What’s really in your food? RFK Jr. wants to close this FDA approval loophole
The U.S. health secretary has vowed to close an FDA loophole that has allowed food companies to self-police the safety of new additives.
The new U.S. health secretary, Robert F. Kennedy Jr., has pledged to close a legal loophole that has enabled food companies to bypass approval by the Food and Drug Administration (FDA) when introducing new additives into their products.
“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 on Monday.
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…
— Secretary Kennedy (@SecKennedy) March 11, 2025
What is a food additive?
Food additives are defined by the U.S.’s National Institute of Health (NIH) as “substances that become part of a food product when they are added during the processing or making of that food.”
The five main purposes of food additives, the NIH says, are to: “give the food a smooth and consistent texture,” “improve or preserve the nutrient value,” “maintain the wholesomeness of foods,” “control the acid-base balance of foods and provide leavening,” and “provide color and enhance flavor”.
How does the FDA’s food additives loophole work?
Known as the “GRAS” loophole, it stems from legislation on food ingredients that was passed by U.S. Congress nearly seven decades ago.
Approved in 1958, the Food Additive Amendment included a provision that enabled substances that are “generally recognized as safe” to be exempted from undergoing the FDA’s typical pre-market approval process.
GRAS designation was originally only intended to cover common items such as salt, pepper, vinegar and garlic, but over the years its scope has been allowed to expand well beyond such ingredients.
Significantly, the FDA amended the process of GRAS determination in 1997, permitting the food industry to decide for itself whether a substance can be considered GRAS.
As a result, the U.S. now operates what Melanie Benesch, the vice-president for government affairs at the Environmental Working Group (EWG), describes as an “honor system” when it comes to introducing new additives.
“Many of these ingredients may be safe, but […] we shouldn’t have an honor system determining what goes into the food that we eat every day, that we feed to our families, and that we will be consuming over the course of our lifetime, that could potentially contribute to our own chronic disease risk,” Benesch told CNBC last month.
How many food additives have benefited from the GRAS loophole?
According to the EWG, 98.7% of the 766 new additives that entered the U.S. food supply between 2000 and 2021 were introduced by virtue of the GRAS loophole, without the need for a green light from the FDA.
By eliminating the self-affirmation system on GRAS substances, the Department of Health and Human Services (HHS) said on Monday, “companies seeking to introduce new ingredients in foods [would be required] to publicly notify the FDA of their intended use of such ingredients, along with underlying safety data, before they are introduced in the food supply.”
Speaking to CNN in the wake of Kennedy’s pledge this week, Marion Nestle, a professor of nutrition at New York University, said: “I’m all for dealing with the GRAS loophole. It’s way past time for the FDA to close it.”
However, figures from the food additive industry have defended the safety of the substances being introduced into the U.S. food supply.
“There’s no cause for concern”
Carla Saunders, the executive director of the International Food Additives Council, told CNBC: “There’s a plethora of scientific evidence needed to ensure that those ingredients are safe, reliable and effective.
“Food additives are what make food possible. There are additional benefits such as extended shelf life, consistency, longevity of products. Everything is very transparent.
“There’s no cause for concern, and the last thing that we should be doing is trying to say that consumers should be scared about the foods that they’re eating.”
When will we be ‘falling back’
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