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FDA Petition Could Redefine the Future of America’s Food System

DAVID A. KESSLER, MD

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It has been four decades since the FDA reviewed the scientific basis of GRAS status of processed refined carbohydrates. It has been during those four decades that America’s obesity crisis has emerged. This petition demonstrates that, based on the lack of scientific evidence, continued GRAS affirmation is neither legal nor credible.

FAB RESEARCH COMMENT:

David Kessler has submitted a petition calling on the Food and Drug Administration (FDA) to remove processed refined carbohydrates from the U.S. food supply by revoking their “Generally Recognized as Safe” (GRAS) status.

These ingredients—including refined sweeteners, maltodextrins, and extruded or modified flours and starches—are the key drivers of ultraprocessed foods, which have been linked to rising rates of obesity, diabetes, autoimmune disorders, and certain cancers.

His petition argues that FDA’s current GRAS determinations are based on outdated science, and fail to account for the biological harms of processed refined carbohydrates for which firm evidence has now been established.

He presents a powerful argument that by revisiting these determinations, the FDA has an opportunity to take transformative action to protect public health—on a scale comparable to tobacco regulation — by reducing the widespread consumption of ultraprocessed foods and compelling the food industry to rethink how it produces what Americans eat.

See this related news article:


David A Kessler M.D. is a highly experienced pediatrician, lawyer, and administrator (both academic and governmental) - who served as Chief Science Officer of the White House COVID-19 Response Team from January 20, 2021 to May 2023. 

As a former Commissioner of the FDA (from 1990-1997) he took an active approach to both food safety, and the regulation of cigarettes and tobacco.

He also has a personal as well as a professional interest in the links between food and addiction - and is the author of a number of widely-acclaimed books on this subject, including: 
 

 

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6th August 2025 - Letter from David A Kessler M.D.
to the US Secretary for Health and Human Services

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Mr. Secretary,

You have made ultraprocessed foods a central focus of your health agenda and argued that the increased intake of ultraprocessed foods is a "primary culprit" behind an epidemic of chronic diseases in the U.S., including obesity, diabetes, autoimmune diseases, and some cancers. You have called for the curbing of ultraprocessed foods in our food supply.

I am submitting a petition to the FDA that provides a realistic, science-based, and legally sound path for the Administration to do just that. It calls on the Agency to remove processed refined carbohydrates from the food supply on the basis that they should no longer be considered “Generally Recognized as Safe” (GRAS). Processed refined carbohydrates are a driver behind the emergence and widespread consumption of ultraprocessed foods and are primary causal determinant of metabolic harm.

Processed refined carbohydrates include 1) refined sweeteners, such as corn syrup, corn solids, glucose syrups, dextrose, invert sugar, xylose, maltose, and high-fructose corn syrups, 2) maltodextrin and refined flour and starches subjected to food extrusion technology, including wheat, corn, tapioca, oat and potato flour, and starches processed by extraction or similar technology, and 3) sucrose, refined flour, and starch when used in combinations with emulsifiers, humectants, dough conditioners, stabilizers and gums, or modified starches. This petition focuses on the “markers” of ultraprocessed foods. This petition does not seek to limit sugar, flour, or starch when used at home.

It has been four decades since the FDA reviewed the scientific basis of GRAS status of processed refined carbohydrates. It has been during those four decades that America’s obesity crisis has emerged. This petition demonstrates that, based on the lack of scientific evidence, continued GRAS affirmation is neither legal nor credible. As demonstrated, FDA’s past GRAS determinations are based on outdated data that did not properly assess the biological effects of these processed refined carbohydrates.

We can no longer stand by and do nothing. The removal of processed refined carbohydrates will prove transformative in protecting the public. I believe the public health benefit may be as significant as those achieved through the regulation of tobacco products. As one who oversaw tobacco regulation at FDA in the 1990s and who has since written extensively on the role of ultraprocessing in our foods, I see similarities between the two.

Just as nicotine causes millions to be addicted and sickened by tobacco, so do processed refined carbohydrates cause much of America’s chronic disease. There is no expert consensus that refined carbohydrates in ultraprocessed foods are safe under present conditions of use. That leaves FDA with no choice but to determine that processed refined carbohydrates, as a matter of science and law can no longer be considered GRAS and thus must be removed from commerce.

Mr. Secretary, the government has an opportunity, and a responsibility, to begin now the process of curbing processed refined carbohydrates in our food supply. On a larger scale, this petition triggers a remaking of the food supply. It will get companies to rethink and redesign the way they make food so that foods are not injurious to health.

Sincerely,

David A. Kessler, MD