STATEMENT: Proposed FDA rule moves toward closing loophole, improving food safety

Proposal would stop food companies from putting unverified ‘generally recognized as safe’ additives in products without notifying regulators

WASHINGTON — The Food and Drug Administration (FDA) on Monday proposed a new rule requiring food companies to notify the agency when they independently determine an ingredient is “generally recognized as safe” (GRAS). Under the current system, manufacturers can self-certify an additive as GRAS without first obtaining FDA approval, and are not required to notify the FDA once they have done so.

Originally, the “generally recognized as safe” designation was intended to allow food producers to include common ingredients such as vinegar and spices in food without the FDA further evaluating or approving those ingredients. 

As Americans consume more ultraprocessed foods, and companies include more synthetic additives, the GRAS designation has extended far beyond the FDA’s initial intent. This creates a significant gap in the nation’s food-safety system: Ingredients can enter and remain in our food system without a formal FDA determination of their safety. Under the proposed rule, manufacturers would be required to notify regulators when they self-certify an additive as GRAS. 

In response to the FDA’s proposed rule, U.S. PIRG Education Fund Federal Legislative Advocate Dina Akhmetshina released the following statement:

“The GRAS designation is an outdated regulatory loophole that has allowed important questions about food safety to go unanswered for too long. As our understanding of food, health and chronic disease has advanced, it is increasingly important that the standards used to determine whether an ingredient is safe keep pace. The FDA’s proposal is a good first step toward empowering regulators to ensure that food ingredients are as safe as Americans deserve.”