More than 100 substances widely used in common US foods, supplements and beverages underwent no health and safety review by the US Food and Drug Administration, a new analysis of federal records finds.
The review of FDA records by the Environmental Working Group (EWG) non-profit reveals that diverse products across the food pyramid, such as Capri Sun drinks, Kettle and Fire organic broth, Acme smoked fish, and Quaker Oats snack bars, use a range of substances that have not undergone review by regulators.
Companies are using the generally recognized as safe (GRAS) rule that was developed in 1958 to allow ingredients such as salt or white vinegar to be used without a burdensome and needless review process.
But companies are increasingly exploiting the rule and sending potentially dangerous new chemicals or substances into the food system without scrutiny, EWG found. Some of these have caused health problems. In 2022, food made with the GRAS ingredient tara flour was believed to have caused over 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 found 111 substances of unknown safety, and the figure is likely higher, though the lack of a safety review does not necessarily mean an ingredient is dangerous The substances are used by popular brands such as Trader Joe’s, Whole Foods, PepsiCo and Casita, federal records reviewed by EWG show.
GRAS is not the only route by which some chemicals are approved. Food colorings or chemicals added to packaging, for example, can be introduced to the food system via a different route, and those are not included in the report.
GRAS requires companies to demonstrate a new food ingredient is safe by providing widely accepted scientific evidence that’s publicly available. Notifying the FDA of that safety data ensures regulatory compliance, EWG wrote, but it is also voluntary – manufacturers can legally self-determine their products to be safe.
Meanwhile, some companies push the boundaries of what is “widely accepted” science and provide limited data or reviews from a small number of scientists convened by the companies, Benesh said.
Companies do not report which products the substances are used in, so the investigation cross-checked their findings with the US Department of Agriculture’s FoodData Central database, which provides public ingredient information for about 4,000 products.
The database showed 49 out of the 111 substances that were not reported. Among those are many known to be potentially dangerous, such as aloe vera extract, which is linked to cancer if ingested and is banned in some medicines over its toxicity.
The investigation turned up 22 extracts, including that from mushroom, green tea, cinnamon and cocoa. While these ingredients appear anodyne and suggest added nutrition, extraction changes the chemical composition. The substances do not carry the same nutritional benefit and the impact on the body is often unknown, said Maricel Maffini, an independent food safety consultant and report co-author.
Benesh noted that the extract could be obtained with a toxic medium, such as benzene or methyl chloride, and the situation presents “complex questions” that are not always answered in GRAS.
“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.
Compounds called catechins found in green tea leaves have been linked to lower cancer rates and other health benefits. But the purified extract form, identified in over 900 products, has been linked to heart and brain defects, fetal leukemia, suppression of estrogen, and liver, kidney and intestinal toxicity.
Mushrooms are considered a strong source of nutrients, but some mushroom extract is linked to liver inflammation. The report found 428 products that used one type of mushroom extract. The FDA in 2024 told companies to stop using a strain of mushroom extract that was causing people to hallucinate and have other nervous system problems, but it remains available in supplements.
The report noted how cola makers used GRAS for caffeine, but in the early 2000s, it was added to highly alcoholic beverages, like Four Loko. After a rash 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 advocates for fewer chemicals in the food system, has said he would close the GRAS loophole, but is instead proposing a weaker action.
The substances the “impressive” EWG report identified likely “represent only the tip of an iceberg that undermines our health”, said Tom Neltner, executive director of the Unleaded Kids non-profit. He previously did work around GRAS and other FDA food safety rules.
“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.”
