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On March 10, Secretary of the Department of Health and Human Services Robert F. Kennedy Jr. directed Food and Drug Administration (FDA) Acting Commissioner Sara Brenner, MD, to take steps to explore potential rulemaking to revise its Substances Generally Recognized as Safe (GRAS) Final Rule and related guidance to eliminate the self-affirmed GRAS pathway—allowing the food and chemical industry to assign GRAS status to food ingredients without oversight. This “pathway” to allowing food additives has long been recognized as a loophole that allows unidentified and potentially harmful additives in food, including by the 2010 U.S. General Accountability Office (GAO) report, Food Safety: FDA Should Strengthen Its Oversight of Food Ingredients Determined to Be Generally Recognized as Safety. 

>> Tell FDA to eliminate the self-affirmed GRAS loophole. Tell Congress to pass the Toxic Free Food Act of 2024. 

In 2016, FDA finalized a rule allowing food companies to add new ingredients to the food supply with almost no federal oversight. Thousands of substances have been added under the rule, which has been in effect since it was first proposed in 1997. The rule, which was meant to provide guidance for companies seeking to classify new food ingredients as GRAS, has been widely criticized because it puts consumers at risk by allowing the food industry to bypass crucial safety checks for new ingredients.  

The GRAS designation is rooted in 1958 amendments to the Federal Food, Drug, and Cosmetic Act, which were meant to require companies to demonstrate the safety of prospective ingredients but created an exemption for common ingredients like vinegar and baking soda that were already widely used and known to be safe. Although the provision was intended to exempt only the most time-tested substances from rigorous pre-market approval requirements, FDA introduced a new rule in 1997 allowing companies to decide for themselves what ingredients qualify as GRAS and whether to report the designations to FDA. 

For example, according to a Consumer Reports article, “GRAS: The hidden Substances in Your Food,” “... the Flavor and Extract Manufacturers Association (FEMA) has classified several possible carcinogens as GRAS, and when pressed has failed to produce peer-reviewed safety data on those chemicals.” However, the unknown ingredients, which have never been reported at all, pose the greatest concern. With the number of food additives reaching several thousand, found in virtually every processed food, there is no way to guarantee that food is free from toxic chemicals or allergens. They can be found in virtually any processed food—from breakfast cereals and energy drinks to frozen dinners and all manner of snacks. 

An independent study by the Pew Charitable Trusts found that from 2003-2013, almost all new chemicals added were deemed by manufacturers to be GRAS. As a result of the adoption of the GRAS process, the Center for Food Safety estimates that 3,000 chemicals that have never been scrutinized by the FDA are in use today.  

In September 2024, U.S. Representative Rosa DeLauro (D-CT) re-introduced the Toxic Free Foods Act, to overhaul FDA's process for determining the safety of chemicals used in the food supply. The Toxic Free Food Act would require FDA to close the GRAS loophole and make the industry's chemical food additives subject to FDA approval. The legislation failed to pass in the last (118th) Congress but should be reintroduced and passed in order to provide a more permanent solution to the problem. 

>> Tell FDA to eliminate the self-affirmed GRAS loophole. Tell Congress to pass the Toxic Free Food Act of 2024. 

The targets for this Action are the U.S. Food and Drug Administration under the U.S. Department of Health and Human Services and the U.S. Congress. 

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↪️ For more information, please stay tuned for the Daily News post on March 31, 2025.