FDA Proposes GRAS Rule, Advances Ultra-Processed Food Definition

The Department of Health and Human Services announced Monday afternoon that the FDA plans to increase oversight of food ingredients by holding manufacturers accountable.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. These acts support President Donald J Trump’s Make America Healthy Again (MAHA) movement, dedicated to bettering nutrition science and public health with modernized oversight.^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. “We cannot reverse America’s chronic disease epidemic without transforming our food system. These historic actions bring greater transparency to what’s in our food and stronger science to federal nutrition policy. President Trump and I promised to Make America Healthy Again, and today we are turning that promise into policy.”

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, under the FDA’s proposed rule, reporting GRAS substances added to any human or animal food would be mandatory. Manufacturers would also be required to report substances already on the market and self-concluded as GRAS within a certain time limit through a streamlined pathway—currently under establishment.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. “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 were from ultra-processed foods and 53% of adults’ caloric intake.³ These data were collected in support of RFK Jr’s initiative to reduce the amount of ultra-processed foods available to consumers.

HHS cites numerous studies 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 consistency across research efforts to measure the impact of ultra-processed foods.

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

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

Both actions further the MAHA agenda aimed at reversing chronic diseases, 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.

References

1. HHS Press Room. Secretary Kennedy announced 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