FDA Proposes GRAS Rule, Advances Ultra-Processed Food Definition

The US Food and Drug Administration (FDA) plans to increase oversight of food ingredients by holding manufacturers accountable, the US Department of Health and Human Services (HHS) announced Monday afternoon.¹

The proposed rule would require food manufacturers to notify the FDA when they conclude that an added substance to human or animal food is deemed Generally Recognized as Safe (GRAS) and expand the existing public inventory of submitted GRAS notifications, thus improving visibility for consumers. HHS and the US Department of Agriculture (USDA) also advanced a proposed definition of ultra-processed foods for federal nutrition policy and research. “This action will bring greater transparency for consumers choosing their ingredients,” USDA Secretary Brooke L. Rollins said.¹ These acts support President Donald J. Trump’s Make America Healthy Again (MAHA) agenda.^1,2

“Nearly 60% of the American diet is made up of ultra-processed foods, and childhood obesity now affects more than one in five American children,” Robert F. Kennedy Jr, HHS secretary, said in a press release.¹

FDA Proposes Mandatory GRAS Notifications for Food Manufacturers

Since GRAS exemption was established in 1958, manufacturers are able to reach their own conclusions on what substances constitute GRAS and voluntarily submit notice to the FDA. However, the FDA’s proposed rule would make GRAS reporting mandatory for any substance added to human or animal food. Manufacturers would also be allowed to report substances already on the market and self-concluded as GRAS within a certain time limit through a streamlined pathway—still being finalized.¹

“Americans deserve confidence that the ingredients in their food are subject to transparent, science-based oversight, and today’s actions strengthen both sides of that equation,” Kyle Diamantas, JD, acting FDA commissioner, said in a press release.¹ “By proposing mandatory GRAS notifications, we are closing critical information gaps and giving the FDA greater visibility into substances entering the food supply.”

HHS and USDA Advance Definition of Ultra-Processed Foods

In 2025, the CDC reported that nearly 62% of children and teens’ daily calories and 53% of adults’ caloric intake came from ultra-processed foods.³These findings feed into RFK Jr’s initiative to reduce the amount of ultra-processed foods available to consumers.

HHS cites research linking high consumption of ultra-processed foods with chronic diseases such as type 2 diabetes and heart disease—both of which are preventable. The absence of a standardized definition has hindered research consistency across the federal government.

The proposed definition was coined with feedback from thousands of stakeholders, including industry, researchers, consumer organizations, and members of the public.¹

“By advancing a proposed definition of ultra-processed foods, we seek to create a stronger foundation for future nutrition research,” Diamantas said.¹

Both actions further the MAHA agenda, which RFK Jr said is dependent on transforming the US food system by implementing greater transparency and “stronger science to federal nutrition policy.”

“Together, these reforms represent a significant step toward a more transparent and modern food safety system,” Diamantas said.¹

References

1. HHS Press Room. Secretary Kennedy announces landmark food policy reforms to advance President Trump’s MAHA agenda. HHS. August 10, 2026. Accessed August 11, 2026. https://www.hhs.gov/press-room/hhs-announces-ultra-processed-foods-gras-reforms.html

2. HHS Press Room. Fact sheet: HHS announces proposed GRAS rule. HHS. August 10, 2026. Accessed August 11, 2026. https://www.hhs.gov/press-room/fact-sheet-hhs-announces-proposed-gras-rule.html

3. Bonavitacola J. Children’s diets primarily made up of ultra-processed foods, finds CDC. AJMC^®. August 7, 2025. Accessed August 11, 2026. https://www.ajmc.com/view/children-s-diets-primarily-made-up-of-ultra-processed-foods-finds-cdc