Proposed Rule to Enhance Food Safety Oversight

U.S. Health and Human Services Secretary Robert F. Kennedy Jr. has suggested a new regulation aimed at addressing a significant loophole that lets companies determine the safety of chemical ingredients without notifying the Food and Drug Administration (FDA).

On Monday, Kennedy celebrated recent changes in food policy by the HHS, which includes plans to reform how companies decide which ingredients can be labeled as “Generally Recognized as Safe” (GRAS), thus avoiding the usual government review.

“We’re proposing a rule that would end the practice of companies making GRAS determinations without notifying the FDA,” he stated. “The proposal will give the agency greater visibility into the substances that are entering our food supply.”

“Under the current system, the FDA does not even have a complete picture of what is entering the food supply, and neither does the American people,” Kennedy remarked.

He noted that the GRAS designation, originally established by Congress in 1958, has become a “massive loophole” exploited by the food industry, permitting the introduction of countless new substances into the U.S. food supply.

“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,” said Acting FDA Commissioner Kyle Diamantas. “By proposing mandatory GRAS notifications, we are closing critical information gaps and giving the FDA greater visibility into substances entering the food supply.”

The proposed regulation would also introduce a timeline for manufacturers to inform the FDA about existing GRAS ingredients. Once a new ingredient is reported, the FDA would have 45 days to assess it and 180 days for a more comprehensive evaluation to confirm its compliance with GRAS standards.

Kennedy has long argued that many chronic health problems in the U.S. are linked to poor dietary choices.

“America spends nearly $5 trillion a year on healthcare—far more than any nation in the world—and we have the worst health outcomes,” he said. “We remain the world’s sickest country.”

This proposal marks a significant effort within the Trump administration’s “Make America Healthy Again” campaign, aimed at reducing harmful and unnatural ingredients in diets. The initiative seeks to address health issues in a more holistic way rather than merely treating symptoms through healthcare and pharmaceutical solutions.

The administration has particularly focused on synthetic food colorings, with several major brands, including M&M’s and Kellogg’s, agreeing to Kennedy’s initiative of replacing artificial dyes with natural alternatives derived from fruits and plants.