More than 100 substances widely used in common foods, supplements and beverages in the U.S. have not undergone any health and safety review by the U.S. Food and Drug Administration, according to a new analysis of federal records.
A review of FDA records by the nonprofit Environmental Working Group (EWG) reveals that various food pyramid products, such as Capri Sun beverages, Kettle and Fire organic broth, Acme smoked fish, and Quaker Oats snack bars, use a variety of substances that have not been reviewed by regulators.
Companies are using the Generally Recognized as Safe (GRAS) rule that was developed in 1958 to allow the use of ingredients like salt or white vinegar without an onerous and unnecessary review process.
But companies are increasingly exploiting the rule and sending new potentially dangerous chemicals or substances into the food system without scrutiny, the EWG found. Some of these have caused health problems. As of 2022, foods 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 to all Americans who assume the FDA is reviewing the safety of chemicals in their food,” said Melanie Benesh, report co-author and EWG vice president of government affairs.
“Instead, food and chemical companies are exploiting a loophole to keep the government and public in the dark,” Benesh said.
The investigation found 111 substances of unknown safety, and the number is likely higher, although the lack of a safety review does not necessarily mean that 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 way some chemicals are approved. Food dyes or chemicals added to packaging, for example, may enter the food system via a different route and are not included in the report.
GRAS requires companies to demonstrate that a new food ingredient is safe by providing widely accepted and publicly available scientific evidence. Notifying the FDA of that safety data ensures regulatory compliance, the EWG wrote, but it is also voluntary: Manufacturers can legally self-determine that their products are 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.
The companies do not report which products the substances are used in, so the investigation cross-referenced its findings with the US Department of Agriculture’s FoodData Central database, which provides public information on the ingredients of about 4,000 products.
The database showed 49 of the 111 substances that were not reported. Among them are many that are known to be potentially dangerous, such as aloe vera extract, which is linked to cancer if ingested and is banned in some medications due to its toxicity.
The research found 22 extracts, including mushrooms, green tea, cinnamon and cocoa. While these ingredients seem nondescript and suggest additional 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 co-author of the report.
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, what you really need is someone who understands the science to ask questions and make sure it’s safe before the food goes on the market,” Benesh said.
Compounds called catechins found in green tea leaves have been linked to lower rates of cancer and other health benefits. But the purified extract form, identified in more than 900 products, has been linked to heart and brain defects, fetal leukemia, estrogen suppression, and liver, kidney and intestinal toxicity.
Mushrooms are considered an important source of nutrients, but some mushroom extracts are linked to liver inflammation. The report found 428 products that used one type of mushroom extract. In 2024, the FDA told companies to stop using a strain of mushroom extract that caused hallucinations and other nervous system problems in people, but is still available in supplements.
The report noted how cola manufacturers used GRAS for caffeine, but in the early 2000s, it was added to high-alcohol drinks, such as Four Loko. After a series of injuries and one death, the FDA effectively banned caffeine in alcoholic beverages in 2010.
“This is not a theoretical exercise; it has real-life consequences,” Maffini said.
Robert F Kennedy Jr, the US secretary of health and human services, whose “Make America Healthy Again” movement advocates for fewer chemicals in the food system, has said he would close the GRAS loophole but instead proposes weaker action.
The substances identified by the “stunning” EWG report likely “represent just the tip of an iceberg undermining our health,” said Tom Neltner, executive director of the nonprofit Unleaded Kids. He previously worked on GRAS and other FDA food safety regulations.
“The FDA, not industry, needs to review the safety of new food chemicals,” Neltner said in an email. “We need Kennedy to make good on his promise to close a loophole that undermines the integrity of our food supply.”
