s the strongest play a citizen can do to affect our food supply that I’ve ever seen.”
But Kessler’s proposed changes are likely to meet significant pushback from major food brands.
Michael Taylor was FDA’s deputy commissioner for foods in 2015 when the agency revoked the GRAS status of partially hydrogenated oils, or trans fats, citing extensive research about their links to risks of heart disease and stroke. The agency gave companies three years to comply and remove those oils from their products.
But at that time, “the handwriting was on the wall” for industry and many companies had already stopped using those trans fats, Taylor said. “Obviously the substances that [Kessler] is describing, it’s a lot of … highly processed, fine carbohydrates, and a lot of products.”
The petition lands as Trump administration officials, led by Kennedy, prepare to release their second MAHA report. While the MAHA Commission’s first dispatch in June singled out potential drivers of chronic illnesses in children — including ingredients in ultraprocessed foods — its second installment is expected to lay out proposed policy changes. The report is due by Tuesday.
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