Last year, Kennedy directed the Food and Drug Administration to investigate revising its Substances Generally Recognized as Safe (GRAS) rule, which allows companies to bypass traditional government notification and review.
The GRAS designation was intended to allow common food ingredients—like vinegar, flour, baking soda or standard spices—to bypass safety reviews and become available to all food manufacturers.
But companies have been taking advantage after FDA created what is known as the “GRAS loophole,” allowing a company to self-certify its ingredients were GRAS, and then voluntarily inform the FDA that it had done so.
FDA is expected to propose, as early as Monday, making notification of GRAS submissions mandatory for most substances.
The proposed rule cleared the White House regulatory review last week.
“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,” Kennedy said in March 2025 when he directed FDA to revise the rule.
The proposal represents a significant effort by the Trump administration to take a food safety goal championed by Kennedy’s Make America Healthy Again movement and turn it into regulatory action.
But there are going to be numerous hurdles to turning a proposal into final action, and food industry opposition is likely to be intense.
