HHS Plans to Close FDA Loophole that Allows Food Companies to “Self-Affirm” Safety of Ingredients
- by Natasha Hobley
- Published
- Environment
On Mar. 10, 2025, U.S. Secretary of Health and Human Services Robert F. Kennedy Jr. ordered the U.S. Food and Drug Administration (FDA) to revise a long-exploited loophole that allows food companies to “self-affirm” that their ingredients are safe.1 2
The FDA’s Generally Recognized as Safe, or GRAS, food designation was created by Congress in 1958. It was originally intended to apply to real ingredients widely recognized as safe such as salt, water, and yeast but has since been used to bypass the FDA’s pre-market review process to allow thousands of chemicals that may or may not be safe into food products.1
As it currently stands, once a food company declares in a statement to the FDA that an ingredient is GRAS, that ingredient can bypass the typical review process— even if the FDA has never proved the ingredient is truly safe. This process has led to the addition of hundreds of chemicals to food products without any safety oversight.1
Food Safety Group Estimates 99 Percent of Food Chemicals Added in Food Through GRAS
According to an analysis by the Environmental Working Group, food and chemical companies have used the GRAS loophole to approve 99 percent of new food chemicals. The FDA currently recommends that companies document the data that led the company to declare an ingredient GRAS and provide it to the agency, but it is only a recommendation and is voluntary, not a requirement.3
But the self-affirming label put on a chemical ingredient in a food by the company selling the food product isn’t the only loophole associated with GRAS. Even when the FDA does raise concerns about health risks, companies can find roundabout ways to never address the FDA’s safety concerns. One example was the FDA questioning a company’s request to approve the chemical substance theobromine as a GRAS ingredient. The company instead withdrew its notification and then had an independent contractor determine that the theobromine ingredient is “GRAS” without ever addressing the safety concerns of the FDA.3
Under Secretary Kennedy, the HHS plans to completely close the GRAS loophole by eliminating the self-affirmation process, forcing the companies to publicly notify the FDA when introducing new ingredients into the food supply, along with submitting the supporting safety data.1
“For far too long, ingredient manufacturers and sponsors have exploited a loophole that has allowed new ingredients and chemicals, often with unknown safety data, to be introduced into the U.S. food supply without notification to the FDA or the public,” Kennedy said in a statement.2 Kennedy also said that eliminating the loophole will provide transparency to consumers and help get our nation’s food supply back on track.1
The public can review and download all GRAS notices published by the FDA, which number more than 1,000.1 Some currently used self-affirmed and company-determined GRAS ingredients in foods include propyl paraben, BHA, and BHT, all which have existing documented health concerns.
On the same day the GRAS announcement was made, Secretary Kennedy also met with food giant leaders such as Kellogg’s, Kraft Heinz, General Mills, and PepsiCo about advancing food safety, removing toxins from our food, and radical food transparency for all Americans, “especially our children,” Kennedy shared in a post on X.1
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