Health and Human Services Secretary Robert F. Kennedy Jr. is seeking to eliminate provisions that enable the food industry to “self-affirm” the safety of new ingredients, a move that aims to reform how companies gain regulatory approval for additives. Last week, Kennedy instructed the Food and Drug Administration (FDA) to investigate potential rule changes to the Generally Recognized as Safe (GRAS) framework, which currently permits food manufacturers to bypass premarket reviews for certain chemicals or additives deemed safe by qualified experts.
Companies can achieve GRAS status through two main avenues. They may either petition the FDA for a review and official GRAS designation for an ingredient or “self-affirm” that their products are safe based on the conclusions of a scientific expert panel. Kennedy criticized the self-affirmation route, asserting that manufacturers have “exploited a loophole” that permits the introduction of new chemicals into the food supply, often lacking sufficient safety data. He emphasized that closing this loophole would enhance transparency for consumers and help ensure that new ingredients are indeed safe, ultimately aiming to “Make America Healthy Again.”
In addition to pursuing potential rule changes, the federal health department is collaborating with Congress to consider legislation regarding the GRAS process. Meanwhile, the FDA may begin to exercise increased scrutiny over self-affirmed GRAS determinations, as suggested by the law firm Akin. However, abolishing the self-affirmation pathway would significantly increase the FDA’s workload, especially at a time when the Trump administration is reducing the federal workforce, which has already led to the elimination of several food safety positions and the resignation of Deputy Commissioner of Human Foods Jim Jones.
Kennedy’s directive to review the GRAS process follows his reported request for some of the nation’s largest food companies, including Kraft Heinz and WK Kellogg, to eliminate artificial dyes from their products before the end of his term. The Consumer Brands Association, representing major packaged food companies, stated that the GRAS system is crucial for enabling innovation to meet consumer demand. Sarah Gallo, Senior Vice President of Product Policy at the association, noted that the consumer packaged goods industry is dedicated to upholding the integrity of America’s food supply and ensuring consumer transparency. She expressed readiness to collaborate with agency experts as the administration considers revisions to the GRAS process.
While nutrition and health advocates have welcomed Kennedy’s review of GRAS, some have raised concerns about whether the FDA needs to do more to regulate ingredients that have reached the market without adequate review. Scott Faber, Senior Vice President for Government Affairs at the Environmental Working Group, highlighted that the most significant danger to consumers is not merely the new food chemicals lacking meaningful FDA review but also the thousands of chemicals currently used in food products that have never undergone FDA scrutiny, or have not been reviewed for decades.
As discussions unfold regarding food safety, questions about specific ingredients such as calcium citrate have emerged, particularly regarding whether calcium citrate is bad for your heart. This topic has sparked interest among consumers and health professionals alike, emphasizing the need for thorough evaluations of food additives and their potential health impacts. The conversation around GRAS reform is crucial, as it holds the potential to reshape how safety assessments are conducted in the food industry.