For decades, food companies have been able to add potentially harmful ingredients to their products without telling the U.S. Food and Drug Administration (FDA) or providing safety data showing the ingredients don’t harm human health — but that may soon change.
Health and Human Services (HHS) Secretary Robert F. Kennedy Jr. on Monday directed the FDA to take steps to eliminate a loophole that allows the use of food ingredients based on food companies’ own assurances that the ingredients are safe.
Under federal law, food additives are subject to premarket review and approval by the FDA — unless the substance is considered, by the food manufacturer, to be “generally recognized as safe” (GRAS).
Jaydee Hanson, policy director for the nonprofit Center for Food Safety (CFS), called the FDA’s GRAS system a “weak regulatory process … where the company does its own research and chooses its own reviewers to self-certify that its product is safe for human consumption.”
Closing the GRAS loophole was one of the things CFS hoped Kennedy would do as HHS secretary, Hanson said.
“The GRAS system has just been a travesty,” Hanson told The Defender. “It’s literally the fox guarding the hen house, and that’s never a good plan.”
Hanson added:
“The process is corrupt. This would be like a firm always doing its own audit, never doing an independent audit. This is exactly the same … So it’s time for this to be fixed. We’ve been asking the FDA to do it for years and they’ve ignored it.”
In 2017, groups including CFS sued the FDA over the GRAS loophole, alleging it was unconstitutional and illegal.
Kennedy said in an X post late yesterday:
“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.
“Eliminating the GRAS loophole will provide transparency to consumers, help get our nation’s food supply back on track by ensuring that ingredients being introduced into foods are safe, and ultimately Make America Healthy Again.”
Kennedy told Acting FDA Commissioner Sara Brenner to have the agency “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,” according to an HHS press release.
The HHS also said it wants to work with Congress to pass laws to close the GRAS loophole.
The HHS did not immediately respond when asked how long it would take for the FDA to eliminate the GRAS loophole or how soon it plans to ask Congress to close it.
Ashka Naik, chief research and policy officer for the nonprofit Corporate Accountability, said the GRAS loophole is just the “tip of the iceberg.”
The larger problem is the “political power” of the food industry in the U.S. “and actually across the world,” she said, adding:
“This would be a moment for us to build even more pressure on Secretary Kennedy and remind him about the immense corporate political power because GRAS didn’t just happen.
“Decades of lobbying and behind-the-curtain manipulation by the industry have gone into making the American food system this unhealthy, and even fatal, for so many.”
950 substances allowed in U.S. foods that are banned in Europe
Kennedy’s directive to the FDA came one day after he met with food industry leaders, including representatives from Kraft Heinz, General Mills, Tyson Foods, WK Kellogg Co, The J.M. Smucker Company and PepsiCo, for a roundtable discussion in Washington, D.C., Fox News reported.
Although the specific topics are unknown, Kennedy said in an X post that the group had a “great discussion … on advancing food safety and radical transparency to protect the health of all Americans, especially our children.”
The Health Research Institute’s Co-founder, CEO and Chief Scientist John Fagan explained why getting the FDA to change its rule on GRAS matters:
“The rule has created a channel, called the ‘Self-Affirmed GRAS,’ that unscrupulous companies use to create the appearance that their products have been verified safe by the FDA, when, in reality, the company’s safety assessment of those products has never been evaluated by the FDA.”
The Health Research Institute is a nonprofit independent lab in Iowa.
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The FDA’s current limits on food ingredients not naturally occurring in nature are very weak compared to those in Europe, according to a KFF Health News report.
There are at least 950 substances allowed in U.S. foods that are not permitted in Europe, including chemicals linked to health concerns, KFF Health News said.
At a March 6 confirmation hearing, Dr. Marty Makary, President Donald Trump’s nominee to run the FDA, said some foods are making it into the U.S. food supply “with a lot of molecules that do not appear in nature.”
According to Makary, “These are chemicals that the industry insists are safe, a subset of which are concerning.”
For instance, Hanson said the FDA allowed the Impossible Burger company to claim that the colorant used in the fake blood was GRAS, “even though their own scientist said that the company had done the GRAS review wrong.”
The FDA largely leaves it up to food companies to do their own research on whether additives and ingredients are safe.
Former FDA Commissioner Robert Califf told a U.S. Senate committee in December that the food industry has “massive amounts” of research to which the FDA has no access, according to KFF Health News.
