Health and Human Services Secretary Robert F. Kennedy Jr. on Monday unveiled a plan to tighten oversight of the decades-old "generally recognized as safe," or GRAS, loophole in federal food regulations.

The proposal directs the Food and Drug Administration to explore rulemaking that would eliminate the self-affirmed GRAS pathway. Under current rules, companies can determine on their own that a substance is safe for use in food without notifying the FDA or providing safety data to the agency.

Kennedy described the change as necessary to restore transparency and ensure ingredients added to the U.S. food supply undergo proper review. "For far too long, ingredient manufacturers and sponsors have exploited a loophole that has allowed new ingredients and chemicals, often with unknown safety data, to be introduced into the U.S. food supply without notification to the FDA or the public," he said in a statement.

The GRAS provision dates to 1958 legislation intended for common ingredients such as vinegar and baking soda. Over time, the self-affirmation option expanded dramatically, allowing thousands of substances into processed foods without government scrutiny, according to critics of the system.

The announcement aligns with Kennedy's broader "Make America Healthy Again" efforts at HHS, which have included scrutiny of ultraprocessed foods and calls for greater accountability from manufacturers. The proposed rule would require companies to submit safety data and notify the FDA publicly before new ingredients reach the market.

Industry groups have raised concerns that the changes could slow innovation and increase regulatory burdens. Federal officials said the plan focuses on notification and review rather than an outright ban on any substances during the rulemaking process.

The move comes amid ongoing public debate over the safety of certain food additives and the role of federal agencies in regulating the nation's food supply. Details of the formal proposal are expected to advance through the standard regulatory review process.