The Department of Health and Human Services (HHS) on Aug. 10 announced a proposed rule to end food manufacturers’ practice of making generally recognized as safe (GRAS) determinations without notifying the Food and Drug Administration.

The rule seeks to close a decades-old information gap, transitioning from a voluntary to a mandatory notification program. It will require any person introducing GRAS additives into the food supply to notify the Food and Drug Administration (FDA).

“It would give FDA greater visibility into the substances used in human and animal food, enabling us to more efficiently, knowledgeably, and timely regulate the safety of our nation’s food supply,” FDA acting Commissioner Kyle Diamantas said at a news conference held at HHS headquarters in Washington.

HHS and the Department of Agriculture also submitted for final review the federal government’s first definition of ultra-processed foods, Health Secretary Robert F. Kennedy Jr. said.

“These two actions will change how the federal government oversees what’s in our food and how we understand the foods that Americans eat,” he said.

Nearly 60 percent of the American diet is made up of ultra-processed foods, and childhood obesity now affects more than 20 percent of American children, according to Kennedy.

“We cannot reverse America’s chronic disease epidemic without transforming our food system,” he said. “These historic actions bring greater transparency to what’s in our food and stronger science to federal nutrition policy. President [Donald] Trump and I promised to Make America Healthy Again, and today we are turning that promise into policy.”

Stronger Oversight on Food Ingredients

Dariush Mozaffarian, director of the Food is Medicine Institute at Tufts University, told The Epoch Times: “Most people assume that when a new substance is added to their food, the FDA knows about it and has reviewed its safety. As you’ve heard, shockingly, this is not the reality.”

The GRAS loophole stems from a 1958 exemption allowing food companies to self-affirm the safety of certain food ingredients.

Although the FDA has operated voluntary notification programs, companies have not been required to notify the agency when making these determinations, according to the federal statement.

Under the proposed rule, manufacturers must immediately notify the FDA when concluding that additives to human or animal food are generally recognized as safe.

For substances already on the market, the proposal would establish a submission pathway requiring manufacturers to provide information about existing uses of self-affirmed GRAS substances.

The FDA will also maintain and expand a public-facing database of submitted notices.

“Secretary Kennedy has brought renewed attention to the food all Americans have been eating, and this action will bring greater transparency for consumers choosing their ingredients,” Agriculture Secretary Brooke Rollins said.

In a statement to The Epoch Times, the International Food Additives Council shared the administration’s goal of achieving a transparent food supply but disagreed with officials’ description of GRAS.

“A public notification requirement largely formalizes what responsible ingredient makers already do,” said Allison Cooke, director of government affairs at the food industry group.

“Consumers need to know there has never been a loophole,” she added. “Every ingredient must meet the same safety standard, backed by publicly available, peer-reviewed science.”

The rule will soon enter a public comment period under the federal rulemaking process.

Definition of Ultra-Processed Foods

On Aug. 3, the FDA submitted a document that proposes a definition of ultra-processed food, which has not yet been made public while it undergoes final review at the White House Office of Management and Budget.

Although research has linked high consumption of ultra-processed foods to preventable chronic diseases, including Type 2 diabetes and heart disease, the absence of a standardized federal definition has limited research consistency across the federal government, according to the federal statement.

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

Each week, food kills 10,000 Americans, causes 1,500 new cases of cancer, and triggers 16,000 new cases of diabetes, according to Mozaffarian.

The resulting healthcare costs and productivity losses drain $1.5 trillion annually from the economy, he added.

A July study of 50,000 adults, coauthored by Mozaffarian, found that ultra-processed foods are linked to worse metabolic health, more chronic diseases, and all-cause mortality.

“Our food is the top driver of disease, disability, and death in the United States,” Mozaffarian said. “To address these harms, America needs a standard national definition.”

The definition will not only inform Americans about choosing better food, but also create an incentive for the food industry to reformulate existing products and create new, healthier ones, according to Mozaffarian.

HHS also encouraged Congress to build on these efforts through legislation that further strengthens the safety of the American food supply.