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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Click here to view References:1 Walsh S. HHS Secretary RFK Jr orders FDA to close food ingredients loophole. UPI Mar. 10, 2025.
2 Reuters. Kennedy asks FDA to revise ‘self affirm’ rule for food ingredient safety. Mar. 11, 2025.
3 Hopkins A. What is GRAS? Environmental Working Group News Mar. 5, 2024.
4 Myers I. The EPA hasn’t banned this brain-damaging pesticide, so states are stepping up. EWG Dec. 5, 2024.
5 Hobley N. EPA must reduce fluoride’s risks to children’s IQ. The Vaccine Reaction Oct. 15, 2024.
6 U.S. Food & Drug Administration. Common ingredients in FDA-approved vaccines.
One Response
This action has more implications than many realize. The new head, Mr Kennedy, he gave everyone a black eye by finally admitting the regulatory system is a sham, a complete and utter illusion, a system incapable of regulating anything or anyone. We aware consumers told everyone; Read the labels! For the past three decades. We have systematically dropped every label and every brand which engaged in these harmful practices for decades, and still could not keep up with the pace of corporate consolidation, company buy outs, and new dangerous adulterated ingredient additions.
That’s why many consumers adopted standard rules of thumb which protect us far better than ‘the government’. Insist on the organic label. Insist on the Non GMO verified groups official label on the package. Never buy anything with contains a bio engineered ingredient on the package. And go to websites like The Cornicopia institute and review their product score cards so at least your essential foods like milk eggs, some wheat and yogurt products, are safe and rest assured you’re paying money into responsible stewards of the food production system and the land, rather than these monolithic corporations whom answer to share holders and never have customers best interests in mind. The entire process is never ending exploitation.
Our pioneer farmers and old fashioned at home cooking experts dealing with something as simple as an apple pie and crust with locally sourced ingredients would have a heart attack and die on the spot if they observed how utterly incompetent and mis managed American food systems have become today. The American consumer whom wants to protect themselves from adulterated foods simply can not rely on the government. Although these are positive events, the system is not going to miraculously divest from a centralized model or make voluntary corrections which cut into the bottom line.
Only you the consumer can drive these changes, by constantly researching labels, ingredients, and company structures to stay aware if buy outs or consolidation happens. It’s pretty darn difficult to support a decentralized model these days, but we can still try. Vote with your wallet. It’s always been the most important vote you’ll ever cast, and you do so daily with wise product purchases. What gets me is anyone is still buying these major brands whom have engaged in these practices for decades. Dare to look, you can not unlearn what you see. Stories like this are why we shop at Natural Grocers store for many staple products. They have dedicated teams which test foods and pull them right off the shelf if these sorts of adulterated ingredients are present. Support the good guys.
Get used to paying a lot more for food, but it’s worth every effort in the end. Non adulterated food is more nutrient rich, tastes better, and you can consume the product without being worried you are nothing more than a lab rat science experiment as they test how much toxin you can consume before falling victim to the reactive health care model, then bleed you dry with medical care costs. Get the plastics out of your life as well.