David Kessler Challenges Trump Administration to Crack Down on Harmful Food Additives with GRAS Petition
Dr. David Kessler, former commissioner of the US Food and Drug Administration (FDA), has initiated a challenge to assess the Trump administration’s commitment to promoting public health. In a recently filed petition, he proposes that certain additives in ultraprocessed foods, such as certain sweeteners and refined flours, should no longer be recognized as safe under the Generally Recognized as Safe (GRAS) designation.
If enacted, this move would compel manufacturers to either remove these products from the market or prove that these ingredients are harmless. This decision would mark a significant shift in the Trump administration’s “Make America Healthy Again” (MAHA) strategy, which has primarily relied on food brands volunteering to eliminate artificial dyes and other additives from their products.
Marion Nestle, Paulette Goddard professor emerita of nutrition, food studies, and public health at New York University, expressed her support for Kessler’s petition in an email, stating that it provides the FDA with a means to define the majority of ultra-processed foods. She believes this could pave the way for regulating these products, aligning with the objectives of MAHA.
Kessler suggests a 12-month timeline for companies to submit petitions to maintain these food additives in their products and then prove their safety. Michael Taylor, a former FDA food regulator and current co-chair of STOP Foodborne Illness, appreciates this initiative, stating that it shifts the burden of proof onto the industry to meet safety standards or discontinue using these substances.
The US Department of Health and Human Services did not respond to a request for comment regarding Kessler’s petition. Federal health officials recently announced their intention to gather public input on defining ultraprocessed foods, which could lead to the establishment of new regulations. The timeline for this process may be expedited by Kessler’s petition, as the FDA is required to respond 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, was instrumental in implementing nutrition labels on food products and regulating tobacco in the 1990s. He sees parallels between these efforts and the current challenge to address the issue of ultraprocessed foods.
Defining ultraprocessed foods has gained traction with the public, but Kessler acknowledges that legally defining these products will be challenging. However, he argues that there is a pressing need for such a definition due to the increasing rates of obesity, diabetes, and heart disease since these ingredients were first allowed under GRAS regulations four decades ago.
The petition targets refined flours and starches subjected to food extrusion technology, including wheat, corn, tapioca, oat, and potato flour, as well as refined sugars like corn syrup, corn solids, dextrose, xylose, maltose, high-fructose corn syrups, and any manufactured sugars, flours, and starches containing common additives in ultraprocessed foods.
Experts agree that reducing excess sugar is crucial for better health, but they praise Kessler’s petition for its focus on additives. Christopher Gardner, director of nutrition studies at the Stanford Prevention Research Center, explains that these additives enable food manufacturers to create inexpensive, high-volume, industrially processed foods with manipulatively flavorful and tasty characteristics.
Several food and nutrition experts have commended Kessler’s petition as a bold move that could potentially reshape the food industry if enacted by the FDA. Leading nutrition researcher Dr. Walter Willett, professor of epidemiology and nutrition at Harvard T.H. Chan School of Public Health, supports this proposal, stating that it accurately represents the true meaning of GRAS, which would exclude a significant proportion of products on grocery shelves.
The GRAS standard, created in 1958, was intended for commonly used ingredients like oil, vinegar, and baking soda. Manufacturers who use these products can rely on existing research to demonstrate their safety, but are required to file GRAS petitions for newer ingredients like refined sugars. However, the FDA’s updated system in the late 1990s allowed companies to voluntarily notify the agency about their determination that their ingredients were generally safe.
A recent analysis conducted by the Environmental Working Group found that nearly 99% of new chemicals used in food or food packaging since 2000 were approved for use not by the FDA but by the food and chemical industry. During this period, food manufacturers requested the FDA’s permission to introduce a new substance only ten times, according to the analysis.
Barry Popkin, W. R. Kenan, Jr. Distinguished Professor at the Gillings School of Global Public Health in Chapel Hill, North Carolina, views Kessler’s petition as “a brilliant move.” He believes that industry is now in a challenging position, as they must prove beyond a reasonable doubt that carbohydrates, along with additives, are healthy and do not pose health risks—a feat he considers nearly impossible.
However, Kessler’s proposed changes are likely to face significant resistance from major food brands. Michael Taylor, who was FDA’s deputy commissioner for foods in 2015 when the agency revoked the GRAS status of partially hydrogenated oils (trans fats), anticipates this opposition. He notes that the substances Kessler is targeting are highly processed fine carbohydrates and products, which may pose a significant challenge for industry compliance.
The petition comes as Trump administration officials, led by Robert F. Kennedy Jr., prepare to release their second MAHA report. While the first report focused on potential drivers of chronic illnesses in children, including ingredients in ultraprocessed foods, the upcoming report is expected to outline proposed policy changes. The report is due by Tuesday.