July 15, 2024

FDA to Publish Final Rule on GRAS; Experts Object

The FDA is publishing its final rule on GRAS (generally recognized as safe) substances in human and animal food tomorrow. The rule “amends and clarifies the criteria in our regulations for when the use of a substance in food for humans or animals is not subject to the premarket approval requirements of the FD&C Act because it is generally recognized as safe under the conditions of its intended use.”


Ingredients on the GRAS list don’t need to be approved by the FDA before they are added to foods, but they must adhere to the same safety standards as approved additives. The GRAS list includes substances that were in use in foods before 1958, or through scientific procedures.

But food safety experts are concerned about the rule and think that it gives companies the power to make decisions about what is GRAS and what is not. Companies will be able to add substances to food without telling the FDA. Those who make the decisions about what is added to foods may have conflicts of interest, and no one knows how “qualified” those decision-makers are.

In addition, the FDA only “strongly encourages” companies to tell the government about their GRAS decisions. The notification procedure in the rule is voluntary, not required by law.

Jessica Almy, Center for Science in the Public Interest Deputy Director of Nutrition Policy issued a statement about this matter, calling the FDA’s rule “flawed.” She said, “decisions about the safety of substances in our food supply should be transparent and unbiased. However, today’s rule gives companies a green light to make decisions about which substances are GRAS and can be added to foods – without even informing the FDA. The FDA should not allow companies to make secret, potentially biased determinations about which substances are safe enough for American families.”

Consumers Union, the publisher of Consumer Reports, says that the new FDA rule on GRAS is unacceptable and fails consumers. That organization said that today’s new rule “puts an official stamp on current practice, which allows food companies to introduce new ingredients into food without any notice to FDA or the public.”

GRAS does not mean that the FDA has studied the ingredient and has declared it safe. It also does not mean that that government monitors the substance’s safety and use, although consumers think that is the case.

Laura MacCleery, Vice President of Policy and Mobilization for Consumer Reports said, “FDA missed a major opportunity to clean up the food system. This final rule on the safety of food ingredients fails consumers. Companies will still be able to introduce novel substances into food in secret, without having to show they are safe. The agency also failed to fix the rampant conflicts of interest that affect the review process for ingredients. That is unacceptable and deeply disappointing.”

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