A new analysis of federal records has revealed that more than 100 substances commonly used in foods, supplements and beverages in the United States were never reviewed for health and safety by the US Food and Drug Administration (FDA).
The investigation, conducted by the non-profit Environmental Working Group (EWG), examined FDA records and found that a wide range of popular products across the food market contain substances that regulators have not formally evaluated. Items identified in the review include Capri Sun drinks, Kettle and Fire organic broth, Acme smoked fish and Quaker Oats snack bars.
Many of these substances have entered the food system through the “generally recognized as safe” (GRAS) rule. The regulation, introduced in 1958, was designed to allow widely accepted ingredients such as salt or white vinegar to be used without requiring a lengthy regulatory review.
However, according to EWG, companies are increasingly taking advantage of the rule to introduce new chemicals or substances into food products without undergoing a formal safety assessment. Some of these ingredients have been linked to health concerns. In 2022, food products made with the GRAS ingredient tara flour were believed to have caused more than 300 illnesses and 113 hospitalizations.
“The report is ‘a wake-up call for every American who assumes the FDA is reviewing the safety of chemicals in their food’,” said Melanie Benesh, a report co-author and EWG’s vice president for government affairs.
“Instead, food and chemical companies are exploiting a loophole to keep both the government and the public in the dark,” Benesh said.
The investigation identified 111 substances whose safety has not been evaluated by the FDA, though researchers note the true number could be higher. The absence of a safety review does not automatically mean the ingredients are harmful, but it does raise concerns about oversight. According to federal records examined by EWG, the substances are used in products sold by well-known brands such as Trader Joe’s, Whole Foods, PepsiCo and Casita.
GRAS is not the only pathway through which substances can be approved for use in the food supply. Other additives, including food colorings or chemicals used in packaging, may be introduced through different regulatory channels and were not included in the report.
Under the GRAS framework, companies are expected to demonstrate that a new food ingredient is safe using widely accepted scientific evidence that is publicly available. Informing the FDA of the safety data ensures regulatory compliance, EWG said, but this step is voluntary. Manufacturers can legally determine on their own that an ingredient is safe without formally notifying the agency.
Benesh said some companies stretch the definition of “widely accepted” science by submitting limited evidence or relying on evaluations from small groups of scientists selected by the companies themselves.
Because manufacturers are not required to disclose which products contain these substances, researchers compared their findings with the US Department of Agriculture’s FoodData Central database. The database provides ingredient information for roughly 4,000 food products.
The comparison showed that 49 of the 111 substances had not been reported in the database. Among them were ingredients considered potentially risky, including aloe vera extract, which has been linked to cancer when ingested and is banned in certain medicines due to its toxicity.
The report also identified 22 plant-based extracts, including those derived from mushroom, green tea, cinnamon and cocoa. While these ingredients may appear harmless and even nutritious, the extraction process alters their chemical composition. According to Maricel Maffini, an independent food safety consultant and co-author of the report, the resulting substances often do not provide the same nutritional benefits and their effects on the body may be unclear.
Benesh also pointed out that some extracts could be produced using toxic solvents such as benzene or methyl chloride, raising further concerns about safety oversight.
“From a regulatory standpoint, you really want someone who understands the science to ask questions and make sure it’s safe before the food goes to market,” Benesh said.
One example highlighted in the report involves catechins, compounds naturally found in green tea leaves and often associated with lower cancer risk and other health benefits. However, when used as purified extracts — found in more than 900 products — they have been linked to heart and brain defects, fetal leukemia, suppression of estrogen, and liver, kidney and intestinal toxicity.
Similarly, mushrooms are widely regarded as nutrient-rich foods, but certain mushroom extracts have been connected to liver inflammation. The report identified 428 products containing one type of mushroom extract. In 2024, the FDA instructed companies to stop using a particular mushroom extract strain after it caused hallucinations and other nervous system issues, though it remains available in some supplements.
The report also cited a past example involving caffeine. Cola manufacturers originally used GRAS status to add caffeine to soft drinks, but in the early 2000s it began appearing in highly alcoholic beverages such as Four Loko. Following a series of injuries and a death, the FDA effectively banned caffeine in alcoholic drinks in 2010.
“This is not a theoretical exercise – this has real life consequences,” Maffini said.
Robert F Kennedy Jr, the US health and human services secretary, whose “make America healthy again” movement calls for reducing chemicals in the food system, has previously said he would close the GRAS loophole. However, critics say the action currently being proposed is weaker than a full closure.
Tom Neltner, executive director of the Unleaded Kids non-profit and a former researcher on GRAS and FDA food safety rules, said the findings highlight a much larger problem.
“The substances the ‘impressive’ EWG report identified likely ‘represent only the tip of an iceberg that undermines our health’,” Neltner said.
“FDA – not industry – needs to be reviewing novel food chemicals for safety,” Neltner said in an email. “We need Kennedy to fulfill his promise to close a loophole that undermines the integrity of our food supply.”
