On Sunday, U.S. Secretary of Health and Human Services (HHS) Robert F. Kennedy Jr., known for his “Make America Healthy Again” (MAHA) agenda, spoke on CBS News 60 Minutes about his plans to close the “Generally Recognized as Safe” (GRAS) “loophole,” which he says was “highjacked by the [food] industry” to add “thousands of new ingredients into our food supply.”

Secretary Kennedy asserted that the U.S. Government “does not know how many ingredients there are in American food,” and cited estimates between 4,000 and 10,000.

He alluded to a developing proposed rule to tighten GRAS oversight that is currently pending White House review. The details of this proposed rule are not yet publicly known.

He also said FDA plans to “answer some of the questions” asked in a petition submitted in August 2025 by David Kessler, M.D., former FDA Commissioner, which urges the agency to revoke the GRAS status of processed, refined carbohydrates. Dr. Kessler believes these ingredients are dominant in many of the ultra-processed foods (UPFs) on U.S. store shelves, and are therefore a main driver of increasing obesity and diet-related diseases.

Secretary Kennedy: “I’m not saying we’re going to regulate UPFs…”

However, when asked why he thinks he will prevail in regulating UPFs despite President Trump’s deregulatory stance, Secretary Kennedy answered, “I’m not saying that we’re going to regulate UPFs. Our job is to make sure everybody understands what they’re getting… to have an informed public.”

What is the GRAS “Loophole?”

Established in 1958 through an amendment to the Federal Food, Drug, and Cosmetic Act, the GRAS process enables food substances to be used without premarket approval by FDA as long as scientific experts determine the substance to be “safe” under the conditions of its intended use. GRAS determinations effectively exempt a food substance from being subjected to the premarket safety review process required for food additives by FDA.

GRAS determinations can be made by experts outside of the government, using literature compiled by food companies. Food companies can choose to voluntarily notify FDA when they have made a GRAS determination about a new substance—or they can begin using the intended ingredient without notifying FDA once they have compiled the scientific evidence required to make their determination.

The GRAS process was originally intended to allow widely used food ingredients, commonly understood to be safe for consumption (e.g., vinegar), to remain on the market without extensive review.

In recent years, GRAS has increasingly come under public scrutiny by lawmakers and scientists alike for the introduction of new ingredients, which have not been proven to be safe, to the food supply.