- HHS Secretary Robert F. Kennedy Jr. directs the FDA to eliminate the GRAS self-affirmation pathway, a regulatory loophole that allows food companies to introduce new ingredients without formal FDA approval, raising concerns about unregulated additives in the U.S. food supply.
- The GRAS system, established in the 1950s, permits food manufacturers to self-certify ingredients as safe without FDA oversight, leading to the introduction of potentially harmful additives like BHA, a possible carcinogen and others with limited safety data.
- A 2022 study revealed that 99 percent of food chemicals introduced since 2000 were approved by the food industry without FDA review, with only 10 out of 766 new chemicals undergoing formal FDA scrutiny between 2000 and 2022.
- Kennedy's directive aligns with the Make America Healthy Again Commission's goals, aiming to address health risks posed by food additives, particularly for children and increase transparency by requiring companies to notify the FDA and provide safety data for new ingredients
- Critics highlight flaws in the GRAS system, including the lack of routine safety checks for additives once on the market, while industry leaders express concerns about potential regulatory burdens, though consumer advocacy groups support the move for safer food standards.
On March 10, Health and Human Services (HHS) Secretary Robert F. Kennedy Jr. announced he has directed the Food and Drug Administration (FDA) to explore eliminating the self-affirmed Generally Recognized As Safe (GRAS) pathway.
This regulatory loophole allows food companies to introduce new ingredients without formal FDA approval, raising alarms about the potential risks of unregulated additives in the U.S. food supply. The decision comes amid mounting evidence that the current system has failed to adequately protect consumers, particularly as processed foods dominate American diets.
The GRAS rule, established in the 1950s, permits food manufacturers to self-certify ingredients as "safe" without notifying the FDA or submitting safety data for review. Critics argue that this system has allowed potentially harmful additives, such as butylated hydroxyanisole (BHA) – a possible carcinogen – to enter the food supply unchecked. A 2022 study by the Environmental Working Group (EWG) revealed that 99 percent of food chemicals introduced since 2000 were approved by the food industry itself, bypassing FDA oversight entirely. Between 2000 and 2022, 766 new food chemicals entered the U.S. market, but only 10 underwent formal FDA review.
"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," Kennedy stated.
The GRAS system: A legacy of lax oversight
The GRAS pathway was originally designed to streamline the approval of common food ingredients like salt and vinegar, which have long histories of safe use. However, as the food industry evolved, the system became a gateway for introducing novel chemicals without rigorous scrutiny. Under current regulations, companies can voluntarily submit GRAS notifications to the FDA, but they are not required to do so. As a result, the FDA reviews only about 75 voluntary submissions annually, leaving countless additives untested by federal regulators.
Kennedy's directive aligns with the goals of President Donald Trump's Make America Healthy Again Commission, established last month to investigate the health risks posed by food additives and chemical exposure.
Critics of the GRAS system point to alarming examples of additives that have slipped through the cracks. BHA, for instance, has been flagged by the National Toxicology Program as a likely carcinogen, yet it remains widely used in processed foods. Similarly, green tea extract EGCG, linked to increased cancer risks, is still classified as GRAS-approved.
The proposed changes would require companies to notify the FDA before introducing new food ingredients, providing safety data and details about intended usage. While consumer advocacy groups have welcomed the move, some industry leaders have expressed concerns about potential regulatory burdens.
Kennedy has already met with CEOs from major food corporations, including Kraft Heinz, General Mills, Tyson Foods, Kellogg's and Pepsi, to discuss increased food safety measures and transparency initiatives. (Related: RFK Jr.'s appointment as HHS secretary: A call to uncover America's health crises.)
Dr. Mona Calvo, a researcher at the Icahn School of Medicine at Mount Sinai, noted that many GRAS-listed additives were approved decades ago, when home-cooked meals were the norm. "Today, with the rise of ultra-processed foods, there is greater exposure to chemical preservatives and artificial ingredients," Calvo said.
Nephrology expert Dr. Jaime Uribarri highlighted another critical flaw in the current system: the lack of routine safety checks once additives are on the market. "Once an additive-containing packaged food is on store shelves, the FDA does not conduct regular testing or periodic safety sampling," Uribarri explained.
As discussions continue, stakeholders from across the food industry and consumer advocacy groups are expected to weigh in on the potential impacts of eliminating the GRAS self-approval process. While some argue that stricter oversight will lead to safer food standards, others warn that it could create logistical challenges for manufacturers.
Watch the video below where RFK Jr. reveals "something is poisoning the American people."
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