Robert F. Kennedy Jr. (RFK Jr.), recently confirmed Secretary of the U.S. Department of Health and Human Services (HHS), has directed the U.S. Food and Drug Administration (FDA) to explore rulemaking to eliminate the “Generally Recognized as Safe” (GRAS) process, which is widely considered by critics to be a “loophole” that allows food companies to introduce ingredients to the food supply without oversight or a formal safety review.

According to a March 10 statement from HHS, at present, FDA strongly encourages manufacturers to submit GRAS notices through the agency’s GRAS Notification Program, but industry can self-affirm that the use of a substance is GRAS without notifying FDA. The agency has completed and published more than 1,000 GRAS notices and evaluates an average of 75 notices per year, record of which is maintained in a public inventory.

“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,” said Secretary Kennedy. “Eliminating this loophole will provide transparency to consumers, help get our nation’s food supply back on track by ensuring that ingredients being introduced into foods are safe, and ultimately, Make America Healthy Again.”

The GRAS “Loophole,” Explained

The GRAS rule was established by FDA in 1972 to allow widely used food ingredients, commonly understood to be safe for consumption through a history of safe use, to remain on the market without extensive review. GRAS is a process in which food companies can determine for themselves whether a food ingredient is “safe” and voluntarily notify FDA. If a company shares its GRAS determination with the agency, FDA will either respond that it has no further questions about the substance’s safety, or that additional evidence is required. In the latter case, the company may either provide more data or withdraw its GRAS notification—while still being able to introduce the new ingredient into the food supply as a GRAS substance.  

Therefore, in the present day, companies have used GRAS as a way to use new additives without subjecting them to formal review.

GRAS has come under increasing scrutiny in recent years by lawmakers and the public. For example, in a September 2024 article published in the New England Journal of Medicine, leading medical and food law experts from Harvard University called the GRAS process as a “laissez-faire approach to monitoring the safety of ingredients [that] poses a threat to public health.” Reinforcing their point, the authors pointed to a 2022 incident of consumers experiencing liver injury due to the consumption of tara flour, a substance that entered the food supply based on a GRAS determination.

Previous Legislative Actions to Address GRAS Rule, Ingredients

A recent wave of state legislative actions aiming to ban certain food ingredients or directly targeting the GRAS process has been inspired by increasing awareness and scrutiny about the “loophole.” The first state bill of its kind, the California Food Safety Act, passed in October 2023 and prohibiting statewide sale or manufacture of foods containing four possibly toxic chemical additives, was a direct legislative response to the GRAS “loophole.” Many pieces of similar legislation have since been introduced in different states; most recently, West Virginia progressed a bill to ban foods containing seven artificial dyes statewide.

Directly addressing the GRAS rule itself, introduced to Congress in September 2024, the Toxic Free Food Act aimed to require FDA to overhaul the GRAS process. More recently, in September 2025, a bill introduced to the New York State Legislature, the Food Safety Chemical and Disclosure Act, would require food companies to disclose their use of any GRAS ingredients to the public.

FDA’s Efforts to Improve Food Ingredient Oversight Stymied by Worsening Resource Constraints

Prior to the Presidential Administration change in January 2025 and the confirmation of Secretary Kennedy, FDA was already making some effort to respond to the lack of federal oversight of food ingredients. Former FDA Deputy Commissioner for Human Foods, James (Jim) Jones, who resigned in February after 89 of his staffers were fired by the administration, was prioritizing the development of a formal post-market chemical review process for ingredients already in the food supply. However, even before mass layoffs and spending freezes took affect at FDA after the Presidential Administration change, Mr. Jones repeatedly expressed that resource constraints would greatly affect the agency’s ability to enforce stricter food chemical safety oversight.

In February, after Mr. Jones’ resignation, a coalition of 15 important public health, food industry, and consumer protection groups voiced their concern, stating, “An under-resourced food safety agency could jeopardize Secretary Kennedy’s stated [Make America Healthy Again] objectives to improve nutrition and ingredient safety for children and adults. Adequate resources are critical not only for outbreak response but also for developing and updating food safety standards, providing science-based industry guidance, and ensuring a well-trained federal-state inspection force to protect the integrity of our food system.”