FDA tightens oversight on foods “Generally Recognized as Safe”

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The US Food and Drug Administration (FDA) is making it harder for manufacturers to deem their own chemical ingredients as safe. 

Today, the FDA proposed a rule that would make it mandatory for manufacturers to notify the agency whenever the manufacturer is adding a substance to food that the company deems to be “Generally Recognized as Safe (GRAS).”

The rule is meant to give the agency greater visibility into substances entering the food supply, and allow it to “better carry out its statutory responsibility to prohibit the use of unsafe additives in food,” acting FDA commissioner Kyle Diamantas said during a conference call.

Prior to proposing the rule, the GRAS notification program was voluntary — companies could choose to notify the FDA about new chemical ingredients they determined are safe for use in food. The proposed rule would make GRAS notification mandatory.

The GRAS rule was developed in the late 1950s by Congress to allow for a regulatory loophole on foods like salt, baking powder, and yeast, which lawmakers felt didn’t require a rigorous review process.

But critics have complained for years that companies have been exploiting the loophole, allowing an array of chemical ingredients to enter the food system unchecked.

An Environmental Working Group (EWG) analysis released in March found that more than 100 substances widely used in common US foods, supplements and beverages underwent no health and safety review by the FDA. 

“While intended as an exemption, over time the GRAS pathway became the primary entry point for the majority of substances entering the US food supply, far exceeding the number of substances coming through the more transparent food additive petition pathway,” Diamantas said during the conference call.

Some critics say the rule doesn’t go far enough. “It’s a baby step with no practical or important implications,” said Charles Benbrook, a longtime agricultural industry analyst.

Benbrook argued that the FDA should have gone a step further — not only requiring manufacturers to notify the agency of new additives and chemicals, but also demanding substantial data supporting their GRAS claims, echoing a citizen petition by former FDA Commissioner David A. Kessler.

“They talk a big game,” said Benbrook, “but they get close to the gate, the industry fires back, has some meetings in the White House with the senior [Make America Great Again] people, and all of a sudden the wind’s out of the balloon.”

With the recent FDA budget cuts, Benbrook said it will be difficult for the FDA to keep up.

He said that after cutting its budget and workforce substantially, the agency cannot reasonably expect the food industry to provide thousands of letters detailing additives companies have introduced into the food supply without notifying the FDA — and expect that process alone to improve oversight.

This proposed rule is available for public comment for 120 days, starting today.

“Its impact will depend on when and how it’s finalized and implemented and whether the administration can resist industry efforts to weaken it,” said Eva Greenthal, a senior policy scientist with the Center for Science in the Public Interest.

Definition on ultra-processed foods still to come

The US Department of Health and Human Services (HHS) also announced today that the agency, along with the US Department of Agriculture (USDA) submitted for final review the federal government’s first proposed definition of UPFs. The agencies did not share details on what the definition would entail.

The highly anticipated definition could be considered to be a win for the “Make America Healthy Again” (MAHA) movement, who have made ultra-processed foods a central issue, with Health and Human Services Secretary Robert F. Kennedy Jr., frequently pointing to UPFs as a key factor behind certain childhood diseases. 

Ultra-processed foods are generally considered to be foods that are low in nutritional quality and high in saturated fats, added sugars, and sodium. Consumer advocacy groups say a uniform definition is the first step towards regulating ultra-processed foods, which have been linked to various health issues such as obesity and cancer.

Today’s announcements come amid a nation-wide push against food additives from the MAHA movement, which opposes ultra-processed foods, artificial dyes, and other chemicals in foods as harmful to human health.

Last September, the Make America Healthy Again Commission released the “Make Our Children Healthy Again Strategy,” which included moves to reduce consumption of ultra-processed foods and artificial food dyes among other actions. The report was criticized as being significantly more friendly to corporate interests than a previous draft version MAHA released in May of 2025.

The impact of the new definition for UPFs is unclear until more details are known.  

A push to define

Last November, a group of food advocates, farmers, chefs and scientists wrote a letter urging the FDA to define ultra-processed foods. “What we recommended is the only meaningful way to respond to food processing. If the hope and purpose is to improve the nutritional quality of the U.S. food supply, it’s the only way to do it,” said Benbrook, who signed the letter.

The letter, sent by the Heartland Health Research Alliance (HHRA) and Swette Center to the FDA cited the need for front-of-package nutrition labels, cancer warnings on processed meats and targets for the food industry to reduce added sugars. 

A three-part series published in the peer-reviewed medical journal The Lancet found that ultra-processed foods are rapidly replacing fresh, minimally processed meals, heightening the risk of multiple chronic diseases such as type 2 diabetes and cardiovascular diseases.

The authors of the studies argue that individual consumer behavior is not enough to have an impact, and that coordinated government policies are needed to restrict UPF production and marketing, reduce high levels of fat, sugar, and salt, and improve access to whole, healthy foods.

According to the Centers for Disease Control and Prevention (CDC), ultra-processed foods accounted for 55% of all daily calories consumed by Americans aged 1 and older during the period of 2021 to 2023. Additionally, those aged 1–18 years old consumed a higher percentage of calories from ultra-processed foods (61.9%) as opposed to adults age 19 and older (53.0%). 

The CDC statistics are based on the NOVA food classification system, which is a framework for defining ultra-processed foods that was originally developed by researchers at the Center for Epidemiological Studies in Health and Nutrition in Brazil.

Featured image: Nina Zeynep Güler For Unsplash+